Effect of an Innovative Online Ayurveda Program for Detox and Lifestyle on Mental and Physical Health in Home-Based Adults: A Pilot Study

Abstract

Background and Objective:

Mental health complaints have significantly increased in Europe over recent years. This study evaluated the effects and safety of a 4-month online, multimodal, complementary intervention on the mental and physical health of home-based adults.

Method:

Ninety-eight home-based adults with mild to severe mental health and related physical symptoms were recruited across Europe through digital advertisements. This single-arm repeated-measures study utilized three individualized treatment groups to evaluate the impact of the Ayurveda Program for Detox and Lifestyle. The online program included a personalized Ayurveda diet, daily routine, yoga exercise, herbal detoxification procedures, and herbal preparations. Standardized online tests were administered monthly for 4 months to assess anxiety, depression, physical symptoms (Patient Health Questionnaire for Somatic, Anxiety, and Depressive Symptoms), fatigue (PROMIS), and body mass index (BMI).

Results:

The study population was predominantly female (85%), with a mean age of 58 years. By the end of the fourth month, primary outcomes indicated a significant decrease in anxiety (55%, p < 0.001) and depression symptoms (45%, p < 0.001). The secondary outcomes showed a significant reduction in physical symptoms, including musculoskeletal, neurological, and digestive issues (42%, p < 0.001); fatigue (31%, p < 0.001); and BMI (2%, p < 0.001). Improvements were consistent across all treatment groups, with no significant differences observed. The intervention was feasible and generally safe, with 91% retention, 70% compliance, and 6% adverse effects.

Conclusion:

The initial results suggest that the Ayurveda Program for Detox and Lifestyle is safe and is associated with significant improvements in the mental and physical health of participants. This trial highlights the potential benefits of integrating complementary lifestyle protocols into standard primary and mental health care practices. Future randomized controlled trials are recommended to control for confounding factors and validate these findings in larger clinical populations.

Introduction

Mental health problems significantly impair cognitive, social, and physical functioning.¹ Research from 2015 to 2019 indicates that in Europe, approximately 11% of adults reported psychological symptoms, 14% experienced anxiety disorders, and 12% suffered from depressive disorders.^2,3 These issues are linked to an increased risk of chronic diseases and suicide, accounting for 15% of all years lived with disability and resulting in 119,000 lost lives in Europe in 2019.^4

–8 During the COVID-19 pandemic, the prevalence of psychological symptoms, depression, and anxiety surged to as high as 31%.^9,10 Despite advancements in treatments, mental health problems and their associated health care costs remain a significant public health concern, with annual costs in the EU exceeding 600 billion EUR, representing more than 4% of the GDP.^8,11

As reported by the World Health Organization (WHO), approximately 65% of the population in developed countries and more than 80% in developing countries use Complementary and Alternative Medicine (CAM) therapies for chronic and treatment-resistant conditions such as anxiety, depression, headaches, and back pain. The WHO recognizes Ayurveda as a CAM system for prevention, diagnosis, and treatment of physical and mental illnesses.¹²

Research indicates that unhealthy diet and sleep habits, sedentary lifestyle, and stress contribute to psychological and physiological disorders.^13
–15 Prior studies targeting these risk factors have shown that CAM can effectively decrease mental and physical health symptoms.^16

–20 However, most CAM trials have focused on single-treatment methods. Few studies have investigated the effects of traditional whole-system (WS) and multimodal CAM interventions that simultaneously address multiple risk factors. Therefore, the overall objective of this study was to evaluate the effects and safety of a comprehensive online Ayurveda WS intervention on the mental and physical health of home-based adults, before conducting a larger, definitive trial.

Methods

Study design

The study employed a single-arm repeated-measures design with three individualized treatment groups to enhance the precision of the effects of a 4-month online Ayurveda program. The treatment protocols were designed according to individual psychophysiological principles (Doshas) in Ayurveda. Participants were allocated into three treatment groups based on the Ayurveda Dosha Self-Assessment: Vāta (n = 32), Pitta (n = 42), or Kapha (n = 24).²¹ By incorporating personalized protocols, the study facilitates the evaluation of the intervention’s effects across various psychophysiological constitutions.

In phase 2 trials, disease response and safety are the primary endpoints, providing direct insights into the treatment’s effects and safety.²² A total of 98 home-based adults were assessed for anxiety, depression, physical symptoms, fatigue, body mass index (BMI), compliance, and side effects every month for 4 months. In the repeated-measures design, subjects serve as their own controls, increasing sensitivity to changes and reducing variability.²³

The experiment was conducted in two stages with different participants to ensure the reliability of the results. The first stage, conducted in English with 51 European subjects (March–June 2021), gathered preliminary data. The second stage, in German with 47 European subjects (March–June 2022), confirmed initial findings and assessed generalizability across languages and cultures. The pilot trial concluded within the planned 4 months as all primary objectives were achieved. The study followed the CONSORT guidelines for pilot trials.²⁴ Interim analyses were conducted after the first month, examining anxiety, depression, and side effects. Stopping guidelines included halting the trial if any participant experienced a severe adverse event or a significant increase in adverse reactions.

Prespecified criteria for determining the feasibility of a future definitive trial included:

At least 70% of participants adhere to the intervention and complete the study.

A statistically significant reduction in anxiety and depression scores, as measured by validated scales.

No serious adverse events related to the intervention.

Procedure

The Center for Maharishi AyurVeda and Holistic Medicine in Austria recruited home-based adults across Europe through digital advertisements to enhance generalizability. Recruitment occurred in two phases: December–March 2021 and December–March 2022. Data were collected through an online survey at baseline and then monthly over 4 months to minimize observer bias. The protocol was approved by the Institutional Review Board of Maharishi International University, Fairfield, IA (Approval No. IRB-MIU-PH-2020-1008, Date: December 04, 2020). The study was registered at ClinicalTrials.gov (NCT06551467). All participants provided electronic informed consent before inclusion.

Participants

Baseline data were collected through an online survey, which also screened for suicidal ideation and health conditions. Participants with potential contraindications underwent teleconference interviews with Ayurveda-trained medical doctors to assess their suitability. Eligible home-based adults had mild to severe anxiety, depression, or physical symptoms. Table 1 outlines the inclusion and exclusion criteria.

Table 1.

Inclusion and Exclusion Criteria

Criterion	Inclusion criteria	Exclusion criteria
Anxiety Symptoms	Scored ≥5 on the GAD-7	Scored <5 on the GAD-7
Depression Symptoms	Scored ≥5 on the PHQ-9	Scored <5 on the PHQ-9
Physical Symptoms	Scored ≥5 on the PHQ-15	Scored <5 on the PHQ-15
Age	Age 18–80 years	Age under 18 or over 80 years
Psychiatric Disorders	No other psychiatric disorders	Other psychiatric disorders (e.g., suicidal risk)
Treatments	Not receiving specialized treatments for anxiety or depression, nor participating in another clinical trial.	Currently undergoing specialized treatments for anxiety and depression, or participating in another clinical trial.
Psychiatric Medication	Stable psychiatric medication regimen for more than 2 months	Psychiatric medication regimen for less than 2 months
Medical Condition	No acute or severe medical conditions	Acute or severe medical condition (e.g., stroke, surgery)
Medical Situations	Individuals who are not pregnant or breastfeeding	Individuals who are pregnant or breastfeeding
Informed Consent	Provided informed consent.	Inability to provide informed consent.

The table provides a detailed explanation of the criteria used to include or exclude participants from the study.

Participants continued their standard medical care for existing or new health conditions during the study. Six participants on psychiatric medication had been on a stable regimen for at least 3 months before enrollment.

Outcomes

The primary outcomes were a reduction in anxiety and depression, while the secondary outcomes included physical symptoms, fatigue, and BMI. Anxiety, depression, and physical symptoms were assessed using the Patient Health Questionnaire for Somatic, Anxiety, and Depressive Symptoms (PHQ-SADS), which combines the GAD-7 (for anxiety),²⁵ PHQ-9 (for depression),²⁶ and PHQ-15 (for physical symptoms).²⁷ Physical symptoms assessed included the most prevalent musculoskeletal, neurological, and digestive symptoms in primary care. Higher scores on these scales indicate greater severity of symptoms, with cut-off points at 5 for mild, 10 for moderate, and 15 for severe symptoms. Studies have confirmed the validity and reliability of the PHQ-SADS in clinical and nonclinical samples.²⁸ The minimal clinically important difference (MCID) is 4 points or 50% change for GAD-7;²⁵ 5 points or 50% for PHQ-9;²⁹ and 2–3 points for PHQ-15.³⁰

Fatigue was assessed using the PROMIS Fatigue Short Form (8a), where higher scores indicate greater fatigue. Scores of 22, 26, and 36 correspond to mild, moderate, and severe fatigue, respectively.³¹ Validation studies confirm the questionnaire’s reliability across various populations, with a minimally important difference of approximately 3–5 points.^32,33 Participants reported their height and weight, and BMI was calculated using a standardized formula.

An Ayurveda Self-Assessment questionnaire determined individual physiological constitution and imbalances.²¹ Compliance, facilitators, barriers, and side effects related to the intervention were monitored using a self-report questionnaire over 4 months. Demographic data and potential confounders were collected through an online survey. This study adhered to WS's research criteria, employing a variety of psychological and physiological outcome measures.³⁴ To minimize bias and improve validity:

Participants were recruited from diverse sources.

Scientifically validated questionnaires were used.

Anonymous online survey completion was ensured.

Participants were instructed to report measurements immediately.

The online survey included additional wellness questions, keeping participants unaware of the study’s focus on specific conditions, potentially reducing placebo effects.¹⁷

Interventions

The Online Ayurveda Program for Detox and Lifestyle is easily replicable and includes personalized herbal remedies (Dravyaguna), detoxification procedures (Shodhana), dietary guidelines (Ahara Vidhi), and daily routine practices (Dinacharya), all based on traditional Ayurvedic medicine principles.^35
–37 While clinical studies on Ayurveda multimodality treatments for anxiety and depression are scarce, some studies have shown significant improvements in mental and physical health, emphasizing the need for further research.^{18,38

–43}

According to Ayurveda texts, three fundamental principles—the three Doshas: Vāta, Pitta, and Kapha—govern all cognitive and physical functions. The intervention aimed to restore and maintain health by considering individual psychophysiological constitution (Prakriti), imbalances (Vikriti), and lifestyle factors.³⁷ Home-based adults received personalized Dosha-specific (Vāta, Pitta, or Kapha) treatment protocols and herbal compounds based on their Dosha Self-Assessment questionnaire, which were sent by the Center for Maharishi AyurVeda and Holistic Medicine in Austria (see Table 2).

Table 2.

Treatment Protocol

PART 1: 7-DAY HERBAL DETOX PREPARATORY PHASE (PURVA KARMA)
This phase prepares the body for the main treatments through herbal preparations, oleation, and sweating therapies: 1. Herbal Preparations (Vati or Gutika): The intake of preparations is designed according to the biorhythm of the Doshas: • Morning (Kapha period): 2–3 tablets of MA1010 (Toxin-Ama Cleanse), a Kapha-balancing herbal preparation. • Midday (Pitta period): 2–3 tablets of MA579 (Liver Rasayana), a Pitta-balancing herbal preparation. • Evening (Vata period): Before dinner, 2–3 tablets of MA2 (Urinary Tract Rasayana), a herbal preparation that balances Apana Vata, which controls the functions of the large intestine, urinary system, and reproductive organs. • Bedtime: 1–2 tablets of MA505 (Triphala Plus) to support liver function and intestinal elimination overnight. Warm water is used as a carrier (Anupanam) for all herbal medicines. 2. Oiling (Snehana): • Internal Oleation (Abhyantara Snehana): Over a 3-day period, 30 mL of ghee (clarified butter) is incorporated into lunch to help loosen toxins and prepare them for elimination. • External Oleation (Bahya Snehana): Perform self-oil massage (Abhyanga). If Abhyanga is contraindicated due to high toxicity (Ama), Ayurvedic doctors may advise Garshana (dry massage) or skip the oleation treatment. 3. Sweating (Swedana): Fomentation therapy with a hot bath or shower after the internal oleation days to further loosen toxins and facilitate their movement towards the gastrointestinal tract for elimination.
Therapy enhancing digestion and metabolism (Pachana Karma)
Pachana Karma: Preparatory Therapy • Objective: To balance the digestive fire (Agni) and eliminate toxins (Ama), enhancing overall health. • Therapy: Dosha-specific herbs, dietary modifications, and lifestyle practices to prepare the body for intensive purification treatments. • Dietary Modifications: A light vegetarian diet with no raw food, three meals a day, and no snacking is recommended.
The Vāta protocol: • MA 927 (Herbal Digest): 1–2 tablets after meals • Spice Mixture (Vāta Churna): During meals • Vāta Tea: Throughout the day	The Pitta protocol: • Pitta Digestive Tea Blend: After meals • Spice Mixture (Pitta Churna): During meals • Pitta Tea: Throughout the day	The Kapha protocol: • Kapha Digestive Tea Blend: After meals • Spice Mixture (Kapha Churna): During meals • Kapha Tea: Throughout the day
PART 2: 3-DAY HERBAL DETOX MAIN TREATMENT (PRADHANA KARMA)
Gastrointestinal Elimination Therapy Protocol Day 8: • Therapy: Introduction of gastrointestinal elimination therapy (Virechana) using Ricinus communis L. in the morning. • Purpose: To cleanse the body of toxins, and remove excess Doshas and toxins from the small and large intestines and liver. • Instructions: Participants, regardless of individual constitution, are instructed to adjust the amount of castor oil based on their BMI, strength, age, and bowel movement consistency, with a range of 5–30 mL for those up to 70. • Diet: A special diet of Kanji (rice soup) as needed is recommended. • Activity: No exercise. Day 9: • Diet: Kitchari made from rice and mung beans or red lentils is recommended. Day 10: • Diet: A light, Dosha-specific vegetarian diet is recommended, with a gradual increase in food intake as appetite and digestion improve. • Activity: Only light walking if desired.

HERBAL COMPOUNDS
Herbal Compound	Main Ingredients	Indications
MA 927 (Herbal Digest)	Saccharum officinarum L., Carum carvi L., Punica granatum L., Cuminum cyminum L., Piper longum L., Zingiber officinale Roscoe, Piper nigrum L., Elettaria cardamomum (L.) Maton	Strengthening digestion and assimilation; recommended for Vāta predominant digestion.
Pitta Digestive Tea Blend	Cuminum cyminum, Foeniculum vulgare, Glycyrrhiza glabra, Coriandrum sativum	Strengthening digestion, recommended for Pitta predominant digestion.
Kapha Digestive Tea Blend	Cuminum cyminum, Coriandrum sativum, Zingiber officinale, Piper nigrum, Trigonella foenum-graecum	Strengthening the digestive power, it is recommended for Kapha predominant digestion.
MA 505 (The Microbiome Balancer, Triphala)	Terminalia chebula, Emblica officinalis, Terminalia belerica, Rosa centifolia	Supports immunity, digestion, and intestinal motility; recommended for all three Dosha-specific constitutions
MA 2 (Genitrac)	Pedalium murex, Emblica officinalis, Tinospora cordifolia	Supports genitourinary function and healthy kidneys; helps flush toxins.
MA 579 (Liver Balance)	Boerhavia diffusa, Azadirachta indica, Trichosanthes dioica, Zingiber officinale, Tinospora cordifolia, Picrorhiza kurroa, Cedrus deodara, Terminalia chebula, Crateva religiosa, Moringa oleifera, Berberis aristata, Phyllanthus niruri	Supports liver functioning; recommended for all three Dosha-specific constitutions.
MA 1010 (Elim-Tox)	Tribulus terrestris, Tinospora cordifolia, Hemidesmus indicus, Glycyrrhiza glabra, Rosa centifolia, Andrographis paniculata, Berberis aristata, Cyperus rotundus, Sphaeranthus indicus, Embelia ribes	Helps detoxify the gastrointestinal tract, especially the colon; recommended for all three Dosha-specific constitutions.
Vāta Churna (Spice mixture)	Cuminum cyminum, Zingiber officinale, Curcuma longa, Saccharum officinarum, Trigonella foenum-graecum, Ferula assa-foetida, Himalayan salt	Improves digestion; recommended for Vāta predominant digestion.
Pitta Churna (Spice mixture)	Coriandrum sativum, Foeniculum vulgare, Cuminum cyminum, Saccharum officinarum, Elettaria cardamomum, Zingiber officinale, Curcuma longa, Cinnamomum verum, Himalayan salt	Enhance digestion; recommended for Pitta predominant digestion.
Kapha Churna (Spice mixture)	Zingiber officinale, Coriandrum sativum, Piper nigrum, Saccharum officinarum, Curcuma longa, Cinnamomum verum, Himalayan salt	It stimulates digestion; it is recommended for Kapha predominant digestion.
Vāta Tea	Glycyrrhiza glabra, Elettaria cardamomum, Zingiber officinale, Cinnamomum verum. Those with hypertension are advised to moderate Glycyrrhiza glabra consumption.	It has a soothing and warming effect for Vāta Dosha. Vāta tea is particularly soothing at times of demanding mental work.
Pitta Tea	Elettaria cardamomum, Glycyrrhiza glabra, Zingiber officinale, Rosa centifolia, Cinnamomum verum	It has a soothing and cooling effect on Pitta Dosha.
Kapha Tea	Zingiber officinale, Syzygium aromaticum, Piper nigrum, Elettaria cardamomum, Curcuma longa, Crocus sativus	It has a soothing, warming, effect on Kapha Dosha.

PART 3: POST-DETOX TREATMENT (PASCHAT KARMA) UP TO 4 MONTHS
Rejuvenation and Restoration Phase • Objective: To bring the body back to a balanced state through individualized Dosha-specific dietary and lifestyle modifications. • Dietary Recommendations: • Oils or Ghee: Included in the daily diet in regulated doses to pacify the Doshas (Shamana Snehana). • Herbal Rejuvenation (Rasayana Therapy): Supports the body’s recovery, enhances vitality, and promotes overall rejuvenation. • Herbal Food Supplements: Recommended to balance Doshas or address specific symptoms. • Spice Mixtures and Teas: Continued use of individualized Dosha-specific spice mixtures and teas.

PART 3: POST-DETOX TREATMENT (PASCHAT KARMA) UP TO 4 MONTHS

Rejuvenation and Restoration Phase
• Objective: To bring the body back to a balanced state through individualized Dosha-specific dietary and lifestyle modifications.
• Dietary Recommendations:
• Oils or Ghee: Included in the daily diet in regulated doses to pacify the Doshas (Shamana Snehana).
• Herbal Rejuvenation (Rasayana Therapy): Supports the body’s recovery, enhances vitality, and promotes overall rejuvenation.
• Herbal Food Supplements: Recommended to balance Doshas or address specific symptoms.
• Spice Mixtures and Teas: Continued use of individualized Dosha-specific spice mixtures and teas.

Personalized Herbal Therapy
The Vāta protocol: • Ashwagandha (Withania somnifera) or MA 1401 (Worry-Free): 1–2 tablets on an empty stomach, twice daily. • Alternative: MA 686 before bed. • MA 5: 1 tablet twice daily on an empty stomach, followed by 1 teaspoon of MA 4 after 30 min.	The Pitta protocol: • Amalaki (Emblica officinalis) or MA 1401 (Worry-Free): 1–2 tablets on an empty stomach, twice daily. • Alternative: MA 686 before bed. • MA 5: 1 tablet twice daily on an empty stomach, followed by 1 teaspoon of MA 4 after 30 min.	The Kapha protocol: • Triphala Guggulu: 1–2 tablets after food, twice daily. • MA 1402 (Blissful-Joy): 1–2 tablets on an empty stomach, twice daily. • MA 5: 1 tablet twice daily on an empty stomach, followed by 1 teaspoon of the sugar-free version of MA 4 after 30 min.

HERBAL COMPOUNDS
MA 1401 (Worry-Free)	Withania somnifera, Tinospora cordifolia, Bacopa monnieri, Nardostachys jatamansi, Convolvulus pluricaulis, Glycyrrhiza glabra, Alpinia galanga, Pearl pisti	Reduces worry and anxiety, calms emotions, nourishes the brain and nerves, supports clarity of mind; recommended for all three Dosha-specific constitutions.
MA 1402 (Blissful-Joy)	Terminalia arjuna, Withania somnifera, Emblica officinalis, Boerhavia diffusa, Convolvulus pluricaulis, Piper nigrum Long pepper, Piper longum, Zingiber officinale	Reduces low mood, uplifts emotions and relieves feelings of sadness and frustration; recommended for all three Dosha-specific constitutions.
MA 686	Withania somnifera, Asparagus racemosus	Reduces worry and anxiety, balances the hormonal system, improves sleep; recommended for all three Dosha-specific constitutions.
MA 5 (Maharishi Amrit Kalash)	Withania somnifera, Glycyrrhiza glabra, Ipomoea digitata, Asparagus adscendens, Emblica officinalis, Tinospora cordifolia, Asparagus racemosus, Vitex trifolia, Convolvulus pluricaulis	Reduces anxiety, depression, and improves cognitive functioning recommended for all three Dosha-specific constitutions.
MA 4 (Maharishi Amrit Kalash) A sugar-free version is also available.	Emblica officinalis, Honey, Terminalia chebula, Clarified butter (from cow’s milk), Cinnamomum zeylanicum, Elettaria cardamomum, Cyperus scariosus, Curcuma longa, Centella asiatica, Cyperus rotundus, Mesua ferrea	Eliminating free radicals, enhances coordination of mind and body, improves immunity, mental and physical health; recommended or all three Dosha-specific constitutions.
Ashwagandha	Withania somnifera	Reduces stress and anxiety, rejuvenates physiology, improves athletic performance, enhances memory, focus, and overall cognitive function, and improves sleep.
Amalaki	Emblica officinalis	Has anti-inflammatory and antioxidant properties, is a source of vitamin C, supports digestive health, alleviates heartburn and GERD symptoms, has anti-aging benefits, and promotes hair growth and skin health.
Triphala Guggulu	Balsamodendron mukul, Terminalia chebula, Terminalia belerica Emblica officinalis, Piper longum	Reduces overweight, high cholesterol, hemorrhoids, sciatica, sluggish bowel movements, etc. It can be recommended for Vāta and Kapha Dosha-specific constitutions. Additionally, it has antioxidant properties.

• Standardization and Certification: The study utilized standardized Maharishi Ayurveda Europe ISO-certified (ISO 9001:2008; ISO 22000:2005) and HACCP-standard (EC Regulation 852/2004) herbal compounds. Maharishi Ayurveda integrates traditional Ayurvedic practices with comprehensive psychological, physiological, and environmental modalities.
• Yoga Exercises: The protocol included Maharishi Yoga Asanas, twisting exercises, and breathing exercises. Maharishi Yoga Asanas consist of 18 specific sequences of yoga poses and alternate nostril breathing exercises (Anulom Vilom Pranayama), practiced effortlessly twice daily. The program encompasses various postures, including sitting, kneeling, standing, inverting, lying (both supine and prone), and balancing. It also includes all six spinal movements: axial extension (lengthening), flexion (bending forward), lateral flexion (bending sideways), extension (backward bending), and axial rotation (twisting). Developed by Jadranko Miklec, twisting exercises involve rotating the spine and torso to improve flexibility, strengthen the core, and enhance spinal health. These exercises also aid digestion and detoxification by stimulating internal organs.
• Personalized Ayurveda Nutritional Recommendations: The protocol incorporated healthy eating practices, focusing on food quality, quantity, and timing. Ayurveda Dosha-specific dietary guidelines for Vāta, Pitta, or Kapha emphasized the importance of a freshly prepared diet rich in vegetables, grains, pulses, nuts, high-fiber foods, fruits, berries, and other sources of antioxidants, vitamins, and minerals. Each Dosha has specific dietary guidelines to balance its unique characteristics:
• Vāta Diet: Recommends warm, moist, and grounding foods such as cooked grains, root vegetables, legumes, dairy, and warming spices like ginger, cinnamon, asafetida, and cumin.
• Pitta Diet: Advises cooling, soothing, and hydrating foods such as fresh fruits, legumes, cabbages, dairy, and cooling spices like mint, cardamom, turmeric, coriander, and fennel.
• Kapha Diet: Emphasizes light, dry, and warming foods such as legumes, leafy greens, and stimulating spices like black pepper, ginger, and ajowan.

The table comprehensively explains the treatment protocol, detailing the specific doses and administration methods.

Two Ayurveda-trained medical doctors led the Ayurveda Program, which included eight interactive live webinars over ten days and a lifestyle program lasting up to 4 months. Each 1.5-hour webinar addressed the etiological factors contributing to mental and physical ill-health:

Sessions 1–2: Focused on digestion, nutrition, and an individualized, Dosha-specific healthy diet.

Sessions 3–4: Elaborated on individualized, Dosha-specific daily routines, oil massages (Abhyaṅga), yoga exercises, and behavioral recommendations.

Sessions 5–6: Explained individualized, Dosha-specific herbal detoxification procedures, gastrointestinal oleation, and elimination therapies (Snehana, Virechana).

Sessions 7–8: Reviewed treatments.^{35
–37,44,45}

During webinars, Ayurveda-trained doctors offered motivational coaching and personalized treatment adjustments. These sessions were as effective as daily doctor visits in a residential setting, providing a cost-effective alternative. After the ten-day detoxification, clients continued to follow diet and lifestyle recommendations, along with the herbal program for mental and physical health, for up to 4 months. During this period, participants were encouraged to contact leading medical doctors for guidance at all hours. All herbal preparations used in the intervention were mild in dose and impact to avoid unwanted reactions.

Statistical analysis

The primary and secondary outcomes were assessed using repeated-measures multivariate analysis of covariance (MANCOVA) with the intention-to-treat method in SPSS. The primary outcomes focused on the severity of anxiety and depression, with three Dosha-specific individualized treatment groups as between-factor groups. Repeated measures were conducted at baseline and at four monthly posttests. The secondary outcomes included physical symptoms, fatigue, and BMI. Covariates for both primary and secondary analyses included meditation practice, vitamin use at baseline, study year, and gender.

If significant interactions were observed, Bonferroni-adjusted simple main effects or ANOVA was conducted as follow-up analyses. The effect size was computed using Cohen’s d, defined as the difference in mean change scores divided by the sample standard deviation of the mean difference.⁴⁶

Based on preliminary data, power analysis indicated that for within-group analyses, eight subjects were needed to detect significant changes in anxiety [effect size (d = 1.22)] and 12 subjects for depression [effect size (d = 0.91)] with 80% power. For between-group analyses with three subgroups, approximately 36 subjects were required for anxiety and 120 participants for depression.

Results

The CONSORT Flow Diagram (Fig. 1) illustrates participant flow through the study phases.⁴⁷ Nine percent of the data were missing completely at random, confirmed by Little’s MCAR test, χ²(270) = 261.700, p = 0.630. Missing values were replaced using the expectation-maximization method in SPSS, enhancing accuracy and statistical power.

FIG. 1.

Adjusted CONSORT Flow Diagram. Adjusted Consolidated Standards of Reporting Trials Flow Diagram illustrates the flow of participants through the study phases.

Baseline demographics

Table 3 presents the baseline demographics of the 98 eligible participants, predominantly female (85%) with a mean age of 58 years.

Table 3.

Baseline Characteristics

Characteristic (n = 98)	Mean (SD), percentage
Gender
Male	14 (14%)
Female	84 (85%)
Other	0
Age	58.74 ± 10.78
Adults 20–39 yrs.	3 (3%)
Middle-Aged Adults 40–64 yrs.	66 (67%)
Senior-Aged Adults 65–80 yrs.	29 (29%)
Ethnicity
Asian	2 (2%)
Black	1 (1%)
White	95 (96%)
Other	0
Education
Post-Secondary Non-Tertiary Education	0
Short-Cycle Tertiary Education	31 (31%)
Bachelor’s or Equivalent	43 (43%)
Master’s or Equivalent	16 (16%)
Doctorate or Equivalent	8 (8%)
Employment Status
Student	0
Employed	72 (73%)
Unemployed	2 (2%)
Retired	24 (24%)
Location
Urban Area: Population >50,000	52 (53%)
Town: Population <50,000, >5000	14 (14%)
Rural Area, <5000	32 (32%)
Personal Development Techniques
Not Practicing Meditation	16 (16%)
Transcendental Meditation	63 (63%)
Other Forms of Meditation	20 (20%)
Anxiety Symptoms	5.90 ± 3.62
Minimal Symptoms, Cut Point <5	35 (35%),2.51 ± 1.27
Mild Symptoms, Cut Point >5	51 (52%), 6.59 ± 1.88
Moderate to Severe Symptoms Reaching Clinical Diagnoses, Cut Point >10	12 (12%), 12.83 ± 1.90
Depression Symptoms	6.61 ± 4.18
Minimal Symptoms, Cut Point <5	32 (32%), 2.63 ± 1.19
Mild Symptoms, Cut Point >5	43 (43%), 6.40 ± 1.78
Moderate to Severe Symptoms Reaching Clinical Diagnoses, Cut Point >10	23 (23%), 12.57 ± 2.55
Physical Symptoms	8.85 ± 3.70
Minimal Symptoms, Cut Point <5	10 (10%), 3.60 ± 1.08
Mild Symptoms, Cut Point >5	52 (53%), 7.12 ± 1.28
Moderate to Severe Symptoms Reaching Somatic Symptom Disorder (SSD), Cut Point >10	35 (35%), 12.81 ± 2.64
Symptom Dominance
Dominance of Anxiety	48 (48%)
Dominance of Depression	50 (50%)
Fatigue	20.28 ± 7.16
Minimal Fatigue, Cut Point <22	58 (58%)
Mild Fatigue, Cut Point >22	15 (15%)
Moderate to Severe Fatigue, Cut Point >26	24 (24%)
Height	167.41 ± 5.41
Weight, Kg	65.75 ± 11.38
Body Mass Index (BMI)	23.36 ± 3.65
BMI is Less Than 18.5 Underweight	9 (9%)
BMI is Less Than 18.5 to 24.9 Healthy Weight	62 (63%)
BMI is 25.0 to 29.9, Overweight	20 (20%)
BMI is 30.0 or Higher, Obese	7 (7%)
Participants on Antidepressants	6 (6%)
Ayurveda Dosha-Specific Physical Constitution
Vāta Dosha-Dominant Physical Constitution	32 (32%)
Pitta Dosha-Dominant Physical Constitution	42 (42%)
Kapha Dosha-Dominant Physical Constitution	24 (24%)
Study Groups
Ayurveda Program In 2021	51 (52%)
Ayurveda Program In 2022	47 (47%)
Compliance Groups
High Compliance (Score >, = 322)	53 (54%)
Medium Compliance (Score >166 < 322)	45 (46%)
Low Compliance (Score <166)	0

The table summarizes the baseline demographic and clinical characteristics of the 98 participants in the study.

Primary outcomes

The repeated-measures MANCOVA, adjusted for meditation, vitamin use, study year, and gender, revealed a significant main effect for anxiety and depression scores [Pillai’s trace = 0.195, F(8,84) = 2.547, p = 0.016, η² = 0.19]. There were no significant differences between the effects of Dosha-specific treatment groups [Pillai’s trace = 0.200, F(16,170) = 1.179, p = 0.290]. However, a significant interaction effect was found in the meditation groups [Pillai’s trace = 0.181, F(8,84) = 2.316, p = 0.027]. The ANOVA test did not confirm a significant interaction for anxiety [F(1,91) = 1.499, p = 0.224] or depression [F(1,91) = 0.176, p = 0.676]. Bonferroni-adjusted pairwise comparisons showed significant differences for each month compared to baseline (p < 0.001), with mean scores remaining stable throughout the 4-month follow-up period (Table 4 and Fig. 2)

FIG. 2.

Monthly Variations in Mean Anxiety and Depression Symptoms. The figure illustrates the monthly variations in anxiety and depression symptoms over 4 months among participants in the Ayurveda Program. The solid lines show trends in anxiety and depression symptoms, with error bars representing the standard deviation and 95% confidence intervals (CI). Each month showed a significant reduction in both anxiety and depression symptoms compared to baseline (p < 0.001). The Estimated Marginal Means (EMMs) reflect the average change scores for anxiety and depression, adjusted for study year, vitamin use, meditation, and gender.

Table 4.

Mean and Mean Change Scores of Primary Measures

Variable	Mean (x̄), SD and mean change ΔM 1M, SE, (95% CI)	Effect size (d)	Mean (x̄) and mean change ΔM 2M, SE, (95% CI)	Effect size (d)	Mean (x̄) and mean change ΔM 3M, SE, (95% CI)	Effect size (d)	Mean (x̄) and mean change ΔM 4M, SE, (95% CI)	Effect size (d)
Anxiety Symptoms	(x̄) = 2.66 ± 2.08, ΔM = 3.24 ± 0.30(2.39 to 4.08), p < 0.001	1.1054%	(x̄) = 3.01 ± 2.63, ΔM = 2.88 ± 0.25 (2.16 to 3.61), p < 0.001	1.1648%	(x̄) = 3.11 ± 3.04, ΔM = 2.79 ± 0.25 (2.07 to 3.50), p < 0.001	1.1347%	(x̄) = 2.62 ± 2.76, ΔM = 3.28 ± 0.25 (2.56 to 3.99), p < 0.001	1.3355%
Depression Symptoms	(x̄) = 3.35 ± 2.39, ΔM = 3.26 ± 0.32 (2.35 to 4.18), p < 0.001	1.0349%	(x̄) = 3.61 ± 2.96, ΔM = 3.00 ± 0.29 (2.17 to 3.83), p < 0.001	1.0545%	(x̄) = 3.77 ± 3.37, ΔM = 2.84 ± 0.31 (1.96 to 3.74), p < 0.001	0.9242%	(x̄) = 3.61 ± 3.21, ΔM = 3.00 ± 0.27 (2.23 to 3.78), p < 0.001	1.1145%

This table presents the mean and mean change scores of primary measures for each month over a 4-month period, including effect sizes and percentage changes compared to baseline.

Note: This table presents the mean scores (x̄) followed by standard deviations (SD), the mean difference (ΔM) with the standard error (SE), the 95% confidence interval (CI), and the effect size (d) for each month. The p-value indicates the statistical significance of the results. The M after the numbers (1M, 2M, etc.) denotes the month the measurements were taken. Effect sizes are followed by the percentage change (PC) compared to baseline.

Secondary outcomes

The repeated-measures MANCOVA, controlling for meditation, vitamin use, study year, and gender, revealed a significant main effect for all secondary outcomes [Pillai’s trace = 0.299, F(12,80) = 2.840, p = 0.003, η² = 0.29]. However, there were no significant differences between the Dosha-specific treatment groups [Pillai’s trace = 0.225, F(24,162) = 0.857, p = 0.660] or other interactions. A Bonferroni correction was applied to control for Type I error, setting the significance level at p < 0.01 for secondary analyses. Table 5 and Figure 3 illustrate the Bonferroni-adjusted significant mean differences for all secondary measures compared to the baseline (p < 0.001). These initial results were sustained over a 4-month follow-up period.

FIG. 3.

Monthly Trends in Secondary Measures. The figure presents the monthly trends in physical symptoms, fatigue, and body mass index (BMI) over 4 months among patients enrolled in the Ayurveda Program. The solid lines show trends in anxiety and depression symptoms, with error bars representing the standard deviation and 95% confidence intervals (CI). Each month showed a significant reduction in physical symptoms, fatigue, and BMI compared to baseline (p < 0.001). The Estimated Marginal Means represent the average levels of these secondary measures, adjusted for the effects of study year, vitamin use, meditation, and gender.

Table 5.

Mean and Mean Change Scores of Secondary Measures

Variable	Mean (x̄) and mean change ΔM 1M, SE, (95% CI)	Effect size (d)	Mean (x̄) and mean change ΔM 2M, SE, (95% CI)	Effect size (d)	Mean (x̄) and mean change ΔM 3M, SE, (95% CI)	Effect size (d)	Mean (x̄) and mean change ΔM 4M, SE, (95% CI)	Effect size (d)
Physical Symptoms	(x̄) = 5.78 ± 2.75, ΔM = 3.07 ± 0.33 (2.11 to 4.03), p < 0.001	0.9334%	(x̄) = 5.45 ± 2.94, ΔM = 3.39 ± 0.30(2.52 to 4.26), p < 0.001	1.1338%	(x̄) = 4.50 ± 2.61, ΔM = 4.34 ± 0.30 (3.46 to 5.22) p < 0.001	1.4349%	(x̄) = 5.12 ± 2.59, ΔM = 3.72 ± 0.32(2.80 to 4.64) p < 0.001	1.1742%
Fatigue	(x̄) = 13.16 ± 4.07, ΔM = 7.11 ± 0.61 (5.35 to 8.86), p < 0.001	1.1735%	(x̄) = 14.31 ± 5.29, ΔM = 5.97 ± 0.60 (4.24 to 7.69), p < 0.001	1.0029%	(x̄) = 13.87 ± 4.71, ΔM = 6.40 ± 0.64 (4.56 to 8.25), p < 0.001	1.0031%	(x̄) = 13.86 ± 4.98, ΔM = 6.42 ± 0.58 (4.74 to 8.08), p < 0.001	1.1131%
BMI	(x̄) = 22.96 ± 3.50, ΔM = 0.39 ± 0.04 (0.27 to 0.51), p < 0.001	0.971.71%	(x̄) = 22.91 ± 3.50, ΔM = 0.44 ± 0.05 (0.29 to 0.59), p < 0.001	0.851.93%	(x̄) = 22.88 ± 3.55, ΔM = 0.47 ± 0.09(0.19 to 0.76), p < 0.001	0.492.05%	(x̄) = 22.82 ± 3.45, ΔM = 0.53 ± 0.06(0.35 to 0.71), p < 0.001	0.852.31%

The table illustrates the monthly mean and mean change scores of secondary measures over a 4-month period, including effect sizes and percentage changes compared to baseline.

Tertiary analyses

A repeated-measures ANCOVA tested the mean differences in the severity groups for anxiety, depression, and physical symptoms. Levene’s test was insignificant for most months across all variables. The alpha level was set to 0.004 and 0.003 to account for multiple tests and potential violations of assumptions.

Anxiety symptom groups

The results of the repeated-measures ANCOVA, adjusted for meditation, vitamin use, study year, and gender, showed a significant main effect for anxiety [Huynh–Feldt F(4,333) = 17.449, p < 0.001, η² = 0.16]. Significant between-subjects effects for anxiety symptom groups were also observed F(2,91) = 67.210, p < 0.001, η² = 0.59. No other covariates or interactions were significant.

Figure 4 shows that the adjusted mean anxiety scores were highest in the moderate to severe anxiety symptoms group (Mean = 7.03, SE = ±0.45), followed by the mild symptoms group (Mean = 4.02, SE = ±0.21), and lowest in the minimal symptoms group (Mean = 1.41, SE = ±0.25). Bonferroni-adjusted pairwise comparisons revealed significant decreases in anxiety scores each month compared to baseline for the moderate to severe and mild symptoms groups (p < 0.001), and for the minimal symptoms group (p = 0.003 to p < 0.001). These improvements were maintained over the 4-month period.

FIG. 4.

Monthly Trends in Anxiety Symptom Severity Groups. The figure depicts the monthly trends in anxiety symptoms over a 4-month period across different severity groups (Minimal, Mild, and Moderate to Severe). The solid lines represent changes in anxiety symptoms for each group, with error bars indicating the standard deviation and 95% confidence intervals (CI). Each month showed a significant reduction in anxiety symptoms in each group compared to baseline. The Estimated Marginal Means reflect the average anxiety levels for each severity group, adjusted for study year, vitamin use, meditation, and gender. Covariates appearing in the model were evaluated at the following values: vitamins = 0.29, study year = 1.48, meditation = 1.04, and gender = 1.14.

Depression symptom groups

The repeated-measures ANCOVA, controlling for meditation, vitamin use, study year, and gender, revealed a significant main effect for depression, Huynh–Feldt F(4,363) = 10.464, p < 0.001, η² = 0.10. Significant between-subjects effects for depression symptom groups were also observed, F(1,91) = 66.712, p < 0.001, η² = 0.59. No other significant interactions were found.

Figure 5 shows the adjusted mean depression scores, highest in the moderate to severe depression symptoms group (Mean = 7.72, SE = ±0.38), followed by the mild symptoms group (Mean = 4.09, SE = ±0.27), and lowest in the minimal symptoms group (Mean = 1.78, SE = ±0.33). Bonferroni-adjusted pairwise comparisons indicated significant changes in depression scores each month compared to baseline for the moderate to severe and mild depression symptom groups (p < 0.001). Improvements remained constant over the 4-month period. However, depression scores in the minimal symptom group did not significantly decrease when correcting for the alpha level (reaching p = 0.003 in the fourth month).

FIG. 5.

Monthly Trends in Depression Symptom Severity Groups. The figure shows the monthly trends in depression symptoms over a 4-month period for different severity groups (Minimal, Mild, and Moderate to Severe). The solid lines illustrate the changes in depression symptoms for each group, with error bars indicating the standard deviation and 95% confidence intervals (CI). In the Mild and Moderate to Severe groups, there was a significant reduction in depression symptoms compared to baseline, whereas the Minimal symptom group did not show a statistically significant change. The EMMs indicate the average depression levels for each severity group, adjusted for study year, vitamin use, meditation, and gender. Covariates appearing in the model were evaluated at the following values: vitamins = 0.29, study year = 1.48, meditation = 1.04, and gender = 1.14.

Physical symptom groups

The repeated-measures ANCOVA, adjusting for meditation, vitamin use, study year, and gender, revealed a significant main effect for physical symptoms, Huynh–Feldt F(4,364) = 12.048, p < 0.002, η² = 0.04. Significant between-subjects effects for physical symptom groups were also observed, F(1,91) = 43.026, p < 0.001, η² = 0.48. No other significant interactions were found. Figure 6 indicates that the adjusted mean physical symptom scores were highest in the moderate to severe group (Mean = 8.01, SE = ± 0.29), followed by the mild group (Mean = 4.99, SE = ± 0.24), and lowest in the minimal group (Mean = 3.39, SE = ± 0.56).

FIG. 6.

Monthly Trends in Physical Symptom Severity Groups. The figure illustrates the monthly trends in physical symptoms over a 4-month period across different severity groups (Minimal, Mild, and Moderate to Severe). The solid lines represent the changes in physical symptoms for each group, with error bars showing the standard deviation and 95% confidence intervals (CI). Significant reductions in physical symptoms were observed in the Mild and Moderate to Severe groups compared to baseline, while the Minimal symptom group did not exhibit a statistically significant change. The EMMs reflect the average levels of physical symptoms for each severity group, adjusted for study year, vitamin use, meditation, and gender. Covariates appearing in the model were evaluated at the following values: vitamins = 0.29, study year = 1.48, meditation = 1.04, and gender = 1.14.

Bonferroni-adjusted pairwise comparisons indicated significant changes in the moderate to severe and mild physical symptom groups each month compared to baseline (p < 0.001), with mean scores remaining stable. The minimal symptom group did not show a significant decrease in physical symptoms over 4 months (p = 1.00).

Feasibility and safety results

Treatment compliance

The Treatment Compliance Questionnaire, developed for this study, included items on diet (14), lifestyle (9), and herbs (1). Patients rated their adherence to each treatment component on a 5-point scale over 4 months, with (5) indicating “daily use” and (0) “never.” Compliance was highest in the first month, with scores of 50.92 ± 9.71 (SD) for diet, 30.92 ± 6.09 (SD) for lifestyle, and 4.21 ± 1.34 (SD) for herbs. By the fourth month, compliance decreased to 47.57 ± 10.32 (SD) for diet (69%), 29.94 ± 6.53 (SD) for lifestyle (67%), and 3.84 ± 1.26 (SD) for herbs (77%).

Side effects, facilitators, and barriers to intervention implementation

Participants described and graded their side effects using a survey, rating them on a 4-point scale: mild, moderate, strong, or severe. They also described the facilitators and barriers to intervention implementation and acceptability. Table 6 provides a detailed summary of the feasibility and safety outcomes from the online survey.

Table 6.

Feasibility and Safety Results

Aspect	Successes	Challenges and recommendations
Recruitment	A total of 98 eligible participants were recruited.	The study aimed to recruit approximately 120 participants based on the power analysis. Future trials can improve feasibility by enhancing recruitment efforts, targeting specific demographics, increasing awareness about Ayurveda health benefits, and offering compensation or free health check-ups to encourage participation. Regularly monitoring recruitment progress and making necessary adjustments may enhance the study’s success.
Recruitment Time	Participants were enrolled over 3 months each year for two years.	The recruitment period was longer than expected. Future studies should apply diverse recruitment methods and extend the recruitment timeframe.
Recruitment Demographics	The study effectively recruited adults from diverse linguistic and cultural backgrounds to enhance the generalizability of the findings.	The sample had fewer male participants (14%) and non-meditating participants (16%), lower clinical symptom levels, and a higher mean age (58 years) than expected. Future studies should employ comprehensive recruitment strategies to enroll a sample size with diverse demographics.
Retention	The follow-up was effective, resulting in a high retention rate of 91%.	Regular reminders were needed each month to ensure effective collection of follow-up forms. Future studies could reduce the frequency of data collection to 3 time points instead of 5 to prevent participant fatigue.
Compliance	Compliance rates were high at 70%, and the intervention was feasible.	Regular coaching and support groups, along with checklists, should continue throughout the study. Additional reminders could be provided to increase compliance.
Cost	The study intervention is cost-effective, guiding participants with low-cost dietary and other health-related solutions.	Despite applying to several funding institutions, the study did not receive funding due to the prioritization of COVID-related research. Future studies should aim to secure funding to provide herbal compounds and offer compensation to encourage participation.
Logistics	63 percent of participants noted that the online materials and questionnaires were accessible, easy to use, and convenient. The study was supported by two experienced staff effectively managing data collection.	Seven percent of participants noted technical challenges in navigating online materials and questionnaires.Future studies could implement advanced participant management and data capture systems with automated reminders, shorten and simplify questionnaires, and use engaging formats like interactive surveys or visual aids to maintain interest and reduce participant burden.
Intervention Delivery	The intervention protocol and delivery were standardized, and dietary guidelines were customized to locally available foods, resulting in smooth delivery.	Participants expressed interest and preferences for regular coaching during the post-detox treatment phase: 21% wanted a Facebook support group, 15% preferred WhatsApp groups, 19% favored follow-up webinars, and 45% did not need support groups. Therefore, more Ayurvedic-trained medical doctors are needed to provide regular follow-up meetings and support groups throughout the study to maintain high satisfaction and smooth implementation.
Acceptability	Nearly all participants (96%) expressed satisfaction with the intervention, while 89% rated the structure and clarity of the protocols as very good or good. Additionally, 93% indicated they would recommend the webinar to others.	A small percentage of participants (4%) were not satisfied with the program, and 7% would not recommend it. Additionally, 11% suggested simplifying the protocols. Future studies could focus on simplifying and improving the structure and clarity of the treatment protocol to enhance its acceptability.
Facilitators and Barriers toIntervention Implementation	Out of the 98 participants, 83% (81 participants) experienced facilitating factors. Among these, 54% (44 participants) experienced internal facilitators, with 77% (34 participants) reporting benefits from treatments, 23% (10 participants) forming habits and routines, 11% (5 participants) having pre-existing knowledge of Ayurveda, and 5% (2 participants) noting a worsening of health if they did not follow the intervention. Additionally, 69% (56 participants) experienced external facilitators, with 82% (46 participants) citing a well-designed system of treatments, 25% (14 participants) benefiting from step-by-step guidance from Ayurveda doctors, and 20% (11 participants) perceiving social support.	Out of the 98 participants, 67% (66 participants) encountered barriers to the intervention. Among these 66 participants, 70% (46 participants) reported internal barriers. Of these, 13% (6 participants) had pre-existing health conditions, 22% (10 participants) developed new health conditions (including 9 cases of COVID-19 and 1 injury), 28% (13 participants) faced psychological barriers, and 59% (27 participants) experienced challenges with health behaviors. Additionally, 59% (39 participants) experienced external barriers, with 41% (16 participants) facing time restrictions, 49% (19 participants) dealing with challenging life situations, and 38% (15 participants) having other obligations. More Ayurvedic-trained medical doctors are needed to more frequent coaching throughout the study, helping participants overcome barriers to effectively implementing the intervention.
Side Effects	Due to the well-designed intervention and expert coaching, 92 participants experienced no side effects.	At the end of the first month, 6% of participants reported side effects, including weakness (n = 1), constipation (n = 1), tiredness (n = 1), low mood (n = 1), and headache (n = 2). Four participants experienced mild side effects (grade 1), two had moderate side effects (grade 2), and none reported strong (grade 3) or severe side effects (grade 4). Causality analysis linked the headaches to caffeine withdrawal and other side effects to the castor oil cleanse. All side effects were transient, lasting no more than 2–3 days. Ayurveda-trained experts were always available to provide guidance or remedies for any challenges.
Outcome Measurements	The study utilized validated questionnaires and consistent measurement protocols. Statistically significant preliminary results repeated over two years, indicated reliability.	Future studies could implement a variety of physiological measures in addition to BMI over longer period to provide objective, reliable, and clinically relevant data. This would strengthen the study design and outcomes by offering a comprehensive evaluation of both psychological and physiological changes, enhancing the understanding of the intervention’s impact, and validating self-reported outcomes.

This table provides an overview of the feasibility and safety results, including participant compliance, barriers and facilitators, adverse events, and overall satisfaction with the treatment protocol.

Note: Some participants experienced both internal and external facilitators or barriers.

Discussion

Given the significant public health concern posed by mental health issues and the potential benefits of CAM therapies, this study evaluated the effects and safety of the Ayurveda Program for Detox and Lifestyle on the mental and physical health of home-based adults. The preliminary findings indicated a significant reduction in mild-to-severe anxiety (55%) and depression (45%) symptoms by the end of the fourth month. Secondary analyses revealed a significant decrease in mild-to-severe physical symptoms, including musculoskeletal, neurological, and digestive symptoms (42%), fatigue (31%), and BMI (2%).

These changes in patient-reported outcomes are clinically relevant, reflecting significant improvements that meet the MCID for GAD-7 (4 points, score <10, ∼50% change),²⁵ PHQ-9 (5 points, score <10, ∼50% change),²⁹ PHQ-15 (2–3 points),³⁰ and PROMIS F-SF (3–5 points).³³ While PHQ-9 scores showed slightly less than a 50% improvement in depression for the entire group, they achieved a 5-point change in the moderate to severe depression symptom groups. Larger changes in BMI were limited as most subjects were within a healthy BMI range. However, meta-analyses indicate that even a 1 kg (2.2 pounds) reduction in overweight can improve fasting blood glucose, blood pressure, serum lipid parameters, and reduce the risk of coronary heart disease.⁴⁸ These findings underscore the clinical importance of even small reductions in overweight.

The effect sizes were large for all measures, with participants showing improvement in four out of five measures (see Supplementary Appendix A1). The Vāta, Pitta, and Kapha treatment groups improved similarly, with no significant differences. Results were consistent over 4 months. Initial improvements were significant during the first month due to the detox program, diet, daily routine, and coaching. In the post-detox phase, herbs, diet, and daily routine adjustments stabilized these changes. Participants’ clinical anxiety, depression, and physical symptoms decreased to mild, nonclinical levels. Minimal post-detox symptoms may have limited further symptom reduction.

The Ayurveda Program for Detox and Lifestyle showed improvements comparable to other treatments, with effect sizes and percentage changes ranging from 30% to 65%.^49
–51 The program’s multimodal approach enhances physiological homeostasis and enables the body to normalize suboptimal functions in the gastrointestinal, neuroendocrine, and immune systems. Research indicates that a healthy diet, yoga, daily routines, phytotherapy, oil massage, and detoxification can reduce stress, anxiety, and depression.,^{17
–19,43,52
–54} These practices improve gastrointestinal health, modulate neuroendocrine-immune responses, and promote neuroplasticity (Figure 7).^{55

–62} Evidence also suggests that Ayurvedic treatments may influence gene expression and enhance healthy epigenetic mechanisms.⁶³

FIG. 7.

Hypothesized Mechanisms of Ayurveda Treatments. The figure illustrates the hypothesized mechanisms of the Ayurveda multimodal approach, which integrates dietary, lifestyle, herbal treatments, and detoxification to address the underlying causes and pathological mechanisms of anxiety and depression symptoms.

At the end of the first month, 6% of participants reported side effects, including weakness, constipation, tiredness, low mood, and headaches. Most side effects were mild (grade 1) or moderate (grade 2), with none being severe. Headaches were linked to caffeine withdrawal, while other side effects were associated with the castor oil cleanse. All side effects were transient, lasting no more than 2–3 days. Ayurveda-trained experts were available around the clock to provide guidance. Compared to the average 30% incidence of common side effects (e.g., gastrointestinal side effects, memory impairment, sexual dysfunction, and insomnia) associated with mental health-related pharmacological treatments,^64
–66 Ayurveda detox-related side effects were minimal, transient, and easily remedied.

The intervention was generally safe, feasible, and cost-effective, with high participant retention of 91% and compliance rates of 70%. The intervention was well-received, with 96% of participants expressing satisfaction and 93% recommending the webinar. Among the 98 participants, 83% experienced facilitating factors, while 67% encountered barriers to intervention implementation. Future studies should prioritize offering participants more frequent coaching from Ayurvedic-trained medical doctors during follow-up periods to help them overcome these barriers.

Additionally, the sample had fewer male participants (14%) and non-meditating participants (16%), and a higher mean age (58 years) than expected. Controlling for meditation, vitamin use, study year, and gender showed no significant interaction effects, indicating stable treatment effects across these variables. This consistency supports the generalizability and reliability of the findings. Future trials should enhance recruitment efforts and target specific demographics.

The trial significantly advanced the understanding of the potential clinical benefits of complementary multimodal lifestyle protocols, paving the way for larger trials and their promising integration into primary and mental health care practices.

Limitations

The single-group design cannot control for confounding factors, including placebo effects, or confirm efficacy.⁶⁷ Additionally, self-report questionnaires may introduce bias. The predominantly female, older adult, nonclinical sample could underestimate effects and limit generalizability. Furthermore, potential selection bias is a significant limitation. Online assessments and interventions also have limitations and may not address all comorbidities. Moreover, the short-term study may not capture long-term outcomes. The multimodality program prevents the determination of the contribution of each treatment, although Ayurveda traditionally uses a holistic approach. Therefore, future studies should include diverse, randomized samples, physical measures, and longer follow-up periods to enhance validity and reliability.

Conclusions

The trial found significant reductions in anxiety, depression, physical symptoms, fatigue, and BMI over 4 months in 98 home-based adults with mild to severe symptoms. These improvements had large effect sizes, indicating clinically significant effects. Future randomized controlled trials are needed to control for confounding factors and validate these findings in larger clinical populations. This study offers health professionals protocols for natural, holistic, accessible, and complementary treatments for anxiety, depression, and physical symptoms.

Footnotes

Acknowledgments

The authors gratefully acknowledge Dr. Wolfgang Schachinger, Dr. Valeria Schachinger, and the team at the Center for Maharishi AyurVeda and Holistic Medicine, Soma, Austria, for their collaboration in intervention development, delivery, and participant enrollment. The authors also sincerely appreciate the expertise of Dr. Marcia Murphy, Dr. Peter Swan, Dr. Jane Bialosky, Dr. William F. Sands, and Dr. Susan L. Dillbeck.

Authors’ Contributions

V.L.: Conceptualization, Methodology, Investigation, Resources, Project administration, Data Curation, Formal analysis, writing-original draft, and visualization. F.T.: Supervision and Methodology. C.A.G.: Critical review. G.M.: Critical review. R.H.S.: Supervision and Critical review

Data Availability Statement

The research data supporting this study’s findings are not publicly accessible due to privacy and ethical constraints related to patient consent. However, anonymized data may be available from the authors upon request with permission from the institutional review board of Maharishi International University, Fairfield, Iowa.

Author Disclosure Statement

The authors declare no personal financial interests, such as stocks, shares, consulting fees, or patents, that could gain or lose value from the publication of this article. The research was not supported by organizations that may gain or lose financially from its publication. The authors are employed by a university where they teach and consult on Ayurveda. They commit to maintaining objectivity and transparency in their reporting and declare no conflicts of interest that may influence decisions related to the study design, data analysis, reporting, or publication of this article.

Funding Information

The study did not receive any funding. All volunteer study participants personally purchased the herbal preparations.

Supplementary Material

Supplementary Appendix A1

Supplementary Appendix A2

Supplementary Appendix A3

References

American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders: DSM-5-TR. 5th ed. American Psychiatric Association: Arlington (VA); 2022.

OECD, European Union. Health at a Glance: Europe 2020: State of Health in the EU Cycle [Internet]. OECD; 2020. (Health at a Glance: Europe). Available from: https://www.oecd-ilibrary.org/social-issues-migration-health/health-at-a-glance-europe-2020_82129230-en [Last accessed: June 3, 2024 ].

World Health Organization. WHO-MSD-MER-2017.2-eng.pdf [Internet]. World Health Organization: Geneva; 2017. Available from: https://apps.who.int/iris/bitstream/handle/10665/254610/WHO-MSD-MER-2017.2-eng.pdf?sequence=1 [Last accessed: June 3, 2023 ].

Swathi

, Manjusha

, Vadakkiniath

, et al. Prevalence and correlates of stress, anxiety, and depression in patients with chronic diseases: A Cross-Sectional Study. Middle East Curr Psychiatry, 2023; 30(1):66; doi: 10.1186/s43045-023-00340-2

Kułak-Bejda

, Bejda

, Waszkiewicz

. Mental disorders, cognitive impairment and the risk of suicide in older adults. Front Psychiatry, 2021; 12:695286. https://www.frontiersin.org/articles/10.3389/fpsyt.2021.695286/full

Obo

, Grossardt

, Virani

, et al. Association of depression and anxiety with the accumulation of chronic conditions. JAMA Netw Open, 2022; 5(5); doi: 10.1001/jamanetworkopen.2022.9817

World Health Organization, WHO-MSD-MER-2017. 2-eng.pdf [Internet]. Geneva: World Health Organization; 2017, 2017. https://apps.who.int/iris/bitstream/handle/10665/254610/WHO-MSD-MER-2017.2-eng.pdf?sequence=1

OECD. OECD-Factsheet-Mental-Health-Health-at-a-Glance-Europe-2018.pdf [Internet]. OECD; 2018. Available from: https://www.oecd.org/health/health-systems/OECD-Factsheet-Mental-Health-Health-at-a-Glance-Europe-2018.pdf [Last accessed: June 4, 2024 ].

Ahmed

, Barnett

, Greenburgh

, et al. Mental health in Europe during the COVID-19 pandemic: A systematic review. Lancet Psychiatry, 2023; 10(7):537–556; doi: 10.1016/S2215-0366(23)00113-X

10.

Gémes

, Bergström

, Papola

, et al. Symptoms of anxiety and depression during the COVID-19 pandemic in six European countries and Australia – differences by prior mental disorders and migration status. J Affect Disord, 2022; 311:214–223; doi: 10.1016/j.jad.2022.05.082

11.

World Health Organization. WHO European framework for action on mental health 2021–2025 [Internet]. WHO Regional Office for Europe: Copenhagen; 2021. Available from: https://www.who.int/europe/publications/i/item/9789289057813 [Last accessed: June 4, 2024 ].

12.

World Health Organization. WHO Traditional Medicine Strategy: 2014-2023. World Health Organization: Geneva; 2013. Available from: https://www.who.int/publications/i/item/9789241506096 [Last accessed: August 23, 2024 ].

13.

Marendić

, Aranza

, et al. Differences between health and non-health science students in lifestyle habits, perceived stress, and psychological well-being: A cross-sectional study. Nutrients, 2024; 16(5):620; doi: 10.3390/nu16050620

14.

Alosaimi

, Sherar

, Griffiths

, et al. Clustering of diet, physical activity, and sedentary behaviour and related physical and mental health outcomes: A systematic review. BMC Public Health, 2023; 23(1):1572; doi: 10.1186/s12889-023-16372-6

15.

Bains

, Abdijadid

. Major depressive disorder. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022. http://www.ncbi.nlm.nih.gov/books/NBK559078/ [Last accessed: 2024, Aug ].

16.

Firth

, Marx

, Dash

, et al. The effects of dietary improvement on symptoms of depression and anxiety: A meta-analysis of randomized controlled trials. Psychosom Med, 2019; 81(3):265; doi: 10.1097/PSY.0000000000000673

17.

Connell

, Toma

, Ho

CH-C

, et al. Data-driven precision nutrition improves clinical outcomes and risk scores for IBS, depression, anxiety, and T2D. Am J Lifestyle Med, 2023; doi: 10.1177/15598276231216393

18.

Martínez-Calderon

, Casuso-Holgado

, Muñoz-Fernandez

, et al. Yoga-based interventions may reduce anxiety symptoms in anxiety disorders and depression symptoms in depressive disorders: A systematic review with meta-analysis and meta-regression. Br J Sports Med, 2023; 57(22):1442–1449; doi: 10.1136/bjsports-2022-106497

19.

Facer-Childs

, Middleton

, Skene

, et al. Resetting the late timing of ‘night owls’ has a positive impact on mental health and performance. Sleep Med, 2019; 60:236–247; doi: 10.1016/j.sleep.2019.05.001

20.

Oliveira

NML

, Hueb

MFD

, de Castro

. Effect of classic massage on the quality of life of university students. Fisioter Mov, 2015; 28(4):793–802; doi: 10.1590/0103-5150.028.004.AO16

21.

Edwards MT, Streiner DL. Development of a reliable Dosha self-assessment questionnaire. Explore (NY) 2022;18(5):573–578; doi: 10.1016/j.explore.2021.09.003

22.

Torres-Saavedra

, Winter

. An overview of phase 2 clinical trial designs. Int J Radiat Oncol Biol Phys, 2022; 112(1):22–29; doi: 10.1016/j.ijrobp.2021.07.1700

23.

Pituch

, Stevens

. Applied Multivariate Statistics for the Social Sciences. 6th ed. Routledge: New York; 2016.

24.

Lancaster

, Thabane

. Guidelines for reporting non-randomised pilot and feasibility studies. Pilot Feasibility Stud, 2019; 5:114; doi: 10.1186/s40814-019-0499-1

25.

Toussaint

, Hüsing

, Gumz

, et al. Sensitivity to change and minimal clinically important difference of the 7-item Generalized Anxiety Disorder Questionnaire (GAD-7). J Affect Disord, 2020; 265:395–401; doi: 10.1016/j.jad.2020.01.032

26.

Shin

, Lee

, Han

, et al. Comparison of the usefulness of the PHQ-8 and PHQ-9 for screening for major depressive disorder: Analysis of psychiatric outpatient data. Psychiatry Investig, 2019; 16(4):300–305; doi: 10.30773/pi.2019.02.01

27.

Hinz

, Ernst

, Glaesmer

, et al. Frequency of somatic symptoms in the general population: Normative values for the Patient Health Questionnaire-15 (PHQ-15). J Psychosom Res, 2017; 96:27–31; doi: 10.1016/j.jpsychores.2016.12.017

28.

Kroenke

, Spitzer

, Williams

, et al. The Patient Health Questionnaire somatic, anxiety, and depressive symptom scales: A systematic review. Gen Hosp Psychiatry, 2010; 32(4):345–359; doi: 10.1016/j.genhosppsych.2010.03.006

29.

Forman-Hoffman

, Nelson

, Ranta

, et al. Significant reduction in depressive symptoms among patients with moderately-severe to severe depressive symptoms after participation in a therapist-supported, evidence-based mobile health program delivered via a smartphone app. Internet Interv, 2021; 25:100408; doi: 10.1016/j.invent.2021.100408

30.

Burton

, Mooney

, Sutton

, et al. Effectiveness of a symptom-clinic intervention delivered by general practitioners with an extended role for people with multiple and persistent physical symptoms in England: The Multiple Symptoms Study 3 pragmatic, multicentre, parallel-group, individually randomised controlled trial. Lancet, 2024; 403(10444):2619–2629; doi: 10.1016/S0140-6736(24)00700-1

31.

PROMIS Fatigue User Manual and Scoring Instructions., 2023, https://www.healthmeasures.net/images/PROMIS/manuals/Scoring_Manual_Only/PROMIS_Fatigue_User_Manual_and_Scoring_Instructions_05Dec2023.pdf

32.

Cook

, Jensen

, Schalet

, et al. PROMIS measures of pain, fatigue, negative affect, physical function, and social function demonstrated clinical validity across a range of chronic conditions. J Clin Epidemiol, 2016; 73:89–102; doi: 10.1016/j.jclinepi.2015.08.038

33.

Nordin

, Taft

, Lundgren-Nilsson

, et al. Minimal important differences for fatigue patient-reported outcome measures—a systematic review. BMC Med Res Methodol, 2016; 16:62; doi: 10.1186/s12874-016-0167-6

34.

Ritenbaugh

, Aickin

, Bradley

, et al. Whole systems research becomes real: New results and next steps. J Altern Complement Med, 2010; 16(1):131–137; doi: 10.1089/acm.2009.0650

35.

Vidyanath

, Hridayam

., (eds). Ashtanga Hridayam. Chaukhamba Surbharati Prakashan: India; 2020.

36.

Murthy

KRS

., (eds.). Astanga Samgraha of Vagbhata. In: Text English Translation Notes Indices Etc. 2nd Revised edition. 3 vols. Chaukhambha Orientalia: India; 1999; p. 1921.

37.

Sharma

., (eds.). Charaka Samhita. Chowkhambha Sanskrit Series Office: India; 2018.

38.

Khot

, Tubaki

, Gonugade

, et al. Efficacy of Brahmi vati in generalized anxiety disorder: A randomized double-blind comparative clinical trial. J Ayurveda Integr Med, 2022; 13(2):100552; doi: 10.1016/j.jaim.2022.100552

39.

Punia

, Chate

, Tubaki

, et al. Efficacy of whole system Ayurveda management protocol in major depressive disorder: A randomized controlled clinical trial. J Ayurveda Integr Med, 2024; 15(2):100896; doi: 10.1016/j.jaim.2024.100896

40.

Kumar

, Singh

, Martin

, Singh

. Clinical assessment of the impact of Shirodhara with water treatment in the management of primary headache with associated anxiety and depression. Ann Ayurvedic Med, 2018; 7(1–2):17–26.

41.

Breslin

, Fakoya

, Wills

, et al. Whole systems approaches to diet and healthy weight: A scoping review of reviews. PLoS One, 2024; 19(3); doi: 10.1371/journal.pone.0292945

42.

Singh

, Olds

, Curtis

, et al. Effectiveness of physical activity interventions for improving depression, anxiety, and distress: An overview of systematic reviews. Br J Sports Med, 2023; 57(18):1203–1209; doi: 10.1136/bjsports-2022-106195

43.

Schneider

, Alexander

, Salerno

, et al. Disease prevention and health promotion in the aging with a traditional system of natural medicine: Maharishi Vedic Medicine. J Aging Health, 2002; 14(1):57–78; doi: 10.1177/089826430201400104

44.

Banerjee

, Debnath

. Ayurnutrigenomics: Ayurveda-inspired personalized nutrition from inception to evidence. J Tradit Complement Med, 2015; 5(4):228–233; doi: 10.1016/j.jtcme.2014.12.009

45.

Gobec

, Travis

. Effects of Maharishi Yoga asanas on mood states, happiness, and experiences during meditation. Int J Yoga, 2018; 11(1):66–71; doi: 10.4103/ijoy.IJOY_66_16

46.

Datanovia. T-test effect size using Cohen’s d measure: Excellent tutorial. Available from: https://www.datanovia.com/en/lessons/t-test-effect-size-using-cohens-d-measure/#google_vignette [Last accessed: June 10, 2024 ].

47.

Cuschieri

. The CONSORT statement. Saudi J Anaesth, 2019; 13(Suppl 1):S30; doi: 10.4103/sja.SJA_559_18

48.

Anderson

, Konz

. Obesity and disease management: Effects of weight loss on comorbid conditions. Obes Res, 2001; 9((Suppl 4)):326S–334S; doi: 10.1038/oby.2001.138[published correction appears in Obes Res. 2003;11(1) table of contents]

49.

Cipriani

, Furukawa

, Salanti

, et al. Comparative efficacy and acceptability of 21 antidepressant drugs for the acute treatment of adults with major depressive disorder: A systematic review and network meta-analysis. Lancet, 2018; 391(10128):1357–1366; doi: 10.1016/S0140-6736(17)32802-7

50.

Zamiri-Miandoab

, Hassanzade

, Mirghafourvand

. The effect of cognitive behavior therapy on anxiety and depression during COVID-19 pandemic: A systematic review and meta-analysis. Ann Gen Psychiatry, 2022; 21(1):40; doi: 10.1186/s12991-022-00417-y

51.

Yeung

, Hernandez

, Mao

, et al. Herbal medicine for depression and anxiety: A systematic review with assessment of potential psycho-oncologic relevance. Phytother Res, 2018; 32(5):865–891; doi: 10.1002/ptr.6033

52.

Zhao

, Yang

, Sahakian

, et al. The brain structure, immunometabolic, and genetic mechanisms underlying the association between lifestyle and depression. Nat Mental Health, 2023; 1:736–750; doi: 10.1038/s44220-023-00120-1

53.

Nidich

, Mills

, Rainforth

, et al. Non-trauma-focused meditation versus exposure therapy in veterans with post-traumatic stress disorder: A randomised controlled trial. Lancet Psychiatry, 2018; 5(12):975–986; doi: 10.1016/S2215-0366(18)30384-5

54.

Basler

. Pilot study investigating the effects of Ayurvedic Abhyanga massage on subjective stress experience. J Altern Complement Med, 2011; 17(5):435–440; doi: 10.1089/acm.2010.0281

55.

Kmail

. Mitigating digestive disorders: Action mechanisms of Mediterranean herbal active compounds. Open Life Sci, 2024; 19(1):20220857; doi: 10.1515/biol-2022-0857

56.

Maddock

, Casazza

, Fernandez

, et al. Acute modulation of cortical glutamate and GABA content by physical activity. J Neurosci, 2016; 36(8):2449–2457; doi: 10.1523/JNEUROSCI.3455-15.2016

57.

Fakhoury

, Eid

, El Ahmad

, et al. Exercise and dietary factors mediate neural plasticity through modulation of BDNF signaling. Brain Plast, 2022; 8(1):121–128; doi: 10.3233/BPL-220140

58.

Tari

, Norevik

, Scrimgeour

, et al. Are the neuroprotective effects of exercise training systemically mediated? Prog Cardiovasc Dis, 2019; 62(2):94–101; doi: 10.1016/j.pcad.2019.02.003

59.

Estrada

, Contreras

. Nutritional modulation of immune and central nervous system homeostasis: The role of diet in development of neuroinflammation and neurological disease. Nutrients, 2019; 11(5):1076; doi: 10.3390/nu11051076

60.

Irwin

. Sleep and inflammation: Partners in sickness and in health. Nat Rev Immunol, 2019; 19(11):702–715; doi: 10.1038/s41577-019-0190-z

61.

Herron

, Fagan

. Lipophil-mediated reduction of toxicants in humans: An evaluation of an Ayurvedic detoxification procedure. Altern Ther Health Med, 2002; 8(5):40–51.

62.

Ranajan

, Jaiswal

, Masram

, et al. A review on pharmacodynamics of Virechanakarama and Virechanopaga Dashemani. Pharma Sci Monitor, 2014; 5(3): 197–204.

63.

Sharma

, Keith Wallace

. Ayurveda and epigenetics. Medicina (Kaunas), 2020; 56(12):687; doi: 10.3390/medicina56120687

64.

Davies

, Read

. A systematic review into the incidence, severity and duration of antidepressant withdrawal effects: Are guidelines evidence-based? Addict Behav, 2019; 97:111–121; doi: 10.1016/j.addbeh.2018.08.027

65.

Wang

, Han

, Bahk

, et al. Addressing the side effects of contemporary antidepressant drugs: A comprehensive review. Chonnam Med J, 2018; 54(2):101–112; doi: 10.4068/cmj.2018.54.2.101

66.

Jakobsen

, Gluud

, Kirsch

, et al. Should antidepressants be used for major depressive disorder? BMJ Evid Based Med, 2020; 25(4):130; doi: 10.1136/bmjebm-2019-111238

67.

Bschor

, Nagel

, Unger

, et al. Differential outcomes of placebo treatment across 9 psychiatric disorders: A systematic review and meta-analysis. JAMA Psychiatry, 2024; 81(8):757–768; doi: 10.1001/jamapsychiatry.2024.0994

Supplementary Material

Please find the following supplemental material available below.

For Open Access articles published under a Creative Commons License, all supplemental material carries the same license as the article it is associated with.

For non-Open Access articles published, all supplemental material carries a non-exclusive license, and permission requests for re-use of supplemental material or any part of supplemental material shall be sent directly to the copyright owner as specified in the copyright notice associated with the article.

0.00 MB

0.33 MB

0.25 MB

0.02 MB