Clinical trial NCT06551467: Effect of an Innovative Online Ayurveda Program on the Mental and Physical Health of Home-Based Adults
Official title: Feasibility Trial of an Innovative Online Ayurveda Program for Detox and Lifestyle: Effect on Mental and Physical Health in Home-Based Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Lead sponsor: Maharishi International University
Sponsor class: OTHER
First posted: 2024-08-13
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This study utilized a single-arm repeated-measures design to monitor changes in the online intervention over time and increase the precision of the outcomes.
Primary purpose: TREATMENT

Brief summary: The overall objective of this study is to evaluate the effects, feasibility, and safety of a comprehensive online Ayurveda whole-systems (WS) intervention that targets the underlying etiological factors influencing mental and physical health symptoms. The primary hypothesis is that home-based adults who participate in the Ayurveda Program for Detox and Lifestyle will experience a decrease in anxiety and depression symptoms over 4 months.

Detailed description: Two Ayurveda-trained medical doctors will lead the Online Ayurveda Program for Detox and Lifestyle, which comprises eight interactive live webinars over ten days. Each 1.5-hour session includes online group meetings focused on addressing the etiological factors contributing to mental and physical ill-health. The program is easily replicable and includes personalized herbal remedies, detoxification procedures, dietary guidelines, yoga exercises, and daily routine practices, all based on traditional Ayurvedic medicine principles. After the ten-day detoxification, participants will continue to follow the diet and lifestyle recommendations and the herbal program for mental and physical health for up to four months. Outcome measures will be assessed at baseline and once a month for four months.

Eligibility criteria: Inclusion Criteria:

* Scored ≥ 5 on the GAD-7
* Scored ≥ 5 on the PHQ-9
* Scored ≥ 5 on the PHQ-15
* Age 18-80 years
* No other psychiatric disorders
* Not receiving specialized treatments for anxiety or depression, nor participating in another clinical trial
* Stable psychiatric medication regimen for more than two months
* No acute or severe medical conditions
* Individuals who are not pregnant or breastfeeding
* Provided informed consent

Exclusion Criteria:

* Scored \< 5 on the GAD-7
* Scored \< 5 on the PHQ-9
* Scored \< 5 on the PHQ-15
* Age under 18 or over 80 years
* Other psychiatric disorders (e.g., suicidal risk)
* Currently undergoing specialized treatments for anxiety and depression, or participating in another clinical trial
* Psychiatric medication regimen for less than 2 months
* Acute or severe medical condition (e.g., stroke, surgery)
* Individuals who are pregnant or breastfeeding
* Inability to provide informed consent

Primary outcomes:
measure: Change in Anxiety Score
timeFrame: Assessed at baseline and once a month for four months
measure: Change in Depression Score
timeFrame: Assessed at baseline and once a month for four months
Secondary outcomes:
measure: Change in Somatic or Physical Symptoms Score Change in Somatic or Physical Symptoms Score
timeFrame: Assessed at baseline and once a month for four months
measure: Change in Fatigue Score
timeFrame: Assessed at baseline and once a month for four months
measure: Changes in Body Mass Index (BMI)
timeFrame: Assessed at baseline and once a month for four months
Other outcomes:
Locations:
city: Geboltskirchen
country: Austria
facility: The Center for Maharishi AyurVeda and Holistic Medicine
Study officials:
affiliation: Maharishi International University
name: Viktoria Luhaste, PhD
role: PRINCIPAL_INVESTIGATOR
References: