CTRI/2025/11/097692 [Registered on: 19/11/2025] Trial Registered Prospectively
Last Modified On:
18/11/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Ayurveda Yoga & Naturopathy
Study Design
Single Arm Study
Public Title of Study
Can an Ayurveda-Based Digital Health Program help Improve Digestion, Metabolic Health, and Women’s Wellness in Adults?
Scientific Title of Study
To Evaluate the Effectiveness of a Whole-System Medicine Approach-Based AIWeLL™ Protocol on Gastric, Metabolic & Women’s Disorders: A Single-Arm Pre-Post Study
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
1. Adults aged 18–60 years, of any gender
2. Active smartphone users
3. Presence of non-severe, non-life-threatening health concerns related to gastric, metabolic, or women’s wellness.
4. Willingness to follow the prescribed Whole-System Medicine (WSM) protocol, including dietary, lifestyle, and mind-body interventions.
5. Ability to provide informed consent and comply with study procedures.
6. No surgical procedures or hospital admissions in the last six months
7. Occasional use of over-the-counter drugs or dietary supplements is allowed, provided they do not significantly affect primary outcomes.
ExclusionCriteria
Details
1. Who do not fall under the set cutoffs of Gastric, Metabolic, Women’s Wellness Group
2. Diagnosis of severe acute or chronic illness requiring urgent or intensive medical care.
3. Pregnant or breastfeeding women.
4. Use of immunosuppressive therapy or active malignancies.
5. History of major psychiatric disorders that may affect adherence to the intervention.
6. Participation in another clinical study within the past three months.
7. History of substance abuse (e.g., alcohol, tobacco, recreational drugs)
8. Occurrence of myocardial infarction, stroke, or angina within the last 3 months prior to enrolment.
9. Individuals with major diagnosed psychiatric disorders (e.g., depression, schizophrenia).
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
For Gastric wellness, Multi-Dimensional Gastrointestinal Symptom Severity Index (GISSI)
For Metabolic wellness, Waist circumference, BMI
For Women wellness, Women Health Questionnaire
0th day, 60th day
Secondary Outcome
Outcome
TimePoints
For Gastric wellness , CBC, URINE ROUTINE, LIVER FUNCTION TEST, AMYLASE, LIPASE, HS- CRP, VITAMIN B12, LIPID PROFILE
For Metabolic wellness, CBC, URINE ROUTINE, FASTING GLUCOSE, FASTING INSULIN, HBA1C, LIPID PROFILE, HS- CRP, APOLIPOPROTEINS (a1), APOLIPOPROTEINS (B), HOMOCYCTINE, RENAL FUNCTION TEST, LIVER FUNCTION TEST, VITAMIN B12, TFT
Total Sample Size="171" Sample Size from India="171" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
N/A
Date of First Enrollment (India)
03/12/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Open to Recruitment
Recruitment Status of Trial (India)
Open to Recruitment
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
The increasing prevalence of chronic and lifestyle-related health conditions has highlighted the need for a comprehensive, patient-centred approach to well-being. Conventional medicine often addresses diseases in isolation, focusing on symptom management rather than holistic health optimization. Whole-System Medicine (WSM) is an integrative approach that considers multiple physiological, psychological, and lifestyle factors to improve overall health outcomes. This study aims to evaluate the effectiveness of a WSM-based intervention on well-being through a structured, stratified wellness protocol.
Research Question: Can a Whole-System Medicine approach, tailored to individual wellness needs (gastric, metabolic, and women’s wellness), improve health outcomes as measured by symptom-based assessments, biomarkers and gut microbiome composition?
Justification for the Study: There is a growing body of evidence suggesting that whole-system, integrative interventions encompassing nutrition, lifestyle modifications, personalized supplementation, and mind-body practices, can significantly improve health outcomes across various wellness domains. However, most existing research focuses on isolated interventions rather than a holistic, system-based methodology.
This study seeks to address this gap by providing robust evidence on the impact of a Whole-System Medicine approach using a single-arm pre-post design, assessing outcomes through symptoms, biomarkers and gut microbiome composition. By stratifying participants based on wellness needs, this study aims to offer targeted yet holistic interventions that align with personalized health optimization.