CTRI/2025/04/084702 [Registered on: 13/04/2025] Trial Registered Prospectively
Last Modified On:
09/04/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Ayurveda Yoga & Naturopathy
Study Design
Single Arm Study
Public Title of Study
Studying the role of the AIWeLL™ Health Program on Individual Well-Being
Scientific Title of Study
To Evaluate the Effectiveness of a Whole-System Medicine Approach-Based AIWeLL™ Protocol on Well-Being: A Single-Arm Pre-Post Study
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Gangadevi BAMS
Designation
Chief Medical Officer
Affiliation
Sri Sarada Ayurveda Clinic
Address
Sri Sarada Ayurveda Clinic, First floor, Megawin Towers, E-29, 2nd Ave, GOCHS Colony, Besant Nagar, Chennai, Tamil Nadu 600090
Chennai TAMIL NADU 600090 India
Phone
9361052618
Fax
Email
dr.gangadevi95@gmail.com
Details of Contact Person Scientific Query
Name
Dr Gangadevi BAMS
Designation
Chief Medical Officer
Affiliation
Sri Sarada Ayurveda Clinic
Address
Sri Sarada Ayurveda Clinic, First floor, Megawin Towers, E-29, 2nd Ave, GOCHS Colony, Besant Nagar, Chennai, Tamil Nadu 600090
TAMIL NADU 600090 India
Phone
9361052618
Fax
Email
dr.gangadevi95@gmail.com
Details of Contact Person Public Query
Name
Dr Gangadevi BAMS
Designation
Chief Medical Officer
Affiliation
Sri Sarada Ayurveda Clinic
Address
Sri Sarada Ayurveda Clinic, First floor, Megawin Towers, E-29, 2nd Ave, GOCHS Colony, Besant Nagar, Chennai, Tamil Nadu 600090
TAMIL NADU 600090 India
Phone
9361052618
Fax
Email
dr.gangadevi95@gmail.com
Source of Monetary or Material Support
AYUR.AI PRIVATE LIMITED, Villa 2, Abhimanyu Homes, Kanathur, Chennai, 603112
Primary Sponsor
Name
AYUR.AI PRIVATE LIMITED
Address
Villa 2, Abhimanyu Homes, Kanathur, Chennai, 603112
Type of Sponsor
Other [Private company ]
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 1
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Dr Gangadevi
Sri Sarada Ayurveda Clinic
Sri Sarada Ayurveda Clinic, Room No.1, Clinical research division, General medicine department, First floor, Megawin Towers, E-29, 2nd Ave, GOCHS Colony, Besant Nagar, Chennai, Tamil Nadu 600090 Chennai TAMIL NADU
9361052618
dr.gangadevi95@gmail.com
Details of Ethics Committee
No of Ethics Committees= 1
Name of Committee
Approval Status
Dr RK Diabetic Foot and Podiatry Institute & Rakesh Jhunjhunwala Amputation Prevention Center Institutional Ethics Committee (RKDF-IEC)
Participants must meet the following general criteria before stratification:
1. Adults aged 25–55 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. No regular use of prescription medications, over-the-counter drugs, or supplements within 2 weeks prior to screening
ExclusionCriteria
Details
Participants will be excluded if they meet any of the following:
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. Patients with prediabetes, diabetes.
8. History of substance abuse (e.g., alcohol, tobacco, recreational drugs)
9. Occurrence of myocardial infarction, stroke, or angina within the last 3 months prior to enrolment.
10. 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
Multi Dimensional Gastrointestinal Symptom Severity Index
Waist circumference BMI
Womens Health Questionnaire
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
Phase 2
Date of First Enrollment (India)
24/04/2025
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)
Not Yet Recruiting
Recruitment Status of Trial (India)
Not Yet Recruiting
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.