Studying the role of the AIWeLL™ Health Program on Individual Well-Being

Phase 2

Not yet recruiting

Conditions: Gastric Wellness Metabolic Wellness Women’s Wellness

Registration Number: CTRI/2025/04/084702

Lead Sponsor: AYUR.AI PRIVATE LIMITED

Brief Summary: The increasing prevalence of chronicand lifestyle-related health conditions has highlighted the need for acomprehensive, patient-centred approach to well-being. Conventional medicineoften addresses diseases in isolation, focusing on symptom management ratherthan holistic health optimization. Whole-System Medicine (WSM) is anintegrative approach that considers multiple physiological, psychological, andlifestyle factors to improve overall health outcomes. This study aims toevaluate the effectiveness of a WSM-based intervention on well-being through astructured, stratified wellness protocol.

Research Question: Can a Whole-SystemMedicine approach, tailored to individual wellness needs (gastric, metabolic,and women’s wellness), improve health outcomes as measured by symptom-basedassessments, biomarkers and gut microbiome composition?

Justification for the Study:

There is a growing body of evidencesuggesting 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 aholistic, system-based methodology.

This study seeks to address this gapby providing robust evidence on the impact of a Whole-System Medicine approachusing a single-arm pre-post design, assessing outcomes through symptoms,biomarkers and gut microbiome composition. By stratifying participants based onwellness needs, this study aims to offer targeted yet holistic interventionsthat align with personalized health optimization.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 171

Inclusion Criteria

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.
Willingness to follow the prescribed Whole-System Medicine (WSM) protocol, including dietary, lifestyle, and mind-body interventions.
Ability to provide informed consent and comply with study procedures.
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.

Exclusion Criteria

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.
Pregnant or breastfeeding women.
Use of immunosuppressive therapy or active malignancies.
History of major psychiatric disorders that may affect adherence to the intervention.
Participation in another clinical study within the past three months.
Patients with prediabetes, diabetes.
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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Multi Dimensional Gastrointestinal Symptom Severity Index	Before and after treatment
Waist circumference BMI	Before and after treatment
Womens Health Questionnaire	Before and after treatment

Secondary Outcome Measures

Name	Time	Method
Complete Blood Count (CBC), Urine Routine	Bilirubin, SGOP, SGPT, LFT, Serum amylase, lipase, lipid profile

Trial Locations

Locations (1): Sri Sarada Ayurveda Clinic
🇮🇳
Chennai, TAMIL NADU, India
Sri Sarada Ayurveda Clinic
🇮🇳Chennai, TAMIL NADU, India
Dr Gangadevi
Principal investigator
9361052618
dr.gangadevi95@gmail.com