Studying How the AIWeLL DM™ Program Helps People Manage Diabetes Better

Not yet recruiting

• Conditions: Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH,

• Registration Number: CTRI/2025/04/084421
• Lead Sponsor: AYUR.AI PRIVATE LIMITED

Brief Summary

Ayurveda, a traditional system of medicine, offers a holistic framework for disease diagnosis, treatment, and prevention. It emphasizes individual constitution (Prakriti) and pathological state (Vikriti), providing a personalized approach to healthcare. Prakriti-based assessments have been correlated with biochemical, genetic, and microbiome markers, demonstrating their potential for phenotyping individuals and predicting predisposition to metabolic disorders, including diabetes. Integrating Ayurvedic principles with modern biomedical approaches may enhance the early identification of at-risk individuals, improve personalized treatment strategies, and support a more comprehensive model for diabetes management and complication prevention.

This study aims to evaluate the effectiveness of a Whole-System Medicine approach incorporating Ayurvedic principles and modern diagnostics through the AIWeLL DM™ Protocol. By leveraging a personalized, multi-dimensional framework, this study seeks to improve diabetes management outcomes and explore potential avenues for disease reversal in select cases.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-22
• Last Update Posted: 2025-07-04

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

• Type 2 diabetes patients, prediabetes 2.
• Duration of Diabetes should be less than 10 years.

Exclusion Criteria

• Type 1 diabetes patients 2.
• Gestational diabetes 3.
• Smokers and alcoholics 4.
• T2DM patients under insulin 5.
• Pregnancy and Lactation 6.
• Diabetes patients with co-morbidities.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Complete Blood Count (CBC), Urine Routine Examination, Diabetic Profile, Lipid Profile, Liver Profile, Kidney Profile	Before treatment, after treatment

Secondary Outcome Measures

Name	Time	Method
CGM indices, Gut microbiome composition (16sRNA metagenomic sequencing)	Before treatment, after treatment

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