| CTRI Number |
CTRI/2025/04/084421 [Registered on: 08/04/2025] Trial Registered Prospectively |
| Last Modified On: |
07/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Studying How the AIWeLL DM™ Program Helps People Manage Diabetes Better |
|
Scientific Title of Study
|
To Evaluate the Effectiveness of a Whole-System Medicine Approach-Based AIWeLL DM™ Protocol on Diabetes: A Single-Arm Pre-Post Study |
| Trial Acronym |
AIWeLL-DM |
|
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
Chennai
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
Chennai
TAMIL NADU
600090
India |
| Phone |
9361052618 |
| Fax |
|
| Email |
dr.gangadevi95@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
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
|
|
|
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, 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) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E119||Type 2 diabetes mellitus without complications. Ayurveda Condition: PRAMEHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Nishakathakadi kashayam, Reference: Sahasryoga, Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 6 Months, anupAna/sahapAna: No, Additional Information: -(2) Medicine Name: Katakakhadiradi kashayam, Reference: Sahasrayoga , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 15(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 6 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Type 2 diabetes patients, prediabetes
2. Duration of Diabetes should be less than 10 years
|
|
| ExclusionCriteria |
| Details |
1. 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
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Complete Blood Count (CBC), Urine Routine Examination, Diabetic Profile, Lipid Profile, Liver Profile, Kidney Profile |
Before treatment, after treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| CGM indices, Gut microbiome composition (16sRNA metagenomic sequencing) |
Before treatment, after treatment |
|
|
Target Sample Size
|
Total Sample Size="129"
Sample Size from India="129"
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)
|
22/04/2025 |
| 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
|
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.
|