| CTRI Number |
CTRI/2025/09/094970 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
01/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
A study to see how type 2 diabetes affects memory and thinking, and whether yoga can help improve them |
|
Scientific Title of Study
|
A STUDY TO EVALUATE THE COGNITIVE DECLINE IN TYPE 2 DIABETES AND
YOGA INTERVENTION |
| Trial Acronym |
Mindcare-D |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S Poongothai |
| Designation |
Senior Scientist Head Clinical Trials Operations |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
No 4 Conran Smith Road Gopalapuram Chennai
Chennai
TAMIL NADU
600086
India |
| Phone |
9840134505 |
| Fax |
|
| Email |
poongothaisubramani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Poongothai |
| Designation |
Senior Scientist Head Clinical Trials Operations |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
No 4 Conran Smith Road Gopalapuram Chennai
Chennai
TAMIL NADU
600086
India |
| Phone |
9840134505 |
| Fax |
|
| Email |
poongothaisubramani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S Poongothai |
| Designation |
Senior Scientist Head Clinical Trials Operations |
| Affiliation |
Madras Diabetes Research Foundation |
| Address |
No 4 Conran Smith Road Gopalapuram Chennai
Chennai
TAMIL NADU
600086
India |
| Phone |
9840134505 |
| Fax |
|
| Email |
poongothaisubramani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Krishnamacharya Yoga Mandiram
31, 4th Cross St, Ramakrishna Nagar, Raja Annamalai Puram, Chennai, Tamil Nadu 600028 |
|
|
Primary Sponsor
|
| Name |
Krishnamacharya Yoga Mandiram |
| Address |
31, 4th Cross St, Ramakrishna Nagar, Raja Annamalai Puram, Chennai, Tamil Nadu 600028 |
| Type of Sponsor |
Other [Yoga Center] |
|
|
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 S Poongothai |
Madras Research Diabetes Foundation |
No.4 Conran Smith Road
Gopalapuram
Chennai
TAMIL NADU |
9840134505
poongothaisubramani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutioanl Ethics Committee of Madras Diabetes Research Foundation |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
Yoga |
45 minutes of yoga session for 24 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
HbA1c greater than or equal to 7.0 to lesser than 10.5
All patients must give written informed consent
|
|
| ExclusionCriteria |
| Details |
Type 1 Diabetes mellitus
Patients with a serum creatinine concentration greater than 132.6 mmol/L (1.5 mg/dL) or liver function impairment (AST and ALT 2.5 times upper limit of normal range)
Patients have laboratory test abnormality (biochemistry, haematology, or urinalysis)
Patients with significant alcohol, drug or medication abuse
Currently under a psychiatrist’s care or using antipsychotic or mood stabilizer medication or have diagnosed dementia or bipolar disorder or schizophrenia.
Pregnant or lactating
Had a documented CVD event (MI, stroke) in past 12 months
Participation is purely voluntary and there will be no coercion by the consenter.
Participants will not receive material compensation to join the study.
All participants will be assured that they have the right to voluntarily withdraw from the study at any time and that withdrawal will not affect their future medical care.
Participants will also be told that their diabetes care provider will be notified of their stress and depressive symptoms.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the cognitive status in patients with type 2 diabetes
Improvement in cognitive function from baseline to 24 weeks
|
24 weeks
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in Quality of life from baseline to 12 weeks
Change in HbA1c from baseline to 24 weeks
Change in BMI from baseline to 24 weeks
Change in blood pressure from baseline to 24 weeks
Change in other biochemical parameters from baseline to 24 weeks |
24 weeks |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
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 4 |
|
Date of First Enrollment (India)
|
29/09/2025 |
| 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="0"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
|
This study aims to assess the prevalence of cognitive dysfunction in patients with type 2 diabetes. This research will evaluate the effectiveness of a yoga intervention for those diagnosed with cognitive impairment. This study also assesses the impact of this yoga program on various health metrics, including quality of life (QOL), glycemic control (measured by HbA1c, fasting and postprandial blood sugars), physical health markers (BMI and blood pressure), and other key biochemical parameters like the lipid profile. Ultimately, the research aims to provide a comprehensive understanding of the potential benefits of yoga as an integrative therapy for managing the multifaceted health challenges faced by people with type 2 diabetes. |