| CTRI Number |
CTRI/2024/08/072487 [Registered on: 13/08/2024] Trial Registered Prospectively |
| Last Modified On: |
10/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Effect of Yog-Vyayama on Type 2 Diabetes Mellitus |
|
Scientific Title of Study
|
Combined Effect of Yoga and Vyayama on Different Levels of HbA1c in Patients with Type 2 Diabetes Mellitus |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sridip Chatterjee |
| Designation |
Associate Professor |
| Affiliation |
Jadavpur University |
| Address |
Department of Physical Education, Jadavpur University, 188, Raja Subodh Chandra Mallick Rd, Jadavpur, Kolkata, West Bengal 700032
Kolkata
WEST BENGAL
700032
India |
| Phone |
9674764085 |
| Fax |
|
| Email |
sridipchatterjee.ped@jadavpuruniversity.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sridip Chatterjee |
| Designation |
Associate Professor |
| Affiliation |
Jadavpur University |
| Address |
Department of Physical Education, Jadavpur University, 188, Raja Subodh Chandra Mallick Rd, Jadavpur, Kolkata, West Bengal 700032
WEST BENGAL
700032
India |
| Phone |
9674764085 |
| Fax |
|
| Email |
sridipchatterjee.ped@jadavpuruniversity.in |
|
Details of Contact Person
Public Query
|
| Name |
Biswajit Dhali |
| Designation |
Research Scholar |
| Affiliation |
Jadavpur University |
| Address |
Department of Physical Education, Jadavpur University, 188, Raja Subodh Chandra Mallick Rd, Jadavpur, Kolkata, West Bengal 700032
Kolkata
WEST BENGAL
700032
India |
| Phone |
9647121103 |
| Fax |
|
| Email |
biswajitdhali.pe.rs@jadavpuruniversity.in |
|
|
Source of Monetary or Material Support
|
| Jadavpur University, 188, Raja Subodh Chandra Mallick Rd, Jadavpur, Kolkata, West Bengal 700032 |
|
|
Primary Sponsor
|
| Name |
University Grant Commission |
| Address |
University Grants Commission Bahadur Shah Zafar Marg, New Delhi - 110002 |
| Type of Sponsor |
Government funding agency |
|
|
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 Sridip Chatterjee |
Jadavpur University |
Department of Physical Education, Jadavpur University, 188, Raja Subodh Chandra Mallick Rd, Jadavpur, Kolkata, West Bengal 700032
Kolkata
WEST BENGAL
Kolkata
WEST BENGAL |
9675764085
sridipchatterjee.ped@jadavpuruniversity.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC - Jadavpur University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Yogvyayama Training
Within group comparison |
There are three type II diabetes mellitus group with following HbA1C levels
1. Pre Diabetes Group A - 5.7 - 6.4 %
2. Diabetes Mellitus Group B - 6.5 - 10 %
3. Diabetes Mellitus Group C - above 10 % |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Type 2 Diabetes Mellitus with a history of diabetes for 0-10 years were selected as subjects.
2. HbA1c level of Subjects were above 5.7 %
3. Age ranging from 40 to 70 from both genders
4. The selected activities were Yoga and Vyayama.
5. 65 Minutes Yoga and Vyayama was take place for 24 weeks and five days per week.
6. Willingness to give written consent for participation in the study |
|
| ExclusionCriteria |
| Details |
1. Patients with type-1 Diabetes, gestational diabetes.
2. Below 5.7% HbA1c Level of Patients
3. Alcoholic Patients, or addiction to any forms of drug usage
4. Patients previously performing yoga or any other regular Physical exercise.
5. Uncontrolled diabetes, Morbid obesity
6. Recent major trauma or surgery that would interfere with participation
7. Pregnant women
8. Participation in any interventional study within the past 6 months
9. Persons identified with any other serious problem that can confound the outcome
10. Diagnosed with cardiovascular diseases, cancer
11. Diagnosed with neurological or psychological disorders
12. Mobility restrictions or inability to do yoga practices |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Blood Glucose level, Fasting Insulin, HbA1c |
Baseline, three months and six months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Lipid Profile, Blood Pressure, Heart Rate, Flexibility, SpO2, Waist circumference, Hip circumference, Grip Strength |
Baseline, three months & six months |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3 |
|
Date of First Enrollment (India)
|
26/08/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
26/08/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 proposed study tries to examine how yoga influences insulin Resistance in different HbA1c level of type-2 diabetic patients, alongside its effect on anthropometric parameters with minimum 65 hrs of yoga and vyayama practice spanning over 24 weeks |