| CTRI Number |
CTRI/2025/01/079715 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
28/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Chair Yoga for patients with Type 2 Diabetes mellitus |
|
Scientific Title of Study
|
Effect of chair yoga On Insulin Resistance in Type II Diabetes Mellitus - A Randomized Controlled Trial |
| 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 S D Janaki |
| Designation |
Post graduate Scholar |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences , Chengalpattu |
| Address |
184/4,International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block, Department of Yoga, Kamarajar Nagar, Chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
8754744965 |
| Fax |
|
| Email |
janakidevarajan18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Gayathri |
| Designation |
Head of the Department ( Yoga) |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu |
| Address |
184/4,International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block, Department of Yoga, Kamarajar Nagar, Chengalpattu
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
8124634017 |
| Fax |
|
| Email |
gayathriannamalai93@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr A Gayathri |
| Designation |
Head of the Department ( Yoga) |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu |
| Address |
184/4,International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block, Department of Yoga, Kamarajar Nagar, Chengalpattu
TAMIL NADU
603001
India |
| Phone |
8124634017 |
| Fax |
|
| Email |
gayathriannamalai93@gmail.com |
|
|
Source of Monetary or Material Support
|
| 184/4,International Institute of Yoga and Naturopathy Medical Sciences,Faculty block, Department of Yoga,Kamarajar nagar,Chengalpattu- 603001, Tamil Nadu, India
|
|
|
Primary Sponsor
|
| Name |
Dr S D Janaki |
| Address |
184/4,International Institute of Yoga and Naturopathy Medical Sciences,Faculty block, Department of Yoga,Kamarajar nagar,Chengalpattu- 603001, Tamil Nadu, India |
| Type of Sponsor |
Other [Self] |
|
|
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 D Janaki |
International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu |
184/4,International Institute of Yoga and Naturopathy Medical Sciences, Faculty Block, Department of Yoga, Kamarajar Nagar, Chengalpattu
Kancheepuram
TAMIL NADU |
8754744965
janakidevarajan18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu, Institutional Ethics Committee |
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 |
| Intervention |
Chair Yoga |
Padahastasana (4 mins)
Sit in the chair comfortably.Inhale and rise the hands up. Exhale and bend forward, catch hold both the ankles with the hands. Hold the position with normal breathing. Slowly release the posture. Repeat for 3 rounds.Then relax for 1 min.
Vakrasana (4 mins)
Sit in the chair comfortably. Inhale slowly, bend the right knee while exhaling twist your body towards right. Cross both the hands over the right leg and place it on the right side. Hold the position and maintain for 30 sec. Slowly release the posture. Practice on the opposite side in the same manner. Repeat for 3 rounds on both the sides.Then relax for 1 min.
Ardha pawanamuktasana (4 mins)
Sit in the chair comfortably. Inhale, while exhaling bend the right knee. With the both hands bring the knee towards the chest. Bend the head and touch the knees with the head. Hold the position and maintain for 30 sec.Slowly release the posture. Practice on the opposite side in the same manner. Repeat for 3 rounds on both the sides.Then relax for 1 min.
Mandukasana ( 4 mins)
Sit in the chair comfortably. Make fist of the hands and place it on the abdomen. Inhale and while exhaling bend forward. Feel the pressure on the abdomen. Hold the position with the normal breathing. Slowly return to the normal position. Repeat for 3 rounds. Relax for 1 min.Katichakrasana ( 4 mins)
Sit in the chair comfortably. Inhale and raise both the hands at shoulder level.While exhaling twist the body to the right . Bring the left hand to the right shoulder and wrap the right arm around the back, bringing the right hand around the left side of the waist, look over the right shoulder as far as is comfortable. Hold the position and maintain for 30 sec.Slowly release the posture. Practice in the left side in the same manner. Repeat for 3 rounds on both the sides.Then relax for 1 min.
Nadi shodhana pranayama ( 5 mins)
Sit in the chair comfortably. Keep the head and spine upright. Relax the whole body and close the eyes. Adopt nasagra mudra with right hand and place the left hand on the knee in chin mudra. Close the right nostril with the thumb, inhale through left nostril. Then close the left nostril with ring finger, exhale through right nostril. Again inhale through right nostril and exhale through left nostril. This is one round. Continue for 4 mins. Relax for 1 min.
Bhramari pranayama (5 mins)
Sit in the chair comfortably. Place the hands in chin or jnana mudra. Close the eyes and relax the whole body.Plug the ears with the index finger. Inhale through the nose. Exhale slowly and make a deep, steady humming sound like the black bee. Continue the practice for 4 mins. Relax for 1 min.
|
| Comparator Agent |
Sitting position |
The control group will rest in sitting position . |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1)Diagnosed subjects of Type2 Diabetes Mellitus, who have been on oral hypoglycemic drug.
2)Patients who are willing to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1)Patients of Diabetes mellitus on insulin therapy.
2)Diabetes associated with systemic complications like diabetic retinopathy,diabetic neuropathy, diabetic nephropathy.
3)Recent surgical history within 6 months.
4)Type 1 Diabetes mellitus.
5)Diagnosed with ischaemic heart disease, angina, hepatic or renal dysfunction. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of Serum insulin, FBS, PPBS and HOMA-IR |
Assessment of Serum insulin, FBS, PPBS and HOMA-IR before and after the intervention (40 days) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of Weight and BMI |
Assessment of Weight and BMI before and after the intervention (40 days) |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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 2 |
|
Date of First Enrollment (India)
|
10/02/2025 |
| 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="1"
Days="10" |
|
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response (Others) - NIL
- For how long will this data be available start date provided 10-02-2025 and end date provided 11-03-2026?
Response (Others) - NIL
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
This study is the Randomized control trail comparing the effectiveness of Chair yoga on insulin resistance in type 2 diabetes patients at 40 days. The study includes five asanas such as Katichakrasana, Vakrasana, Mandukasana, Padahastasana and Pawanamuktasana and Pranayamas includes Nadi suddhi pranayama and Bhramari pranayama. Participants will practice these poses in a seated position in the chair. The study will help to assess whether chair yoga can be effective and accessible intervention for people with type diabetes mellitus, particularly older adults or those with limited mobility. |