| CTRI Number |
CTRI/2024/11/076115 [Registered on: 01/11/2024] Trial Registered Prospectively |
| Last Modified On: |
28/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of yoga on children with type 1 diabetes mellitus |
|
Scientific Title of Study
|
Effect of yoga on glycemic control and insulin requirements in children with type 1 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 |
Suganya C |
| Designation |
Assistant Professor of Paediatrics |
| Affiliation |
Institute of child health Madras Medical College |
| Address |
Room No:5, Diabetology out patient department, second floor, Japan building,
Institute of child health,
Madras Medical College
Egmore
Chennai
Chennai
TAMIL NADU
600008
India |
| Phone |
8903463935 |
| Fax |
|
| Email |
ajayselvasugi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Suganya C |
| Designation |
Assistant Professor of Paediatrics |
| Affiliation |
Institute of child health Madras Medical College |
| Address |
Room No:5, Diabetology out patient department, second floor, Japan building,
Institute of child health
Madras Medical College
Egmore
Chennai
Chennai
TAMIL NADU
600008
India |
| Phone |
8903463935 |
| Fax |
|
| Email |
ajayselvasugi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Suganya C |
| Designation |
Assistant Professor of Paediatrics |
| Affiliation |
Institute of child health Madras Medical College |
| Address |
Room No:5, Diabetology out patient department, second floor, Japan building,
Institute of child health
Madras Medical College
Egmore
Chennai
Chennai
TAMIL NADU
600008
India |
| Phone |
8903463935 |
| Fax |
|
| Email |
ajayselvasugi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of child health Madras medical college
Egmore
Chennai 600008
Tamilnadu
India |
|
|
Primary Sponsor
|
| Name |
Suganya C |
| Address |
Institute of child health
Madras Medical College
Egmore
Chennai-600008 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Vinitha M |
Institute of child health
Madras Medical College
Egmore
Chennai-600008 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrSuganya C |
Institute of child health |
Room No:5, Diabetology out patient department, second floor, Japan building,
Institute of child health
Madras Medical College
Egmore
Chennai-600008
Tamil Nadu
India
Chennai
TAMIL NADU |
8903463935
ajayselvasugi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Madras Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E109||Type 1 diabetes mellitus without complications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Yoga |
Effect of daily practice of yoga for a minimum of 20 minutes for a period of 3 months on glycemic control and insulin requirements in children with type1 diabetes mellitus |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
15.00 Year(s) |
| Gender |
Both |
| Details |
Children attending diabetology opd between 8 to 15 years of age with type1 diabetes mellitus on treatment for past one year |
|
| ExclusionCriteria |
| Details |
1.Children not willing to practice yoga.
2.Children not willing for periodic follow up. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HbA1c levels before and after yoga therapy in patients with type1 Diabetes mellitus |
one year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The insulin dose in U/kg before and after yoga therapy in patients with type1 Diabetes mellitus |
one year |
|
|
Target Sample Size
|
Total Sample Size="78"
Sample Size from India="78"
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)
|
15/11/2024 |
| 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 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
|
Children attending the diabetology out patient department will be recruited as per inclusion criteria. Patients and parents will be educated about the benefits of yoga therapy. After obtaining informed consent, intervention pack with standard yoga therapy will be taught to the patient. Semi structured proforma containing demographic and disease related data will be filled. Standard yoga therapy includes aasanas ,pranayama,and mudras. Yoga will be taught and patient will be advised to practice yoga at home for a minimum of 20 minutes daily. Regular phone calls will be made by the principal investigator to participants 2 times a week in order to facilitate compliance. Regualr insulin administration and diet advice will be followed. History about diet pattern and daily physical activities which may act as confounding factors will be taken into account.HbA1c levels and insulin requirements will be calculated at the beginning and at the end of three months. This study evaluates the effect of yoga on glycemic control and insulin requirements in children with type 1 diabetes mellitus.
Aasanas -Surya namaskar, Uthita janu sirasasana, Pawanamuktasana, Navasana, Ardha matsyendrasana, Sarvangasana, Sethubhundasana, Trikonasana, Pachimottasana, Halasana. Pranayama -Nadishodhana Pranayama, Kapalabhathi pranayama, Chandranadi pranayama,Bhastrika Pranayama, Bharamari pranayama. Mudras -Vipareeta karni, Bhujangi mudra |