| CTRI Number |
CTRI/2025/02/081133 [Registered on: 21/02/2025] Trial Registered Prospectively |
| Last Modified On: |
20/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Impact of banana leaf bath on insulin resistance in patients with type 2 diabetes mellitus-a single group pre-test and post-test study |
|
Scientific Title of Study
|
Impact of banana leaf bath practised in yoga and naturopathy system of medicine on insulin resistance in patients with type 2 diabetes mellitus-a single group pre-test and post-test study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrSharon |
| Designation |
PG Scholar |
| Affiliation |
Government Yoga and Naturopathy medical college |
| Address |
Department of Naturopathy, second floor, Government Yoga and
Naturopathy medical college and hospital PG block,
Arumbakkam,Chennai-600106
Chennai
TAMIL NADU
600106
INDIA
Chennai
TAMIL NADU
600106
India |
| Phone |
8838016756 |
| Fax |
|
| Email |
sharonnazarious@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Mooventhan |
| Designation |
Assistant medical officer cum Lecturer, Department of Research |
| Affiliation |
Government Yoga and Naturopathy medical college |
| Address |
Department of Research, second floor, Government Yoga and
Naturopathy medical college and hospital PG block,
Arumbakkam,Chennai-600106
Chennai
TAMIL NADU
600106
INDIA
Chennai
TAMIL NADU
600106
India |
| Phone |
9844457496 |
| Fax |
|
| Email |
dr.mooventhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSharon |
| Designation |
PG Scholar |
| Affiliation |
Government Yoga and Naturopathy medical college |
| Address |
Department of Naturopathy, second floor, Government Yoga and
Naturopathy medical college and hospital PG block,
Arumbakkam,Chennai-600106
Chennai
TAMIL NADU
600106
INDIA
Department of Naturopathy, second floor, Government Yoga and
Naturopathy medical college and hospital PG block,
Arumbakkam,Chennai-600106
Chennai
TAMIL NADU
600106
INDIA
Chennai
TAMIL NADU
600106
India |
| Phone |
08838016756 |
| Fax |
|
| Email |
sharonnazarious@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Yoga and Naturopathy medical college and hospital, Arumbakkam,Chennai-600106 |
|
|
Primary Sponsor
|
| Name |
Government Yoga and Naturopathy medical college and hospital |
| Address |
Government Yoga and
Naturopathy medical college and hospital PG block,
Arumbakkam,Chennai-600106
Chennai
TAMIL NADU
600106 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| DrSharon |
Government Yoga and Naturopathy medical college and hospital |
2nd floor, Department
of Naturopathy,
Government Yoga and
Naturopathy medical
college and hospital,
Arumbakkam
Chennai
TAMIL NADU
Chennai
TAMIL NADU |
08838016756
sharonnazarious@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Yoga and Naturopathy Medical College and Hospital, Chennai Institutional ethical 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 |
Banana leaf bath |
All participants will be instructed to take banana leaf bath for 20-30 minutes, twice a week for 4 weeks. Assessments will be done before and after the completion of 4 weeks intervention period. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 30 to 60 years, Both male and female, Known case of T2DM |
|
| ExclusionCriteria |
| Details |
Type 1 Diabetes mellitus, Pregnant women, History of angina, ketoacidosis, myocardial infarction, open wounds |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
HOMA-IR
|
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) will be calculated before and after the completion of 4 weeks intervention period
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Anthropometric measurements
Blood pressure & Pulse rate
PSQI
PANAS |
Anthropometric measurements
Blood pressure & Pulse rate
PSQI will be taken before & after the completion of 4 weeks intervention period |
|
|
Target Sample Size
|
Total Sample Size="31"
Sample Size from India="31"
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)
|
15/03/2025 |
| 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="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
|
A single group pre-test and post-test study will be conducted in Type 2 Diabetes mellitus patients to evaluate insulin resistance after taking plantain leaf bath for twice a week for a month. 31 participants will be recruited
from Government Yoga and Naturopathy medical college and hospital. After baseline assessment of outcome
variables, Banana leaf bath will be given to the subjects for twice a week for 1 month and post data will be collected. The
values collected at baseline and after 1 month of intervention will be analyzed. |