| CTRI Number |
CTRI/2023/03/051078 [Registered on: 27/03/2023] Trial Registered Prospectively |
| Last Modified On: |
27/03/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Prevention of Obesity with Ayurvedic Lifestyle, Naturopathic Modalities and Yoga Techniques among Overweight population |
|
Scientific Title of Study
|
Primary level Prevention of Obesity incorporating Ayurvedic Lifestyle, Selected Naturopathic Modalities and Yoga Techniques among Overweight population |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr JAYAN D |
| Designation |
PROFFESSOR AND HOD |
| Affiliation |
GOVERNMENT AYURVEDA COLLEGE TRIPUNITHURA |
| Address |
DEPARTMENT OF SWASTHAVRITTA
GOVERNMENT AYURVEDA COLLEGE TRIPUNITHURA.
Ernakulam
KERALA
682301
India |
| Phone |
9447104383 |
| Fax |
|
| Email |
dr.jayan.d@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr JAYAN D |
| Designation |
PROFFESSOR AND HOD |
| Affiliation |
GOVERNMENT AYURVEDA COLLEGE TRIPUNITHURA |
| Address |
DEPARTMENT OF SWASTHAVRITTA
GOVERNMENT AYURVEDA COLLEGE TRIPUNITHURA.
KERALA
682301
India |
| Phone |
9447104383 |
| Fax |
|
| Email |
dr.jayan.d@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr JAYAN D |
| Designation |
PROFFESSOR AND HOD |
| Affiliation |
GOVERNMENT AYURVEDA COLLEGE TRIPUNITHURA |
| Address |
DEPARTMENT OF SWASTHAVRITTA
GOVERNMENT AYURVEDA COLLEGE TRIPUNITHURA.
KERALA
682301
India |
| Phone |
9447104383 |
| Fax |
|
| Email |
dr.jayan.d@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT AYURVEDA COLLEGE TRIPUNITHURA |
|
|
Primary Sponsor
|
| Name |
GOVERNMENT OF KERALA |
| Address |
GOVERNMENT AYURVEDA COLLEGE
TRIPUNITHURA |
| 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 |
| Dr Jayan D |
GOVT.AYURVEDA COLLEGE TRIPUNITHURA |
DEPARTMENT OF SWASTHAVRITTA
GOVT. AYURVEDA COLLEGE TRIPUNITHURA
Ernakulam
KERALA |
9447104383
dr.jayan.d@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE GOVT.AYURVEDA COLLEGE TRIPUNITHURA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E663||Overweight. Ayurveda Condition: MEDOVRUDDHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: Subjects will be advised to wake up early in the morning before 6am. Yoga practice for about 45 minutes daily for two months. Advised to have food as per mathrahara concept. , Ritucarya: , Acara Rasayana:, Other:Nahuropathic juice therapy daily for two months after yoga practice.
Steam bath once in a week for two months
, Pathya/Apathya:yes, Pathya:Main diet quantity is to fill the half of their stomach.
6 hours sleep at night time. , Apathya:Over eating. Excess quantity of food at a time. More sweet foods, Bakery foods, junk foods, Day sleep. |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Participants providing informed consent.
Subjects of all sexes of age group between 20-50 years of age with BMI between 25 and 29.99 |
|
| ExclusionCriteria |
| Details |
subjects with severe systemic illness, pregnant ladies, lactating mothers, and subjects unfit for hydrotherapy and yoga techniques.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Assessment of
A. Body weight, BMI, Mid Arm Circumference, Waist circumference, Waist hip ratio
B. FBS, Lipid Profile |
Assessment of BMI, weight, Mid arm Circumference, Waist circumference, Waist hip ratio, on
0th day
31st day
61st day of intervention.
B. FBS, Lipid Profile on
0th day
61st day
Follow up assessment of all these measurements on 91st day.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Nil
|
Nil
|
|
|
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)
|
27/03/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The main aim of the research project is to promote the benefits of healthy ayurvedic life style, selected naturopathic modalities and yoga techniques among over weight population thus reduce the chance of development of obesity associated risk conditions in future. 100 Patients will be selected as per inclusion exclusion criteria with structured case proforma from the OPD of swasthavritta department Government Ayurveda College Tripunithura. Subjects will be given yoga training and juice therapy for a period of two months and steam bath will be given once in a week for two months. Assessment and comparison of BMI, weight, waist circumference, waist hip ratio on 0th day, 31st day, and 61st day . Laboratory parameters of FBS ,Lipid profile evaluating before the onset of intervention and two months after the intervention. Follow up will be done on 91st day of intervention. |