| CTRI Number |
CTRI/2024/09/073557 [Registered on: 06/09/2024] Trial Registered Prospectively |
| Last Modified On: |
28/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARING the benefits of suryanamaskar and paschimottanasna in the management of obesity |
|
Scientific Title of Study
|
A comparative study of suryanamskara and paschimottanasana in the management of sthaulya wsr to obesity |
| 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 Nitesh Kumar |
| Designation |
PG Scholar |
| Affiliation |
Institute for ayurved studies and research, faculty of ayurveda kurukshetra |
| Address |
Room No 63 department of swasthavritta and yoga institute for ayurved studies and research shri krishna ayush university Sector 8 Umri road Kurukshetra
Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
09991261696 |
| Fax |
|
| Email |
niteshbhargav586@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nitesh Kumar |
| Designation |
Pg Scholar |
| Affiliation |
Institute For Ayurved Studies and Research, Faculty of Ayurved, Kurukshetra |
| Address |
OPD NO. 2 Department of Swasthavritta And Yoga. Institute For Ayurved Studies and Research,Shri Krishna Ayush University, Sector 8 Umri road Kurukshetra
Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
09991261696 |
| Fax |
|
| Email |
niteshbhargav586@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nitesh Kumar |
| Designation |
PG Scholar |
| Affiliation |
Institute For Ayurved Studies And Research |
| Address |
OPD no. 2 Department of Swasthavritta And Yoga, Institute For Ayurved Studies And Research .Shri Krishna Ayush University, Sector 8 Umri road Kurukshetra
Haryana
Kurukshetra
HARYANA
136118
India |
| Phone |
9991261696 |
| Fax |
|
| Email |
niteshbhargav586@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute For Ayurved Studies and Research, Shri Krishna AYUSH University, Sector-8 Umri road, Kurukshetra-136118
Haryana
India |
|
|
Primary Sponsor
|
| Name |
Institute For Ayurved Studies and Research Shri Krishna AYUSH University Kurukshetra |
| Address |
Institute For Ayurved Studies and Research, Shri Krishna AYUSH University, Sector-8 Umri road, Kurukshetra-136118
Haryana
India |
| 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 Seema Rani |
Institute For Ayurved Studies And Research |
OPD No 2 Department of Swasthavritta And Yoga,sec 8 umri road
Kurukshetra
HARYANA |
9466786108
seemaranimd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
overweight and obesity |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:YOGA include Suryanamskara is advised to perform for 20 minute for period 60 days , Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:yoga include Paschimottanasana for 20 minutes(MORNING) for 60 days., Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patient willing to sign the consent form, the patients between the age of 25 to 50 years of either sex presenting with clinical features of sthaulya (obesity), patient having bmi 24.9kg/m2 to 34.9kg/m2 |
|
| ExclusionCriteria |
| Details |
Age below 25 and above 50 years, patient with complicated and history of chronic disorder or any health challenging diseases, patient having bmi below 24.9kg/m2, patient having obesity due to secondary causes (dm, hypertension)
5. Systemic illness like history of tuberculosis , carcinoma and endocrine disorder
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| change in bmi of patient will be assessed. |
60 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to access the effect of yoga module in the management of sthaulya w.s.r obesity |
18 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
20/09/2024 |
| 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 Yet Recruiting |
| 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
|
WHO defines overweight and obesity as an abnormal or excessive buildup of fat that poses a major threat to health. Yoga exercises are known for their positive effects on health . Surynamaskara have a wide range of benefits in many health condition in obesity. Aim of the study is to control the obesity with the help of yoga. Total 60 obese patient are taken from Swasthrakshanam OPD. Group A advise to perform suryanamskara .for 20mint.GROUP B advise to perform Paschimottanasana for 20 mint. . Total study duration is 60 days. |