| CTRI Number |
CTRI/2025/04/084882 [Registered on: 16/04/2025] Trial Registered Prospectively |
| Last Modified On: |
14/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the effect of Paschimottanasana (seated forward bend yoga) in Central (Abdominal) Obesity |
|
Scientific Title of Study
|
A Single Arm Clinical study to assess the efficacy of
Paschimottanasana in the management of Central 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 Monika Arvind Kalyankar |
| Designation |
MD Scholar Swasthavritta |
| Affiliation |
PSMs LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Center |
| Address |
Swasthavritta Opd, Room No 3 Prakash Shikshan Mandals Loknete Rajarambapu Patil Ayurvedic Medical College and Hospital Post Graduate Institute and Research Center Islampur
Sangli
MAHARASHTRA
415409
India |
| Phone |
8888651122 |
| Fax |
|
| Email |
monica.kalyankar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rahul Nakil |
| Designation |
HOD Swasthavritta Department |
| Affiliation |
PSMs LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Center |
| Address |
Swasthavritta Opd, Room No 3 Prakash Shikshan Mandals Loknete Rajarambapu Patil Ayurvedic Medical College and Hospital Post Graduate Institute and Research Center Islampur
Sangli
MAHARASHTRA
415409
India |
| Phone |
9822287051 |
| Fax |
|
| Email |
rahul_nakil@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rahul Nakil |
| Designation |
HOD Swasthavritta Department |
| Affiliation |
PSMs LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Center |
| Address |
Swasthavritta Opd, Room No 3 Prakash Shikshan Mandals Loknete Rajarambapu Patil Ayurvedic Medical College and Hospital Post Graduate Institute and Research Center Islampur
Sangli
MAHARASHTRA
415409
India |
| Phone |
9822287051 |
| Fax |
|
| Email |
rahul_nakil@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Prakash Shikshan Mandals Loknete Rajarambapu Patil Ayurvedic Medical College and Hospital Post Graduate Institute and Research Center Islampur 415409 Sangli Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Dr Monika Arvind Kalyankar |
| Address |
Swasthavritta Opd Room No 3 Prakash Shikshan Mandals Loknete Rajarambapu Patil Ayurvedic Medical College and Hospital Post Graduate Institute and Research Center Islampur 415409 Sangli Maharashtra India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Monika Arvind Kalyankar |
PSMs LRP Ayurvedic Medical College and Hospital Post Graduate Institute and Research Center |
3rd Opd Department of Swasthavritta lrpamc Urun Islampur 415409 India
Sangli
MAHARASHTRA |
8888651122
monica.kalyankar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Prakash Shikshan Mandals Loknete Rajarambapu Patil Ayurvedic Medical College and Hospital Post Graduate Institute and Research Centers Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E65||Localized adiposity. Ayurveda Condition: MEDOVRUDDHIH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Frequency five cycles daily, Total duration of Intervention will be Fourty five days, Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Waist Hip Ratio (WHR) of those male patients greater than 0.90 and that of
female patients greater than 0.85 will be included.
2. Patients who fulfill above criterion will be diagnosed as patients of Central
Obesity and they will be included irrespective of their gender, education
and socio - economic status.
3. Patients in the age group of 20 to 50 years having BMI upto 30 kg/m2 will be
included.
4. Patients who are willing to participate in the research study and have a
sedentary lifestyle but do not sleep during daytime, take normal food and
water intake will be included. |
|
| ExclusionCriteria |
| Details |
1. Patients below 20 years or above 50 years of age and having BMI above 30
kg/m2 will be excluded.
2. Patients who have any other hereditary, genetic, metabolic and systemic
disorders will be excluded.
3. Patients who have any major illness, disease or post abdominal operative
and under steroidal, antidepressant, anticholinergic or any other drug
treatment for a long time will be excluded.
4. Patients who have major problems related to bones and joints like diseases
of spine, limbs, hip and or knee joint e.t.c. and malignancies will be
excluded.
5. Pregnant Ladies and Lactating mothers will be excluded.
6. Known alcoholic and drug abusers will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Paschimottanasana in Central Obesity. |
Assessment on 0th, 15th, 30th and 45th day of commencement of study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the effect of Paschimottanasana on health.
2. To study literature review on Paschimottanasana.
3. To study literature review on Central Obesity. |
Assessment on 0th, 15th, 30th and 45th day of commencement of study |
|
|
Target Sample Size
|
Total Sample Size="65"
Sample Size from India="65"
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)
|
26/05/2025 |
| 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="6"
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
|
This is a Single Arm Clinical Trial whose Primary Objective is to Assess the efficacy of Paschimottamasana in the management of Central Obesity. 65 Diagnosed patients of Central Obesity will be chosen and trained 7 days initially to ensure that they can perform the Paschimottanasana in an ideal way. Then the main study will commence in which they will be advised to perform 5 cycles of Paschimottanasana daily on empty stomach around 7 am for 45 days. Follow up will be taken on 15th, 30th and 45th day after the commencement of the main study. Final Conclusions will be drawn on the basis of Statistical analysis and Overall Asessment. |