| CTRI Number |
CTRI/2025/03/082395 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Management of Swelling in post menopause by yoga techniques. |
|
Scientific Title of Study
|
Effect of Yoga on Inflammatory Markers in Postmenopausal Women. |
| 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 Renuka Rajesh Deshpande |
| Designation |
PG Scholar |
| Affiliation |
Bharati Vidyapeeth Deemed to be University College of Ayurved Pune |
| Address |
Department of Swasthavritta and Yoga Bharati Vidyapeeth Deemed to be University College of Ayurved Dhankawadi Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9403328167 |
| Fax |
|
| Email |
renuka.deshpande-ayurved@bvp.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kirti Bhati |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth Deemed to be University College of Ayurved Pune |
| Address |
Department of Swasthavritta and Yoga Bharati Vidyapeeth Deemed to be University College of Ayurved Dhankawadi Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9423010166 |
| Fax |
|
| Email |
kirti.bhati@bharatividyapeeth.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kirti Bhati |
| Designation |
Professor |
| Affiliation |
Bharati Vidyapeeth Deemed to be University College of Ayurved Pune |
| Address |
Department of Swasthavritta and Yoga Bharati Vidyapeeth Deemed to be University College of Ayurved Dhankawadi Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
9423010166 |
| Fax |
|
| Email |
kirti.bhati@bharatividyapeeth.edu |
|
|
Source of Monetary or Material Support
|
| Bharati vidyapeeth deemed to be University college of Ayurved and Hospital Dhankawadi, Pune, 411043 Maharashtra, India |
|
|
Primary Sponsor
|
| Name |
Dr Renuka Rajesh Deshpande |
| Address |
Bharati Vidyapeeth (deemed to be University) College of Ayurved and Hospital, Swasthavritta And Yoga OPD, ground floor opd no- 15, Pune |
| Type of Sponsor |
Other [self] |
|
|
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 Renuka Rajesh Deshpande |
Bharati vidyapeeth deemed to be university college of Ayurved and Hospital Pune |
Bharati vidyapeeth deemed to be university Ayurved Hospital ,
Swasthavritta Opd no 15 ground floor Dhankawadi Pune MAHARASHTRA.
Pune
MAHARASHTRA |
9403328167
renuka.despande-ayurved@bvp.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE [BV (DU) COA-EC] |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:E878||Other disorders of electrolyte andfluid balance, not elsewhere classified. Ayurveda Condition: SVAYATHUH/SOTHAH/SOPAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Comparator Arm | Lifestyle | - | - | Dinacarya: N/A, Ritucarya: N/A, Acara Rasayana:N/A, Other:LIFESTYLE MODIFICATIONS AND DIETARY REGULATIONS.
LIFE STYLE MODULE SUCH AS NUTRITION, EXERCISE, SLEEP, STRESS PROTOCOLS WILL BE GIVEN TO PARTICIPANTS.
, Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Intervention Arm | Lifestyle | - | - | Dinacarya: N/A, Ritucarya: N/A, Acara Rasayana:N/A, Other:BASIC DIET PLAN AND LIFE STYLE MANAGEENT WILL BE GIVEN TO PARTICIPANTS AND S-VYASA YOGA PROTOCOL WILL BE FOLLOWED
YOGASANAS LISTED-
ARDHACHAKRASAN
PARIVRUTTA
TRIKONASAN
SHASANKASAN
ARDHAUSHTRASAN
VAKRASAN
NAUKASEN
DHANURASAN
TRIKONASAN
PARSHWAKONASAN BUTTERFLY POSE
ARDHAMATSYENDRASEN
BHUJANGASEN
SHALABHASAN
PRANAYAMA- NADISHUDDHI, SEETALI, SITKARI, BHRAMARI , Pathya/Apathya:no, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
1)Postmenopausal women with Age 45-55 years.
2) Women within 5 years of menopause.
3) Overweight and obeys women (BMI: 23-35kg/m2). |
|
| ExclusionCriteria |
| Details |
1)Women with known history of diabetes mellitus or on medication?
2) Women with known history of dyslipidemia,anemia, Thyroid dysfunction, Hypertension
3) Women with known case of cardiovascular disease, hepatic, pulmonary, renal dysfunction, psychiatric illness.
4) Women with dyspnea on walking.
5) Women who are unfit to practice yoga due to musculoskeletal conditions.
6) Women involved in daily physical activities or yoga. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
improvement in inflammatory markers improvement on Anthropometry
Improvement in QOL
|
30h day
60th day
90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| improvement in sleep cycle & improvement in mental health |
30h day
60th day
90th day |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
05/04/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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
|
Despite a wide range of researches on oxidative stress in post menopausal women has been conducted , there is still a knowledge gap in previous studies. Health care professionals are in search for proper guidance to relieve post menopausal symptoms in women as there are limited research evidence to guide decisions. Thus this study aims to bridge gaps in knowledge to ensure better lifestyle modification in women which will help them to lead a healthy life and needs further trials to prove its mechanism of action and efficacy. Therefore, a clinical trial on effect of yoga on inflammatory markers in post menopausal women will add good value to the array of women health. |