| CTRI Number |
CTRI/2025/01/079483 [Registered on: 27/01/2025] Trial Registered Prospectively |
| Last Modified On: |
27/05/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Process of Care Changes |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Impact of yoga on stress markers in women who have undergone menopause |
|
Scientific Title of Study
|
Effect of yoga on oxidative stress markers in post menopausal 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 Payal Nagmote |
| Designation |
PG Scholar |
| Affiliation |
Bharati Vidyapeeth(Deemed to be University) College of Ayurved and Hospital |
| Address |
Department of Swasthavritta Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital Dhankawadi Katraj Pune
Pune
MAHARASHTRA
411043
India |
| Phone |
7028369039 |
| Fax |
|
| Email |
payal.nagmote-ayurved@bvp.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kirti Bhati |
| Designation |
Professor and Head of Department |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital |
| Address |
Department of Swasthavritta Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital Dhankawadi Katraj 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 and Head of Department |
| Affiliation |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital |
| Address |
Department of Swasthavritta Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital Dhankawadi Katraj 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 Katraj, Pune 411043 |
|
|
Primary Sponsor
|
| Name |
Dr Payal Nagmote |
| Address |
Bharati Vidyapeeth (Deemed to be University) College of Ayuved and Hospital Department of Swasthavritta Dhankawadi Katraj Pune 411043 |
| 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 Payal Nagmote |
Bharati Vidyapeeth (Deemed to be University) College of Ayurved and Hospital |
Bharati Vidyapeeth College of Ayurveda, Department of Swasthavritta and yoga, opd no-15 Dhankawadi Katraj Pune
Pune
MAHARASHTRA |
07028369039
payal.nagmote-ayurved@bvp.edu.in |
|
|
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 |
Post menopausal and overweight |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Ardhachakrasan, parivrutta trikonasan , shasankasan , ardhaushtrasan , vakrasan , naukasen , dhanurasan , sitkari , bhramari , trikonasan , parshwakonasan , butterflypose , ardhamatsyendrasen , bhujangasen , shalabhasan , seetali, , Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Comparator Arm | Lifestyle | - | - | Dinacarya: , Ritucarya: , Acara Rasayana:, Other:Morning Jogging or skipping
OR
Stepping up and down
OR
Fast walking (15 minutes)
Lunch After lunch walking 15 minutes
Dinner After dinner slow walking 15 minutes
Sleep At night 6-7 hours
, Pathya/Apathya:, Pathya:, Apathya: |
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Female |
| Details |
1. Menopausal women who have achieved menopause within 1 to 5 years of age gap
2. Menopausal women who are overweight with BMI ranging from 23 to 35 kg/m sq |
|
| ExclusionCriteria |
| Details |
1. Women with comorbidities such as diabetes, dyslipidemia, anaemia or any thyroid dysfunction and are on regular medications.
2. Women with cardiovascular diseases or hepatic or renal dysfunction, dyspnoea while walking, hypertension or observed raised BP while screening (systolic greater than 140, dystolic less than 90)
3. Women with musculo skeletal conditions and are physically unfit to practice yoga
4. Women already involved in intense physical exercise or yoga in last 3 months |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| LESS SCORE IN QOL, IMPROVEMENT IN ANTHROPOMETRY, Improvement on oxidative stress markers by 10% |
1st, 30th, 60th and 90th days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Improvement in sleep cycle AND
Improvement in mental health |
1st, 30th, 60th & 90th days |
|
|
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)
|
14/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
14/02/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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 oxidative stress markers in post menopausal women will add good value to
the array of women health. |