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CTRI Number  CTRI/2025/09/094115 [Registered on: 02/09/2025] Trial Registered Prospectively
Last Modified On: 30/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Evaluating Yoga to Improve Cardiovascular Health in Post-Menopausal Women 
Scientific Title of Study   Impact of yoga on cardiovascular health in post-menopausal women: A randomized controlled clinical study 
Trial Acronym  SAKHI-2025 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Supriya Bhalerao 
Designation  Professor  
Affiliation  Interactive Research School for Health Affairs Bharati Vidyapeeth Deemed University 
Address  Obesity and Diabetes Department, Interactive Research School for Health Affairs Bharati Vidyapeeth Deemed-to-be University Dhankawadi, Pune-Satara Road.

Pune
MAHARASHTRA
411043
India 
Phone  9869555272  
Fax    
Email  supriya.bhalerao@bharatividyapeeth.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Supriya Bhalerao 
Designation  Professor  
Affiliation  Interactive Research School for Health Affairs Bharati Vidyapeeth Deemed University 
Address  Obesity and Diabetes Department, Interactive Research School for Health Affairs Bharati Vidyapeeth Deemed-to-be University Dhankawadi, Pune-Satara Road.

Pune
MAHARASHTRA
411043
India 
Phone  9869555272  
Fax    
Email  supriya.bhalerao@bharatividyapeeth.edu  
 
Details of Contact Person
Public Query  
Name  Priya Gahlot 
Designation  Junior Research Fellow 
Affiliation  Interactive Research School for Health Affairs 
Address  Obesity and Diabetes Department, Interactive Research School for Health Affairs Bharati Vidyapeeth Deemed-to-be University Dhankawadi, Pune-Satara Road

Pune
MAHARASHTRA
411038
India 
Phone  9166428782  
Fax    
Email  priya.gahlot@bharatividyapeeth.edu  
 
Source of Monetary or Material Support  
Department of Science and Technology under Vigyan Dhara in SHRI (science & heritage research initiative) scheme, New-Delhi, India - 110016 
 
Primary Sponsor  
Name  Department of Science and Technology under SHRI (Science & Heritage Research Initiative) scheme 
Address  Science and Heritage Research Initiative Cell, Department of Science and Technology, Ministry of Science and Technology, Government of India, New Delhi - 110016 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Priya Gahlot  Bharati Hospital & Research Centre  OPD Room No-07, Medicine Department, Ground floor, old building, Bharati Hospital & Research Centre, Pune-Satara Road, Katraj, Pune – 411043 MAHARASHTRA
Pune
MAHARASHTRA 		 9860258443

priya.gahlot@bharatividyapeeth.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE BHARATI VIDYAPEETH DEEMED UNIVERSITY  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E889||Metabolic disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Lifestyle Modification  Follow Lifestyle Recommendations for 90 Days  
Intervention  Yoga   S-Vyasa Yoga for 60 minutes daily for 6 days in a week for 90 Days 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  55.00 Year(s)
Gender  Female 
Details  1. Women in the age group 45-55 years within 5 years of menopause
2. Overweight or obese women (BMI 23-35kg/m2) with either of the following conditions:
a. Self-reported cardiovascular risk factor:
i. Family History of cardiac disease
ii. Smoking
iii. Alcohol use
iv. Physical inactivity
v. Stress
vi. Inadequate sleep
b. T2DM (known or diagnosed while screening)
c. Dyslipidemia (known or diagnosed while screening)
3. Women ready to follow and abide by all study procedures 
 
ExclusionCriteria 
Details  1. Women with HbA1c more than or equal to 7%
2. Women with Triglycerides more than or equal to 200mg/dL and HDL less than or equal to 40mg/dL
3. Women with Hemoglobin less than or equal to 8g/dL or Serum Creatinine more than or equal to 1.02mg/dL
4. Women with Hypertension (Systolic pressure greater than 140mmHg and Diastolic pressure greater than 90mmHg with or without medication)
5. Women with a known history of cardiovascular diseases
6. Women with ST-T wave changes on electrocardiogram (ECG)
7. Women who are medically unfit to practise yoga, like musculoskeletal or orthopaedic conditions, etc.
8. Women on any kind of medication for psychiatric illness or hormone therapy, or have undergone hysterectomy
9. Women involved in intense physical activities (weight training, aerobics, gym workouts, running, or yoga) in the last 3 months 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
More number of participants benefiting in the yoga group than the lifestyle counselling group  Baseline (Day 0) and End of Study (Day 90) 
 
Secondary Outcome  
Outcome  TimePoints 
Better improvement in VO 2 max in the yoga group than the lifestyle counselling group  Baseline (Day 0) and End of Study (Day 90) 
 
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   N/A 
Date of First Enrollment (India)   15/09/2025 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
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  
The open-label, randomized, controlled clinical study aims to evaluate the impact of yoga on cardiovascular health and low-grade inflammation in postmenopausal women. 
The study will last for 90 days with a sample size: 60 participants, 30 in each group.

Eligibility criteria:- 
Inclusive criteria: 
  • Women in the age group 45-55 years within 5 years of menopause 
  • Overweight or obese women (BMI of more than or equal 23 kg/m 2 and less than or equal 35 kg/m 2 ) with either of the following conditions: 
    •  Self-reported cardiovascular risk factor: 
      •   Family History of cardiac disease 
      •   Smoking
      •   Alcohol use 
      •   Physical inactivity 
      •   Stress 
      •   Inadequate sleep 
    • T2DM (known or diagnosed while screening) 
    • Dyslipidemia (known or diagnosed while screening) 
  • Women ready to follow and abide by all study procedures 
Exclusion criteria: 
  • Women with HbA1c more than or equal 7 percent
  • Women with Triglycerides more than or equal 200 mg/dL and HDL less than or equal 40 mg/dL 
  • Women with Hemoglobin less than or equal 8 g/dL or Serum creatinine more than or equal 1.02 mg/dL
  • Women with Hypertension (Systolic pressure more than 140 mm Hg and diastolic pressure more than 90 mm Hg with or without medication) 
  • Women with a known history of cardiovascular diseases 
  • Women with ST-T wave changes on electrocardiogram (ECG) 
  • Women who are medically unfit to practise yoga, like musculoskeletal conditions, orthopaedic conditions, etc. 
  • Women on any kind of medication for psychiatric illness or hormone therapy, or have undergone hysterectomy 
  • Women involved in intense physical activities (weight training, aerobics, gym, running) or yoga in the last 3 months
Participants who are eligible as per the criteria will be recruited from community screening and hospital-based programs and will be randomly allocated to two groups:
  • Group A: Lifestyle counselling
  • Group B: Yoga along with lifestyle counselling
Lifestyle counselling participant will be required to follow the lifestyle recommendation focused on nutrition, exercise, sleep, and stress management. They will be asked to download the Google Fit App on their mobile phones and enter their meals and sleep in the app. They will be instructed to send screenshots of their activity, nutrition and sleep once weekly. If the lifestyle entries in the Google Fit App are less than 24 per month, they will be withdrawn from the study.

The yoga module, based on the S-VYASA protocol, will be conducted online six days a week. For the convenience of the participants, the sessions will be conducted twice daily (morning/evening). The participant can choose any one of the 2 sessions. The participants are expected to attend a minimum of 20 sessions in a month. If the missed sessions exceed more than 20, they will be withdrawn from the study.

Assessments will be performed at baseline (Day 0) and at the end of the study (Day 90) and will include:
  • Cardiovascular parameters: VO2 max (Cooper’s Test), 
  • Vitals: Pulse rate and blood pressure
  • Anthropometry: body composition and waist & hip circumference
  • Biochemical and biomarker profiling: 
    • Glycemic (fasting blood sugar, fasting insulin), 
    • Lipid (Triglycerides, hdl, ldl, total cholesterol), 
    • Cardiac(oxidised ldl, vascular cell adhesion molecule,nitric oxide,Amyloid-A), 
    • Oxidative stress(lactate dehydrogenase, 8-hydroxy-2-deoxyguanosine), 
    • Inflammatory(TNF-alpha, plasminogen activator inhibitor-a, adiponectin, Hs-CRP), and 
    • Hormonal marker(Estrogen)
  • Questionnaires: MENQOL, DASS, and PSQI 
Study Outcome:
1. A higher number of participants showing clinical improvement in the yoga group compared to the lifestyle counselling group
2. Greater improvement in VO2 max in the yoga group compared to the lifestyle counselling group

Optional evaluations may be done at Day 30 and Day 60, but primary endpoint analysis will focus on baseline and Day 90 data. Safety monitoring, adverse event reporting, and adherence checks (yoga attendance and lifestyle diary entries) will be performed throughout the study.

Concomitant care: 
Participants will continue to take medicines for their other medical conditions, like dyslipidemia, hypertension, skin allergies, and diabetes, during the course of the study. A record of their concomitant medications will be maintained.

Dropouts and Withdrawals: 
The investigator shall withdraw the subjects from the study if- 
Occurrence of any medical condition or circumstance that exposes the subject to substantial risk and/or does not allow the subject to adhere to the requirements of the protocol. 
Any serious adverse event (SAE), clinically significant adverse event, severe laboratory abnormality, or other medical condition that indicates to the Investigator that continued participation is not in the best interest of the subject. 
Participant’s failure to comply with protocol requirements or study-related procedures. 
Participants in the yoga group who attend less than 20 yoga sessions per month. 
Participants who have less than 24 lifestyle entries in the Google Fit App per month. 
Participants that withdraw consent.
 
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