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CTRI Number  CTRI/2025/09/095403 [Registered on: 25/09/2025] Trial Registered Prospectively
Last Modified On: 24/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Effect of menopause care bundle on health of women around menopause 
Scientific Title of Study   Assessing the impact of Menopause care bundle on health related quality of life in Perimenopausal Women : A Randomised Controlled Trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Urmila Sunda 
Designation  Assistant Professor 
Affiliation  AIIMS ,Rajkot 
Address  Department of obstetrics and gynecology, IPD block, AIIMS Rajkot, Village Khanderi ,District Rajkot

Rajkot
GUJARAT
360110
India 
Phone  9958479118  
Fax    
Email  drurmilasundagwalior@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Urmila Sunda 
Designation  Assistant Professor 
Affiliation  AIIMS ,Rajkot 
Address  Department of obstetrics and gynecology, IPD block, AIIMS Rajkot, Village Khanderi ,District Rajkot

Rajkot
GUJARAT
360110
India 
Phone  9958479118  
Fax    
Email  drurmilasundagwalior@gmail.com  
 
Details of Contact Person
Public Query  
Name  Urmila Sunda 
Designation  Assistant Professor 
Affiliation  AIIMS ,Rajkot 
Address  Department of obstetrics and gynecology, IPD block, AIIMS Rajkot, Village Khanderi ,District Rajkot

Rajkot
GUJARAT
360110
India 
Phone  9958479118  
Fax    
Email  drurmilasundagwalior@gmail.com  
 
Source of Monetary or Material Support  
AIIMS ,Rajkot 
 
Primary Sponsor  
Name  AIIMS Rajkot 
Address  AIIMS Rajkot, Village Khanderi, District Rajkot, Gujarat 360110 
Type of Sponsor  Research institution and hospital 
 
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 
Urmila Sunda  AIIMS Rajkot  Department of obstetrics and gynecology, IPD block, AIIMS Rajkot, Village Khanderi ,District Rajkot
Rajkot
GUJARAT 		 09958479118

drurmilasundagwalior@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, AIIMS Rajkot  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N951||Menopausal and female climactericstates,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Comprehensive lifestyle modification as a bundle of care  Health education to improve understanding, sensitisation and positive conversation Dietary guidance -individualised diet chart Exercise- including abdominal core exercises and pelvic floor muscle exercise 
Comparator Agent  Symptomatic care  Treat according to the symptomatology of the participant as standard care 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  50.00 Year(s)
Gender  Female 
Details  Women (in the age group 40-50 years) with Perimenopausal symptoms who have given consent for participation and have not received HRT in the last three months before the study  
 
ExclusionCriteria 
Details  The patient who has received HRT within the last 3 months.
A woman who has received HRT within the last 3 months,
A diagnosed case of atherosclerotic cardiovascular disease and psychiatric illness, and on treatment.
Iatrogenic menopausal status.
A patient who has undergone any pelvic floor surgery.
Refusal of consent 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The outcome will be measured by Comparing MENQOL scores in both groups after the 12th week of intervention  12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
BCA, body fat percentage, and echocardiographic changes to assess cardiometabolic health and comparison of pelvic floor muscle strength by measuring the modified Oxford scale score in both groups  12 weeks 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
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)   06/10/2025 
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)   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 study is a randomised, parallel group interventional trial assessing the effectiveness of a comprehensive lifestyle modification strategy, implemented through a bundle-of-care approach, in improving the menopause-related quality of life, cardiometabolic health, and genitourinary well-being of perimenopausal women.  The study will target perimenopausal women, typically aged 40-50 years, who are experiencing the transitional phase of menopause and facing associated health challenges. The intervention group will receive menopause care as a bundle of care approach and will be reassessed at 12 weeks of intervention. The Bundle of Care approach will involve integrated lifestyle modifications, including Dietary changes aimed at promoting overall health and addressing specific risks related to perimenopause, physical activity interventions focused on exercise routines that improve cardiovascular, metabolic, and musculoskeletal health, stress management techniques such as mindfulness, relaxation practices through health education to address emotional well-being. These interventions will be designed to be sustainable and feasible for long-term implementation in daily life and menopause-related quality of life. The control group will receive routine symptomatic care as per standard. The impact of lifestyle modifications will be assessed using the MENQOL scoring system at 12 weeks. In secondary outcomes, the research will focus on the changes in cardiometabolic markers such as blood pressure, body mass index (BMI), lipid profile (cholesterol levels), glucose metabolism, and genitourinary health in terms of improvement in urinary symptoms, vaginal health, and sexual function at 12 weeks of intervention. This research aims to fill a gap in understanding how a comprehensive, bundled lifestyle modification strategy can address the diverse health challenges faced by perimenopausal women and contribute to better long-term health outcomes. These interventions can be an integral part of geriatric healthcare practices for the healthy ageing of women.

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