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Effect of menopause care bundle on health of women around menopause

Assessing the impact of Menopause care bundle on health related quality of life in Perimenopausal Women : A Randomised Controlled Trial - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/095403
Enrollment
200
Registered
2025-09-25
Start date
Unknown
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N951- Menopausal and female climactericstates

Interventions

Intervention1: Comprehensive lifestyle modification as a bundle of care: Health education to improve understanding, sensitisation and positive conversation Dietary guidance -individualised diet chart

Sponsors

AIIMS Rajkot
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
The outcome will be measured by Comparing MENQOL scores in both groups after the 12th week of interventionTimepoint: 12 weeks

Secondary

MeasureTime frame
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 groupsTimepoint: 12 weeks

Countries

India

Contacts

Public ContactUrmila Sunda

AIIMS ,Rajkot

drurmilasundagwalior@gmail.com9958479118

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026