Effect of Borage in Postmenopausal Syndrome
Phase 2
- Conditions
- Health Condition 1: N958- Other specified menopausal and perimenopausal disorders
- Registration Number
- CTRI/2024/05/067952
- Lead Sponsor
- ational Institute of Unani Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
All postmenopausal women (at least 1 year without menstrual cycle) with postmenopausal symptoms as per MKI scale.
All postmenopausal women with follicle stimulating hormone (FSH) more than 30 IU/ml.
Exclusion Criteria
Women with undiagnosed vaginal bleeding, surgical menopause (bilateral oophorectomy and malignancies.
Use of hormone therapy or oral contraceptives within two months.
Women with co-morbidities such as uncontrolled hypertension (Stage 2 hypertension more than 140/90 mmHg), uncontrolled diabetes mellitus (FBS more than 130mg/dl or PPBS more than 180mg/dl or RBS more than 200mg/dl or HbA1c more than 7.00%), uncontrolled hypothyroid
Women with diagnosed psychiatric diseases
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Modified Kupperman Index questionnaireTimepoint: Every month for 3 months during treatment and 1 month after treatment
- Secondary Outcome Measures
Name Time Method DASS-21, Vaginal Health Index score and Vaginal maturation Index <br/ ><br>Timepoint: Before intervention and after treatment at 3rd month