Health Condition 1: N951- Menopausal and female climactericstates
Conditions
Interventions
Intervention1: Badranjboya (Melissa officinalis L.): The drug will be pounded, sieved and mixed well to make a homogenous powder. Five grams will be administered daily orally for 8 weeks.
Control In
Sponsors
National Institute of Unani Medicine
Eligibility
Inclusion criteria
Inclusion criteria: All postmenopausal women (at least 1 year without menstrual cycle) with any postmenopausal symptoms as per Modified Kupperman Index scale (MKI) greater than or equal to 7 Women with Pittsburgh Sleep Quality Index score greater than or equal to 5 Women with psychological menopausal symptoms as per Depression, Anxiety and Stress Scale (DASS-21 scale). All postmenopausal women with follicle stimulating hormone (FSH) greater than 30 IU/ml.
Exclusion criteria
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 180 mg/dl or RBS more than 200mg/dl or HbA1c more than 7.00 percent), uncontrolled hypothyroid. Women with extremely severe psychological menopausal symptoms with DASS-21 scores for Depression more than 28, Anxiety more than 20 and Stress more than 34. Women with obstructive sleep apnea, restless leg syndrome, parasomnia, substances use such as alcohol or on sleeping pills. Women with diagnosed psychiatric diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Modified Kupperman Index questionnaireTimepoint: 4, 8, 12 and 16 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in DASS-21, PSQI, & Palpitation as per MKI score. Timepoint: At baseline week 8 & 16 weeks | — |
Countries
India
Contacts
Public ContactArshiya Sultana
National Institute of Unani Medicine
Outcome results
None listed