Health Condition 1: R398- Other symptoms and signs involvingthe genitourinary system
Conditions
Interventions
Intervention1: Tukhme Anisoon: Four grams, in two divided doses twice daily, in capsule will be administered orally for 8 weeks
Control Intervention1: Placebo: roasted rice flour. Dose and duration sa
Sponsors
National Institute of Unani Medicine
Eligibility
Inclusion criteria
Inclusion criteria: Women aged 40 to 60 years. Women who either postmenopausal for =12 months or peri-menopausal (with amenorrhea lasting 2 to 11 months in the preceding year) will be included. Peri-menopausal women = 40 years old and had no other demonstrable reason for their amenorrhea.4 Women with psychological menopausal symptoms as per Depression Anxiety and Stress Scale(DASS-21 scale). Women with other menopausal symptoms such as vasomotor and somatic symptoms as per Modified Kupperman Index
Exclusion criteria
Exclusion criteria: Diagnosed cases of major depressive disorder, bipolar disorder, panic and phobic disorder, etc. Women with known systemic and endocrine diseases like uncontrolled hypertension and uncontrolled diabetes mellitus. Women with undiagnosed vaginal bleeding, history of endometrial hyperplasia, rapidly growing leiomyomata, history of surgical menopause. Women with hypersensitivity to drugs and past and present history of taking HRT, anxiolytics, antidepressants, mood stabilizers, and sedatives within two months. Pregnant and lactating women. Women with any kind of malignancies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in DASS-21 questionnaireTimepoint: Every month for 4 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Modified Kupperman Index questionnaire and change in Menopause Symptoms Treatment Satisfaction Questionnaire (MS-TSQ)Timepoint: Every month for 4 months | — |
Countries
India
Contacts
Public ContactDr Arshiya Sultana
National Institute of Unani Medicine
Outcome results
None listed