Health Condition 1: null- Menopausal transition symptoms
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • Menopausal transition women aged 35 or more • Presence of any of these symptoms: menstrual changes, hypomenorrhoea, hot flushes, night sweats, sleep disturbances, palpitation, arthralgia, fatigue, anxiety, depression, urinary and sexual problems • Women with early and late transition: Early transition: changes in cycle length of >=7 days either direction observed for at least two consecutive cycles or 60 days amenorrhoea. Late transition: 90 days to 11 months amenorrhoea.
Exclusion criteria
Exclusion criteria: •Women with known systemic and endocrine diseases like uncontrolled hypertension and diabetes mellitus, thyroid dysfunctions. •Women with undiagnosed vaginal bleeding, history of surgical menopause. •Women with hypersensitivity to drugs and past history of taken HRT within two months •Pregnant and lactating women •Women with any kind of malignancies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The efficacy and safety of the test drug will be assessed by Menopausal Rating Scale (MRS).Timepoint: three months | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in menstrual irregularities (amenorrhoea, oligomenorrhoea and hypomenorrhoea)Timepoint: three months | — |
Countries
India
Contacts
National Institute of Unani Medicine