Health Condition 1: N951- Menopausal and female climactericstates
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Menopausal Rating Scale (MRS) score 12-35 2. Female patients of age 35 55 years. 3. Having different type of disturbed sleep patterns e.g. sleep onset insomnia, sleep maintenance insomnia, nocturnal awakenings. 4. Subjective sleep disturbance defined as Pittsburgh Sleep Quality Index (PSQI) greater than 5 at screening. 5. Perimenopausal women having poor quality of sleep for more than 1 month.
Exclusion criteria
Exclusion criteria: 1. Patient with uncontrolled diabetes, hypertension, any thyroid disorder, and severe obesity. 2. Fatal familial insomniacs. 3. Patients with severe mental illnesses. 4. Surgical menopause. 5. Patients having a known history of major cardiac disease or surgery. 6. Use of Hormonal Replacement Therapy (HRT) 7. History of substance abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment of sleep quality using the Pittsburgh Sleep Quality Index (PSQI).Timepoint: Day 1, Day 45 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Assessment of signs and symptoms Associated with Poor Quality Of Sleep. 2. Assessment of menopause-specific quality of life using the MENQOL questionnaire. 3. Assessment of Menopausal Rating Scale (MRS). 4. Assessment of serum estradiol. Timepoint: 1. Assessment of Menopausal Rating Scale (MRS)-Day 0,Day 45 2. Assessment of signs and symptoms Associated with Poor Quality Of Sleep- Day 1, Day 45 3. Assessment of menopause-specific quality of life using the MENQOL questionnaire- Day 1, Day 45 4. Assessment of serum estradiol-Day 1, Day 45 | — |
Countries
India
Contacts
Ayurvedic and Unani Tibbia College and Hospital karol bagh, New Delhi-110005