Health Condition 1: N959- Unspecified menopausal and perimenopausal disorder
Conditions
Interventions
Intervention1: Study: Ashwagandha Standardized extract capsule 300 mg
Dose: 1 capsule twice daily orally with water for 8 weeks
Control Intervention1: Control: Capsule identical to study capsule of As
Sponsors
Dr D Y Patil Medical College Hospital and Research Center
Eligibility
Inclusion criteria
Inclusion criteria: 1. Perimenopausal women with intact uterus and ovaries 2. Participants who complained of irregular menstrual cycle in the past 12 months, with a forward or postpone of a cycle more 7 days. At least 2 cycles were missing during the past 12 months, or reported menopause for at least 60 days 3. Females with complaints of perimenopausal symptoms, e.g., hot flash, insomnia, migraine, easy irritation, etc. 4. Body mass index 18-35 kg/m2 5. Subject who has given written informed consent to participate in the study and understand the nature of the study 6. Not illiterate
Exclusion criteria
Exclusion criteria: 1. Taking any form of herbal extract in the last 3 months before study entry 2. On hormone replacement therapy for more than 3 months 3. Present active medical, surgical and gynecological problems 4. History of drug or alcohol abuse 5. Ovariectomy 6. History of breast or cervical carcinoma 7. Taking medication that affect bone metabolism, including glucocorticoids, anticonvulsant and methotrexate 8. Clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, hematologic or other major systemic diseases making implementation of the protocol or other interpretation of the study result difficult 9. Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study 10. Evidence of uncooperative attitude, including poor compliance 11. Inability to attend follow-up visit 12. Subject with any other medical condition (for example uncontrolled infection) that may, in the opinion of the Investigator, interfere with the study objective
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite score of Menopause Rating Scale (MRS)Timepoint: Baseline, 4 weeks, 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood pressure (systolic and diastolic)Timepoint: Baseline, 4 weeks, 8 weeks;CLinical adverse eventsTimepoint: Baseline, 4 weeks, 8 weeks;Composite score of Menopause Specific Quality of Life (MEN-QOL) questionnaireTimepoint: Baseline, 4 weeks, 8 weeks;Global Assessment of Tolerability to Therapy (PGATT)Timepoint: End of therapy (8 weeks);Hot flash scoreTimepoint: Baseline, 4 weeks, 8 weeks;Menstrual cycleTimepoint: Baseline, 8 weeks;Menstrual PainTimepoint: Baseline, 4 weeks, 8 weeks;Serum hormone levels (FSH, LH, Estradiol, Testesterone)Timepoint: Baseline, 4 weeks, 8 weeks;Waist circumferenceTimepoint: Baseline, 4 weeks, 8 weeks | — |
Countries
India
Contacts
Public ContactDeepak Langade
Dr D Y Patil Medical College, Hospital And Research Center
Outcome results
None listed