Study the efficacy and safety of Ashwagandha extract in Women with Perimenopausal Symptoms

Not Applicable

Completed

• Conditions: Health Condition 1: N959- Unspecified menopausal and perimenopausal disorder

• Registration Number: CTRI/2019/10/021547
• Lead Sponsor: Dr D Y Patil Medical College Hospital and Research Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-12-29
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite score of Menopause Rating Scale (MRS)Timepoint: Baseline, 4 weeks, 8 weeks

Secondary Outcome Measures

Name	Time	Method
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