Study to find the effect of Ashwagandha and shatavari on quality of life,and blood vessel functio

Phase 4

• Conditions: Health Condition 1: Z728- Other problems related to lifestyle

• Registration Number: CTRI/2019/07/020347
• Lead Sponsor: Department of clinical pharmacology and therapeutics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Women of age between 40-55 years.

2.Amenorrhea for ââ?°Â¥12 months ââ?¬â?? where menopause is defined as having no menstrual period for 12 consecutive months by The American College of Obstetricians and Gynecologists - ACOG.

3.Willing to participate in the study for 24 weeks

Exclusion Criteria

1.Subjects with evidence/ history of malignancy.

2.Surgical menopause subjects.

3.Established cases of mental illness, hypertension, diabetes mellitus, rheumatoid arthritis, coronary artery disease, hepatic and renal impairment.

4.History of use of statins or other drugs for cholesterol control within 3 months of the study initiation.

5.Chronic smoking and/or regular alcohol intake.

6.Body mass index (BMI) less than 20 or greater than 32.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primry outcome: <br/ ><br>1.Changes in QOL using MENQOL questionnaire with 24 weeks treatment compared to baseline. <br/ ><br>2.Changes in biomarkers of bone health (CTX, BAP, OPG, sRANKL) <br/ ><br>3.Changes in RI - Reflection index at the end of 24 weeks treatment compared to baseline. <br/ ><br> <br/ ><br>Timepoint: Baseline, 4, 8, 12 and 24 weeks

Secondary Outcome Measures

Name	Time	Method
1. Changes in biomarkers of oxidative stress (MDA, GSH, NO); inflammatory biomarker-hsCRP, and platelet aggregation at 24 weeks treatment compared to baseline. <br/ ><br>2. Changes in lipid profile at 24 weeks treatment compared to baseline. <br/ ><br>3. Safety and tolerability will be assessed at the end of 24 weeks treatment compared to baseline <br/ ><br>Timepoint: Baseline, 4, 8, 12 and 24 weeks