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

Evaluation of the effect of extracts of Withania somnifera and Asparagus racemosus on quality of life, endothelial function and biomarkers in post-menopausal women.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/07/020347
Enrollment
120
Registered
2019-07-24
Start date
Unknown
Completion date
Unknown
Last updated
2022-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: Z728- Other problems related to lifestyle

Interventions

Intervention1: Extract of Withania somnifera: Extract of Withania somnifera (Sensoril) 125 mg - once daily for 24 weeks Intervention2: Extract of Withania somnifera: Extract of Withania somnifera (Sen

Sponsors

Department of clinical pharmacology and therapeutics
Lead Sponsor
Dr G Srinivas
Collaborator

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

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

Secondary

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

Countries

India

Contacts

Public ContactSRINIVAS GUNDAGANI

Nizam�s Institute of Medical Sciences

ushapingali@yahoo.com9849574143

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026