Shatavari for Menopausal Symptoms Study

This study is testing two dietary supplements, Shatavari extract and a combination of Shatavari and Ashwagandha extracts, to see if they can help with menopausal symptoms like hot flashes and mood changes. Researchers want to compare these supplements to a placebo (an inactive substance like a sugar pill) to understand their effectiveness and safety. You might be able to join if you are a woman between 45 and 65 years old, have an intact uterus and ovaries, and are experiencing menopausal symptoms and irregular periods. The study aims to enroll 51 participants, but the current recruitment status is unclear.

Study design
This is a randomized, double-blind, placebo-controlled study with three groups. About 51 participants will be randomly assigned to receive Shatavari, Shatavari plus Ashwagandha, or a placebo.
What's involved
You would take one capsule daily for 8 weeks. You will have visits at the beginning, after 4 weeks, and at the end of 8 weeks, which include physical exams and blood draws.
Compensation
Not stated in the trial record.
Follow-up
Your menopausal symptoms will be assessed at the start of the study, after 4 weeks, and at the end of the 8-week treatment period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06716554

Efficacy and Safety of Shatavari for Treatment of Menopausal Symptoms in Women: A Randomized, Double-blind, Three-arm, Parallel, Placebo-controlled Study

Recruiting
NAAges 45–55InterventionalTreatment
SF Research Institute, Inc.
~51 participants
Updated 2024-12-04 on ClinicalTrials.gov
What's tested:Shatavari extractShatavari + Ashwagandha extractPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Menopause Rating Scale (MRS)
Measured over MRS assessment will be done at Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1), Visit 2 (Week 4), and Visit 3- End of study visit, (Week 8).
Menopause
Hot Flashes
Mood
1 sites across 1 states
California1

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  • Menopause Rating Scale (MRS)MRS assessment will be done at Visit 1, Screening Visit/ Enrolment Visit/ Baseline Visit, (Day 1), Visit 2 (Week 4), and Visit 3- End of study visit, (Week 8).

    The scale consisted of 11 items, ranging from no symptoms to very severe symptoms. The total score of the MRS ranges from 0 (asymptomatic) to 44 (highest degree of complaints). The minimal/maximal scores vary between the three dimensions, depending on the number of complaints allocated to the respective dimension of symptoms.