Efficacy and Safety of Shatavari Root Extract for Premenstrual Syndrome in Women (NCT07441096) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy and Safety of Shatavari Root Extract for Premenstrual Syndrome in Women
United States60 participantsStarted 2026-03-20
Plain-language summary
Premenstrual syndrome (PMS) is a common condition that affects women of reproductive age and is associated with emotional, physical, and behavioral symptoms such as mood swings, irritability, stress, sleep problems, fatigue, and abdominal discomfort. These symptoms typically occur during the days leading up to menstruation and may interfere with daily activities and overall quality of life.
This study is designed to evaluate the efficacy and safety of Shatavari (Asparagus racemosus) root extract compared with placebo in women with mild to moderate PMS. Eligible participants will be randomly assigned to receive either Shatavari root extract (300 mg) or an identical placebo capsule once daily for 12 weeks. The study will assess changes in PMS symptoms, stress levels, sleep quality, and quality of life using validated questionnaires, along with measurements of salivary cortisol. Safety will be evaluated through clinical laboratory tests and monitoring of adverse events throughout the study.
Who can participate
Age range
18 Years – 40 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Healthy women aged 18-40 years with intact uterus and ovaries.
. Females with complaints of experiencing mild to moderate PMS confirmed by one baseline cycle using the DRSP.
. PSST sores consistent with PMS and not meeting criteria for severe PMS or PMDD.
. Body mass index 18-35 kg/m2.
. Subject who has given written informed consent to participate in the study and understand the nature of the study.
. Able to read and write in English or any other vernacular language.
. No plan to commence new treatments over the study period.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Daily Record of Severity of Problems (DRSP) Total Score