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Shatavari Root Extract for Premenstrual Syndrome

This study is looking at whether Shatavari Root Extract can help women with mild to moderate premenstrual syndrome (PMS). PMS can cause symptoms like mood swings, fatigue, and discomfort before your period. Researchers want to see if Shatavari Root Extract is safe and effective compared to a placebo (an inactive capsule that looks the same). You could be eligible if you are a woman between 18 and 40 years old with mild to moderate PMS. The study will measure changes in your PMS symptoms over 12 weeks using a daily symptom record. The current recruitment status is unclear.

Study design
This is a randomized, double-blind study, meaning participants will be randomly assigned to receive either Shatavari Root Extract or a placebo, and neither you nor the study team will know which you are receiving. The study plans to enroll 60 women.
What's involved
Participants will take one capsule by mouth once daily in the morning with water for 12 weeks. Your PMS symptoms will be measured at the start, and again at weeks 4, 8, and 12.
Compensation
Not stated in the trial record.
Follow-up
Your PMS symptoms will be tracked for 12 weeks, with the last measurement at Week 12.

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

NCT07441096

Efficacy and Safety of Shatavari Root Extract for Premenstrual Syndrome in Women

Not Yet Recruiting
NAAges 18–40InterventionalTreatment
SF Research Institute, Inc.
~60 participants
Updated 2026-03-03 on ClinicalTrials.gov
What's tested:Shatavari Root ExtractPlacebo Capsule

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Daily Record of Severity of Problems (DRSP) Total Score
Measured over Baseline, Week 4, Week 8, and Week 12

Conditions

Premenstrual Syndrome
Women Health

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Premenstrual syndrome

NCT07441096

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • San Francisco Research Institute

    San Francisco, Californiastudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Dr. John Ademola
[email protected]
415-845-4638
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Exclusion

1\. Participants taking any form of herbal extract in the last 3 months before study entry. 2. Participants who are on hormone replacement therapy (HRT) for more than 3 months. 3. Participants who are pregnant. 4. Participants with irregular menstrual cycles in the past 12 months (cycle length variability \>7 days), ≥2 missed cycles in the past 12 months, or amenorrhea ≥60 days. 5. Participants with Present active medical, surgical, and gynaecological problems. 6. Participants with a history of alcohol, tobacco dependence, or any substance abuse. 7. Participants who had undergone bilateral ovariectomy 8. Participants with history of breast or cervical carcinoma 9. Participants who taking medication that affect bone metabolism, including glucocorticoid, anticonvulsant, and methotrexate. 10. Participants with clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, haematologic or other major systemic diseases making implementation of the protocol or other interpretation of the study results difficult. 11. Participants with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. 12. Participants with demonstrated inability to comply with study procedures or follow-up visits. 13. Participants with inability to attend follow-up visit 14. Participants with any other medical condition (for example uncontrolled infection) that may, in the opinion of the Investigator, interfere with the study objective. 15. Patients who had participated in other clinical trials during the previous 3 months. 16. Patients who have any clinical condition, according to the investigator who does not allow safe fulfilment of clinical trial protocol.

What this trial measures

  • Change in Daily Record of Severity of Problems (DRSP) Total ScoreBaseline, Week 4, Week 8, and Week 12

    The Daily Record of Severity of Problems (DRSP) is a validated patient-reported questionnaire used to assess emotional, physical, and functional symptoms associated with premenstrual syndrome (PMS). The DRSP consists of 21 items scored daily from 1 (not at all) to 6 (extreme). The total score ranges from 21 to 126, with higher scores indicating greater symptom severity (worse outcome). DRSP scores will be recorded daily and averaged/summarized for each assessment visit. This outcome measures the mean change from baseline in DRSP total score, where a reduction in score indicates improvement in premenstrual symptom severity.