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

Part of paid clinical trials in San Francisco, California.

Sponsor
SF Research Institute, Inc.
Study ID
NCT07441096
Status
Not Yet Recruiting

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Conditions

  • Premenstrual Syndrome
  • Women Health

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 40 Years
Healthy Volunteers
Accepted

Interventions

  • Shatavari Root Extract — DIETARY_SUPPLEMENT
    Shatavari (Asparagus racemosus) root extract is a standardized herbal dietary supplement formulated as an oral capsule. Each capsule contains 300 mg of Shatavari root extract standardized to total shatavarins. Participants will take one capsule orally once daily in the morning with water for a duration of 12 weeks.
  • Placebo Capsule — OTHER
    The placebo is an oral capsule identical in appearance to the active intervention and contains 300 mg of starch. Participants will take one capsule orally once daily in the morning with water for 12 weeks.

Study Details

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.

Key Dates

Start date
Mar 20, 2026
Status verified
Feb 2026
Primary completion
Jun 22, 2026
Completion
Jul 8, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Shatavari Root Extract
    Participants assigned to this arm will receive Shatavari (Asparagus racemosus) root extract capsules at a dose of 300 mg taken orally once daily for 12 weeks.
  • Placebo Comparator: Placebo (Inactive capsule)
    Participants assigned to this arm will receive an identical placebo capsule containing starch, taken orally once daily for 12 weeks.

Primary Outcome Measure

Change in Daily Record of Severity of Problems (DRSP) Total Score [ Time Frame: Baseline, Week 4, Week 8, and Week 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
San Francisco Research InstituteSan FranciscoCalifornia94132
Komal Makwana
[email protected]
267-466-9000

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By research site
San Francisco Research Institute· San Francisco, CA

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