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

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.

NCT Number	NCT07441096
Lead Sponsor	SF Research Institute, Inc. Collaborators: Ixoreal Biomed Private Limited
Conditions	Premenstrual Syndrome, Women Health
Enrollment	60 participants
Start Date	2026-03-20
Primary Completion	2026-06-22 (estimated)
Study Completion	2026-07-08 (estimated)
Updated on ClinicalTrials.gov	2026-03-03