NCT07441096

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

Efficacy and Safety of Shatavari (Asparagus Racemosus) Root Extract for the Treatment of Premenstrual Syndrome Symptoms in Women: A Randomized, Double-Blind, Two-Arm, Parallel, Placebo-Controlled Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: SF Research Institute, Inc. · Network
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

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.

Detailed description

Premenstrual syndrome (PMS) is characterized by recurrent emotional, physical, and behavioral symptoms that occur during the luteal phase of the menstrual cycle and resolve shortly after the onset of menstruation. A significant proportion of women experience PMS, and in many cases the symptoms are severe enough to impair daily functioning, work productivity, and interpersonal relationships. Hormonal fluctuations, stress sensitivity, and neuroendocrine dysregulation are considered key contributors to the condition. Shatavari (Asparagus racemosus) is a traditional Ayurvedic herb widely used to support women's reproductive health. It is regarded as an adaptogenic and hormonal-modulating botanical, containing bioactive constituents such as steroidal saponins (shatavarins) that may help regulate hormonal balance and stress response. Traditional use and emerging scientific evidence suggest that Shatavari may be beneficial in alleviating mood disturbances, fatigue, sleep problems, and stress-related symptoms commonly associated with PMS. This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of a standardized Shatavari root extract in women with mild to moderate PMS. Approximately 160 premenopausal women aged 18 to 40 years will be enrolled across study sites in India and the United States. Eligibility will be confirmed using clinical history and prospective symptom assessment with the Daily Record of Severity of Problems (DRSP) during a baseline cycle. Participants will be randomized in a 1:1 ratio to receive either Shatavari root extract (300 mg) or an identical placebo capsule once daily for 12 weeks. Study visits will occur at baseline and at Weeks 4, 8, and 12. Efficacy will be evaluated using validated patient-reported outcome measures including the DRSP, Perceived Stress Scale (PSS), Pittsburgh Sleep Quality Index (PSQI), and Women's Quality of Life Questionnaire (WOMQOL). Neuroendocrine stress response will be assessed through salivary cortisol measurements, including cortisol awakening response and bedtime cortisol levels, collected at baseline and at the end of the study. Safety will be monitored throughout the study through physical examinations, vital signs, laboratory assessments of liver, renal, and thyroid function, and systematic recording of treatment-emergent adverse events and serious adverse events. The findings of this study are expected to provide clinical evidence regarding the efficacy, safety, and tolerability of Shatavari root extract for the management of premenstrual syndrome symptoms and to support future confirmatory clinical research.

Conditions

• Premenstrual Syndrome
• Women Health

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Shatavari Root Extract	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.
OTHER	Placebo Capsule	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.

Timeline

• Start date: 2026-03-20
• Primary completion: 2026-06-22
• Completion: 2026-07-08
• First posted: 2026-02-27
• Last updated: 2026-03-03

Locations

1 site across 1 country: United States