NCT07441109

Shatavari Root Extract for Perimenopausal Symptoms

Efficacy and Safety of Shatavari (Asparagus Racemosus) Root Extract for Treatment of Perimenopausal Symptoms in Women: A Randomized, Double-Blind, 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: 40 Years – 45 Years
• Healthy volunteers: Accepted

Summary

This randomized, double-blind, placebo-controlled clinical study evaluates the efficacy and safety of a standardized Shatavari (Asparagus racemosus) root extract in women experiencing perimenopausal symptoms. Participants will receive either Shatavari root extract or a matched placebo for 12 weeks. Efficacy will be assessed using validated menopause-specific symptom, quality-of-life, stress, mood, and sleep questionnaires, along with physiological stress markers. Safety will be evaluated through laboratory assessments and adverse event monitoring.

Detailed description

Perimenopause is characterized by fluctuating estrogen levels that contribute to vasomotor symptoms, mood disturbances, sleep disorders, and reduced quality of life. Shatavari (Asparagus racemosus) is a traditionally used Ayurvedic herb known for its adaptogenic and phytoestrogenic properties, supporting hormonal balance and stress regulation. This multi-center, prospective, randomized, double-blind, parallel-group study will enroll 160 perimenopausal women in India and the United States. Eligible participants will be randomized in a 1:1 ratio to receive either a standardized Shatavari root extract capsule (300 mg/day) or a matched placebo for 12 weeks. Primary efficacy will be assessed using the Menopause Rating Scale (MRS). Secondary outcomes include menopause-specific quality of life, hot flash interference, perceived stress, mood, sleep quality, and salivary cortisol measures. Safety will be evaluated through laboratory investigations and monitoring of adverse events.

Conditions

• Perimenopause
• Women Health

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Shatavari (Asparagus racemosus) Root Extract	A standardized Shatavari root extract manufactured under cGMP conditions with an herb-to-extract ratio of 13:1 and standardized to contain ≥10% total Shatavarins. Participants will self-administer one capsule daily for 12 weeks.
OTHER	Placebo Capsule	An inert starch-filled capsule identical in appearance, color, and packaging to the active intervention, administered once daily for 12 weeks to maintain blinding.

Timeline

• Start date: 2026-03-11
• Primary completion: 2026-06-15
• Completion: 2026-06-29
• First posted: 2026-02-27
• Last updated: 2026-03-03

Locations

1 site across 1 country: United States