Efficacy and Safety of Shatavari (Asparagus Racemosus) Root Extract for Treatment of Perimenopausal Symptoms in Women: A Randomized, Double-Blind, Parallel, Placebo-Controlled Study
SF Research Institute, Inc.
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.
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 e…
Eligibility
- Age range
- 40–45 years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Menopausal women aged \>40 to 45 years with intact uterus and ovaries. 2. Participants who complained of irregular menstrual cycle in the past 12 months, with a forward or postpone of a cycle more 7 days. At least 2 cycles were missing during the past 12 months or reported menopause for at least 60 days. 3. Females with complaints of at least two of the menopausal symptoms, e.g., hot flashes, night sweats, mood swings, sleep disturbance, breast tenderness 4. Body mass index 18-35 kg/m2 5. Subject who has given written informed consent to participate in the study and und…
Interventions
- Dietary SupplementShatavari (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.
- OtherPlacebo 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.
Location
- San Francisco Research InstituteSan Francisco, California