Efficacy and Safety of Shatavari (Asparagus Racemosus) Root Extract in Women's Sexual Wellness: A Prospective, Randomized, Double-Blind, Two-Arm, Parallel, Placebo-Controlled Study
SF Research Institute, Inc.
Summary
This randomized, double-blind, placebo-controlled clinical study is designed to evaluate the efficacy and safety of a standardized Shatavari (Asparagus racemosus) root extract (SRI-81) in improving women's sexual wellness. Sexual wellness is assessed as a multidimensional construct encompassing sexual function, sexual distress, sexual satisfaction, perceived stress, quality of life, and physiological stress markers. Participants will receive either Shatavari root extract or placebo for 12 weeks, with assessments conducted at baseline and follow-up visits.
Description
Women's sexual wellness is influenced by biological, psychological, and social factors. Stress and neuroendocrine imbalance play a central role in sexual dysfunction and distress. Shatavari (Asparagus racemosus), a traditional Ayurvedic herb, has been historically used to support female reproductive health, hormonal balance, and stress modulation. This multi-national, prospective, randomized, double-blind, parallel-group study will enroll women aged 20 to 50 years in India and the United States. Eligible participants with reduced sexual function and elevated perceived stress will be randomize…
Eligibility
- Age range
- 20–50 years
- Sex
- Female
- Healthy volunteers
- Yes
Inclusion Criteria: 1. Women between 20 to 50 years of age. 2. Sexually active, attempting sexual activity, or experiencing concerns related to sexual desire or function, with a partner and have a FSFI total score ≤ 26.55. 3. Have a PSS-10 score of ≥ 14 at screening. 4. Women presenting with signs and symptoms suggestive of stress (e.g., difficulty, concentrating, physical exhaustion, anxiety, restlessness, insomnia, headache, fatigue, loss of appetite, worry, sweating, mental confusion, etc.). 5. Participants who are reliable, honest, compliant, and agree to co operate with all trial evaluat…
Interventions
- Dietary SupplementShatavari (Asparagus racemosus) Root Extract
The investigational intervention is a standardized Shatavari (Asparagus racemosus Willd.) root extract (SRI-81), manufactured under current Good Manufacturing Practice (cGMP) conditions. Each capsule contains 300 mg of Shatavari root extract with an herb-to-extract ratio of 13:1 and is standardized to contain ≥10% total Shatavarins, quantified by high-performance liquid chromatography (HPLC). Participants will self-administer one capsule orally once daily after breakfast with water for 12 weeks. The product is designed to support stress modulation and neuroendocrine balance, which may contribute to improvements in women's sexual wellness outcomes.
- OtherPlacebo Capsule
The placebo intervention consists of an orally administered capsule containing 300 mg of inert starch. The placebo capsules are identical in size, color, appearance, and packaging to the active Shatavari intervention to ensure double blinding of participants and study personnel. Participants will self-administer one capsule once daily after breakfast with water for 12 weeks. The placebo contains no active herbal or pharmacological ingredients and is used solely for comparison with the investigational Shatavari root extract.
Location
- San Francisco Research InstituteSan Francisco, California