Efficacy and Safety of Shatavari Root Extract in Women's Sexual Wellness

Conditions

• Sexual Wellness
• Women Health

Eligibility Criteria

Sex

FEMALE

Age

20 Years - 50 Years

Healthy Volunteers

Accepted

Interventions

• Shatavari (Asparagus racemosus) Root Extract — DIETARY_SUPPLEMENT
  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.
• Placebo Capsule — OTHER
  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.

Study Details

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.

Key Dates

Start date

Apr 29, 2026

Status verified

Apr 2026

Primary completion

Jul 30, 2026

Completion

Aug 15, 2026

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Shatavari Root Extract (SRI-81) 300 mg
  Participants randomized to this arm will receive a standardized Shatavari (Asparagus racemosus) root extract (SRI-81) capsule containing 300 mg, administered orally once daily after breakfast with water for a duration of 12 weeks. The intervention is intended to evaluate the efficacy and safety of Shatavari root extract in improving women's sexual wellness, including sexual function, sexual distress, sexual satisfaction, perceived stress, quality of life, and physiological stress markers, compared with placebo.
• Placebo Comparator: Placebo Capsule (Starch) 300 mg
  Participants randomized to this arm will receive an identical placebo capsule containing 300 mg of starch, administered orally once daily after breakfast with water for 12 weeks. The placebo is matched in appearance, color, and packaging to the active intervention to maintain blinding. This arm serves as the comparator for evaluating the efficacy and safety of Shatavari root extract in women's sexual wellness.

Primary Outcome Measure

Change in Female Sexual Function Index (FSFI) total score [ Time Frame: Baseline, Week 4, Week 8, Week 12 ]

Central Contacts

• Dr. John Ademola
  415-845-4638
  [email protected]

Locations (1)

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