Actively Recruiting
Efficacy and Safety of Shatavari Root Extract in Women's Sexual Wellness
Led by SF Research Institute, Inc. · Updated on 2026-04-27
60
Participants Needed
1
Research Sites
15 weeks
Total Duration
On this page
Sponsors
S
SF Research Institute, Inc.
Lead Sponsor
I
Ixoreal Biomed Private Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Shatavari Root Extract in Women's Sexual Wellness
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women between 20 to 50 years of age.
- Sexually active or attempting sexual activity, or experiencing concerns related to sexual desire or function with a partner, with a Female Sexual Function Index (FSFI) total score of 26.55 or less.
- Have a Perceived Stress Scale (PSS-10) score of 14 or higher at screening.
- Show signs and symptoms suggestive of stress such as difficulty concentrating, physical exhaustion, anxiety, restlessness, insomnia, headache, fatigue, loss of appetite, worry, sweating, or mental confusion.
- Are reliable, honest, compliant, and willing to cooperate with all trial evaluations.
- Have sufficient understanding to communicate effectively and are willing to discuss sexual functioning with study staff.
- Can read and write in English or another vernacular language.
- Do not plan to start new treatments during the study period.
- Are able and willing to sign informed consent and comply with all study procedures.
You will not qualify if you...
- Have taken any form of herbal extract in the last 3 months before study entry.
- Have hormonal imbalances including polycystic ovary syndrome (PCOS), or symptoms of perimenopause or menopause.
- Are on hormone replacement therapy for more than 3 months.
- Have any active medical, surgical, or gynecological problems.
- Have a history of alcohol, tobacco dependence, or other substance abuse.
- Have clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, hematologic, or other major systemic diseases that interfere with the study.
- Have mental conditions that impair understanding of the study.
- Are unable to comply with study procedures or have poor compliance.
- Are unable to attend follow-up visits.
- Have known allergy to Shatavari or any study ingredients.
- Have participated in other clinical trials in the past 3 months.
- Have any clinical condition that prevents safe participation in the trial as judged by the investigator.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
San Francisco Research Institute
San Francisco, California, United States, 94132
Actively Recruiting
Research Team
D
Dr. John Ademola
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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