Actively Recruiting
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
Led by SF Research Institute, Inc. · Updated on 2026-04-27
60
Participants Needed
1
Research Sites
2 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 trial investigates the effects of a standardized Shatavari (Asparagus racemosus) root extract on women's sexual wellness, focusing on sexual function, distress, satisfaction, stress, quality of life, and physiological stress markers. The study is a randomized, double-blind, placebo-controlled clinical trial involving women aged 20 to 50 years with reduced sexual function and elevated stress. It aims to evaluate the efficacy and safety of Shatavari root extract in improving these aspects of sexual wellness. Participants will be randomly assigned to one of two groups: one receiving a daily 300 mg capsule of Shatavari root extract and the other receiving a matching placebo capsule containing starch. Both treatments are taken orally once daily after breakfast for 12 weeks. The study is conducted in multiple countries and follows a parallel-group design with quadruple blinding to ensure unbiased results. Throughout the 12-week trial, participants will undergo assessments at baseline and at weeks 4, 8, and 12, including questionnaires measuring sexual function, distress, satisfaction, perceived stress, and quality of life. Salivary cortisol tests and laboratory evaluations of thyroid, liver, and kidney functions will also be performed. Safety is monitored by recording adverse events from baseline to week 12. Participants are expected to comply with study procedures and attend scheduled visits for thorough monitoring and evaluation.
CONDITIONS
Brief 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 experiencing concerns related to sexual desire or function with a partner, with a Female Sexual Function Index (FSFI) total score of 26.55 or lower.
- Have a Perceived Stress Scale (PSS-10) score of 14 or higher at screening.
- Present signs or symptoms suggestive of stress, such as difficulty concentrating, physical exhaustion, anxiety, restlessness, insomnia, headache, fatigue, loss of appetite, worry, sweating, or mental confusion.
- Reliable, honest, compliant, and willing to cooperate with all trial evaluations.
- Able to communicate effectively and willing to discuss sexual functioning with the study staff.
- Able to read and write in English or other local languages.
- No plan to start new treatments during the study period.
- Willing and able to sign informed consent and comply with study procedures.
You will not qualify if you...
- Use of any herbal extract within 3 months before study entry.
- Hormonal imbalance including PCOS, and symptoms of perimenopause or menopause.
- Hormone replacement therapy (HRT) use for more than 3 months.
- Any active medical, surgical, or gynecological problems.
- History of alcohol, tobacco dependence, or substance abuse.
- Clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, hematologic, or other major systemic diseases.
- Mental conditions preventing understanding of the study.
- Inability to comply with study procedures or poor compliance.
- Inability to attend follow-up visits.
- Known allergy to Shatavari or any study ingredient.
- Participation in other clinical trials within the previous 3 months.
- Any clinical condition preventing safe participation according to the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants take either a Shatavari root extract capsule or a matched placebo capsule once daily after breakfast for 12 weeks to evaluate effects on sexual wellness and stress.
Visits at baseline, Week 4, Week 8, and Week 12 for assessments
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
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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