Shatavari root extract for women's sexual wellness

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

This trial will test whether taking a daily Shatavari root supplement for 12 weeks helps women aged 20–50 with low sexual function and high perceived stress improve sexual wellness.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 20 Years to 50 Years
• Sex: Female
• Sponsor: SF Research Institute, Inc. (Research network)
• Locations: 1 site (San Francisco, California)
• Trial ID: NCT07441083 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, placebo-controlled, parallel-group trial enrolling sexually active women aged 20–50 with reduced sexual function and elevated perceived stress. Participants are randomized 1:1 to receive 300 mg/day of a standardized Shatavari (Asparagus racemosus) root extract (SRI-81) or matched placebo for 12 weeks, with baseline and follow-up visits. The primary efficacy measure is the Female Sexual Function Index (FSFI), with secondary outcomes including sexual distress, sexual satisfaction, perceived stress, quality of life, salivary cortisol, and routine laboratory safety tests. Safety is monitored via adverse event reporting and laboratory assessments throughout the treatment period.

Who should consider this trial

Good fit: Women aged 20–50 who are sexually active (or attempting activity), have an FSFI total score ≤26.55 and a Perceived Stress Scale (PSS-10) score ≥14, and can attend study visits are ideal candidates.

Not a fit: Women without reduced sexual function or without elevated perceived stress, or those starting new treatments during the study period, are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If effective, this supplement could offer a low-risk, nonhormonal option to improve sexual function and reduce stress-related sexual distress in affected women.

How similar studies have performed: There are limited clinical data and some preclinical or small-scale reports suggesting Shatavari may support female reproductive health and stress modulation, but large randomized trials for sexual wellness are scarce.

Eligibility criteria

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 evaluations as well as to be able to perform them as per investigator's opinion.
6. Participants having sufficient understanding to communicate effectively with the investigator and are willing to discuss their sexual functioning with the investigative staff.
7. Able to read and write in English or any other vernacular language.
8. No plan to commence new treatments over the study period.
9. Must have the ability and willingness to sign a written informed consent and to comply with all study procedures.

Exclusion Criteria:

1. Participants taking any form of herbal extract in the last 3 months before study entry.
2. Participants with hormonal imbalance including PCOS, and symptoms of perimenopause and menopause
3. Participants who are on hormone replacement therapy (HRT) for more than 3 months.
4. Participants with any active medical, surgical, or gynaecological problems.
5. Participants with a history of alcohol, tobacco dependence, or any other substance abuse
6. Participants with clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, haematologic or other major systemic diseases making implementation of the protocol or other interpretation of the study result difficult.
7. Participants with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
8. Participants with demonstrated inability to comply with the study procedures, including poor compliance.
9. Participants with inability to attend follow-up visits.
10. Patients with known hypersensitivity to Shatavari, or any of the ingredients of study interventions.
11. Patients who had participated in other clinical trials during the previous 3 months.
12. Patients who have any clinical condition, according to the investigator who does not allow safe fulfilment of clinical trial protocol.

Where this trial is running

San Francisco, California

• San Francisco Research Institute — San Francisco, California, United States (Recruiting)

Study contacts

• Study coordinator: Dr. John Ademola

Conditions Sexual Wellness; Women Health; dietary supplement; shatavari