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NCT07441083

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

Sponsor: SF Research Institute, Inc.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

FEMALE

Age Range

20 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-03-17

Completion Date

2026-07-10

Last Updated

2026-03-03

Healthy Volunteers

Yes

Conditions

Sexual Wellness Women Health

Interventions

DIETARY_SUPPLEMENT

Shatavari (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.

OTHER

Placebo 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.

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.

Locations (1)

San Francisco Research Institute

San Francisco, California, United States