NCT07441083 · SF Research Institute, Inc.
Efficacy and Safety of Shatavari Root Extract in Women's Sexual Wellness
What this study is about
This randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment clinical study is designed to evaluate the effectiveness and safety of a standardized Shatavari (Asparagus racemosus) root extract (SRI-81) in improving women's sexual wellness.
View original scientific description
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.
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.
Primary outcome measures
Change in Female Sexual Function Index (FSFI) total score
Time frame: Baseline, Week 4, Week 8, Week 12
The Female Sexual Function Index (FSFI) is a validated 19-item self-reported questionnaire assessing female sexual function across six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The total score ranges from 2.0 to 36.0, with higher scores indicating better sexual function (better outcome). This outcome measures the mean change from baseline in FSFI total score, where an increase in score indicates improvement in female sexual function.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Women between 20 to 50 years of age.
- 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.
- Have a PSS-10 score of ≥ 14 at screening.
- 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.).
- 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.
- Participants having sufficient understanding to communicate effectively with the investigator and are willing to discuss their sexual functioning with the investigative staff.
- Able to read and write in English or any other vernacular language.
- No plan to commence new treatments over the study period.
- Must have the ability and willingness to sign a written informed consent and to comply with all study procedures.
Exclusion criteria
- Participants taking any form of herbal extract in the last 3 months before study entry.
- Participants with hormonal imbalance including PCOS, and symptoms of perimenopause and menopause
- Participants who are on hormone replacement therapy (HRT) for more than 3 months.
- Participants with any active medical, surgical, or gynaecological problems.
- Participants with a history of alcohol, tobacco dependence, or any other substance abuse
- 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.
- Participants with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- Participants with demonstrated inability to comply with the study procedures, including poor compliance.
- Participants with inability to attend follow-up visits.
- Patients with known hypersensitivity to Shatavari, or any of the ingredients of study interventions.
- Patients who had participated in other clinical trials during the previous 3 months.
- Patients who have any clinical condition, according to the investigator who does not allow safe fulfilment of clinical trial protocol.
Where
- San Francisco, California
Collaborators
Ixoreal Biomed Private Limited
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 27, 2026 · Source of record for eligibility and locations