Sexual WellnessNCT07441083
Efficacy and Safety of Shatavari Root Extract in Women's Sexual Wellness
A study testing Shatavari (Asparagus racemosus) Root Extract in people with Sexual Wellness and Women Health, run by SF Research Institute, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sexual Wellness, Women Health
- What is being tested?
- Shatavari (Asparagus racemosus) Root Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Apr 2026to 15 Aug 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
San Francisco Research Institute
San Francisco, California, 94132
Khaleeq Rehman, 415-690-9641, khaleeqr.sfinstitute@gmail.com
About this study
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
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.
Read the detailed description
Women's sexual wellness is influenced by biological, psychological, and social factors. Stress and neuroendocrine imbalance play a central role in sexual dysfunction and distress. Shatavari (Asparagus racemosus), a traditional Ayurvedic herb, has been historically used to support female reproductive health, hormonal balance, and stress modulation.
This multi-national, prospective, randomized, double-blind, parallel-group study will enroll women aged 20 to 50 years in India and the United States. Eligible participants with reduced sexual function and elevated perceived stress will be randomized in a 1:1 ratio to receive either SRI-81 Shatavari root extract (300 mg/day) or a matched placebo for 12 weeks.
Efficacy will be primarily assessed using the Female Sexual Function Index (FSFI). Secondary outcomes include sexual distress, sexual satisfaction, perceived stress, quality of life, salivary cortisol measures, and laboratory safety parameters. Safety will be evaluated through adverse event monitoring and laboratory investigations.
- Conditions
- Sexual Wellness, Women Health
- Being tested
- Shatavari (Asparagus racemosus) Root Extract, Placebo Capsule
- Keywords
- dietary supplement, shatavari
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shatavari (Asparagus racemosus) Root ExtractDietary supplement
Also called 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.
Placebo CapsuleOther
Also called Starch 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.
| Study group | Role | What they receive |
|---|---|---|
| Shatavari Root Extract (SRI-81) 300 mg | Experimental | Participants randomized to this arm will receive a standardized Shatavari (Asparagus racemosus) root extract (SRI-81) capsule containing 300 mg, administered orally once daily after breakfast with water for a duration of 12 weeks. The intervention is intended to evaluate the efficacy and safety of Shatavari root extract in improving women's sexual wellness, including sexual function, sexual distress, sexual satisfaction, perceived stress, quality of life, and physiological stress markers, compared with placebo. Receives: Dietary Supplement: Shatavari (Asparagus racemosus) Root Extract |
| Placebo Capsule (Starch) 300 mg | Placebo comparator | Participants randomized to this arm will receive an identical placebo capsule containing 300 mg of starch, administered orally once daily after breakfast with water for 12 weeks. The placebo is matched in appearance, color, and packaging to the active intervention to maintain blinding. This arm serves as the comparator for evaluating the efficacy and safety of Shatavari root extract in women's sexual wellness. Receives: Other: Placebo Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Female Sexual Function Index (FSFI) total score
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.
Measured: Baseline, Week 4, Week 8, Week 12
Secondary outcomes (11)
Change in Female Sexual Distress Scale (FSDS) Score
The Female Sexual Distress Scale (FSDS) is a validated patient-reported outcome measure assessing sexually related personal distress in women. The total score ranges from 0 to 52, with higher scores indicating greater sexual distress (worse outcome).
This outcome evaluates the mean change from baseline in FSDS total score, where a reduction in score indicates improvement in sexual distress.
Measured: Baseline, Week 4, Week 8, Week 12
Change in Global Measure of Sexual Satisfaction (GMSEX) Score
The Global Measure of Sexual Satisfaction (GMSEX) is a validated instrument consisting of five bipolar adjective pairs, each rated on a 7-point scale. The total score ranges from 5 to 35, with higher scores indicating greater sexual satisfaction (better outcome).
This outcome evaluates the mean change from baseline in GMSEX total score, where an increase in score indicates improvement in subjective sexual satisfaction.
Measured: Baseline, Week 4, Week 8, Week 12
Change in Perceived Stress Scale (PSS-10) Score
The Perceived Stress Scale-10 (PSS-10) is a validated 10-item questionnaire measuring perceived stress over the previous month. Each item is scored from 0 (never) to 4 (very often). The total score ranges from 0 to 40, with higher scores indicating greater perceived stress (worse outcome).
This outcome assesses the mean change from baseline in PSS-10 total score, where a reduction in score indicates improvement in perceived stress.
Measured: Baseline, Week 4, Week 8, Week 12
Change in PROMIS-29 Quality-of-Life Scores
The Patient-Reported Outcomes Measurement Information System-29 (PROMIS-29) Profile assesses health-related quality of life across seven domains: physical function, anxiety, depression, fatigue, sleep disturbance, social participation, and pain interference, along with a pain intensity item. Domain scores are standardized T-scores with a mean of 50 and standard deviation of 10 in the reference population. T-scores typically range from approximately 20 to 80.
For negatively worded domains (e.g., anxiety, depression, fatigue, sleep disturbance, pain interference), higher scores indicate worse symptoms (worse outcome).
For positively worded domains (e.g., physical function, ability to participate in social roles), higher scores indicate better functioning (better outcome).
This outcome evaluates the mean change from baseline in PROMIS-29 domain T-scores and summary scores, interpreted according to domain directionality.
Measured: Baseline, Week 4, Week 8, Week 12
Change in Salivary Cortisol Awakening Response (CAR)
Salivary cortisol awakening response (CAR) is a physiological marker of hypothalamic-pituitary-adrenal (HPA) axis activity. This outcome evaluates the mean change from baseline in cortisol levels measured immediately upon awakening and 30 minutes post-awakening.
Measured: Baseline and Week 12
Change in Bedtime Salivary Cortisol Levels
Bedtime salivary cortisol reflects diurnal cortisol regulation and stress physiology. This outcome evaluates the mean change from baseline in bedtime salivary cortisol levels measured between 9:00 PM and 10:00 PM.
Measured: Baseline and Week 12
Change in Thyroid Function Test Parameters (T3, T4, TSH)
Thyroid function will be assessed using serum triiodothyronine (T3), thyroxine (T4), and thyroid-stimulating hormone (TSH). This outcome evaluates mean changes from baseline in thyroid hormone levels to monitor endocrine safety.
Measured: Baseline and Week 12
Change in Liver Function Test Parameters
Liver safety will be evaluated using serum alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and bilirubin. This outcome assesses mean changes from baseline to monitor hepatic safety.
Measured: Baseline and Week 12
Change in Renal Function Test Parameters
Renal safety will be evaluated using serum creatinine and blood urea nitrogen (BUN). This outcome assesses mean changes from baseline to evaluate kidney function during the study.
Measured: Baseline and Week 12
Incidence of Treatment-Emergent Adverse Events (TEAEs)
Treatment-emergent adverse events (TEAEs) are defined as any adverse events occurring or worsening after administration of the study intervention. This outcome measures the number and proportion of participants experiencing TEAEs during the study period.
Measured: Baseline to Week 12
Incidence of Treatment-Emergent Serious Adverse Events (TESAEs)
Treatment-emergent serious adverse events (TESAEs) include events that result in death, are life-threatening, require hospitalization, or result in significant disability. This outcome measures the number and proportion of participants experiencing TESAEs.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start29 Apr 2026 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sexual WellnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SF Research Institute, Inc.
- Sponsor type
- Research network
- Collaborators
- Ixoreal Biomed Private Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441083
- Sponsor's protocol ID
- Ixo/2025/1314/SHT/SexWel/GB/01
- Status last verified
- Apr 2026
- First submitted
- 23 Feb 2026
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No