Efficacy and Safety of Shatavari Root Extract in Women's Sexual Wellness
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-50
SponsorSF Research Institute, Inc.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Shatavari (Asparagus racemosus) Root Extract
Dietary supplementThe 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 Capsule
Other interventionThe 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Shatavari Root Extract (SRI-81) 300 mgExperimental treatment 1 intervention
Group B: Placebo Capsule (Starch) 300 mgPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, Week 4, Week 8, Week 12Secondary outcomes
1
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.
Time frame
Baseline, Week 4, Week 8, Week 122
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.
Time frame
Baseline, Week 4, Week 8, Week 123
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.
Time frame
Baseline, Week 4, Week 8, Week 124
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.
Time frame
Baseline, Week 4, Week 8, Week 12Sponsors and contacts
Click on the lead sponsor to view all of their trials.
SF Research Institute, Inc.
Lead sponsor
Ixoreal Biomed Private Limited
Collaborator
Source ClinicalTrials.gov