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
Qualifiers
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
Treatments tested in this trial
- Shatavari (Asparagus racemosus) Root Extract
- Placebo Capsule
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
SF Research Institute, Inc.
Lead sponsor
Ixoreal Biomed Private Limited
Collaborator
Source ClinicalTrials.gov