San Francisco Research Institute
San Francisco, California, 94127, United States
NCT Number: NCT07182253
Sexual health is a key part of a woman's overall physical, emotional, and mental well-being-even in the absence of any medical or psychological problems. It includes aspects such as sexual desire, arousal, satisfaction, and confidence in intimate relationships. Everyday factors like stress, fatigue, work-life balance, and hormonal changes can impact these areas, even in otherwise healthy women. Unfortunately, sexual wellness is often under-discussed in both clinical practice and research, especially for women who are not experiencing a diagnosed disorder.
This study is designed to explore whether Ashwagandha root extract (KSM-66), a natural herbal supplement known for its stress-reducing and vitality-enhancing properties, can help support and maintain sexual wellness in healthy adult women. Unlike treatments aimed at correcting dysfunction, this research focuses on enhancing natural sexual function-improving desire, mood, and satisfaction as part of overall health. Participants take either Ashwagandha or a placebo over several weeks, and their experiences are measured using validated tools like the Female Sexual Function Index (FSFI).
Understanding and supporting sexual wellness through natural means can improve not only intimacy and relationship satisfaction, but also self-esteem, mood, and general life satisfaction. By addressing sexual health proactively in healthy individuals, this study contributes to a more complete picture of women's health and well-being.
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Notify Me18 year–55 year
Female
Interventional
Not applicable
San Francisco, California, 94127, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Two off-white capsules, each containing 300 mg KSM-66 Ashwagandha root extract powder only.
Two off-white capsules containing starch powder only
Time frame: Baseline, Week 4, Week 8
Mean change in FSFI scores from Visit 1 (Screening Visit/ Enrolment Visit/ Baseline Visit- Day 1), Visit 2 (Week 4) to Visit 3- End of study (Week 8) in healthy women
Time frame: Baseline, Week 4, Week 8
Mean change in SSEs from Visit 1 (Screening Visit/ Enrolment Visit/ Baseline Visit- Day 1), Visit 2 (Week 4) to Visit 3- End of study (Week 8) in healthy women
Time frame: Baseline, Week 4, Week 8
Mean change in FSDS scores from Visit 1 (Screening Visit/ Enrolment Visit/ Baseline Visit- Day 1), Visit 2 (Week 4) to Visit 3- End of study (Week 8) in healthy women
Time frame: Baseline, Week 4, Week 8
Mean change in serum hormones (Estrogen-E2, Progesterone, FSH, LH, Prolactin, and Testosterone) from Visit 1 (Screening Visit/ Enrolment Visit/ Baseline Visit- Day 1) to Visit 3- End of study (Week 8) in healthy women
Time frame: Baseline, Week 4, Week 8
Mean change in PSS-10 scores from Visit 1 (Screening Visit/ Enrolment Visit/ Baseline Visit- Day 1), Visit 2 (Week 4) to Visit 3- End of study (Week 8) in healthy women
Time frame: Baseline, Week 4, Week 8
Mean change in SF-12 scores from Visit 1 (Screening Visit/ Enrolment Visit/ Baseline Visit- Day 1), Visit 2 (Week 4) to Visit 3- End of study (Week 8) in healthy women
Time frame: Baseline, Week 4, Week 8
Number and proportion of Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Event (TESAE) over 8 weeks treatment period
SF Research Institute, Inc.
Network
Effects of Ashwagandha Extract (Capsule KSM-66 300 mg) on Sexual Health in Healthy Women: A Prospective, Randomized, Double-Blind, Placebo- Controlled Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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