Female Sexual HealthNCT07182253
Effect of Single Dose of Ashwagandha Root Extract on Sexual Health in Women.
A study testing KSM-66 Ashwagandha® capsule in people with Female Sexual Health, run by SF Research Institute, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Female Sexual Health
- What is being tested?
- KSM-66 Ashwagandha® capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2025to 28 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Female participants between 18 to 55 years of age. 2. The participate should inform their partner about the study 3. Her partner should be willing to let her participate in the study 4. Participants willing to try to have sexual intercourse regularly. 5. Participants in a stable, monogamous, heterosexual relationship that is secure and communicative, for at least 6 months prior to the Screening Visit.
- 6. Participant's partner is expected to be physically present at least 50% of each month.
- 7. Participants who have used a medically acceptable method of contraception for at least 3 months before the baseline Visit (Visit 1) and continue to use that medically acceptable method of contraception during the trial.
- 8. 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.
- 9. Participants or LAR can and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements.
- 10. Participants having sufficient understanding to communicate effectively with the investigator and are willing to discuss their sexual functioning with the investigative staff.
- 11. Participants who are willing to have 4 or more attempts of sexual intercourse each month.
Who cannot join
- 1. Participants who are not willing to take an investigational product. 2. Any acute illness which may hamper the study participation as per principal investigator discretion at the time of enrolment.
- 3. Participants having any clinically significant medical history, medical finding or an on- going medical or psychiatric condition exists which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol.
- 4. Individuals participating in any other studies, including macro/micro/any other forms of dietary supplements/multivitamins or disease-specific oral nutrition supplements (for improving the sexual function during the 3 months prior to study commencement).
- 5. Participants having a history of hypersensitivity reactions (i.e., allergic or oversensitivity to usual doses).
- 6. Participants with current alcohol or drug addiction or with a history of drug dependence or abuse within the past one year.
- 7. Participants who indicate that their sexual partner has inadequately treated sexual problems that could interfere with the Subjects response to treatment.
Show all 11Show fewer
- 8. Participants who have entered the menopausal transition or menopause or have had a hysterectomy.
- 9. Participants with findings of infection, inflammation, undue tenderness, or shrinkage (atrophy) of the female genital organs, at the Screening Visit.
- 10. Participants who are breastfeeding or have breastfed within the last 6 months prior to the Baseline Visit.
- 11. Participants who are pregnant or have been pregnant within the last 6 months prior to the Baseline Visit.
- 12. Participants having primary hypoactive sexual desire. 13. Participants with a history of malignancy. 14. Participate itself are not planning to get pregnant for next six months 15. Participants who cannot cooperate to complete the subject records during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco Research Institute
San Francisco, California, 94127
About this study
Official title: Effects of Ashwagandha Extract (Capsule KSM-66 300 mg) on Sexual Health in Healthy Women: A Prospective, Randomized, Double-Blind, Placebo- Controlled Study
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.
- Conditions
- Female Sexual Health
- Being tested
- KSM-66 Ashwagandha® capsule, Identical Placebo capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KSM-66 Ashwagandha® capsuleDietary supplement
Two off-white capsules, each containing 300 mg KSM-66 Ashwagandha root extract powder only.
Identical Placebo capsuleOther
Two off-white capsules containing starch powder only
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm 1: Interventional KSM-66 Ashwagandha® capsule (300 mg) | Active comparator | KSM-66 Ashwagandha root extract Receives: Dietary Supplement: KSM-66 Ashwagandha® capsule |
| Treatment Arm 2: Identical placebo capsule | Placebo comparator | Starch Receives: Other: Identical Placebo capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the effects of the KSM-66 Ashwagandha formulation on sexual health in healthy women, assessed based on Female Sexual Function Index (FSFI) in healthy women
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
Measured: Baseline, Week 4, Week 8
Secondary outcomes (6)
To evaluate the effects of the KSM-66 Ashwagandha formulation on sexual health in healthy women, assessed based on the Satisfying Sexual Events (SSEs) in healthy women
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
Measured: Baseline, Week 4, Week 8
To evaluate the effects of the KSM-66 Ashwagandha formulation on sexual health in healthy women, assessed based on the Female Sexual Distress Scale (FSDS) in healthy women
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
Measured: Baseline, Week 4, Week 8
To investigate the effects of KSM-66 Ashwagandha formulation on serum hormones (Estrogen-E2, Progesterone, FSH, LH, Prolactin, and Testosterone) in healthy women
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
Measured: Baseline, Week 4, Week 8
To evaluate the effects of KSM-66 Ashwagandha formulation on stress using the Perceived Stress Scale (PSS-10)
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
Measured: Baseline, Week 4, Week 8
To evaluate the effect of the KSM-66 Ashwagandha formulation on Quality of Life (SF-12 QoL) in healthy women
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
Measured: Baseline, Week 4, Week 8
To evaluate the safety of KSM-66 Ashwagandha formulation in healthy women
Number and proportion of Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Event (TESAE) over 8 weeks treatment period
Measured: Baseline, Week 4, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start31 Mar 2025
- Primary completion19 May 2025
- Study completion28 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Female Sexual HealthStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- SF Research Institute, Inc.
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182253
- Sponsor's protocol ID
- Ixoreal-FSD-CT-1022
- Status last verified
- Dec 2025
- First submitted
- 11 Sep 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Ashwagandha Extract (Capsule KSM-66 300 mg) on Sexual Health in Healthy Women: A Prospective, Randomized, Double-Blind, Placebo- Controlled Study
- ClinicalTrials.gov ID
- NCT07182253
- Acronym / sponsor ID
- Ixoreal-FSD-CT-1022
- Conditions
- Female Sexual Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- SF Research Institute, Inc.Research network
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 19 May 2025 (actual)
- Study completion
- 28 May 2025 (actual)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm 1: Interventional KSM-66 Ashwagandha® capsule (300 mg) | Active comparator | Dietary Supplement: KSM-66 Ashwagandha® capsuleKSM-66 Ashwagandha root extract |
| Treatment Arm 2: Identical placebo capsule | Placebo comparator | Other: Identical Placebo capsuleStarch |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 1. Female participants between 18 to 55 years of age. 2. The participate should inform their partner about the study 3. Her partner should be willing to let her participate in the study 4. Participants willing to try to have sexual intercourse regularly. 5. Participants in a stable, monogamous, heterosexual relationship that is secure and communicative, for at least 6 months prior to the Screening Visit.
- 6. Participant's partner is expected to be physically present at least 50% of each month.
- 7. Participants who have used a medically acceptable method of contraception for at least 3 months before the baseline Visit (Visit 1) and continue to use that medically acceptable method of contraception during the trial.
- 8. 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.
- 9. Participants or LAR can and willing to give meaningful, written informed consent prior to participation in the trial, in accordance with regulatory requirements.
Key exclusion criteria (11 listed)
- 1. Participants who are not willing to take an investigational product. 2. Any acute illness which may hamper the study participation as per principal investigator discretion at the time of enrolment.
- 3. Participants having any clinically significant medical history, medical finding or an on- going medical or psychiatric condition exists which in the opinion of the Investigator could jeopardize the safety of the subject, impact validity of the study results or interfere with the completion of study according to the protocol.
- 4. Individuals participating in any other studies, including macro/micro/any other forms of dietary supplements/multivitamins or disease-specific oral nutrition supplements (for improving the sexual function during the 3 months prior to study commencement).
- 5. Participants having a history of hypersensitivity reactions (i.e., allergic or oversensitivity to usual doses).
- 6. Participants with current alcohol or drug addiction or with a history of drug dependence or abuse within the past one year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KSM-66 Ashwagandha® capsuleTwo off-white capsules, each containing 300 mg KSM-66 Ashwagandha root extract powder only. | Dietary supplement | Treatment Arm 1: Interventional KSM-66 Ashwagandha® capsule (300 mg) |
| Identical Placebo capsuleTwo off-white capsules containing starch powder only | Other | Treatment Arm 2: Identical placebo capsule |
Primary outcome
To evaluate the effects of the KSM-66 Ashwagandha formulation on sexual health in healthy women, assessed based on Female Sexual Function Index (FSFI) in healthy women
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
6 secondary outcomes
To evaluate the effects of the KSM-66 Ashwagandha formulation on sexual health in healthy women, assessed based on the Satisfying Sexual Events (SSEs) in healthy women
Time frame: Baseline, Week 4, Week 8
To evaluate the effects of the KSM-66 Ashwagandha formulation on sexual health in healthy women, assessed based on the Female Sexual Distress Scale (FSDS) in healthy women
Time frame: Baseline, Week 4, Week 8
To investigate the effects of KSM-66 Ashwagandha formulation on serum hormones (Estrogen-E2, Progesterone, FSH, LH, Prolactin, and Testosterone) in healthy women
Time frame: Baseline, Week 4, Week 8
To evaluate the effects of KSM-66 Ashwagandha formulation on stress using the Perceived Stress Scale (PSS-10)
Time frame: Baseline, Week 4, Week 8
To evaluate the effect of the KSM-66 Ashwagandha formulation on Quality of Life (SF-12 QoL) in healthy women
Time frame: Baseline, Week 4, Week 8
To evaluate the safety of KSM-66 Ashwagandha formulation in healthy women
Time frame: Baseline, Week 4, Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KSM-66 Ashwagandha® capsule in people with Female Sexual Health, run by SF Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the effects of the KSM-66 Ashwagandha formulation on sexual health in healthy women, assessed based on Female Sexual Function Index (FSFI) in healthy women (time frame: Baseline, Week 4, Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.