Status:
COMPLETED
Effect of Single Dose of Ashwagandha Root Extract on Sexual Health in Women.
Lead Sponsor:
SF Research Institute, Inc.
Conditions:
Female Sexual Health
Eligibility:
FEMALE
18-55 years
Phase:
NA
Brief 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, aro...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
March 31 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT07182253
Start Date
March 31 2025
End Date
May 28 2025
Last Update
December 18 2025
Active Locations (1)
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1
San Francisco Research Institute
San Francisco, California, United States, 94127