Status:
COMPLETED
Efficacy and Safety of Shatavari in Women Sexual Wellness: A Prospective, Randomized, Double-Blind, Three-arm, Parallel, Placebo-Controlled Study
Lead Sponsor:
SF Research Institute, Inc.
Collaborating Sponsors:
Ixoreal Biomed Inc.
Conditions:
Sexual Health
Eligibility:
FEMALE
18-55 years
Phase:
NA
Brief Summary
This is a Multi-center, Multi-national, Prospective, Randomized, Double-Blind, Placebo- Controlled three arm study to evaluate the efficacy and safety of Shatavari in Women Sexual Wellness. Participan...
Detailed Description
To qualify for the study, participants must be Women between 18 to 55 years of age. Women must be willing to have 4 or more attempts of sexual intercourse each month. Women presenting with signs and s...
Eligibility Criteria
Inclusion
- Women between 18 to 55 years of age.
- Women willing to have 4 or more attempts of sexual intercourse each month.
- 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.).
- 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.
- Participants having sufficient understanding to communicate effectively with the investigator and are willing to discuss their sexual functioning with the investigative staff.
- Able to read and write in English or any other vernacular language.
- No plan to commence new treatments over the study period.
- Must have the ability and willingness to sign an informed consent and to comply with all study procedures
Exclusion
- Participants taking any form of herbal extract in the last 3 months before study entry.
- Participants who are on hormone replacement therapy (HRT) for more than 3 months.
- Participants with any active medical, surgical, or gynaecological problems.
- Participants with a history of alcohol, tobacco dependence, or any other substance abuse
- Participants with clinically relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, haematologic or other major systemic diseases making implementation of the protocol or other interpretation of the study result difficult.
- Participants with mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study.
- Participants with evidence of uncooperative attitude, including poor compliance.
- Participants with inability to attend follow-up visits.
- Patients with known hypersensitivity to Shatavari, Ashwagandha or any of the ingredients of study medication.
- Patients who had participated in other clinical trials during the previous 3 months.
- Patients who have any clinical condition, according to the investigator who does not allow safe fulfilment of clinical trial protocol.
Key Trial Info
Start Date :
October 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2025
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT06972706
Start Date
October 26 2024
End Date
February 28 2025
Last Update
May 15 2025
Active Locations (1)
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1
San Francisco Research Institute
San Francisco, California, United States, 94127