Clinical Study on Amore-Female Sexual Wellness Drink of Sipwise Beverages in Sexual Wellness in Females.
- Registration Number
- CTRI/2021/04/032884
- Lead Sponsor
- Sipwise Beverages Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
1. Healthy Adult Females between the ages of 21 and 65 -both ages inclusive- who are in a heterosexual, monogamous relationship with an active sexual life.
2. Subjects who have scored 38 to 57 -both scores inclusive- in the Female Sexual Function Index at the time of screening.
3. Heterosexual partner to be physically living with the subject.
4. Subjects willing to practice double barrier contraceptive methods throughout the study.
5. Subjects who are willing to abstain from use of herbal, allopathic or home remedies-oral or topical-for any sexual condition not limited to aphrodisiacs, achieving and maintenance of erection, improvement in sexual life etc.
6. Subjects phenotypically female at birth and with normal presentation of genitourinary and reproductive system that allows for a normal sexual life.
7. Subjects who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during screening and treatment period.
8. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
1. Subjects with known hypersensitivity to the ingredients of the investigational product.
2. Subjects with history or diagnosis of psychiatric disorders
3. Subjects with history of uncontrolled diabetes, hypertension or major cardiac illness like congestive heart failure etc.
4. Subjects with history of seizures.
5. Subjects on remission from cancer of any type less than 5 years at the time of screening.
6. Subjects who have participated in a clinical study less than 1 month before screening.
7. Any significant medical condition-e.g., significant psychiatric or neurological disorders, active alcohol or drug abuse, etc.-, any medical condition that is unstable or poorly controlled or other factor-e.g., planned relocation- that the Investigator felt would interfere with study evaluations and study participation.
8. Subjects who are planning a pregnancy and - or currently breastfeeding.
9. Subjects who are mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol.
10. Subjects who in the opinion of the Investigator or the Medical Experts are not eligible for enrolment in the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Female Sexual Function Index-FSFI-: Improvement of greater than or equal to 20% from baseline in comparison with placebo. <br/ ><br>2. Subject IP Feedback Questionnaire: Total Score of greater than or equal to 20 in comparison with Placebo. <br/ ><br>Timepoint: 1. Female Sexual Function Index-FSFI-: Day 1, Day 30, Day 60 <br/ ><br>2. Subject IP Feedback Questionnaire: Day 60 <br/ ><br>
- Secondary Outcome Measures
Name Time Method ot applicableTimepoint: Not applicable