None listed
Conditions
Interventions
None listed
Sponsors
Mr. Anil M Makwana
Eligibility
Inclusion criteria
Inclusion criteria: 1. Willing and able to provide written informed consent for the study before the initiation of any study-specific procedures. 2. Heatly Female or male aged 18-45 years (both inclusive) 3. Willing to cooperate and participate by following study requirements for the duration of the study and to report any changes in health status or medications, adverse event symptoms, or reactions immediately. 4. Subjects willing to tale test product provided by the sponsor. 5. Willingness to not using any treatment for sexual dysfunction and/or seeking performance enhancement and/or appetite-related concerns. 6. Male subjects (including vasectomized) with partners who are of childbearing potential (whether pregnant or not) must use condoms prior to first IP application and until 7 days after last IP application. Male subjects should also avoid semen donation or providing semen for in-vitro fertilization during the study duration. 7. For female subjects: a. Females of non-childbearing potential who are surgically sterile (documented hysterectomy, bilateral oophorectomy or bilateral salpingectomy) at least 6 months prior to first IP application or congenitally sterile as assessed by a physician, or 1-year postmenopausal (no menses for 12 months without an alternative medical cause plus serum follicle stimulating hormone [FSH] levels consistent with postmenopausal status) in women not using hormonal contraception or hormonal replacement therapy. b. Females of childbearing potential must: i. Have negative urine pregnancy test at screening visit; ii. Have negative urine pregnancy test at baseline prior to initiating the treatment. iii. Willing to use highly effective methods of contraception throughout the study and for 7 days after last application.
Exclusion criteria
Exclusion criteria: 1. Unwilling or unable to comply with scheduled visits, product application plan, laboratory tests, or other study procedures and study restrictions. 2. Hormonal disorders or current medications affecting sexual function. 3. Subjects diagnosed with known allergies to test products. 4. Severe chronic illnesses or mental health disorders 5. Subjects who are nursing, pregnant, or planning to become pregnant during the study according to subject self-report. 6. Subjects with a known history of immunosuppression/immune deficiency disorders [including (HIV infection or AIDS) as determined by study documentation that the investigator or designee deems inappropriate for participation or could interfere with the outcome of the study. 7. Subjects with an uncontrolled disease such as asthma, diabetes, hypertension, hyperthyroidism, or hypothyroidism. Subjects having multiple health conditions may be excluded from participation even if the conditions are controlled by diet, medications, etc. 8. Subjects who are currently participating in any other clinical study or have participated in any clinical study within 4 weeks prior to inclusion into the study. 9. Subjects who started hormone replacement therapies (HRT) or hormones for birth control less than 3 months prior to study entry or who plan on starting, stopping, or changing doses of HRT or hormones for birth control during the study. 10. At the time of signing the informed consent document (ICD), if the subject is a regular user (including recreational use) of any illicit drug or has a recent history (within the past year) of substance abuse (including alcohol). 11. Immediate family member who is at the research site or sponsoring staff who is directly involved in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess changes in serum levels of key hormones (Prolactin, Testosterone, FSH, LH) and to evaluate semen analysis (in males).Timepoint: baseline and 6 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the improvement in overall sexual function in males and females, as measured by standardized scales (IIEF for males and FSFI for females).Timepoint: baseline and 6 weeks;To measure the impact of the formula on Nitric Oxide levels, through Strip TestTimepoint: baseline and 6 weeks;Safety and TolerabilityTimepoint: at each follow-up visit | — |
Countries
India
Contacts
Public ContactMr Ankit Sakhreliya
NIOS Clinical
Outcome results
None listed