None listed
Conditions
Interventions
None listed
Sponsors
Giosun Healthcare Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Healthy females aged between 18 and 40 years. 2.Participants must be in good general health as determined by medical history and clinical judgment of the investigator. 3.Participants must provide written informed consent before any study procedures are performed. 4.Participants should not have participated in any other clinical trial during the past three months. 5.Participants must be willing and able to comply with the study procedures, including the use of VG Tone Up Cream as instructed and the maintenance of a daily diary.
Exclusion criteria
Exclusion criteria: 1.Females with sexually transmittable diseases, immune-compromised states, or menstrual irregularities. 2.Pregnant or lactating women. 3.Post-menopausal women. 4.Subjects with any other co-morbid conditions that can affect the study outcome. 5.Known hypersensitivity to any of the components of VG Tone Up Cream or the reference formulation. 6.The presence of any other condition that leads the investigator to conclude that the participant is inappropriate for inclusion in this clinical study, including but not limited to mental health disorders, substance abuse, or any other significant medical condition. 7.Participation in another clinical trial within the past three months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Evaluate the Improvement in Genital Comfort. 2. Assess the Reduction of Malodorous External Genitalia 3.Evaluate Comfort During Sexual Intercourse 4.Assess Satisfaction with Intimate Hygiene 5.Evaluate Improvement in Self-Esteem Timepoint: Day 1, Day 15 and Day 30 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Mid-Study Evaluation: To assess interim improvements, monitor compliance, and detect any early adverse events. 2.Incidence and Severity of Adverse Events- Number and severity of adverse events reported by participants throughout the study period. 3. Compliance with Product Usage-Percentage of days participants use the product as instructed, recorded in daily diaries.Timepoint: Day 1, Day 15 and Day 30 | — |
Countries
India
Contacts
Public ContactMs Arpita Malgi
Samahitha Research Solutions
Outcome results
None listed