None listed
Conditions
Interventions
Intervention1: Feminine Intimate Wash product: As per investigator direction,Topical Application of the product for 28 days
Control Intervention1: Control: As per investigator direction for 84 days
Sponsors
ITC Life Sciences and Technology Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1. Healthy women in the age group of 18- 55 years. 2. Atleast one instance of UTI in the past 6 months. 3. Women willing to abide by the study protocol and study restrictions including abstinence from: use of any other product besides the allotted product during the study course, changing their usual brand of sanitary products and laundry detergents during the study course,showering/ bathing / cleaning their genitals with the test product on the day of study visit,depilation of pubic hair through topical products/waxing/ shaving (Trimming with scissors allowed)during the study course,oral or topical Anti-biotic/ Anti mycotic/Anti inflammatory medicine or OTC / products without informing to the study investigator.
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant or lactating 2. Women with a known history or present condition of allergic response to any cosmetic products/ fragranced product which may influence the study result. 3. Women with bacterial vaginosis/ candidiasis/ mycotic infections / active psoriasis/ eczema/ other active skin disorder / any form of chronic infection / allergy / disease which may influence the study result. 4. Women in the post menopausal age group 5. Women with vulvo-vaginal dryness 6. Women who are currently taking or had taken antibiotics course in the past 3 months 7. Women who have changed the contraceptive medications or Menopausal / Hormonal treatment in the past 3 months or are contemplating to do so.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety of Feminine Intimate Wash productTimepoint: Day 0, Day 28 | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of the Feminine Intimate Wash productTimepoint: Day 0, Day 28 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd
Outcome results
None listed