Health Condition 1: N908- Other specified noninflammatory disorders of vulva and perineum
Conditions
Interventions
Intervention1: Feminine Hygiene Wash of Cavinkare: Composition: 1.Water 52.98-64.75 2.Cocamidopropyl betane 18.00-22.00 3.Coco glucoside 9.00-11.00 4.Glycerin 2.70-3.30 5.Lauryl glucoside 1.80-2.20 6.
Sponsors
Cavinkare, India.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Proper written informed consent obtained from the patient before any procedure performed. 2. Healthy females with perineal discomfort between the age group of 18-65 years. 3. Subjects not have participated in any other clinical trial during the past 3 months
Exclusion criteria
Exclusion criteria: 1. Female Subjects with sexually transmittable diseases and immune-compromised state & menstrual irregularities. 2. Pregnant or lactating women 3. Subjects with known history of vaginal candidal infections. 4. Hypersensitivity to any of the components of the test or reference formulation. 5. The presence of any other condition that leads the investigator to conclude that the patient is inappropriate for inclusion in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. An assessment for vulval pH and degree of pruritus,burning, vulvo vaginal erythema and oedema, dryness and dyspareunia 2. Vulval swabs will be taken before administering the test product for bacterial and fungal culture. Swabs will also be taken at the end of the study 3. self-assessment scoring by the subject on subject’s overall condition 4. Quality of life will also be assessed using SF 12 questionnaireTimepoint: Baseline and at 2 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To monitor for any adverse events during the study periodTimepoint: Baseline to 2 weeks | — |
Countries
India
Contacts
Public ContactDr Gayathri Sivakumar
SRM Medical College Hospital and Research Centre
Outcome results
None listed