Health Condition 1: Z298- Encounter for other specified prophylactic measures
Conditions
Interventions
Intervention1: Discourage and stop use of feminine intimate hygienic wash products: 1) Intervention arm in which the use of feminine intimate vaginal hygiene wash products for vaginal irrigation will
Sponsors
Department of Health Research
Eligibility
Inclusion criteria
Inclusion criteria: Healthy females of childbearing age group (15-49 years) presenting in Obstetrics and Gynecology OPD of KIMS Hospital, Bhubaneswar using feminine intimate hygiene products for 1 month or more without signs and symptoms of vulvovaginitis at presentation.
Exclusion criteria
Exclusion criteria: 1. Pregnant women will be excluded 2. Women with Diabetes. 3. Male partner having concurrent genital infection. 4. Long term antibiotic and steroid users. 5. Taking immunosuppressant or any other immunosuppressive diseases. 6. Malignancy. 7. Current signs and symptoms of vulvovaginitis or vaginosis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome measure- The primary outcome which is being followed is the occurrence of vulvovaginitis or the recurrence of vulvovaginitis in the intervention vs comparator groups. This will be done at 6 and 12 months from enrollment.Timepoint: At 6 months and 12 months from enrolment. Primary outcome measure- The primary outcome which is being followed is the occurrence of vulvovaginitis or the recurrence of vulvovaginitis in the intervention vs comparator groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Vaginal microbiome profile in the intervention vs comparator groups at baseline, 6 months & 12 months from enrolment.Timepoint: Vaginal microbiome profile in the intervention vs comparator groups at baseline,6 months & 12 months from enrolment | — |
Countries
India
Contacts
Public ContactIra Praharaj
Indian Council of Medical Research
Outcome results
None listed