Health Condition 1: - Health Condition 2: N909- Noninflammatory disorder of vulvaand perineum, unspecified
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Married women Female patients aged 18 50 years presenting with acute as well as recurrent pruritus vulvae Diagnosed with non-specific vaginal discharge, itching, erythema, or an inflammatory vaginal condition. Not receiving any treatment for pruritus vulvae in the past 2 weeks Patient who is willing to participate and give written informed consent Patient who is willing to undergo regular follow-up.
Exclusion criteria
Exclusion criteria: Unmarried women Pregnant and breastfeeding women. Those who were unable to fill in the questionnaires were excluded. Women were also excluded when the pruritus lasted longer than 4 weeks Pruritus caused by an infection or other specific cause such as postmenopausal atrophy, ulcer, malignancy, psoriasis, atopic dermatitis elsewhere, or lichen sclerosus. Known systemic diseases causing pruritus, e.g., Diabetes mellitus, Chronic renal failure, Chronic liver disease, Thyroid disorders Malignancy of vulva, vagina, cervix, or elsewhere Active genital infections requiring immediate allopathic treatment (e.g., herpes simplex, syphilis, etc.) Recent use (within 2 weeks) of Systemic steroids, Antihistamines, Antifungal or antibiotic therapy, or Immunosuppressive drugs. Allergy or hypersensitivity to any component of the test drugs Non-cooperative patients / unable to comply with follow-up visits Severe psychiatric illness interfering with compliance or reporting
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in vaginal symptoms such as itching, discharge, erythema, and discomfort based on standardized clinical scoring in pruritus severity measured by Visual Analog Scale (VAS) for itch (0 10) Timepoint: Reduction in vaginal symptoms such as itching, discharge, erythema, and discomfort based on standardized clinical scoring in pruritus severity measured by Visual Analog Scale (VAS) for itch (0 10) | — |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of patients with complete recovery, and changes in general health according to COOP/WONCA health charts. Patient-reported satisfaction means improvement in associated symptoms: Burning, redness, local discharge, pain Objective findings on examination: Erythema, excoriation, lichenification, lesions Recurrence rate at follow-up, and any adverse drug reactions (ADRs).Timepoint: 30 days on weekly followups | — |
Countries
India
Contacts
Ajmal Khan Tibbiya College and Hospital