Health Condition 1: B373- Candidiasis of vulva and vagina
Conditions
Interventions
Intervention1: sertaconazole: Sertaconazole 500 mg vaginal pessary,To be used one single dose for one day only
Control Intervention1:
Clotrimazole
:
Clotrimazole vaginal pessary 200 mg OD for three
Sponsors
Pt B D Sharma PGIMS Rohtak
Eligibility
Inclusion criteria
Inclusion criteria: Patients in reproductive age group (18-45 years). Patients with clinical signs and symptoms of vulvovaginal candidiasis (complaints of vaginal pruritus, burning sensation, vulvar soreness or thick curdy discharge) with confirmed candidiasis on microscopic examination by potassium hydroxide (KOH) smear and gram staining. Patients who are ready to give written informed consent. Patients with less than three episodes of vulvovaginal candidiasis within previous year.
Exclusion criteria
Exclusion criteria: Pregnant or lactating females. Patients with history of previous treatment with systemic antifungal agents within past four weeks or previous topical antifungal treatment within one week. Having any sexually transmitted disease or gynaecological abnormality requiring treatment. History of diabetes mellitus History of chronic illness. Past history of hypersensitivity to imidazole agents. Patients on immunosuppressant therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measures will be changes in sign and symptoms of vulvovaginal candidiasis, Visual Analogue Scale (VAS) score (for Pruritus, vulvar soreness and vaginal discharge)and microscopic examination(Gram Staining and KOH wet mount )Timepoint: 0,1,2,4 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical effectiveness, Global clinical response assessment and quality of life (QOL)Timepoint: Clinical effectiveness, Global clinical response assessment at 2, 4 week Quality of life (QOL) at 0,2,4 week | — |
Countries
India
Contacts
Public ContactDr Poonam Arora
Pt. B. D. Sharma PGIMS, Rohtak
Outcome results
None listed