A clinical study to compare the effect of two drugs, sertaconazole and clotrimazole given vaginally in patients with uncomplicated vulvovaginal candida fungal infection.
- Conditions
- Health Condition 1: B373- Candidiasis of vulva and vagina
- Registration Number
- CTRI/2020/04/024690
- Lead Sponsor
- Pt B D Sharma PGIMS Rohtak
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Clinical effectiveness, Global clinical response assessment and quality of life (QOL)Timepoint: Clinical effectiveness, Global clinical response assessment at 2, 4 week <br/ ><br>Quality of life (QOL) at 0,2,4 week