Health Condition 1: B373- Candidiasis of vulva and vagina
Conditions
Interventions
Intervention1: Itraconazole and
Fenticonazole: Itraconazole - Dosage Form: Capsule
Dosage: 100 mg
Dosage Frequency: 2 capsules twice daily for 2 days administered orally
Fenticonazole - Dosage Form:
Sponsors
Jeevak hospital
Eligibility
Inclusion criteria
Inclusion criteria: - Patients aged >= 18 years and - Patients with acute vulvovaginal candidiasis (VVC) diagnosed clinically by presence of curdy white vaginal discharge. - Patients who are ready to give written informed consent, which includes a commitment to comply with all requirements, specified in the study protocol, among others a negative urine pregnancy test in the case of women of childbearing age. - Patients who the study staff deems reliable and mentally competent to carry out the study.
Exclusion criteria
Exclusion criteria: - Pregnant or nursing females. - Patients with chronic or recurrent VVC. - Patients who have received systemic or intravaginal antifungal treatment in the past 1 month. - Patients with concurrent bacterial, viral or trichomonal vaginal infection. - Patients with known hypersensitivity to the study drugs. - Patients with immunosuppressive disease or on immunosuppressive drugs. - Patients with liver dysfunction. - Patients with a history of seizures - Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the Investigator(s) could affect the subjectâ??s safety or interfere with the study assessments. - Any history of or concomitant medical condition that in the opinion of the Investigator(s) would compromise the subjectâ??s ability to safely complete the study. - History of drug or alcohol dependency or abuse within approximately the last 2 years. - Currently enrolled in another clinical study or used any investigational drug or device within 30 days preceding informed consent or were scheduled to participate in another clinical study that involved an investigational product or investigational drug during the course of this study. - Any patient whom the investigator judged to be inappropriate for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary effectiveness endpoint will be percentage of patients achieving clinical cure. (Clinical cure is defined as clear or almost clear symptoms [abnormal vaginal discharge, itching, redness, dysuria, dyspareunia]Timepoint: Day 1 and Day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Improvement in each symptom and sign from baseline in each visit, which will include physician as well as patientâ??s assessment of these signs and symptoms.Timepoint: Day 1 and Day 7 | — |
Countries
India
Contacts
Public ContactDr Piyush Prabhat
Jeevak hospital
Outcome results
None listed