An open label, randomized, parallel group, comparative study to evaluate efficacy and safety of castor oil EMULGEL compared to clotrimazole vaginal tablet in the treatment of subjects with vulvo-vaginal candidiasis.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Clinical cure rate (proportion of participants achieving clinical cure)
研究概览
简要总结
This study is a randomized, open label,comparative, parallel-group trial comparing the safety and efficacyof castor oil EMULGEL compared to clotrimazole 200mg vaginal tablet in thetreatment of 80 subjects with vulvo-vaginal candidiasis that will beconducted at D.Y.Patil Hospital, Navi Mumbai. The primary outcome measures willbe therapeutic cure at follow up visit (Day 4 for clotrimazole and Day 6 forcastor oil). The secondary outcomes will be:
1. Microbiological cure rate (Directmicroscopy/wet smear): Number of positive findings in direct microscopy incomparison to first visit.
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Therapeutic cure rate: Clinical andmicrobiological cure combined.
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Total Severity Score (TSS): Individual clinicalsigns and symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Female patients in reproductive age group (18-45 years).
- •Patients willing to give written informed consent.
- •Patients with clinical signs and symptoms of vulvovaginal candidiasis (complaints of vaginal pruritus, burning sensation, vulvar soreness or thick curdy discharge).
排除标准
- •Pregnant or lactating women.
- •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 gynecological abnormality requiring treatment.
- •History of diabetes mellitus or other chronic illness.
- •Immunocompromised patients or patients on immunosuppressant therapy.
- •Presence of concomitant vaginitis caused by other infections (e.g., Bacterial vaginosis, Trichomonas vaginalis, Chlamydia trachomatis or Neisseria gonorrhea).
- •Hypersensitivity to azoles or any component of the formulation.
- •History of drug or alcohol dependency or abuse.
- •Currently enrolled in another clinical study or used any investigational drug or device within 30 days preceding informed consent or scheduled to do the same during the course of this study.
结局指标
主要结局
Clinical cure rate (proportion of participants achieving clinical cure)
时间窗: At baseline, Day-4 for Clotrimazole 200mg & Day 6 for Castor oil EMULGEL
次要结局
- 1. Microbiological cure rate (Direct microscopy/wet smear): Number of positive findings in direct microscopy in comparison to first visit.(2. Therapeutic cure rate: Clinical and microbiological cure combined.)