CTRI/2023/04/051978尚未招募3 期
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. -
D Y Patil University School of Medicine Navi Mumbai0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Female patients in reproductive age group (18-45 years).
- •2. Patients willing to give written informed consent.
- •3. 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
- •1. Pregnant or lactating women.
- •2. Patients with history of previous treatment with systemic antifungal agents within past four weeks or previous topical antifungal treatment within one week.
- •3. Having any sexually transmitted disease or gynecological abnormality requiring treatment.
- •4. History of diabetes mellitus or other chronic illness.
- •5. Immunocompromised patients or patients on immunosuppressant therapy.
- •6. Presence of concomitant vaginitis caused by other infections (e.g., Bacterial vaginosis, Trichomonas vaginalis, Chlamydia trachomatis or Neisseria gonorrhea).
- •7. Hypersensitivity to azoles or any component of the formulation.
- •8. History of drug or alcohol dependency or abuse.
- •9. 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.
研究者
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