Efficacy of Voriconazole Loaded Spanlastics Gel Versus Clotriamazole Cream on Treating Vulvovaginal Candidasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- efficacy of nano voriconazole versus Clotrimazole in Treatment of vaginal candidiasis albicans and removal of symptoms
研究概览
简要总结
To investigate and compare the efficacy of voriconazole loaded spanlastics (VCZ loaded SPs) optimum gel formula (F2 VCZ loaded SP gel) versus Clotrimazole cream in treating candida albicans causing vulvovaginal candidiasis for different durations of 3 days and 5 days.
详细描述
The current study will be prospective controlled randomized clinical trial. 28 female patients suffering from vulvovaginal candidiasis will be enrolled in the following 2 groups:
Gp 1 (Test group): including 14 patients with vulvovaginal candidiasis albicans that will be randomized in the following subgroups:
Gp 1a: will be treated with F2 VCZ loaded SP gel for 3 days. Gp 1 b: Will be treated with F2 VCZ loaded SP gel for 5 days. Gp 2 (Control group): including 14 patients with vulvovaginal candidiasis albicans will be randomized in the following sub groups Gp 2 a: will be treated with the Clotrimazole cream available in the market for 3 days.
Gp 2 b: Will be treated with the Clotrimazole cream available in the market for 5 days.
Smears will be taken from the patients before starting the therapeutic protocol and after finishing it. Compliance of the patients to the creams will be assesses
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aging from 20 t0 40 years old suffering from vulvovaginal candidiasis caused by albicans species.
排除标准
- •Pregnant women, female suffering from vulvovaginal candidiasis caused by other species rather than C. albicans.
研究组 & 干预措施
Voriconazole Group
干预措施: Voriconazole Powder (Drug)
Clotriamazole group
干预措施: Voriconazole Powder (Drug)
结局指标
主要结局
efficacy of nano voriconazole versus Clotrimazole in Treatment of vaginal candidiasis albicans and removal of symptoms
时间窗: 1Month
To assess and compare the efficacy of nano voriconazole versus Clotrimazole in Treatment of vaginal candidiasis albicans in 3 and 5 days via smear cultures
次要结局
未报告次要终点
研究者
Raghda R.S. Hussein
Assistant Professor of Clinical Pharmacy and Head of Department
Beni-Suef University