NCT04626258尚未招募4 期
A Randomized Controlled Trial to Compare the Efficacy of a Medical Grade Honey Formulation (L-Mesitran®) and Fluconazol (Diflucan®) for the Treatment of Recurrent Vulvovaginal Candidiasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 252
- 主要终点
- Vaginal swab
研究概览
简要总结
The purpose of this study is to compare the efficacy of Flucanzol versus L-mesitran in the treatment of patients with recurrent vulvovaginal candidiasis. The investigator will look at vaginal swabs after 1, 6 and 12 months. The investigator included 252 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •• Women of at least 18 years old
- •Recurrent vulvovaginal candidiasis (At least 3 episodes of clinical symptoms during the last year)
- •Clinical and microbiological diagnosis of (recurrent) vulvovaginal candidiasis at time of consultation
- •Capacity to understand, consent, and comply with the trial procedures
排除标准
- •Mixed vaginal infections
- •Pregnancy or the intention to become pregnant during the study period
- •Women using systemic or topical antifungal medication during the last 2 weeks prior to inclusion
- •Known allergies for Fluconazole or honey
- •Candida with resistance for Fluconazole
研究组 & 干预措施
Active comparator: Fluconazol
Active Comparator
Once a month one capsule Fluconazol 150 mg
干预措施: Fluconazole (Drug)
L-Mesitran
Experimental
The first month every day apply L-mesitran, the next five months apply L-mesitran every week on the vagina
干预措施: L-Mesitran (Other)
结局指标
主要结局
Vaginal swab
时间窗: 12 months
The main study parameter is the mycological cure rate after one month of therapy for both the treatment (L-Mesitran®) and control (Diflucan®) groups.
次要结局
- Side effect of medication will be termined with questionnaires(12 months)
- Quality of life will be termined with questionnaires(12 months)
研究者
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