Monthly Itraconazole Versus Classic Homeopathy for the Treatment of Recurrent Vulvovaginal Candidiasis: a Randomised Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Candida Culture Free After Maintenance Therapy
研究概览
简要总结
A prospective study to evaluate the efficacy of classic homeopathic therapy compared to maintenance itraconazole therapy with and without additional exogenous lactobacillus for treatment of recurrent Candida vaginitis.
详细描述
Objective:
Antimycotics effectively treat sporadic and recurrent vulvovaginal candidiasis (RVVC). Classic homeopathy (CH) is also used to treat this condition. We compared the efficacy of CH and itraconazole in reducing the frequency of RVVC episodes.
Design:
Single-centre, prospective, randomized.
Sample:
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 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years, premenopausal
- •Negative pregnancy test
- •Signed informed consent
- •At least 4 Episodes of Candidiasis within the last year
- •Candida detectable by culture
- •Negative Hepatitis- and HIV-Serology
- •No Allergy to Itraconazole
排除标准
- •Under 18 years
研究组 & 干预措施
itraconazole
6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid).
干预措施: itraconazole (Drug)
itraconazole + lactobacilli agent
6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid). Additionally, Lactobacillus vaginal tablets monthly given through 6 days.
干预措施: itraconazole (Drug)
itraconazole + lactobacilli agent
6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid). Additionally, Lactobacillus vaginal tablets monthly given through 6 days.
干预措施: lactobacillus gasseri (Drug)
classic homeopathy (CH)
CH treatment was provided by a licensed CH practitioner. Specifically, a personal history was taken and an individualised treatment scheme was prescribed. The most often used homeopathic remedies were carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, and sepia M. Potencies of homeopathic remedies ranged from C 30 to C 1000.
干预措施: classic homeopathy (carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, sepia M, etc. as prescribed) (Drug)
结局指标
主要结局
Candida Culture Free After Maintenance Therapy
时间窗: 12 months
candida culture free (monthly vaginal cultures were obtained)
次要结局
未报告次要终点