Multicenter Pilot Study to Compare the Efficacy of a Combination of Vaginal Capsules With Acid Boric, L.Gasseri and L.Rhamnosus Versus the Reference Medication in Patients With Vaginal Candidiasis or Bacterial Vaginosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score.
研究概览
简要总结
The purpose of this study is to determine whether a formula of boric acid and probiotics for vaginal application is effective in the treatment of symptomatic episodes of vulvovaginitis in comparison to pharmacological reference controls (depending on the suspected diagnosis).
详细描述
Multicentre, Open, Prospective, Randomized, Controlled. Women with suspected vaginal infection will be randomized and distributed into two groups (control or boric acid + probiotics). Follow-up will last for three months and consists in 3 visits and a telephone interview.
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
- 否
入选标准
- •Age over 18 years and agreement to participate by signing the consent form.
- •Women with clinical manifestations of acute infectious vulvovaginitis (burning, pruritus, erythema, oedema, and abnormal vaginal discharge).
排除标准
- •Clinical findings compatible with Chlamydia trachomatis, Neisseria gonorrhoeae or Trichomonas vaginalis infection.
- •Use of anti-fungal, antibiotic or probiotic medication within last 2 weeks prior to the study.
- •Patients receiving other treatment (drug, probiotics or vitamin supplements) that can significantly interfere with study evaluations during the 3 months of follow-up.
- •Pregnant or high risk for pregnancy.
研究组 & 干预措施
Boric acid and probiotics
Boric acid with L.gasseri and L.rhamnosus
干预措施: Boric acid and probiotics (Device)
Antibiotic/Antifungal
Antibiotic: Clindamicine Antifungal: Clotrimazol
干预措施: Antibiotic (Clindamycin) (Drug)
Antibiotic/Antifungal
Antibiotic: Clindamicine Antifungal: Clotrimazol
干预措施: Antifungal (Clotrimazole) (Drug)
结局指标
主要结局
Change in the Presence of Vaginitis Clinical Symptoms Determined by Sobel Score.
时间窗: Baseline and at 2 weeks after treatment finalization
Semi-quantitative scale where itching, erythema, edema, stinging and abnormal vaginal discharge are scored from 0 to 3: absent (0), mild (1), moderate (2), severe (3). Worse result is 3 (severe)
次要结局
- Change in the Level of Lactobacillus in Vaginal Flora Determined by Vaginal Cultures.(Baseline and 2 weeks after treatment finalization)
- Number of Participants With Recurrent Infections(At 3 months after recruitment)