跳至主要内容
临床试验/NCT03234517
NCT03234517Unknown2 期

Continuous Versus Interrupted Use.of Vaginal Probiotic Plus Vaginal Clindamycin Cream for Bacterial Vaginosis a Randomized Controlled Study

Zagazig University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
200
试验地点
1
主要终点
initial cure rate

研究概览

简要总结

Vaginal Clindamycin Cream Plus Vaginal probiotic for treatment of Bacterial Vaginosis

详细描述

Vaginal Clindamycin Cream was used initially for treatment of Bacterial Vaginosis followed by Vaginal probiotic either in cnotinous or interrupted manner, then assessment of the results of treatment at different time intervals was done.

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
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • more than 18 years
  • has recurrent Bacterial Vaginosis

排除标准

  • pregnancy
  • use of other antmicrobial
  • not provide informed consent

研究组 & 干预措施

Vaginal Clindamycin Cream Plus continuous Vaginal Probiotic

Experimental

Vaginal Clindamycin Cream followed by continuous Vaginal Probiotic use for 60 days

干预措施: Vaginal Clindamycin Cream (Drug)

Vaginal Clindamycin Cream Plus continuous Vaginal Probiotic

Experimental

Vaginal Clindamycin Cream followed by continuous Vaginal Probiotic use for 60 days

干预措施: Vaginal Probiotic (Drug)

Vaginal Clindamycin Cream Plus interrupted Vaginal Probiotic

Active Comparator

Vaginal Clindamycin Cream followed by interrupted Vaginal Probiotic use

干预措施: Vaginal Clindamycin Cream (Drug)

Vaginal Clindamycin Cream Plus interrupted Vaginal Probiotic

Active Comparator

Vaginal Clindamycin Cream followed by interrupted Vaginal Probiotic use

干预措施: Vaginal Probiotic (Drug)

结局指标

主要结局

initial cure rate

时间窗: 2 months

number of women completely cured

次要结局

  • recurrence rate(4,6,8and12 months)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

IBRAHIM ABD ELGAFOR

assistant professor

Zagazig University

研究点 (1)

Loading locations...

相似试验