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临床试验/CTRI/2014/04/004557
CTRI/2014/04/004557已完成4 期

a randomized, double blind, comparative study of oral metronidazole and tinidazole in treatment of bacterial vaginosis

Dr Indu M raja1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2013年3月1日最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
120
试验地点
1
主要终点
compare the cure rate of oral metronidazol with tinidazol

研究概览

简要总结

Bacerial vaginosis is a clinical syndrome of unknown etiology characterized by y over growth of vaginal anaerobes such as Gardenella vaginalis, bacteroids, mycoplasma. It is the commonest form of lower reproductive tract infection. currently metronidazole is considered as the drug of choice with cure rate of 77.9% . there are also studies showing effecac of tinidazole in treating bacterial vaginosis. it is better tolerated compared to metronidazole. this study is aiming in comparing the cure rates of metronidazole an tinidazole. as secondary endpoint  we are comparing the safety profile in both the groups

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • women diagnosed with bacterial vaginosis.

排除标准

  • pregnant and lactating mothers, history of smoking and alcohol, previous history of bactrial vaginosis, with STDs, HIV or genital malignancies, antimicrobial use in previous 14 days.

结局指标

主要结局

compare the cure rate of oral metronidazol with tinidazol

时间窗: compare the cure rate at the end of 5 days of oral metronidazol with tinidazol

次要结局

  • compare adverse effects of metronidazol with tinidazol(5days)

研究者

发起方
Dr Indu M raja
申办方类型
Other [Dr Indu M raja]

研究点 (1)

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