Oral Tinidazole Treatment of Refractory Trichomonas Vaginitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Cure rate of refractory trichomoniasis
研究概览
简要总结
We compare two oral tinidazole regimens for refractory trichomonas vaginitis.
详细描述
Refractory trichomonas vaginitis has become a clinical problem, which has a direct impact on the health and life of patients. Refractory trichomonas vaginitis is mainly caused by drug resistance of trichomonas. Drug resistant trichomonas has appeared China. Increasing the dosage of anti trichomonal drugs is the main treatment method at present. The aim of this study was to evaluate the efficacy and safety of two oral tinidazole regimens for refractory trichomonas vaginitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women be at least 18 years of age
- •Failure of conventional treatment (recommended by guidelines including tinidazole, 2g once daily for 5-7 days)
排除标准
- •Allergy to metronidazole or tinidazol
- •Pregnant or nursing
- •HIV or other chronic disease
研究组 & 干预措施
Tinidazole 56
Tinidazole , 2g， twice daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days.
干预措施: Tinidazole 42 (Drug)
Tinidazole 42
Tinidazole , 1g, three times daily for 14 days. At the same time, metronidazole, 400 mg, once a day, vaginal administration, 14 days.
干预措施: Tinidazole 56 (Drug)
结局指标
主要结局
Cure rate of refractory trichomoniasis
时间窗: 24 weeks
Evaluate the efficacy of oral tinidazole tablets in the treatment of refractory trichomoniasis.Diagnosis of vaginal trichomoniasis is performed by microscopy of vaginal secretions. Cure or failure was based on positive or negative T. vaginalis on vaginal secretions by microscopy examination.
次要结局
- Safety of tinidazole tablets(24 weeks)
研究者
Shangrong Fan
Profesor
Peking University Shenzhen Hospital