CTRI/2007/091/000022已完成3 期
To evaluate the efficacy of a lactobacilli preparation on Bacterial vaginosis, HIV infectivity and vaginal immunity in healthy subjects and subjects with bacterial vaginosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Healthy women of reproductive age group over 18 years
- •Bacterial vaginosis to be excluded by Nugent score (healthy patients)
- •b.Bacterial vaginosis diagnosis is based on the Nugent method (in patients with bacterial vaginosis)
- •Exclusion of any other vaginal infection by standard diagnostic procedure.
- •Written informed consent
排除标准
- •Post menopausal women
- •Pregnant women
- •Abnormal uterine bleeding (not including cervical contact bleeding on sampling) or vaginal bleeding of unknown origin.
- •AIDS patients or patients with any kind of cancer or tumor
- •Diabetes mellitus
- •Drug addiction
- •Antibiotic use (local or systemic) in the previous 20 days.
- •Use of any vaginal medication in the previous 7 days.
- •Participation in any other study 30 days before beginning of the present study.
- •Known or suspected hypersensitivity to any of the ingredients of the trial medication.
- •No informed consent.
- •Patient not willing to comply with the trial instructions.
研究者
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