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临床试验/CTRI/2007/091/000022
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

CD Pharma India Pvt Ltd0 个研究点目标入组 140 人开始时间: 待定最近更新:

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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