Prevention of recurrence of Bacterial Vaginosis using Lactobacilli containing vaginal tablets (Flora â??Balance) among HIV infected women treated with standard Metronidazole Therapy : A 12 Months, Double blind,Randomized,Placebo controlled, Phase IV study

Indian Council of Medical Research0 个研究点目标入组 80 人开始时间: 待定最近更新: 2023年5月1日

试验速览

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•Positive HIV serology obtained prior to enrollment HIV infected women
•Age 18 years to 40 years
•Having regular menstrual cycles
•Willing to be abstinent for the period when she is using vaginal tablets (either lactobacilli containing or placebo) i.e 15 days in the first month and 8 days every month for next three months
•Having Facility to store study vaginal tablets at desired temperature (between 2-8 degree) for 8 days every month for first four months
•Able and willing to provide written informed consent
•Bacterial vaginosis positive as defined by amselâ??s criteria and confirmed by Nugentâ??s score

•Oral or Vaginal antimicrobial or probiotics therapy within 14 days prior to enrollment
•Pregnancy or lactating upto 6 months
•Reported or known allergy /sensitivity to Tab Metronidazole or lactobacilli containing formulations
•Use of any vaginal medication in the previous 7 days of enrollment
•Any condition that in the opinion of the study staff would make participation in the study unsafe complicate interpretation of study outcome data or otherwise interfere with achieving the study objective

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