The Effectiveness of Vaginal Hygiene Wash as Adjunct Treatment in Bacterial Vaginosis- a Randomized Double Blind Controlled Trial With Microbial Analysis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 56
- 主要终点
- Visual analog scale of symptoms after treatment
研究概览
简要总结
This study compares the effect of vaginal hygiene wash versus placebo as adjunct treatment with oral metronidazole in treatment of women with bacterial vaginosis
详细描述
This is a randomized controlled trial comparing the trial hygiene wash against placebo wash as adjunct treatment with oral metronidazole in women with bacterial vaginosis, with microbial analysis of vaginal flora compared to healthy control women
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
the trial hygiene wash and placebo wash are labelled A or B in identical packaging by manufacturer's company and blinded from both participants and investigators and only revealed at the end of data completion
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •premenopausal women who are sexually active 2.willing to use hygiene wash together with prescribed oral antibiotics
- •able to undergo pelvic examination for sampling of vaginal discharge
排除标准
- •Unable to comply with pelvic examination or hygiene wash
- •Concurrent use of hormonal treatment or antibiotic therapy
- •Intrauterine device either copper or levonorgestrel-releasing system
- •Women with known diabetes mellitus
- •Pregnant women
结局指标
主要结局
Visual analog scale of symptoms after treatment
时间窗: 2 weeks after treatment
self-evaluation of symptom using Visual analog scale (VAS) scale 0 to 10 based on questionnaire, 5 symptoms assessed are 1) level of comfort in the genital region, 2) malodorous external genitalia, 3) comfort in sexual intercourse, 4) satisfaction regarding intimate hygiene, and 5) self-esteem
Microbial profile of vaginal flora before treatment
时间窗: Before treatment
DNA quantitative polymerase chain reaction (qPCR) array analysis of vaginal swab taken before treatment which includes Lactobacillus, Gardnerella, Prevotella, Candida, and Trichomonas vaginalis
Bacterial vaginosis cure rate
时间窗: 2 weeks after treatment
Percentage of participants who have negative bacterial vaginosis (BV) blue test after completed treatment
Visual analog scale of symptoms before treatment
时间窗: before treatment
self-evaluation of symptom using Visual analog scale (VAS) scale 0 to 10 based on questionnaire, 5 symptoms assessed are 1) level of comfort in the genital region, 2) malodorous external genitalia, 3) comfort in sexual intercourse, 4) satisfaction regarding intimate hygiene, and 5) self-esteem
Cytokines concentration before treatment
时间窗: before treatment
Concentration of cytokines (interleukins (IL-6, IL-8, IL-10), tumor necrosis factor (TNF-alpha) all in pg/mL at baseline
Cytokines concentration after treatment
时间窗: 2 weeks after treatment
Concentration of cytokines (interleukins (IL-6, IL-8, IL-10), tumor necrosis factor (TNF-alpha) all in pg/ml after completed treatment
Microbial profile of vaginal flora after treatment
时间窗: 2 weeks after treatment
DNA quantitative polymerase chain reaction (qPCR) array analysis of vaginal swab taken before treatment which includes Lactobacillus, Gardnerella, Prevotella, Candida, and Trichomonas vaginalis
次要结局
- Microbial analysis of vaginal flora 1 month after completed treatment(1 month after completed treatment)
- Recurrence of symptoms 1 month after completed treatment(1 month after completed treatment)