The Efficacy and Safety Study of Honghe Fujie Lotion for the Treatment of Bacterial Vaginosis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 240
- 试验地点
- 8
- 主要终点
- The percentage of patients with remission according to Nugent score < 7
研究概览
简要总结
This is a Randomized, Positive -Controlled, Multi-center Trial enrolling 240 subjects with Bacterial Vaginosis who will be randomized at a ratio of 1:1 to receive active Honghe Fujie lotion or Metronidazole Suppositories. The primary objective is to assess the safety and tolerability of Honghe Fujie lotion compared to Metronidazole Suppositories.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal women with sex history.
- •Age: 20 - 50 years.
- •Clinical diagnosis of Bacterial Vaginosis.
- •Nugent scale ≥
- •Patient is willing to participate voluntarily and to sign a written patient informed consent.
排除标准
- •Evidence of other female genital tractor infectious diseases (e.g. trichomonas vaginitis, VVC, suspected gonorrhea，HSV infection and pointed condyloma etc.).
- •Pruritus vulvae or pain caused by nonneoplastic epithelial disorders of vulva（e.g. Vulvar squamous epithelial hyperplasia ,vulvar lichen, diabetic vulvitis etc.).
- •Server gynecopathy（e.g. Gynecological malignant tumor etc.）.
- •Liver function impairment with the value of ALT or AST over 2-fold of normal value.Renal dysfunction with the value of serum creatinine over normal value.
- •Patient accompanied with server systemic diseases (gastrointestinal, cardio,cerebral, blood circulatory, endocrine, and renal system).
- •Receiving locally applied drugs within 1 week or currently using vaginal medicines.
- •Significant drug or alcohol abuse or a history of mental illness patients.
- •Researchers determine poor adherence, or any other unsuitable reasons for patients to participate in this study.
- •Diagnosis with other disease that necessities immunosuppressant or hormone therapy.
- •Pregnancy, breast feeding and the possible pregnancy during study. Patient who is participating in other trials or has been participated in other trials in recent 1 months.
- •Allergic to one or more components of study medicine.
研究组 & 干预措施
Honghe Fujie lotion group
干预措施: Honghe Fujie lotion (Drug)
Metronidazole Suppositories group
干预措施: Metronidazole Suppositories (Drug)
结局指标
主要结局
The percentage of patients with remission according to Nugent score < 7
时间窗: 28 days after the end of treatment
The Nugent score is determined by a microscopic assessment of a Gram stain of vaginal fluid，calculated by assessing for the presence of large Gram-positive rods (Lactobacillus morphotypes; decrease in Lactobacillus scored as 0 to 4), small Gram-variable rods (Gardnerella vaginalis morphotypes; scored as 0 to 4), and curved Gram-variable rods (Mobiluncus spp. morphotypes; scored as 0 to 2) . Nugent score is is the addition of these three sub scales,and can range from 0 to 10.
次要结局
- The pH of vaginal secretions(0,3 days, 28 days after the end of treatment)
- Change of Nugent score(3 days, 28 days after the end of treatment compare with baseline)
- Pattern of Chinese medicine symptoms(0,3 days after the end of treatment)
- H2O2 concentration of vaginal secretions(0,3 days, 28 days after the end of treatment)