The Efficacy and Safety Study of Clindamycin Palmitate Hydrochloride Dispersible Tablet for the Treatment of Bacterial Vaginosis
试验速览
- 阶段
- 4 期
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Nugent score
研究概览
简要总结
Randomized, double blind, positive drug parallel comparison, multi-centre clinical trial to assess the Efficacy and Safety of Clindamycin palmitate hydrochloride dispersible tablet for the treatment of bacterial vaginosis
详细描述
Treatment group: Clindamycin palmitate hydrochloride dispersible tablet . Control group: Metronidazole Tablet.
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)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients clinically diagnosed with bacterial vaginosis, should meet the following criteria: vaginal Gram stain integration score (Nugent score) ≥7 points
- •Female patients aged 18 to 55 years old.
- •Patients signed the Informed Consent Form(ICF).
排除标准
- •Patients with vulvovaginitis caused by other infectional reasons such as vaginitis vulvovaginal candidiasis, trichomoniasis vaginitis.
- •Patients received systemic or vaginal antimicrobial therapy in a week before enrolled.
- •Patients with other vaginal or vulvar disorders which could effect the evaluation of efficacy.
- •Pregnant or lactating patients.
- •Menopausal women.
- •Menopause definition: perimenopausal women stop menstruations for a year.
- •Women with diabetes.
- •Dependent on alcohol and could not prohibit during the study period.
- •Women with liver and kidney disfunction, blood disorders, mental illness or other serious diseases.
- •Women allergic to metronidazole, clindamycin.
- •With poor compliance.
研究组 & 干预措施
Clindamycin palmitate hydrochloride
Clindamycin palmitate hydrochloride dispersible tablet 300mg, oral after meal, twice daily, a total of 7days
干预措施: Clindamycin palmitate hydrochloride dispersible tablet (Drug)
Metronidazole
Metronidazole Tablet 400mg, oral after meal , twice daily, a total of 7days
干预措施: Metronidazole Tablet (Drug)
结局指标
主要结局
Nugent score
时间窗: From the first day of randomization to 4-10 and 23-33 days after the end,expected to be up to 33 days.Evaluate changes from baseline to the end of the study.
score of Vaginal secretions for Gram stain
次要结局
- Itching score(From the first day of randomization to 4-10 and 23-33 days after the end,expected to be up to 33 days.Evaluate changes from baseline to the end of the study.)
- Leucorrhea routine examination(From the first day of randomization to 4-10 and 23-33 days after the end,expected to be up to 33 days.Evaluate changes from baseline to the end of the study.)
- The pH of vaginal secretions;(From the first day of randomization to 4-10 and 23-33 days after the end,expected to be up to 33 days.Evaluate changes from baseline to the end of the study.)
- Vaginal secretions(From the first day of randomization to 4-10 and 23-33 days after the end,expected to be up to 33 days.Evaluate changes from baseline to the end of the study.)