Medical Ethics Committee of Peking University Shenzhen Hospital
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Cure rate
研究概览
简要总结
Aerobic vaginitis was treated by using Baofukang Suppository 7 days group or Baofukang Suppository 14 days group.To evaluate the efficacy and safety after treatment.
详细描述
Aerobic vaginitis was treated by using Baofukang Suppository 7 days group or Baofukang Suppository 14 days group.
Group 1: Baofukang Suppository (1.74g), for vaginal use, 2 capsules per night for 7 days.
Group 2: Baofukang Suppository (1.74g), for vaginal use, 2 capsules per night for 14 days.
The efficacy and safety will be evaluated 7~14 days after treatment and 35~42 days after treatment.
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
- None
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
- •Aerobic vaginitis diagnosed based on present ：
- •Vaginal dischareg ;
- •Donders score≥3;
排除标准
- •Patients with other vaginitis, cervical erosion, or suspected gonorrhea, herpes simplex virus infection and other vulvar diseases;
- •Patients received systemic or vaginal antifungal or antibiotic treatment within two weeks before admission.
- •Pregnancy, lactation and intentional pregnancy;
- •Women with liver and kidney dysfunction, low immune function, diabetes, psychosis or other serious diseases;
- •Allergic constitution and patients allergic to drug ingredients in this study;
- •Those with poor compliance.
结局指标
主要结局
Cure rate
时间窗: First month after the treatment
A vaginal smear composite Donders score of 1 to 2 represents normality. A score of more than 2 is aerobic vaginitis. There are four variables(Lactobacillary; leucocytes; toxic leukocytes; parabasal cells; background flora).Detail see folowing references.
次要结局
- Side affect(First week after treatment)
研究者
Shangrong Fan
Principal Investigator
Peking University Shenzhen Hospital