Sanjin Tablets for the Treatment of Acute Simple Lower Urinary Tract Infection and Its Influence on Recurrence Rate: a Randomized, Double Blind, Parallel Control of Positive Drugs, Multi-center Clinical Study
试验速览
- 阶段
- 4 期
- 入组人数
- 252
- 主要终点
- The lower urinary tract infection symptoms of 252 participants will be assessed
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety and immune mechanism of Sanjin tablets for the treatment of acute simple lower urinary tract infection and its influence on recurrence rate.
详细描述
In order to evaluating the efficacy, safety and immune mechanism of Sanjin tablets for the treatment of acute simple lower urinary tract infection and its influence on recurrence rate and through research data to guide clinical, improving the rational use of drugs, especially the rational application of antibiotics. In this study, a randomized, double blind, parallel control of positive drugs, multi-center clinical study will be established. According to the relevant regulations of the CFDA, 252 cases need to be registered at least. These cases will be divided into treatment group（Sanjin tablets+ levofloxacin simulants），control group 1（Sanjin tablets simulants +levofloxacin）and control group 2（Sanjin tablets+ levofloxacin）. Each group will be treated for 7 days and followed up for 2 times. The efficacy indicators of this study were mainly from three dimensions: syndrome, laboratory routine examination and bacteriology examination. The symptom scores and cytokine changes of each group before and after treatment were observed.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 18 to 50 years of age.
- •Meets the western diagnostic criteria of acute simple lower urinary tract infection, the disease duration does not exceed 72 hours.
- •Urine retention in the screening period -1-0 days, bacterial culture results were sensitive to levofloxacin.(Urine retention for bacterial culture and clinical treatment at the same time)
- •The syndrome differentiation of TCM is syndrome of dampness-heat in lower jiao.
- •Did not receive antibiotic treatment within 48 hours Before being selected.
- •The inclusion of those who confirmed not pregnant
- •Those who agree to participate in this clinical trial and sign the informed consent, the process of informed consent meet the relevant provisions of the GCP.
排除标准
- •Those who are allergic to the test drug ingredients or quinolones.
- •In the past, there was a history of bacterial culture that was not sensitive to levofloxacin.
- •Diagnosed as complicated urinary tract infection.
- •Patients with urinary calculi or obstruction, urinary tuberculosis, renal papillary necrosis, perinephric abscess or neurogenic bladder.
- •Combined with vaginitis symptoms, genital ulcers or gonorrhea.
- •Combined with severe cardiopulmonary disease, liver and kidney disease, advanced tumor, blood, central nervous system (such as the history of epilepsy) or other serious or progressive disease.
- •A patient who has a neurological or mental illness and cannot cooperate.
- •Infected persons who must use other antibacterial drugs in combination.
- •Pregnancy, lactating women or recent birth planners.
- •Those who have participated in other clinical trials within 3 months before being selected.
研究组 & 干预措施
Sanjin tablets group
Sanjin tablets+ levofloxacin simulants
干预措施: Sanjin tablets (Drug)
Levofloxacin group
Sanjin tablets simulants +levofloxacin
干预措施: Sanjin tablets simulants (Drug)
Sanjin tablets+ Levofloxacin group
Sanjin tablets+ levofloxacin
干预措施: Levofloxacin (Drug)
结局指标
主要结局
The lower urinary tract infection symptoms of 252 participants will be assessed
时间窗: After 7 days of medication
The symptoms mainly includes frequent urination,urgent urination,urinary pain, lower abdominal pain and pain in the kidney area.If these symptoms disappear after 7 days of medication,it indicates the subject is cured.
次要结局
- The urine leukocyte of 252 participants will be assessed(After 7 days of medication)
- The recurrence rate of subjects who is cured in 252 participants will be assessed by urine leukocyte(28 days after the end of treatment)
- The bacteriological examination of 252 participants(After 7 days of medication)
- The recurrence rate of subjects who is cured in 252 participants will be assessed by lower urinary tract infection symptoms(28 days after the end of treatment)
- The recurrence rate of subjects who is cured in 252 participants will be assessed by bacteriological examination(28 days after the end of treatment)
研究者
Yanming Xie
Deputy director
China Academy of Chinese Medical Sciences