Efficacy and Safety of Combined With Andrographolide Sulfonate on the Basis of Conventional Therapy in Patients With Acute Exacerbation of Chronic Bronchitis: a Randomized, Single Blind, Placebo-controlled, Multicenter Study
试验速览
- 阶段
- 4 期
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- cured rate
研究概览
简要总结
A multicenter,randomized,single-blind, placebo-controlled,phase 4 clinical trial to evaluate the efficacy and safety of andrographolide sulfonate in patients with acute exacerbation of chronic bronchitis
详细描述
The patient after passing the screening, with the ratio of 1:1, were randomly assigned to experimental group or control group. Experimental group: on the basis of Conventional Therapy,Xiyanping injection(andrographolide sulfonate) 10-20ml/d, With 0.9% normal saline 100ml-250ml diluted intravenous drip (not with other drugs in the same container mixed use), control drip speed per minute of 30-40 drops. control group: on the basis of Conventional Therapy,Xiyanping injection simulation(0.9% normal saline) 10-20ml/d, The treatment method is the same as the experimental group.
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.18-75 years, males or females;
- •2.patients met the acute exacerbation of chronic bronchitis diagnosis;
- •3.Patients with bronchitis were acute attacked 2-6 days,who had a history of chronic bronchitis more than 2 years.
- •Patients compliance is good, written informed consent was obtained from all participants before the study.
排除标准
- •1.Patients had a history of andrographolide sulfonate or andrographolide allergy.
- •2.Pregnancy, lactation, and absence of contraception in women of fertile age.
- •3.Judging by the researchers, Past or present illness of patients may affect to participate in the trial or affect the outcome of the study, including cardio-pulmonary diseases, malignant diseases, autoimmune diseases, hepatorenal disease, blood diseases, nervous system diseases, immune system diseases and endocrine diseases
- •4.After checking, Patients with pulmonary tuberculosis, bronchial asthma, bronchial pneumonia, bronchiectasis, pneumoconiosis, silicosis, lung cancer, pulmonary infiltration or other allergic respiratory diseases and other chronic lung diseases
- •5.Patients using systemic steroids or other immunosuppressive therapy
- •6.Patients with severe cardiopulmonary dysfunction, abnormal liver and kidney function, blood system diseases
- •7.Patients are alcohol (daily drink alcoholic wine is more than 40g) or drug abuse or drug addicts in the past year.
- •8.Patients were participated in any study of drug trials in the last 30 days.
- •9.According to the researchers' judgment, anyone who are not suitable for the study.
研究组 & 干预措施
Experimental group
Conventional Therapy + Xiyanping injection(andrographolide sulfonate)
干预措施: andrographolide sulfonate (Drug)
control group
Conventional Therapy + Xiyanping injection simulation/andrographolide sulfonate simulation(0.9% normal saline)
干预措施: andrographolide sulfonate simulation (Drug)
结局指标
主要结局
cured rate
时间窗: less than 14 days
clinical symptoms(fever, cough, expectoration and gasp) and signs totally disappear, the period of lab tests（WBC,CRP, chest X-ray） return to normal is recorded。
次要结局
- the incidence of complications(less than 14 days)
- days of antibiotic use(less than 14 days)
- effective time window(less than 14 days)
- direct medical cost(less than 14 days)
- number of participants with treatment-related adverse events(less than 14 days)
- bacterial eradication rate(less than 14 days)