The Efficacy and Safety of Andrographolide Sulfonate in the Treatment of Acute Bronchitis: a Randomized,Double-blind,Placebo Parallel Controlled,Multicenter Study
试验速览
- 阶段
- 4 期
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- cured rate
研究概览
简要总结
A multicenter, randomized, double-blind, placebo-controlled, phase 4 clinical trial to evaluate the efficacy and safety of andrographolide sulfonate in patients with acute 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: 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: Xiyanping injection simulation(0.9% Sodium Chloride Injection) 10-20ml/d, The treatment method is the same as the experimental group. Treatment cycle: less than 7 days (the longest period of treatment is 7 days, if the clinical symptoms were relieved in the treatment, patients were stoped 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1.18-65 years, males or females;
- •2.patients met the acute bronchitis diagnosis;
- •3.patients'all symptoms (including cough) appeared no longer than 72 h before inclusion to the trial;
- •4.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
andrographolide sulfonate(Xiyanping injection) 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.
干预措施: andrographolide sulfonate (Drug)
control group
andrographolide sulfonate simulation(0.9% normal saline) 10-20ml/d, The treatment method is the same as the experimental group.
干预措施: andrographolide sulfonate simulation (Drug)
结局指标
主要结局
cured rate
时间窗: less than 7 days
clinical symptoms(fever, cough) and signs(pulmonary rales) totally disappear, the period of lab tests return to normal is recorded
次要结局
- effective time window(less than 7 days)
- the incidence of complications(less than 7 days)
- time from admission to recovery of fever(less than 7 days)
- days of Anti infective Drugs use(less than 7 days)
- number of participants with treatment-related adverse events(less than 7 days)