Evaluate the Efficacy and Safety of Andrographolide Sulfonate in Patients With Acute Bronchitis

Study Overview
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Brief Summary
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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

Detailed Description
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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).

Official Title
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The Efficacy and Safety of Andrographolide Sulfonate in the Treatment of Acute Bronchitis: a Randomized,Double-blind,Placebo Parallel Controlled,Multicenter Study

Conditions
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Acute Bronchitis

Intervention / Treatment
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* Drug: andrographolide sulfonate
* Drug: andrographolide sulfonate simulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental group<br>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. | Drug: andrographolide sulfonate<br>* Xiyanping injection 10-20ml/d, With 0.9% Sodium Chloride Injection 100ml-250ml diluted intravenous drip (not with other drugs in the same container mixed use), control drip speed per minute of 30-40 drops.<br>* Other names: Xiyanping injection;|
| Placebo Comparator: control group<br>andrographolide sulfonate simulation(0.9% normal saline) 10-20ml/d, The treatment method is the same as the experimental group. | Drug: andrographolide sulfonate simulation<br>* Xiyanping injection simulation(0.9% normal saline) 10-20ml/d, The treatment method is the same as the experimental group.<br>* Other names: Xiyanping injection simulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cured rate | clinical symptoms(fever, cough) and signs(pulmonary rales) totally disappear, the period of lab tests return to normal is recorded | less than 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effective time window | days range from treatment is received to the effectiveness is observed, and symptoms disappear | less than 7 days | 
| time from admission to recovery of fever | In the absence of other antipyretic drugs, the time from Xiyangping injection beganning to use to Axillary temperature below 37.5℃ , and last more than 24 hours without fever. | less than 7 days | 
| the incidence of complications | Such as, the incidence of Pneumonia, chronic bronchitis, bronchiectasis,and so on. | less than 7 days | 
| days of Anti infective Drugs use | oral anti infective Drugs use days and intravenous Anti infective Drugs use days are recorded | less than 7 days | 
| number of participants with treatment-related adverse events | the total incidence of adverse events,the incidence of adverse events associated with Xiyanping injection, the incidence of patients with grade 3 through grade 4 adverse events that are related to study drug, graded according to NCI-CTC V4.0 . Observe and record all adverse events and serious adverse events, including physical examination, vital signs, laboratory tests (Hematology, blood biochemistry, urine routine, stool routine), ECG changes and so on. | less than 7 days |