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

Qingfeng Pharmaceutical

Status and phase: Unknown; Phase 4

Conditions: Acute Bronchitis

Treatments: Drug: andrographolide sulfonate simulation; Drug: andrographolide sulfonate

Study type: Interventional

Funder types: Industry

Identifiers

NCT03132623

JXQF-XYP-1609

Details and patient eligibility

About

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

Full description

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).

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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144 participants in 2 patient groups, including a placebo group

Experimental group

Active Comparator group

Description:

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.

Treatment:

Drug: andrographolide sulfonate

control group

Placebo Comparator group

Description:

andrographolide sulfonate simulation(0.9% normal saline) 10-20ml/d, The treatment method is the same as the experimental group.

Treatment:

Drug: andrographolide sulfonate simulation