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

• Status: Unknown status
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
• Treatments: Andrographolide

Criteria

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.