Overview
A Study of Andrographolide Sulfonate in Patients With Acute Exacerbation of Chronic Bronchitis
Status:
Unknown status
Unknown status
Trial end date:
2018-06-01
2018-06-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
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 bronchitisPhase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Jiangxi Qingfeng Pharmaceutical Co. Ltd.Treatments:
Andrographolide
Criteria
Inclusion Criteria:- 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.
- 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.