A Study of Andrographolide Sulfonate in Patients With Acute Exacerbation of Chronic Bronchitis

Qingfeng Pharmaceutical

Status and phase: Unknown; Phase 4

Conditions: Acute Exacerbation of Chronic Bronchitis

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT03132610

JXQF-XYP-1608

Details and patient eligibility

About

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 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: on the basis of Conventional Therapy,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: on the basis of Conventional Therapy,Xiyanping injection simulation(0.9% normal saline) 10-20ml/d, The treatment method is the same as the experimental group.

Enrollment: 240 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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240 participants in 2 patient groups, including a placebo group

Experimental group

Active Comparator group

Description:

Conventional Therapy + Xiyanping injection(andrographolide sulfonate)

Treatment:

Drug: andrographolide sulfonate

control group

Placebo Comparator group

Description:

Conventional Therapy + Xiyanping injection simulation/andrographolide sulfonate simulation(0.9% normal saline)

Treatment:

Drug: andrographolide sulfonate simulation