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

Last updated: April 26, 2017
Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Overall Status: Trial Status Unknown

Phase

4

Condition

Bronchitis

Treatment

N/A

Clinical Study ID

NCT03132610
JXQF-XYP-1608
  • Ages 18-75
  • All Genders

Study 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 bronchitis

Eligibility Criteria

Inclusion

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 chronicbronchitis more than 2 years.

    1. Patients compliance is good, written informed consent was obtained from allparticipants before the study.

Exclusion

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 toparticipate in the trial or affect the outcome of the study, includingcardio-pulmonary diseases, malignant diseases, autoimmune diseases, hepatorenaldisease, blood diseases, nervous system diseases, immune system diseases and endocrinediseases

  • 4.After checking, Patients with pulmonary tuberculosis, bronchial asthma, bronchialpneumonia, bronchiectasis, pneumoconiosis, silicosis, lung cancer, pulmonaryinfiltration 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 kidneyfunction, blood system diseases

  • 7.Patients are alcohol (daily drink alcoholic wine is more than 40g) or drug abuse ordrug 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.

Study Design

Total Participants: 240
Study Start date:
December 01, 2016
Estimated Completion Date:
June 01, 2018

Study 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.

Connect with a study center

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330029
    China

    Active - Recruiting

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