Clinical observation on the efficacy, safety and pharmacoeconomics of Guben Kechuan granule in treating chronic bronchitis

Phase 4

• Conditions: chronic bronchitis

• Registration Number: ITMCTR2200006560
• Lead Sponsor: CHINA-JAPAN FRIENDSHIP HOSPITA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

(1) Consistent with the diagnosis of chronic bronchitis;

(2) The scores of main symptoms of chronic bronchitis (cough, expectoration and wheezing) were all = 1 point;

(3) Age 18-75 years old (including 18 and 75 years old), gender is not limited;

(4) Voluntarily participate in this clinical trial, give informed consent and sign the informed consent form.

Exclusion Criteria

(1) Acute bronchitis or acute exacerbation of chronic bronchitis in recent 1 month;

(2) Pulmonary tuberculosis, eosinophilic bronchitis, bronchial lung cancer, idiopathic pulmonary fibrosis, pneumonia, bronchial asthma, bronchiectasis, gastroesophageal reflux and other diseases with cough, expectoration or wheezing symptoms;

(3) Have taken drugs similar to the functional indications of the test drug in the past 2 weeks;

(4) SCR of renal function is greater than the upper limit of reference value or ALT and AST of liver function are more than 2 times of the upper limit of reference value;

(5) Complicated with serious primary diseases such as cardiovascular, cerebrovascular, liver, kidney, digestive and hematopoietic system;

(6) Have a long history of alcohol and drug abuse;

(7) Pregnant and lactating women and during the trial cannot be strictly contraception;

(8) Have a history of allergy to test drug components;

(9) Having intellectual disability or mental disorder;

(10) Participated in other clinical trials in the past 3 months;

(11) The investigator considers it inappropriate to participate in this clinical trial.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
immunity;Symptom evaluation of chronic bronchitis (cough, expectoration, wheezing);AECB;Inflammatory factor;Pulmonary function;EQ5D;