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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2200006560
Enrollment
Unknown
Registered
2022-09-04
Start date
2022-09-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic bronchitis

Interventions

Test group:Guben Kechuan granules, 3 times a day, 1 bag each time (2G / bag)
Blank control group:Patient education
Positive drug control group:Guilong Kechuanning capsule, 3 capsules each time, 3 times a day

Sponsors

CHINA-JAPAN FRIENDSHIP HOSPITAL
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
immunity;Symptom evaluation of chronic bronchitis (cough, expectoration, wheezing);AECB;Inflammatory factor;Pulmonary function;EQ5D;

Countries

China

Contacts

Public ContactDaowen Yang
13910331107@139.com13910331107

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026