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A multi-center, randomized, double-blind, placebo-controlled clinical trial for the efficacy and safety of corbrin capsules in the treatment of chronic bronchitis

A multi-center, randomized, double-blind, placebo-controlled clinical trial for the efficacy and safety of corbrin capsules in the treatment of chronic bronchitis

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900025707
Enrollment
Unknown
Registered
2019-09-06
Start date
2019-09-11
Completion date
Unknown
Last updated
2019-09-09

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

Conditions

Chronic Bronchitis

Interventions

The placebo group:Patients were given a simulated placebo, 4 pills /t.i.d.
treatment group:Patients were given corbrin capsules, 4 capsules /t.i.d.

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. meet the diagnostic criteria for chronic bronchitis; 2. main symptoms of chronic bronchitis (cough, sputum, wheezing) score <= 1; 3. at least 2 acute exacerbations of chronic bronchitis occurred in the past 1 year (confirmed by the treatment records); 4. aged 18-75 (including 18 and 75) years, regardless of gender; 5. volunteer to participate in this clinical trial, give informed consent and sign informed consent.

Exclusion criteria

Exclusion criteria: 1. acute exacerbations of chronic bronchitis occurred in the past 1 month; 2. complicated with tuberculosis, eosinophilic bronchitis, bronchial lung cancer, idiopathic pulmonary fibrosis, bronchial asthma, wheezing, bronchiectasis, cardiac insufficiency, chronic pharyngitis, postnasal drip syndrome or gastroesophageal reflux; 3. the percentage of pulmonary function FEV1 in patients with bronchial dilator inhalation is 1.5 times; 7. long-term history of alcoholism and drug abuse; 8. pregnant and lactating women and women during the trial cannot strictly control contraception; 9. allergic to the ingredients of the tested drugs; 10. participated in other clinical trials in the past 3 months; 11. the researchers considered it inappropriate to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
pulmonary function (FEV1, FVC, MMEF, PEF);Chest computed tomography;The immune function(Total CD3+T cells, CD3+CD4+T cell subsets, CD3+CD8+T cell subsets CD4+/CD8+T cell subsets);Liver function (ALT, AST, ALP, Tbil, GGT);Renal function (Urea, Scr);

Countries

China

Contacts

Public ContactZhang Hongchun

China-Japan Friendship Hospital

13701226664@139.com+86 13701226664

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026