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Qingkepingchuan granules for acute exacerbation of COPD patients with syndrome of phlegm heat obstructing lung: a randomized, double-blind, placebo-controlled trial

Qingkepingchuan granules for acute exacerbation of COPD patients with syndrome of phlegm heat obstructing lung: a randomized, double-blind, placebo-controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043009
Enrollment
Unknown
Registered
2021-02-04
Start date
2021-02-08
Completion date
Unknown
Last updated
2021-04-12

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

Conditions

Chronic obstructive pulmonary disease

Interventions

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 40 to 85 years; 2. Patients who meet the diagnostic criteria of COPD comprehensive evaluation group B, C and D, and they are in the acute exacerbation stage; 3. Patients who are diagnosed with moderate to severe AECOPD; 4. Patients who meet the Chinese medicine syndrome classification of phlegm heat obstructing lung; 5. Patients who sign the written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Other respiratory diseases: bronchial asthma, bronchiectasis, bullae, pleural effusion, active tuberculosis and other lung diseases; 2. Severe or uncontrollable diseases: hematological diseases; liver dysfunction (ALT or AST >=3 ULN, total bilirubin>=1.5 ULN), renal dysfunction (serum creatinine >177 umol/L or 2mg/dl), congestive heart failure (III-IV); immune deficiency, tumor, organ or bone marrow transplantation, HIV or immunosuppressive therapy in recent 3 months; 3. Patients with diabetes or impaired glucose tolerance; 4. Systemic glucocorticoids were needed in recent 3 months; 5. Patients with confirmed history of alcohol, drug abuse or mental illness; 6. Patients with dysphagia or gastrointestinal disease affecting drug absorption (reflux esophagitis, chronic diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastrinoma, short bowel syndrome, after subtotal gastrectomy); 7. Patients who have known hypersensitivity to the study medication or some of its ingredients; 8. Patients have been exposed to the study drug within one month before enrollment; 9. Patients who are pregnant or lactating.

Design outcomes

Primary

MeasureTime frame
CASA-Q;

Secondary

MeasureTime frame
COPD assessment test;mMRC;CCQ;WBC;CRP;PCT;Classification of sputum cytology;Average treatment days;

Countries

China

Contacts

Public ContactLin Lin

Guangdong Provincial Hospital of Chinese Medicine

drlinlin@163.com+86 020-80887233-38605

Outcome results

None listed

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