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

Phase 1

Not yet recruiting

• Conditions: Chronic obstructive pulmonary disease

• Registration Number: ITMCTR2100004373
• Lead Sponsor: Guangdong Provincial Hospital of Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 20 February 2023

Recruitment & Eligibility

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

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

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.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
CASA-Q;

Secondary Outcome Measures

Name	Time	Method
COPD assessment test;CRP;Average treatment days;Classification of sputum cytology;CCQ;WBC;mMRC;PCT;