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Qingke Pingchuan granules for adult community-acquired pneumonia with syndrome of phlegm heat obstructing lung: a randomized, double-blind, placebo-controlled trial

Phase 1
Recruiting
Conditions
Community-Acquired Pneumonia
Registration Number
ITMCTR2100004416
Lead Sponsor
Guangdong Provincial Hospital of Chinese Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Recruiting
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

1. Patients who are aged 18–65 years;
2. Patients who meet the diagnostic criteria of CAP;
3. Patients who meet the Chinese medicine syndrome classification of phlegm heat obstructing lung;
4. CURB-65 score is 0-2 points;
5. Patients who sign the written informed consent form.

Exclusion Criteria

1. Severe pneumonia;
2. Other respiratory diseases: bronchial asthma, bronchiectasis, bullae, pleural effusion, active tuberculosis and other lung diseases;
3. Severe or uncontrollable basic diseases:hematological diseases; liver dysfunction (ALT or AST >= 3ULN, total bilirubin >= 1.5ULN), renal dysfunction (serum creatinine > 177µmol/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;
4. Patients with diabetes or impaired glucose tolerance;
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. Patines 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
NameTimeMethod
Modified imaging absorption assessment scale for pneumonia;
Secondary Outcome Measures
NameTimeMethod
WBC;Classification of sputum cytology;CASA-Q;The proportion and time of phlegm disappearance;CRP;CURB-65;PCT;Cough symptom score;Average treatment days;The proportion and time of cough disappearance;
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