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Table 4 Selection criteria for eligible patients

From: Efficacy and safety of Qing-Feng-Gan-Ke Granules in patients with postinfectious cough: study protocol of a novel-design phase III placebo-controlled, double-blind randomized trial

Inclusion criteria for study part A Inclusion criteria for study part B
Postinfectious cough Postinfectious cough
Syndrome of “pathogenic-wind invading lung” Syndrome of “pathogenic-wind invading lung”
Daytime cough symptom score ≥ 2 and/or nighttime cough symptom score ≥ 2 Total cough symptom score ≥ 4
Persistent cough ≥ 3 weeks and ≤ 6 weeks Persistent cough ≥ 3 weeks and ≤ 6 weeks
Age 18-65 years old Age 18-65 years old
Agreement to participate and provision of informed consent Agreement to participate and provision of informed consent
Exclusion criteria
Body temperature > 37.3 °C
Use of any medication intended to treat PIC within one week before enrollment
ALT/AST > 1.5 times than the upper limit of normal reference values; Abnormal blood creatinine; Urine protein qualitative test > +; Blood leukocyte count < 3.0 × 109/L or > 10.0 × 109/L; and/or neutrophil percentage > 80%
History of any severe underlying diseases (e.g. cardiovascular, hematological, hepatic, renal); or other life-threatening disabling conditions and concomitant diseases (e.g. cancer, AIDS)
Pregnancy or potential pregnancy or lactation
Hypersensitivity or allergy to any component of the test drug
Current psychiatric disorders or legal disability
Current or previous admission to other investigational drug studies within 3 months before enrollment
Inability to complete the trial as decided by the investigators