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Table 2 Inclusion and exclusion criteria

From: Efficacy and safety of Jia Wei Bushen Yiqi formulas as an adjunct therapy to systemic glucocorticoids on acute exacerbation of COPD: study protocol for a randomized, double-blinded, multi-center, placebo-controlled clinical trial

Inclusion criteria

1. Age is between 40–90 years old

2. Weight is between 45–85 kg

3. Acute exacerbation of COPD with clinical grade 1–2 that only requires ordinary hospitalization

4. Syndrome differentiation as Fei_Shen_Qi_Yu_Re Zheng in TCM

5. Voluntarily signed informed consent

Exclusion criteria

1. Patients who also have bronchial asthma, bronchiectasis, active tuberculosis, pulmonary fibrosis, pneumothorax, pleural effusion, pulmonary embolism, or neuromuscular disease affecting respiratory function

2. Patients who also have leukemia, aplastic anemia, myelodysplastic syndrome, thrombocytopenia, multiple myeloma, or other blood diseases

3. Patients who also have malignant tumors

3. Patients who also have rheumatic immune diseases and adrenal insufficiency or patients requiring hormones or immunosuppressants

4. Pregnant or planning to become pregnant or lactating women

5. Severe impairment of heart, liver and kidney function (heart function 3–4 degree, aspartate aminotransferase (ALT) and/or alanine aminotransferase (AST) exceeds 1.5 times of the upper limit of normal, creatinine (Cr) exceeds the upper limit of normal)

6. Received systemic glucocorticoids within 2 weeks or participation in other drug clinical trials within 3 months prior to the trial

7. Other conditions that the investigators consider to be improper