Traditional Chinese medicine may reduce the dosage of systemic glucocorticoids in required patients with acute exacerbation of chronic obstructive pulmonary disease:study protocol for a randomized placebo-controlled trial
- Conditions
- AECOPD
- Registration Number
- ITMCTR2000002970
- Lead Sponsor
- Hospital of Chengdu University of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Patients who meet the diagnosis of phlegm-heat congested lung syndrome of AECOPD and need systemic glucocorticoid administration;
2. COPD GOLD stage 3 or 4 (post-bronchodilator forced FEV1/FVC < 70% and FEV1 < 50% of predicted);
3. Age from 40 to 65 years old and have symptomatic COPD (CAT scores >= 10), regardless of sex;
4. Expected survival time >= 30 days;
5. Patients and their families agree to participate and sign informed consent.
1. Atypical bacterial infections, such as atypical pathogens and drug-resistant bacteria;
2. Complicated with a severe tumor, unstable coronary heart disease, abnormal liver and kidney function, cerebrovascular accident, and other diseases;
3. Other associated active or clinically significant respiratory diseases that have a significant impact on the study, such as active pulmonary tuberculosis, lung cancer, bronchiectasis, pulmonary hypertension, pulmonary interstitial disease, and other active lung diseases;
4. Severe hypertension, diabetes, peptic ulcer, and other glucocorticoids contraindications;
5. Patients who require invasive mechanical ventilation;
6. Pregnant, lactating, and menstrual women;
7. Patients with mental disorders who are unable to actively cooperate with treatment;
8. Patients with a history of allergies to related drugs.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The dosage of systemic glucocorticoids (at which the CAT scores improve by 50%).;
- Secondary Outcome Measures
Name Time Method Symptoms and quality of life scores during the follow up;Pulmonary function;Exercise tolerance;Symptoms scores;Length of hospital stay;Inflammatory indicators;