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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000002970
Enrollment
Unknown
Registered
2020-02-04
Start date
2020-06-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AECOPD

Interventions

Sponsors

Hospital of Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 65 Years

Inclusion criteria

Inclusion criteria: 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 = 10), regardless of sex; 4. Expected survival time >= 30 days; 5. Patients and their families agree to participate and sign informed consent.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
The dosage of systemic glucocorticoids (at which the CAT scores improve by 50%).;

Secondary

MeasureTime frame
Symptoms and quality of life scores during the follow up;Pulmonary function;Exercise tolerance;Symptoms scores;Length of hospital stay;Inflammatory indicators;

Countries

China

Contacts

Public ContactChen Keling

School of Clinical Medicine, Chengdu University of TCM

1079767304@qq.com+86 13982228521

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026