Status:
UNKNOWN
Effects of Traditional Chinese Medicine on AECOPD Patients
Lead Sponsor:
Henan University of Traditional Chinese Medicine
Conditions:
Pulmonary Disease, Chronic Obstructive
Acute Exacerbation
Eligibility:
All Genders
40-80 years
Phase:
PHASE3
Brief Summary
This is a multi-center, randomized, double-blind, controlled trial to compare the efficacy of two therapies for patients with AECOPD. 378 subjects will be randomly assigned to one therapies (conventio...
Eligibility Criteria
Inclusion
- A confirmed diagnosis of moderate to very severe AECOPD
- Age between 40 and 80 years
- Syndrome differentiation meets criteria of syndrome of external cold and internal fluid,syndrome of phlegm-heat congesting lung,or syndrome of phlegm-damp amassing in lung
- Without participations in other interventional trials in the previous one month
- With the informed consent signed
Exclusion
- Pregnant and lactating women
- Dementia, mental disorders and reluctant partners
- Complicated with heart failure (NYHA Class IV), or Serious cardiac arrhythmias, or unstable hemodynamics
- Current respiratory disorders other than COPD (e.g., bronchiectasis, active tuberculosis, pneumothorax, Pleural effusion, pulmonary thromboembolic, or Neuromuscular diseases affect respiratory movement function)
- Combined tumor
- Treated outside the hospital for more than 7 days
- Need to carry out invasive mechanical ventilation respiratory failure
- Complicated with serious hepatic and renal diseases (liver cirrhosis, portal hypertension, bleeding of varicose veins, dialysis, or renal transplantation)
- Bedridden for various reasons
- Allergic to the used medicine
Key Trial Info
Start Date :
March 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2019
Estimated Enrollment :
378 Patients enrolled
Trial Details
Trial ID
NCT03428412
Start Date
March 1 2018
End Date
December 31 2019
Last Update
February 9 2018
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