Effects of Traditional Chinese Medicine on AECOPD Patients

• Status: Unknown status
• Trial end date: 2019-12-31
• Target enrollment: 0
• Participant gender: All

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 (conventional drug, and the combination of conventional drug and TCM) for 14 days treatment. After the treatment period, subjects in two arms will be followed up for 4 weeks. The primary outcomes will include COPD Assessment Test (CAT), and secondary outcomes include treatment failure rate, treatment success rate, hospitalization time, hospital admission rate, endotracheal intubation rate, mortality and quality of life (COPD-PRO, SF-36).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henan University of Traditional Chinese Medicine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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