Effects of Traditional Chinese Medicine on AECOPD Patients

Henan University of Traditional Chinese Medicine

Status and phase: Unknown; Phase 3

Conditions: Acute Exacerbation; Pulmonary Disease, Chronic Obstructive; Medicine, Chinese Traditional

Treatments: Drug: TCM placebo and conventional drug; Drug: TCM and conventional drug

Study type: Interventional

Funder types: Other

Identifiers

NCT03428412

TCM for AECOPD

Details and patient eligibility

About

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).

Enrollment: 378 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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378 participants in 2 patient groups, including a placebo group

TCM plus conventional drug

Experimental group

Description:

The experimental group will receive three type of TCM in addition conventional drug according to 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines for AECOPD.

Treatment:

Drug: TCM and conventional drug

TCM placebo plus conventional drug

Placebo Comparator group

Description:

The control group will receive three type of placebo TCM in addition conventional drug according to 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines for AECOPD.

Treatment:

Drug: TCM placebo and conventional drug