Effect of Traditional Chinese Medicine on Outcomes in Patients With Mild/Moderate Chronic Obstructive Pulmonary Disease

Henan University of Traditional Chinese Medicine

Status and phase: Unknown; Phase 2

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: placebo chinese medicine; Drug: Traditional Chinese Medicine

Study type: Interventional

Funder types: Other

Identifiers

NCT01486186

TCM for COPD

Details and patient eligibility

About

The purpose of this study is evaluate the effects and safety of Traditional Chinese medicine for prevention and management of mild/moderate chronic obstructive pulmonary disease (COPD).

Full description

This is a multicenter, randomized, double-blind, placebo controlled study to evaluate the effect of Traditional Chinese medicine (TCM) in COPD subjects. Following a 14 day run-in period, approximately 504 subjects will be randomly assigned to double-blind treatment for 52 weeks. After the 52 weeks treatment period, subjects in both treatment arms will follow-up 52 weeks. The primary measure of efficacy is the frequency of exacerbations and spirometric values (e.g. FEV1). Secondary efficacy measures include Dyspnea (MMRC), Quality of life ( CAT,SF-36), Exercise Capacity( 6MWD). Safety will be assessed through the collection of adverse events. There will be a total of 5 study visits ( randomization, and after 13, 26, 39 and 52 weeks of treatment). A follow-up contact for collection of effect and adverse event will be conducted approximately 52 weeks following the last study visit.

Enrollment: 504 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A confirmed diagnosis of mild/moderate COPD.
• Age between 40 and 80 years.
• Syndrome differentiation belongs to Syndrome of lung-qi deficiency, Syndrome of deficiency of pulmonosplenic qi, Syndrome of insufficiency of QI of the lung and kidney.
• Without participation in other interventional trials in the previous one month.
• With the informed consent signed.

Exclusion criteria

• Pregnant or breast-feeding women.
• Any psychiatric condition rendering the patient unable to understand the nature, scope and possible consequences of the study .
• Complicated with severe heart failure (class Ⅳ NYHA heart function) or unstable hemodynamics.
• Complicated with bronchial asthma, bronchiectasis or active tuberculosis；
• Complicated with obliterative bronchiolitis or diffuse pantothenic bronchiolitis，
• Complicated with pneumothorax, pleural effusion or pulmonary embolism.
• Complicated with neuromuscular disorder which affects the respiration.
• Complicated with tumors.
• Complicated with serious hepatic and renal diseases.
• Long periods of bed rest.
• Use of oral or parenteral corticosteroids before 1 months of Visit 1 .
• With immunodeficiency.
• Participating in other trials or allergic to the used medicine.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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504 participants in 2 patient groups, including a placebo group

traditional chinese medicine

Experimental group

Description:

The experimental group will receive three type of TCM, they are Baofei granule, Bufeijianpi granule and Bufeiyishen granule.

Treatment:

Drug: Traditional Chinese Medicine

placebo

Placebo Comparator group

Description:

placebo chinese medicine in addition to best care according to clinical guidelines for COPD patients

Treatment:

Drug: placebo chinese medicine