Status:
UNKNOWN
Effect of Traditional Chinese Medicine on Outcomes in Patients With Mild/Moderate Chronic Obstructive Pulmonary Disease
Lead Sponsor:
Henan University of Traditional Chinese Medicine
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
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).
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2014
Estimated Enrollment :
504 Patients enrolled
Trial Details
Trial ID
NCT01486186
Start Date
December 1 2011
End Date
December 1 2014
Last Update
December 6 2011
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