Status:
UNKNOWN
Effect of Traditional Chinese Medicine on Outcomes in Patients With Severe / Very Severe COPD
Lead Sponsor:
Henan University of Traditional Chinese Medicine
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40-80 years
Phase:
PHASE3
Brief Summary
The aim of this study is to compare the effectiveness of two treatments for severe / very severe COPD patients: one, conventional medicine based on 2013 Global Initiative for Chronic Obstructive Lung ...
Detailed Description
Patients with severe or very severe COPD are more likely to suffer repeated exacerbations and more rapidly declining lung function generating increased risk of death and time to a COPD related hospita...
Eligibility Criteria
Inclusion
- A confirmed diagnosis of severe to very severe COPD.
- medically stable
- Age between 40 and 80 years.
- Syndrome differentiation belongs to syndrome of deficiency of pulmonosplenic qi, syndrome of insufficiency of qi of the lung and kidney, syndrome of insufficiency of qi and yin of the lung and kidney.
- with a two-week wash-out period prior to randomization
- Without participations 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.
- Current respiratory disorders other than COPD (e.g., bronchiectasis, bronchial asthma, tuberculosis, lung fibrosis, pulmonary thromboembolic, diffuse panbronchiolitis).
- Complicated with a neuromuscular disorder, which affected the respiration.
- Complicated with heart failure (NYHA Class III or IV),or myocardial infarction within six months ,or unstable hemodynamics.
- Complicated with malignancy, congenital or acquired immune deficiency.
- Complicated with serious hepatic and renal diseases (liver cirrhosis, portal hypertension, bleeding of varicose veins, dialysis, or renal transplantation).
- Participating in other trials or allergic to the used medicine.
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
564 Patients enrolled
Trial Details
Trial ID
NCT02270424
Start Date
October 1 2014
End Date
December 1 2016
Last Update
October 21 2014
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