Status:
UNKNOWN
A Randomized Comparative Effectiveness Research Trial of Three Treatments for COPD Patients
Lead Sponsor:
Henan University of Traditional Chinese Medicine
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The aim of this study is to compare the effectiveness and economic evaluation of three treatments for Chronic Obstructive Pulmonary Disease (COPD) patients: one, conventional medicine based on 2011 Gl...
Detailed Description
COPD affects millions worldwide. The high prevalence, morbidity, mortality and economic burdens of COPD are increasing steadily. Although many therapies exist and are being developed to relieve sympto...
Eligibility Criteria
Inclusion
- A confirmed diagnosis of mild to very severe COPD.
- medically stable
- Age between 18 and 80 years.
- Syndrome differentiation belongs to Syndrome of lung-qi deficiency, Syndrome of deficiency of pulmonic-splenic qi, Syndrome of insufficiency of qi of the lung and kidney, syndrome of insufficiency of qi and yin of the lung and kidney.
- 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 .
- Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within the last 5 years.
- Current respiratory disorders other than COPD (e.g., bronchiectasis, tuberculosis, lung fibrosis, pulmonary thromboembolic).
- Complicated with heart failure (NYHA Class III or IV),or myocardial infarction within six months ,or unstable hemodynamics.
- 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 :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2015
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT01836016
Start Date
May 1 2013
End Date
May 1 2015
Last Update
April 19 2013
Active Locations (1)
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1
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, China, 450000