Effect of Traditional Chinese Medicine on Outcomes in Patients With Severe / Very Severe COPD

• Status: Unknown status
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

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 Disease (GOLD) and Chinese Treatment Guidelines; the other, TCM treatments and conventional medicine, which have been evaluated and have certain effect.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henan University of Traditional Chinese Medicine
• Treatments: Fluticasone; Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Fluticasone-Salmeterol Drug Combination; Salmeterol Xinafoate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.