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

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.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Salmeterol / fluticasone (Seretide®)

According to the revised 2013 GOLD, Salmeterol / fluticasone was used to severe and very severe COPD patients for 52weeks: Salmeterol / fluticasone (Seretide®, GlaxoSmithKline), 50/500 μg / dose, 60 inhalations. 50/500 μg each time, twice daily.

DRUG

Bufeijianpi granule

According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of deficiency of pulmono-splenic qi will be given Bufeijianpi granule, twice daily for 52 weeks for lower dosage.

DRUG

Bufeiyishen granule

According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi of the lung and kidney will be given Bufeiyishen granule, twice daily for 52 weeks for lower dosage.

DRUG

Yiqizishen granule

According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi and yin of the lung and kidney will be given Yiqizishen granule granule, twice daily for 52 weeks for lower dosage.

DRUG

Placebo Bufeijianpi granule

According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of deficiency of pulmono-splenic qi will be given placebo Bufeijianpi granule, twice daily for 52 weeks for lower dosage.

DRUG

Placebo Bufeiyishen granule

According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi of the lung and kidney will be given placebo Bufeiyishen granule, twice daily for 52 weeks for lower dosage.

DRUG

Placebo Yiqizishen granule

According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi and yin of the lung and kidney will be given placebo Yiqizishen granule granule, twice daily for 52 weeks for lower dosage.

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine

  lead OTHER

Principal Investigators

• Jiansheng Li, Doctor · The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-10-31

Primary Completion

2016-12-31

Completion

2016-12-31