NCT01486186

Effect of Traditional Chinese Medicine on Outcomes in Patients With Mild/Moderate Chronic Obstructive Pulmonary Disease

Detection and Intervention on Mild/Moderate Chronic Obstructive Pulmonary Disease by Traditional Chinese Medicine Treatment and Application

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 504 (estimated)
• Sponsor: Henan University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 40 Years – 80 Years
• Healthy volunteers: Not accepted

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 504 subjects will be randomly assigned to double-blind treatment for 52 weeks. After the 52 weeks treatment period, subjects in both treatment arms will follow-up 52 weeks. The primary measure of efficacy is the frequency of exacerbations and spirometric values (e.g. FEV1). Secondary efficacy measures include Dyspnea (MMRC), Quality of life ( CAT,SF-36), Exercise Capacity( 6MWD). Safety will be assessed through the collection of adverse events. There will be a total of 5 study visits ( randomization, and after 13, 26, 39 and 52 weeks of treatment). A follow-up contact for collection of effect and adverse event will be conducted approximately 52 weeks following the last study visit.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

Type	Name	Description
DRUG	Traditional Chinese Medicine	A herbal extract twice daily for 52 weeks for lower dosage, There are 3 Recipe for the 3 traditional Chinese syndrome, they are syndrome of lung-qi deficiency, syndrome of deficiency of pulmonosplenic qi, syndrome of insufficiency of QI of the lung and kidney.
DRUG	placebo chinese medicine	There are 3 placebo Recipe for the 3 traditional Chinese syndrome.

Timeline

• Start date: 2011-12-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2011-12-06
• Last updated: 2011-12-06