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

Pulmonary Disease, Chronic Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01486186
• Other study ID #: TCM for COPD
• Status: Not yet recruiting
• Phase: Phase 2
• First received: November 15, 2011
• Last updated: December 2, 2011
• Start date: December 2011
• Est. completion date: December 2014

Study information

• Verified date: December 2011
• Source: Henan University of Traditional Chinese Medicine
• Contact: wang minghang, doctor
• Phone: +86 371 66248624
• Email: wmh107hn[@]163.com
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 504
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• A confirmed diagnosis of mild/moderate COPD.

• Age between 40 and 80 years.

• Syndrome differentiation belongs to Syndrome of lung-qi deficiency, Syndrome of deficiency of pulmonosplenic qi, Syndrome of insufficiency of QI of the lung and kidney.

• Without participation 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 .

• Complicated with severe heart failure (class ? NYHA heart function) or unstable hemodynamics.

• Complicated with bronchial asthma, bronchiectasis or active tuberculosis;

• Complicated with obliterative bronchiolitis or diffuse pantothenic bronchiolitis,

• Complicated with pneumothorax, pleural effusion or pulmonary embolism.

• Complicated with neuromuscular disorder which affects the respiration.

• Complicated with tumors.

• Complicated with serious hepatic and renal diseases.

• Long periods of bed rest.

• Use of oral or parenteral corticosteroids before 1 months of Visit 1 .

• With immunodeficiency.

• Participating in other trials or allergic to the used medicine.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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.
• placebo chinese medicine
There are 3 placebo Recipe for the 3 traditional Chinese syndrome.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Henan University of Traditional Chinese Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pulmonary function(FEV1)		Change from Baseline in FEV1 at Week 26 and 52 of the treatment phase, Week 26 and 52 of the followup phase	No
Primary	the frequency of exacerbation		Change from Baseline in the frequency of exacerbation at Week 26 and 52 of the treatment phase, Week 26 and 52 of the followup phase	No
Secondary	Dyspnea		Change from Baseline in MMRC at Week 13, 26, 39 and 52 of the treatment phase, Week 26 and 52 of the followup phase	No
Secondary	Quality of life	using COPD Assessment Test ( CAT) and short-form 36-item questionnaire (SF-36)	Change from Baseline in CAT and SF-36 at Week 13, 26, 39 and 52 of the treatment phase, Week 26 and 52 of the followup phase	No
Secondary	6 Minutes Walking Distance Test ( 6MWD)		Change from Baseline in 6MWD at Week 13, 26, 39 and 52 of the treatment phase, Week 26 and 52 of the followup phase	No