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

NCT ID: NCT01486186

Last Updated: 2011-12-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 504 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2014-12-31

Brief 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

Keywords

Pulmonary Disease, Chronic Obstructive; Double-Blind Method; Medicine, Chinese Traditional; Humans; Treatment Outcome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

traditional chinese medicine

The experimental group will receive three type of TCM, they are Baofei granule, Bufeijianpi granule and Bufeiyishen granule.

Group Type: EXPERIMENTAL

Traditional Chinese Medicine

Intervention Type: DRUG

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

placebo chinese medicine in addition to best care according to clinical guidelines for COPD patients

Group Type: PLACEBO_COMPARATOR

placebo chinese medicine

Intervention Type: DRUG

There are 3 placebo Recipe for the 3 traditional Chinese syndrome.

Interventions

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.

Intervention Type: DRUG

placebo chinese medicine

There are 3 placebo Recipe for the 3 traditional Chinese syndrome.

Intervention Type: DRUG

Other Intervention Names

Baofei granule; Bufeijianpi granule; Bufeiyishen granule; placebo Baofei granule; placebo Bufeijianpi granule; placebo Bufeiyishen granule

Eligibility Criteria

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 Ⅳ 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Henan University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li jiansheng, doctor

Role: STUDY_CHAIR

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Central Contacts

wang minghang, doctor

Role: CONTACT

Phone: +86 371 66248624

Email: wmh107hn@163.com

References

Wang M, Li J, Li S, Wang H, Yu X, Zhang H. Effect of traditional Chinese medicine on outcomes in patients with mild/moderate chronic obstructive pulmonary disease: study protocol for a randomized placebo-controlled trial. Trials. 2012 Jul 16;13:109. doi: 10.1186/1745-6215-13-109.

Reference Type: DERIVED

PMID: 22799753 (View on PubMed)

Other Identifiers

TCM for COPD

Identifier Type: -

Identifier Source: org_study_id