Effect of Traditional Chinese Medicine on Outcomes in Patients With Mild/Moderate Chronic Obstructive Pulmonary Disease
December 2, 2011 updated by: Henan University of Traditional Chinese Medicine
Detection and Intervention on Mild/Moderate Chronic Obstructive Pulmonary Disease by Traditional Chinese Medicine Treatment and Application
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).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
504
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
36 years to 76 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: traditional chinese medicine
The experimental group will receive three type of TCM, they are Baofei granule, Bufeijianpi granule and Bufeiyishen granule.
|
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.
Other Names:
|
|
Placebo Comparator: placebo
placebo chinese medicine in addition to best care according to clinical guidelines for COPD patients
|
There are 3 placebo Recipe for the 3 traditional Chinese syndrome.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
pulmonary function（FEV1）
Time Frame: Change from Baseline in FEV1 at Week 26 and 52 of the treatment phase, Week 26 and 52 of the followup phase
|
Change from Baseline in FEV1 at Week 26 and 52 of the treatment phase, Week 26 and 52 of the followup phase
|
|
the frequency of exacerbation
Time Frame: 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
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dyspnea
Time Frame: Change from Baseline in MMRC at Week 13, 26, 39 and 52 of the treatment phase, Week 26 and 52 of the followup phase
|
Change from Baseline in MMRC at Week 13, 26, 39 and 52 of the treatment phase, Week 26 and 52 of the followup phase
|
|
|
Quality of life
Time Frame: 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
|
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
|
|
6 Minutes Walking Distance Test ( 6MWD)
Time Frame: Change from Baseline in 6MWD at Week 13, 26, 39 and 52 of the treatment phase, Week 26 and 52 of the followup phase
|
Change from Baseline in 6MWD at Week 13, 26, 39 and 52 of the treatment phase, Week 26 and 52 of the followup phase
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Li jiansheng, doctor, The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2011
Primary Completion (Anticipated)
December 1, 2014
Study Completion (Anticipated)
December 1, 2014
Study Registration Dates
First Submitted
November 15, 2011
First Submitted That Met QC Criteria
December 2, 2011
First Posted (Estimate)
December 6, 2011
Study Record Updates
Last Update Posted (Estimate)
December 6, 2011
Last Update Submitted That Met QC Criteria
December 2, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TCM for COPD
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.