Effect of Traditional Chinese Medicine on Outcomes in Patients With Mild/Moderate Chronic Obstructive Pulmonary Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01486186|
Recruitment Status : Unknown
Verified December 2011 by Henan University of Traditional Chinese Medicine.
Recruitment status was: Not yet recruiting
First Posted : December 6, 2011
Last Update Posted : December 6, 2011
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Disease, Chronic Obstructive||Drug: Traditional Chinese Medicine Drug: placebo chinese medicine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||504 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Detection and Intervention on Mild/Moderate Chronic Obstructive Pulmonary Disease by Traditional Chinese Medicine Treatment and Application|
|Study Start Date :||December 2011|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2014|
Experimental: traditional chinese medicine
The experimental group will receive three type of TCM, they are Baofei granule, Bufeijianpi granule and Bufeiyishen granule.
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 Comparator: placebo
placebo chinese medicine in addition to best care according to clinical guidelines for COPD patients
Drug: placebo chinese medicine
There are 3 placebo Recipe for the 3 traditional Chinese syndrome.
- 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 ]
- 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 ]
- 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 ]
- 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)
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01486186
|Contact: wang minghang, doctor||+86 371 firstname.lastname@example.org|
|Study Chair:||Li jiansheng, doctor||The First Affiliated Hospital of Henan University of Traditional Chinese Medicine|