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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified December 2011 by Henan University of Traditional Chinese Medicine
Sponsor:
Information provided by (Responsible Party):
Henan University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier:
NCT01486186
First received: November 15, 2011
Last updated: December 2, 2011
Last verified: December 2011
  Purpose

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).


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: Traditional Chinese Medicine
Drug: placebo chinese medicine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Detection and Intervention on Mild/Moderate Chronic Obstructive Pulmonary Disease by Traditional Chinese Medicine Treatment and Application

Resource links provided by NLM:


Further study details as provided by Henan University of Traditional Chinese Medicine:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 504
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Names:
  • Baofei granule
  • Bufeijianpi granule
  • Bufeiyishen granule
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.
Other Names:
  • placebo Baofei granule
  • placebo Bufeijianpi granule
  • placebo Bufeiyishen granule

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.

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01486186

Contacts
Contact: wang minghang, doctor +86 371 66248624 wmh107hn@163.com

Sponsors and Collaborators
Henan University of Traditional Chinese Medicine
Investigators
Study Chair: Li jiansheng, doctor The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
  More Information

No publications provided by Henan University of Traditional Chinese Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Henan University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT01486186     History of Changes
Other Study ID Numbers: TCM for COPD
Study First Received: November 15, 2011
Last Updated: December 2, 2011
Health Authority: China: State Administration of Traditional Chinese Medicine of the People's Republic of China

Keywords provided by Henan University of Traditional Chinese Medicine:
Pulmonary Disease, Chronic Obstructive
Double-Blind Method
Medicine, Chinese Traditional
Humans
Treatment Outcome

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014