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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status

Unknown status

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Traditional Chinese Medicine

placebo chinese medicine

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring Pulmonary Disease, Chronic Obstructive, Double-Blind Method, Medicine, Chinese Traditional, Humans, Treatment Outcome

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

traditional chinese medicine

placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

pulmonary function（FEV1）

the frequency of exacerbation

Secondary Outcome Measures

Dyspnea

Quality of life

using COPD Assessment Test ( CAT) and short-form 36-item questionnaire (SF-36)

6 Minutes Walking Distance Test ( 6MWD)

Full Information

NCT ID

NCT01486186

First Posted

November 15, 2011

Last Updated

December 2, 2011

Sponsor

Henan University of Traditional Chinese Medicine

1. Study Identification

Unique Protocol Identification Number

NCT01486186

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2011

Overall Recruitment Status

Unknown status

Study Start Date

December 2011 (undefined)

Primary Completion Date

December 2014 (Anticipated)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Henan University of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Disease, Chronic Obstructive

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

504 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

traditional chinese medicine

Arm Type

Experimental

Arm Description

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

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Traditional Chinese Medicine

Other Intervention Name(s)

Baofei granule, Bufeijianpi granule, Bufeiyishen granule

Intervention Description

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

Intervention Name(s)

placebo chinese medicine

Other Intervention Name(s)

placebo Baofei granule, placebo Bufeijianpi granule, placebo Bufeiyishen granule

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Title

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

Secondary Outcome Measure Information:

Title

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

Title

Quality of life

Description

using COPD Assessment Test ( CAT) and short-form 36-item questionnaire (SF-36)

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

wang minghang, doctor

Phone

+86 371 66248624

wmh107hn@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Li jiansheng, doctor

Organizational Affiliation

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Official's Role

Study Chair

12. IPD Sharing Statement

Citations:

PubMed Identifier

22799753

Citation

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.

Results Reference

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

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