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

NCT01486186 | Unknown Phase 2 DMC

• 1 other identifier: TCM for COPD
• Study Type: interventional
• Target: 504
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

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

Outcome Measures

Primary Outcomes (2)

• pulmonary function（FEV1）

  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

  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 Outcomes (3)

• Dyspnea

  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

  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)

  Change from Baseline in 6MWD at Week 13, 26, 39 and 52 of the treatment phase, Week 26 and 52 of the followup phase

Study Arms (2)

traditional chinese medicine

EXPERIMENTAL

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

Drug: Traditional Chinese Medicine

placebo

PLACEBO COMPARATOR

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

Drug: placebo chinese medicine

Interventions

Traditional Chinese Medicine 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.

Also known as: Baofei granule, Bufeijianpi granule, Bufeiyishen granule

traditional chinese medicine

placebo chinese medicine DRUG

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

Also known as: placebo Baofei granule, placebo Bufeijianpi granule, placebo Bufeiyishen granule

placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine: lead

Related Publications (1)

• 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.

  PMID: 22799753 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Medicine, Chinese Traditional

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Medicine, East Asian Traditional; Medicine, Traditional; Complementary Therapies; Therapeutics

Study Officials

• Li jiansheng, doctor

  The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

  STUDY CHAIR

Central Study Contacts

wang minghang, doctor

CONTACT

+86 371 66248624; wmh107hn@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2011
• First Posted: December 6, 2011
• Study Start: December 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 6, 2011

Record last verified: 2011-12