Effect of Traditional Chinese Medicine on Outcomes in COPD Patients

NCT03007914 | Unknown DMC

• 1 other identifier: TCM for COPD Cohort
• Study Type: observational
• Target: 2,540
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to compare the effectiveness of the treatments in two cohort for COPD patients: one, traditional Chinese medicine (TCM) cohort, which have been evaluated and have certain effect; the other, conventional medicine treatments cohort, based on 2015 Global Initiative for Chronic Obstructive Lung Disease (GOLD).

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Pulmonary Disease, Chronic Obstructive; Medicine, Chinese Traditional; Humans; Treatment Outcome

Outcome Measures

Primary Outcomes (1)

• The frequency of exacerbation

  Change from Baseline in the frequency of exacerbation at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.

Secondary Outcomes (8)

• All cause mortality

  The all-cause mortality in 2 years of the follow up phase.

• Forced expiratory volume in one second

  Change from Baseline in the one second (FEV1) at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.

• Dyspnea

  Change from Baseline in MMRC at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.

• Minutes Walking Distance Test (6MWD)

  Change from Baseline in the 6MWD at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.

• COPD Assessment Test (CAT)

  Change from Baseline in the CAT at the months 3, 6, 9, 12, 15, 18, 21, and 24 of the follow up phase.

Study Arms (2)

TCM cohort

Patients continue to receive the routine TCM treatments recommended by 2011 Chinese treatment guidelines of TCM for COPD.

Conventional medicine cohort

Patients continue to receive the conventional medicine recommended by 2014 GOLD and Chinese treatment guidelines for COPD.

Eligibility Criteria

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

Study Population

COPD patients

You may qualify if:

• A confirmed diagnosis of COPD.
• Medically stable.
• Age between 40 and 80 years.
• Syndrome differentiation belongs to syndrome of deficiency of deficiency of lung qi, deficiency of pulmonic-splenic qi, syndrome of insufficiency of qi of the lung and kidney, syndrome of insufficiency of qi and yin of the lung and kidney.
• With the informed consent signed.
• Capable of complying with the dosing regimen and visit schedules.

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.
• Malignancy for which patient has undergone resection, radiation therapy or chemotherapy within the last 5 years.
• Current respiratory disorders other than COPD (e.g., bronchiectasis, bronchial asthma, tuberculosis, lung fibrosis, pulmonary thromboembolic, diffuse panbronchiolitis).
• Complicated with heart failure (NYHA Class III or IV),or myocardial infarction within six months ,or unstable hemodynamics.
• Complicated with serious hepatic and renal diseases (liver cirrhosis, portal hypertension, bleeding of varicose veins, dialysis, or renal transplantation).
• Complicated with congenital or acquired immune deficiency.
• Participating in other trials or allergic to the used medicine.

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine: lead

Biospecimen

Retention: SAMPLES WITHOUT DNA

The biological sample bank includes serum samples, plasma samples, sputum samples, urine samples, stool samples.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Study Officials

• Jiansheng Li, Doctor

  The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

  STUDY CHAIR

Central Study Contacts

Yang Xie, Doctor

CONTACT

+86 371 66248624; xieyanghn@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2016
• First Posted: January 2, 2017
• Study Start: December 1, 2016
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: January 2, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share