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TCM Cohort for Elderly COPD

ConditionChronic Obstructive Pulmonary Disease (COPD)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age60+
SponsorHenan University of Traditional Chinese Medicine

About this trial

This study evaluates the real-world clinical efficacy of traditional Chinese medicine (TCM) in elderly Chronic obstructive pulmonary disease (COPD) patients and explores syndrome characteristics and their associations with biomarkers.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients diagnosed with COPD;

Age ≥ 60 years old;

Voluntary participation in this study, and sign the informed consent form.

Disqualifiers

Patients with various mental illnesses or other conditions that prevent normal communication;

Patients with a history of pulmonary surgery, such as lung volume reduction surgery or lung transplantation;

Patients with confirmed human immunodeficiency virus infection or acquired immunodeficiency syndrome.

Trial population

COPD is a common chronic respiratory disease characterized by persistent respiratory symptoms and airflow limitation, with recurrent acute exacerbations and progressive impairment of respiratory function.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Traditional Chinese medicine (TCM)

    Drug

    According to the standardised use of TCM protocols, the group is divided into an exposed group (TCM cohort) and an unexposed group (non-TCM cohort).

  • Non-traditional Chinese medicine (non-TCM)

    Drug

    All intervention measures that do not meet the criteria for TCM exposure are regarded as non-TCM exposure.

Treatment groups

2,386 Participants
are divided into 2 treatment groups
Group A: Traditional Chinese Medicine cohort1 intervention
Group B: Non-Traditional Chinese Medicine cohort1 intervention

Trial outcomes

Primary outcomes

1

Annual acute exacerbation rate

The annual acute exacerbation rate will be calculated in each group at the end of the trial.

Time frame
Up to week 52.

Secondary outcomes

1

Forced Vital Capacity (FVC)

FVC will be applied to assess pulmonary function.

Time frame
Evaluate the FVC at weeks 26 and 52.
2

Forced Expiratory Volume in One Second (FEV1)

FEV1 will be applied to assess pulmonary function.

Time frame
Evaluate the FEV1 at weeks 26 and 52.
3

FEV1/FVC Ratio

FEV1/FVC Ratio will be applied to assess pulmonary function.

Time frame
Evaluate the FEV1/FVC Ratio at weeks 26 and 52.
4

6-Minute Walk Distance (6MWD)

The 6MWD will be applied to evaluate the exercise capacity. The higher values indicate the better exercise capacity.

Time frame
Evaluate the 6MWD at weeks 26 and 52.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Henan University of Traditional Chinese Medicine

Lead sponsor

The First Affiliated Hospital of Henan University of Chinese Medicine

Collaborator

The First Affiliated Hospital of Guangzhou Medical University

Collaborator

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: