Respiratory Disease Cohort Studies of Chinese Medicine for COPD(RESEARCH-COPD)

NCT06577701 | Not Yet Recruiting DMC

• 1 other identifier: RESEARCH-COPD
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study will establish a registration research platform, a clinical research database and a biospecimen bank for the prevention and treatment of COPD with Chinese medicine. Based on the COPD registry database, a cohort of Chinese medicine for COPD prevention and treatment will be established.

Conditions

Chronic Obstructive Pulmoriary Disease (COPD); Preserved Ratio Impaired Spirometry (PRISM)

Keywords

Chronic Obstructive Pulmoriary Disease (COPD); Preserved Ratio Impaired Spirometry (PRISM); Complication (medicine); Traditional Chinese Medicine; Registration; Cohort study

Outcome Measures

Primary Outcomes (2)

• Frequencies of acute exacerbations (AEs)

  The frequencies of acute exacerbations (AEs) will be recorded.

  Frequency of acute exacerbations at months 3, 6, 9, 12, 15, 18, 21, and 24.

• Incidence of COPD

  The incidence of COPD will be recorded.

  24 months after enrollment.

Secondary Outcomes (8)

• 6 Six Minute Walk Distance (6MWD)

  6MWD at months 3, 6, 9, 12, 15, 18, 21, and 24.

• Traditional Chinese medicine syndromes

  The Traditional Chinese medicine syndromes at months 3, 6, 9, 12, 15, 18, 21, and 24.

• Forced expiratory volume in one second (FEV1)

  Change from baseline FEV1 at months 6, 12, 18 and 24.

• Forced vital capacity (FVC)

  Change from baseline FVC at months 6, 12, 18 and 24.

• FVC as the percentage of the predicted value (FVC%)

  Change from baseline FVC% at months 6, 12, 18 and 24.

Study Arms (2)

Traditional Chinese Medicine cohort

Regulated use of Chinese medicine treatment protocols is included as an exposure factor. Continuous medication for more than 3 months per year, or intermittent medication for more than 6 months per year was the exposure group (TCM diagnosis and treatment plan cohort).

Drug: traditional Chinese medicine (TCM)

Non Traditional Chinese Medicine cohort

Other patients who did not fit into the TCM group.

Drug: non traditional Chinese medicine (non-TCM)

Interventions

traditional Chinese medicine (TCM) DRUG

Regulated use of Chinese medicine treatment protocols is included as an exposure factor. Exposure was defined as taking the medication continuously for more than 3 months per year, or taking the medication intermittently for more than 6 months per year. According to the standardised use of TCM protocols, the group was divided into an exposed group (TCM protocols cohort) and a non-exposed group (non-TCM protocols cohort).

Traditional Chinese Medicine cohort

non traditional Chinese medicine (non-TCM) DRUG

Regulated use of Chinese medicine treatment protocols is included as an exposure factor. Exposure was defined as taking the medication continuously for more than 3 months per year, or taking the medication intermittently for more than 6 months per year. According to the standardised use of TCM protocols, the group was divided into an exposed group (TCM protocols cohort) and a non-exposed group (non-TCM protocols cohort).

Non Traditional Chinese Medicine cohort

Eligibility Criteria

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

Study Population

Chronic Obstructive Pulmonary Disease (COPD) is a major disease that poses a serious threat to public health, with a prevalence rate of 13.7% in China for people aged 40 years and older, and a prevalence rate of 20.51% in high-risk groups, with a prevalence rate of COPD in high-risk groups of 33.39%, Early screening and identification are of great significance in delaying the progression of lung function and reducing the incidence of COPD. At the same time, patients with COPD are often comorbid with other diseases, and comorbidities have a significant impact on disease progression, consultation, hospitalization, morbidity and mortality, requiring more standardized and systematic recommendations to guide clinical practice.

You may qualify if:

• Meets diagnostic criteria for chronic obstructive pulmonary disease (COPD) or preserved ratio impaired spirometry (PRISm).
• Age ranges from 18 years to 80 years.
• The investigators agreed to participate in this clinical study by voluntarily signing an informed consent form.

You may not qualify if:

• Patients with delirium, dementia, various mental illnesses.
• Pregnant and planned pregnant or lactating women.
• Patients with other serious systemic diseases.
• Patients who, in the opinion of the investigator, are not suitable for participation in this study.

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine: lead

Study Sites (1)

The First Affiliated Hospital of Henan University of Chinese Medicine

Zhengzhou, Henan, China

Location

MeSH Terms

Interventions

Medicine, Chinese Traditional

Intervention Hierarchy (Ancestors)

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

Study Officials

• Jiansheng Li, Professor

  The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

  STUDY CHAIR

Central Study Contacts

Yang Xie, Ph.D

CONTACT

13526621325; 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: August 27, 2024
• First Posted: August 29, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): October 30, 2027
• Last Updated: September 19, 2024

Record last verified: 2023-11

Locations

CN (1)