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Starting soon Observational

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

NCT06577701 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2024-10-01
Last updated
2024-09-19

Condition(s) studied

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

Investigational drug(s) / intervention(s)

traditional Chinese medicine (TCM)non traditional Chinese medicine (non-TCM)

traditional Chinese medicine (TCM): 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 (non-TCM): 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).

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Frequencies of acute exacerbations (AEs) — Frequency of acute exacerbations at months 3, 6, 9, 12, 15, 18, 21, and 24.
    The frequencies of acute exacerbations (AEs) will be recorded.
  • Incidence of COPD — 24 months after enrollment.
    The incidence of COPD will be recorded.

Trial sites (1)

FacilityCityRegionStatus
The First Affiliated Hospital of Henan University of Chinese Medicine Zhengzhou Henan
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06577701 on ClinicalTrials.gov ↗ ← All trials in China