REspiratory diSEAse cohoRt Studies of CHinese Medicine for ILD (RESEARCH-ILD)

NCT06577753 | Recruiting DMC

• 1 other identifier: RESEARCH-ILD
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a traditional Chinese medicine cohort for interstitial lung disease（ILD） in China, including at least 5000 patients with ILD and followed up for at least 5 years. The aim is to focus on the demographic characteristics, clinical features, disease occurrence and development characteristics, TCM syndrome evolution patterns, and clinical efficacy of TCM treatment for ILD in the real world.

Conditions

Interstitial Lung Disease

Keywords

Interstitial Lung Disease; Traditional Chinese Medicine; Cohort study

Outcome Measures

Primary Outcomes (2)

• All-cause mortality

  The all-cause mortality will be recorded.

  up to week 13, 26, 39, 52, 65, 78 ,91 and 104 weeks.

• Lung transplantation

  The lung transplantation will be calculated in each cohort at the end of the trial.

  Up to week 13, 26, 39, 52, 65, 78 ,91 and 104 weeks.

Secondary Outcomes (10)

• Frequencies of acute exacerbations (AEs)

  The frequencies of acute exacerbations at weeks 13, 26, 39, 52, 65, 78, 91 and 104.

• Proportion of progressive-free survival

  The Proportion of progressive-free survival at weeks 13, 26, 39, 52, 65, 78, 91 and 104.

• 6 Six Minute Walk Distance(6MWD)

  Change from baseline 6MWD at week 13, 26, 39, 52, 65, 78, 91 and 104.

• Pulse Oxygen Saturation（SPO2）

  Change from baseline SPO2 at week 13, 26, 39, 52, 65, 78, 91 and 104.

• Traditional Chinese medicine syndromes

  The traditional Chinese medicine syndromes at weeks 13, 26, 39, 52, 65, 78 ,91 and 104.s.

Study Arms (2)

Traditional Chinese Medicine cohort

ILD subjects who have continuously used traditional Chinese medicine for standardized treatment for 3 months or more within 1 year, or have accumulated treatment time for 6 months or more.

Non Traditional Chinese Medicine cohort

Other ILD patients who do not meet the traditional Chinese medicine cohort.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Interstitial lung disease (ILD) is a group of lung diseases characterized by inflammation and/or fibrosis of the lung parenchyma, often accompanied by progressive respiratory distress, which may ultimately lead to end-stage respiratory failure.

You may qualify if:

• Patients who meet the diagnosis of ILD;
• Age≥18 years old;
• Ability to provide independent informed consent.

You may not qualify if:

• Patients with acute ILD caused by known reasons, but the lesions disappear within 2 weeks after treatment. Example: Interstitial pneumonia caused by infections such as mycoplasma/virus, and those who recover after treatment are excluded.

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

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jian-sheng Li, Professor

  The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

  STUDY CHAIR

Central Study Contacts

Xue-qing Yu, Ph.D

CONTACT

+8613525518843; yxqshi@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: April 15, 2024
• Primary Completion (Estimated): December 30, 2029
• Study Completion (Estimated): December 30, 2030
• Last Updated: August 29, 2024

Record last verified: 2023-12

Locations

CN (1)