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

NCT ID: NCT06577753

Last Updated: 2024-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-15

Study Completion Date

2030-12-30

Brief Summary

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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.

Detailed Description

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This study focuses on ILD patients and adopts a prospective cohort study design, with traditional Chinese medicine treatment as the exposure factor. The subjects are divided into a traditional Chinese medicine cohort and a non traditional Chinese medicine cohort, with demographic characteristics, mortality rate, lung transplant rate, annual acute exacerbation frequency, traditional Chinese medicine syndrome, 6MWT, lung function, dyspnea score, quality of life, and other observation indicators. Follow up for at least 5 years will be conducted, and at least 5000 ILD patients will be included, focusing on the demographic characteristics, clinical characteristics, disease occurrence and development characteristics, traditional Chinese medicine syndrome evolution rules, and clinical efficacy of traditional Chinese medicine treatment for ILD in the real world.

Conditions

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Interstitial Lung Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Non Traditional Chinese Medicine cohort

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Henan University of Traditional Chinese Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jian-sheng Li, Professor

Role: STUDY_CHAIR

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Locations

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The First Affiliated Hospital of Henan University of Chinese Medicine

Zhengzhou, Henan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xue-qing Yu, Ph.D

Role: CONTACT

+8613525518843

Facility Contacts

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Xue-qing Yu, Ph.D

Role: primary

+8613525518843

Other Identifiers

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RESEARCH-ILD

Identifier Type: -

Identifier Source: org_study_id

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