Idiopathic Pulmonary Fibrosis Cohort of TCM

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

NOT_YET_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-05

Study Completion Date

2028-11-30

Brief Summary

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This study, based on past registration records, evaluates the clinical efficacy of traditional Chinese medicine in treating IPF in the real world, identifies advantageous populations and clinical targets, and provides references for precision traditional Chinese medicine treatment.

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Detailed Description

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This study is based on a previously established registry of interstitial lung disease, with traditional Chinese medicine treatment as the exposure factor. A total of at least 1000 IPF patients will be continuously enrolled and followed up for 2 years; it will further observe the pattern of syndromes, disease characteristics, and their interrelationships during disease development, and evaluate the clinical efficacy of traditional Chinese medicine in treating IPF using indicators such as annual acute exacerbation rate and clinical symptoms. Based on the differences in efficacy indicators, it will identify the advantageous population, clarify the clinical efficacy advantage targets, and provide a basis for precision treatment with traditional Chinese medicine.

Conditions

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Idiopathic Pulmonary Fibrosis (IPF)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Traditional Chinese Medicine cohort

IPF 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, are classified into the traditional Chinese medicine cohort.

Traditional Chinese medicine (TCM)

Intervention Type DRUG

Regulated use of Chinese medicine treatment protocols is included as an exposure factor. Exposure is defined as taking the medication continuously for more than 3 months per year, or intermittently for more than 6 months per year. 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 cohort

Other IPF patients who do not meet the inclusion criteria for traditional Chinese medicine cohort, are classified into the non-traditional Chinese medicine cohort.

Non-traditional Chinese medicine (non-TCM)

Intervention Type DRUG

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

Interventions

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Traditional Chinese medicine (TCM)

Regulated use of Chinese medicine treatment protocols is included as an exposure factor. Exposure is defined as taking the medication continuously for more than 3 months per year, or intermittently for more than 6 months per year. 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).

Intervention Type DRUG

Non-traditional Chinese medicine (non-TCM)

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patients diagnosed with IPF;
2. Age ≥ 40 years old;
3. Voluntary participation in this study,And sign the informed consent form.

Exclusion Criteria

1. Patients with confusion, dementia, consciousness disorders, and various mental illnesses;
2. Patients who are unable to take care of themselves and have been bedridden for a long time.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No