Idiopathic Pulmonary Fibrosis Cohort of TCM
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Traditional Chinese medicine (TCM), Non-traditional Chinese medicine (non-TCM).
- Who it may be relevant to
- Registry conditions: Idiopathic Pulmonary Fibrosis (IPF). Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Idiopathic Pulmonary Fibrosis Cohort Studies of Chinese Medicine
Overview
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.
Detailed description
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.
Interventions
- Drug 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). - 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.
Primary outcome measures
- Annual acute exacerbation rate [Time frame: Up to week 104]
Secondary outcome measures (12)
- Progression-Free Survival(PFS） [Time frame: Evaluate the PFS at weeks 13, 26, 39, 52, 65, 78, 91, and 104.]
- All-cause mortality rate [Time frame: Up to week 104.]
- Lung transplantation rate [Time frame: Up to week 104.]
- The Traditional Chinese Medicine(TCM) Syndromes [Time frame: Evaluate the TCM s]yndromes at baseline and at weeks 13, 26, 39, 52, 65, 78, 91, and 104.]
- Clinical symptoms and Signs [Time frame: Evaluate the clinical symptoms and signs up at baseline and at weeks 13, 26, 39, 52, 65, 78, 91, and 104.]
- Forced vital capacity (FVC) [Time frame: Evaluate the FVC at baseline and at weeks 26, 52, 78 and 104.]
- FVC as the percentage of the predicted value (FVC%) [Time frame: Evaluate the FVC% at baseline and at weeks 26, 52, 78 and 104.]
- Diffusing capacity of the lungs for carbon monoxide (DLCO) [Time frame: Evaluate the DLCO at baseline and at weeks 26, 52, 78 and 104.]
- DLCO as the percentage of the predicted value (DLCO%) [Time frame: Evaluate the DLCO% at baseline and at weeks 26, 52, 78 and 104.]
- 6 Six Minute Walk Distance(6MWD) [Time frame: Evaluate the 6MWD at baseline and at weeks 13, 26, 39, 52, 65, 78, 91, and 104.]
- The 30 - second sit - to - stand test(30s STS) [Time frame: Evaluate the 30s STS at baseline and at weeks 13, 26, 39, 52, 65, 78, 91, and 104.]
- A Tool to Assess Quality of life (ATAQ-IPF) total scores [Time frame: Evaluate the ATAQ-IPF total scores at baseline and at weeks 13, 26, 39, 52, 65, 78, 91, and 104.]
Eligibility criteria
Inclusion criteria
- Patients diagnosed with IPF;
- Age ≥ 40 years old;
- Voluntary participation in this study,And sign the informed consent form.
Exclusion criteria
- Patients with confusion, dementia, consciousness disorders, and various mental illnesses;
- Patients who are unable to take care of themselves and have been bedridden for a long time.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The First Affiliated Hospital of Henan University of Chinese Medicine — Zhengzhou
Identifiers
NCT: NCT07162870 · Cohort of IPF