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Idiopathic Pulmonary Fibrosis Cohort of TCM 1,000 Real-World Evidence
Clinical Trial NCT07162870 is an observational study for Idiopathic Pulmonary Fibrosis (IPF) and is currently not yet recruiting. Enrollment is planned to begin on 5 September 2025 and continue until the study accrues 1,000 participants. Led by Henan University of Traditional Chinese Medicine, this study is expected to complete by 30 November 2028. The latest data from ClinicalTrials.gov was last updated on 9 September 2025.
Brief Summary
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 o...Show More
Official Title
Idiopathic Pulmonary Fibrosis Cohort Studies of Chinese Medicine
Conditions
Idiopathic Pulmonary Fibrosis (IPF)Other Study IDs
- Cohort of IPF
NCT ID Number
Start Date (Actual)
2025-09-05
Last Update Posted
2025-09-09
Completion Date (Estimated)
2028-11-30
Enrollment (Estimated)
1,000
Study Type
Observational
Status
Not yet recruiting
Keywords
Idiopathic Pulmonary Fibrosis
TCM
Cohort
TCM
Cohort
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
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) 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) All intervention measures that do not meet the criteria for TCM exposure are regarded as non-TCM exposure. |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Annual acute exacerbation rate | The annual acute exacerbation rate will be calculated in each group at the end of the trial. | Up to week 104 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Progression-Free Survival(PFS） | According to "Idiopathic Pulmonary Fibrosis in Adults (Update) and Progressive Pulmonary Fibrosis: An Official Clinical Practice Guideline of the ATS/ERS/JRS/ALAT ": The time from enrollment to the first meeting of disease progression (at least two of respiratory symptoms, physiological evidence and radiological evidence). | Evaluate the PFS at weeks 13, 26, 39, 52, 65, 78, 91, and 104. |
All-cause mortality rate | The all-cause mortality rate will be calculated in each group at the end of the trial. | Up to week 104. |
Lung transplantation rate | The lung transplantation will be calculated in each cohort at the end of the trial. | Up to week 104. |
The Traditional Chinese Medicine(TCM) Syndromes | Evaluating TCM syndromes by collecting patients' symptoms, signs, tongue and pulse information. | Evaluate the TCM s]yndromes at baseline and at weeks 13, 26, 39, 52, 65, 78, 91, and 104. |
Clinical symptoms and Signs | Clinical symptoms and Signs will be evaluated through a scale. The scale includes coughing, expectoration, chest tightness, shortness of breath, wheezin. The Clinical Symptom Rating Scale includes 6 items: cough, expectoration, chest tightness, shortness of breath, wheezing, and cyanosis. Each item has a score of 0-3, totaling 18 points. The higher the score, the worse he patient's condition. | 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) | FVC will be applied to assess pulmonary function. | Evaluate the FVC at baseline and at weeks 26, 52, 78 and 104. |
FVC as the percentage of the predicted value (FVC%) | FVC% will be applied to assess pulmonary function. | Evaluate the FVC% at baseline and at weeks 26, 52, 78 and 104. |
Diffusing capacity of the lungs for carbon monoxide (DLCO) | DLCO will be applied to assess pulmonary function. | Evaluate the DLCO at baseline and at weeks 26, 52, 78 and 104. |
DLCO as the percentage of the predicted value (DLCO%) | DLCO% will be applied to assess pulmonary function. | Evaluate the DLCO% at baseline and at weeks 26, 52, 78 and 104. |
6 Six Minute Walk Distance(6MWD) | The 6MWD will be applied to evaluate the exercise capacity. The higher values indicate the better exercise capacity. | 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) | The 30 second sitting and standing test will be used to evaluate lower limb strenath and cardiopulmonary function. | 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 | ATAQ-IPF is currently a specialized scale for evaluating the quality of life, consisting of 13 dimensions and 74 items, with each item scoring 1-5 points. The higher the score, the worse the quality of life. | Evaluate the ATAQ-IPF total scores at baseline and at weeks 13, 26, 39, 52, 65, 78, 91, and 104. |
St. George's respiratory questionnaire (SGRQ) total scores | SGRQ is a scale used to evaluate the quality of life of patients, which includes three dimensions: symptoms, mobility, and the impact of disease on daily life, with a total of 50 items. The total score range of SGRQ is usually between 0 and 100, with higher scores leading to poorer quality of life. | Evaluate the SGRQ total scores at baseline and at weeks 13, 26, 39, 52, 65, 78, 91, and 104. |
Dyspnea | Dyspnea will be assessed by 22.modified Medical Research Council(mMRC) scores. A score of 0-4 will be given according to the degree of immediate dyspnea. A higher score indicates a worse condition. | Evaluate the mMRC total scores at baseline and at weeks 13, 26, 39, 52, 65, 78, 91, and 104. |
C-reactive protein (CRP) | The CRP level will be detected by ELISA technology. | Evaluate the CRP level at baseline and at weeks 26, 52, 78 and 104. |
Krebs Von den Lungen-6(KL-6) | The KL-6 level will be detected by ELISA technology. | Evaluate the KL-6 level at baseline and at weeks 26, 52, 78 and 104. |
The pulmonary artery systolic pressure (PASP) | The PASP will be measured byechocardiogram. | Evaluate the PASP at baseline and at weeks 26, 52, 78 and 104. |
The diameter of the pulmonary artery | The diameter of the pulmonary artery will be measured byechocardiogram. | Evaluate the diameter of the pulmonary artery at baseline and at weeks 26, 52, 78 and 104. |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
40 Years
Eligible Sexes
All
- Patients diagnosed with IPF;
- Age ≥ 40 years old;
- Voluntary participation in this study,And sign the informed consent form.
- 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.
Henan University of Traditional Chinese MedicineStudy Central Contact
Contact: xueqing yu, Ph.D, +8613525518843, [email protected]
Contact: jiansheng li, Professor
1 Study Locations in 1 Countries
Henan
The First Affiliated Hospital of Henan University of Chinese Medicine, Zhengzhou, Henan, 450000, China
xueqing yu, Ph.D, Contact, +8613525518843, [email protected]
jiansheng li, Professor, Contact