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NCT Number: NCT07162870

Idiopathic Pulmonary Fibrosis Cohort of TCM

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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Key information

Conditions

Idiopathic Pulmonary Fibrosis (IPF) Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Henan University of Chinese Medicine

Zhengzhou, Henan, 450000, China

Location contact

jiansheng li, Professor

CONTACT

xueqing yu, Ph.D

CONTACT

[email protected]

+8613525518843

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Traditional Chinese medicine (TCM)

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 (non-TCM)

Drug

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

Primary outcomes

  1. Annual acute exacerbation rate

    Time frame: Up to week 104

    The annual acute exacerbation rate will be calculated in each group at the end of the trial.

Secondary outcomes

  1. Progression-Free Survival(PFS）

    Time frame: Evaluate the PFS at weeks 13, 26, 39, 52, 65, 78, 91, and 104.

    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).

  2. All-cause mortality rate

    Time frame: Up to week 104.

    The all-cause mortality rate will be calculated in each group at the end of the trial.

  3. Lung transplantation rate

    Time frame: Up to week 104.

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

  4. 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.

    Evaluating TCM syndromes by collecting patients' symptoms, signs, tongue and pulse information.

  5. 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.

    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.

  6. Forced vital capacity (FVC)

    Time frame: Evaluate the FVC at baseline and at weeks 26, 52, 78 and 104.

    FVC will be applied to assess pulmonary function.

  7. FVC as the percentage of the predicted value (FVC%)

    Time frame: Evaluate the FVC% at baseline and at weeks 26, 52, 78 and 104.

    FVC% will be applied to assess pulmonary function.

  8. 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 will be applied to assess pulmonary function.

  9. DLCO as the percentage of the predicted value (DLCO%)

    Time frame: Evaluate the DLCO% at baseline and at weeks 26, 52, 78 and 104.

    DLCO% will be applied to assess pulmonary function.

  10. 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 6MWD will be applied to evaluate the exercise capacity. The higher values indicate the better exercise capacity.

  11. 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.

    The 30 second sitting and standing test will be used to evaluate lower limb strenath and cardiopulmonary function.

  12. 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.

    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.

  13. St. George's respiratory questionnaire (SGRQ) total scores

    Time frame: Evaluate the SGRQ total scores at baseline and at weeks 13, 26, 39, 52, 65, 78, 91, and 104.

    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.

  14. Dyspnea

    Time frame: Evaluate the mMRC total scores at baseline and at weeks 13, 26, 39, 52, 65, 78, 91, and 104.

    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.

  15. C-reactive protein (CRP)

    Time frame: Evaluate the CRP level at baseline and at weeks 26, 52, 78 and 104.

    The CRP level will be detected by ELISA technology.

  16. Krebs Von den Lungen-6(KL-6)

    Time frame: Evaluate the KL-6 level at baseline and at weeks 26, 52, 78 and 104.

    The KL-6 level will be detected by ELISA technology.

  17. The pulmonary artery systolic pressure (PASP)

    Time frame: Evaluate the PASP at baseline and at weeks 26, 52, 78 and 104.

    The PASP will be measured byechocardiogram.

  18. The diameter of the pulmonary artery

    Time frame: Evaluate the diameter of the pulmonary artery at baseline and at weeks 26, 52, 78 and 104.

    The diameter of the pulmonary artery will be measured byechocardiogram.

Study contacts

Contact information is provided by the study sponsor or research team.

jiansheng li, Professor

CONTACT

xueqing yu, Ph.D

CONTACT

[email protected]

+8613525518843

Sponsors and collaborators

Lead sponsor

Henan University of Traditional Chinese Medicine

Other

Collaborators

  • China-Japan Friendship Hospital
  • Shanghai Pulmonary Hospital, Shanghai, China
  • The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
  • The First Affiliated Hospital of Zhengzhou University

Registry information

Official study title

Idiopathic Pulmonary Fibrosis Cohort Studies of Chinese Medicine

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 9, 2025
Registry last updated
Sep 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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