Idiopathic Pulmonary Fibrosis Cohort of TCM
ConditionIdiopathic Pulmonary Fibrosis (IPF)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40+
SponsorHenan University of Traditional Chinese Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients diagnosed with IPF;
Age ≥ 40 years old;
Voluntary participation in this study,And sign the informed consent form.
Disqualifiers
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.
Trial population
Idiopathic pulmonary fibrosis (IPF) is a special type of idiopathic interstitial pneumonia, which is mainly manifested by irritating dry cough and progressive dyspnea.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Traditional Chinese medicine (TCM)
DrugRegulated 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)
DrugAll intervention measures that do not meet the criteria for TCM exposure are regarded as non-TCM exposure.
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: Traditional Chinese Medicine cohort1 intervention
Group B: Non-Traditional Chinese Medicine cohort1 intervention
Trial outcomes
Primary outcomes
1
Annual acute exacerbation rate
The annual acute exacerbation rate will be calculated in each group at the end of the trial.
Time frame
Up to week 104Secondary outcomes
1
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).
Time frame
Evaluate the PFS at weeks 13, 26, 39, 52, 65, 78, 91, and 104.2
All-cause mortality rate
The all-cause mortality rate will be calculated in each group at the end of the trial.
Time frame
Up to week 104.3
Lung transplantation rate
The lung transplantation will be calculated in each cohort at the end of the trial.
Time frame
Up to week 104.4
The Traditional Chinese Medicine(TCM) Syndromes
Evaluating TCM syndromes by collecting patients' symptoms, signs, tongue and pulse information.
Time frame
Evaluate the TCM s]yndromes at baseline and at weeks 13, 26, 39, 52, 65, 78, 91, and 104.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Henan University of Traditional Chinese Medicine
Lead sponsor
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Collaborator
China-Japan Friendship Hospital
Collaborator
The First Affiliated Hospital of Zhengzhou University
Collaborator
Shanghai Pulmonary Hospital, Shanghai, China
Collaborator
Source ClinicalTrials.gov
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