Idiopathic Pulmonary Fibrosis Cohort of TCM
1 other identifier
observational
1,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2025
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 29, 2025
CompletedStudy Start
First participant enrolled
September 5, 2025
CompletedFirst Posted
Study publicly available on registry
September 9, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 30, 2028
September 9, 2025
August 1, 2025
3.2 years
June 29, 2025
August 31, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (18)
Progression-Free Survival(PFS）
Evaluate the PFS at weeks 13, 26, 39, 52, 65, 78, 91, and 104.
All-cause mortality rate
Up to week 104.
Lung transplantation rate
Up to week 104.
The Traditional Chinese Medicine(TCM) Syndromes
Evaluate the TCM s]yndromes at baseline and at weeks 13, 26, 39, 52, 65, 78, 91, and 104.
Clinical symptoms and Signs
Evaluate the clinical symptoms and signs up at baseline and at weeks 13, 26, 39, 52, 65, 78, 91, and 104.
- +13 more secondary outcomes
Study Arms (2)
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.
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.
Interventions
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).
All intervention measures that do not meet the criteria for TCM exposure are regarded as non-TCM exposure.
Eligibility Criteria
Idiopathic pulmonary fibrosis (IPF) is a special type of idiopathic interstitial pneumonia, which is mainly manifested by irritating dry cough and progressive dyspnea.
You may qualify if:
- Patients diagnosed with IPF;
- Age ≥ 40 years old;
- Voluntary participation in this study,And sign the informed consent form.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Henan University of Traditional Chinese Medicinelead
- The First Affiliated Hospital of Henan University of Traditional Chinese Medicinecollaborator
- China-Japan Friendship Hospitalcollaborator
- The First Affiliated Hospital of Zhengzhou Universitycollaborator
- Shanghai Pulmonary Hospital, Shanghai, Chinacollaborator
Study Sites (1)
The First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan, 450000, China
Biospecimen
blood,Tongue coating
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
jiansheng li, Professor
CONTACT
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2025
First Posted
September 9, 2025
Study Start
September 5, 2025
Primary Completion (Estimated)
October 30, 2028
Study Completion (Estimated)
November 30, 2028
Last Updated
September 9, 2025
Record last verified: 2025-08