Idiopathic Pulmonary Fibrosis (IPF)NCT07162870
Idiopathic Pulmonary Fibrosis Cohort of TCM
An observational study of Idiopathic Pulmonary Fibrosis (IPF), run by Henan University of Traditional Chinese Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF)
- What is being tested?
- Traditional Chinese medicine (TCM) and Non-traditional Chinese medicine (non-TCM)
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 5 Sep 2025to 30 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Idiopathic pulmonary fibrosis (IPF) is a special type of idiopathic interstitial pneumonia, which is mainly manifested by irritating dry cough and progressive dyspnea.
Who may be able to join
- Patients diagnosed with IPF;
- Age ≥ 40 years old;
- Voluntary participation in this study,And sign the informed consent form.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
jiansheng li, Professor contact
China1 site
The First Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan, 450000
xueqing yu, Ph.D, +8613525518843, yxqshi@163.com
jiansheng li, Professor
About this study
Official title: Idiopathic Pulmonary Fibrosis Cohort Studies of Chinese Medicine
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.
Read the 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.
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Being tested
- Traditional Chinese medicine (TCM), Non-traditional Chinese medicine (non-TCM)
- Keywords
- Idiopathic Pulmonary Fibrosis, TCM, Cohort
- Medical subject headings
- Idiopathic Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Traditional Chinese medicine (TCM) | |
| 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. Receives: Drug: Non-traditional Chinese medicine (non-TCM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Annual acute exacerbation rate
The annual acute exacerbation rate will be calculated in each group at the end of the trial.
Measured: Up to week 104
Secondary outcomes (18)
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).
Measured: 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.
Measured: Up to week 104.
Lung transplantation rate
The lung transplantation will be calculated in each cohort at the end of the trial.
Measured: Up to week 104.
The Traditional Chinese Medicine(TCM) Syndromes
Evaluating TCM syndromes by collecting patients' symptoms, signs, tongue and pulse information.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Evaluate the diameter of the pulmonary artery at baseline and at weeks 26, 52, 78 and 104.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2025
- Study start5 Sep 2025 (estimated)
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Fibrosis (IPF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, China-Japan Friendship Hospital, The First Affiliated Hospital of Zhengzhou University, Shanghai Pulmonary Hospital, Shanghai, China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07162870
- Sponsor's protocol ID
- Cohort of IPF
- Status last verified
- Aug 2025
- First submitted
- 29 Jun 2025
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Idiopathic Pulmonary Fibrosis Cohort Studies of Chinese Medicine
- ClinicalTrials.gov ID
- NCT07162870
- Acronym / sponsor ID
- Cohort of IPF
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Keywords
- Idiopathic Pulmonary Fibrosis, TCM, Cohort
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, China-Japan Friendship Hospital, The First Affiliated Hospital of Zhengzhou University, Shanghai Pulmonary Hospital, Shanghai, China
- Study start
- 5 Sep 2025 (estimated)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 9 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional Chinese Medicine cohort | – | Drug: Traditional Chinese medicine (TCM)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 | – | Drug: Non-traditional Chinese medicine (non-TCM)Other IPF patients who do not meet the inclusion criteria for traditional Chinese medicine cohort, are classified into the non-traditional Chinese medicine cohort. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Idiopathic pulmonary fibrosis (IPF) is a special type of idiopathic interstitial pneumonia, which is mainly manifested by irritating dry cough and progressive dyspnea.
Key inclusion criteria (3 listed)
- Patients diagnosed with IPF;
- Age ≥ 40 years old;
- Voluntary participation in this study,And sign the informed consent form.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | 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. | Drug | Non-Traditional Chinese Medicine cohort |
Primary outcome
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.
18 secondary outcomes
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.
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.
Dyspnea
Time frame: Evaluate the mMRC total scores at baseline and at weeks 13, 26, 39, 52, 65, 78, 91, and 104.
C-reactive protein (CRP)
Time frame: Evaluate the CRP level at baseline and at weeks 26, 52, 78 and 104.
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 pulmonary artery systolic pressure (PASP)
Time frame: Evaluate the PASP at baseline and at weeks 26, 52, 78 and 104.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
jiansheng li, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Pulmonary Fibrosis (IPF), run by Henan University of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact xueqing yu, Ph.D (+8613525518843, yxqshi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Annual acute exacerbation rate (time frame: Up to week 104). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.