Idiopathic Pulmonary Fibrosis (IPF)NCT07178392
Disease-syndrome Characteristics of IPF
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 previous registration records, aims to explore the syndrome patterns, disease characteristics, and their interrelationships of IPF at different stages, grades, and in its natural course, thus providing a multidimensional interpretation of the syndrome patterns and characteristics of IPF. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF)
- How many people
- 2,864 participants
- Where
- 1 siteChina
- Study dates
- 15 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 18 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 ≥ 18 years old;
- Voluntarily participate in this study and sign an informed consent form.
Who cannot join
- Patients with confusion, dementia, consciousness disorders, and various mental illnesses;
- Those 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, +8613525518843, yxqshi@163.com
About this study
Official title: Research on the Disease-syndrome Characteristics of Idiopathic Pulmonary Fibrosis
This study, based on previous registration records, aims to explore the syndrome patterns, disease characteristics, and their interrelationships of IPF at different stages, grades, and in its natural course, thus providing a multidimensional interpretation of the syndrome patterns and characteristics of IPF.
Read the detailed description
This study, based on previous registration records, uses a cross-sectional survey design to collect demographic information, disease-related data, syndrome data, and auxiliary examination data from 2864 IPF patients in China. It aims to elucidate the syndrome types, disease characteristics, and the interrelationships between them of IPF at different stages, grades, and in its natural course.
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Keywords
- Idiopathic Pulmonary Fibrosis, TCM, Epidemiological investigation, characteristics
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Participants fill out the questionnaire | Participants fill out the questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease Stage
Recording the disease staging of IPF patients. According to the Adult Idiopathic Pulmonary Fibrosis (Revised Edition) and Progressive Pulmonary Fibrosis: ATS/ERS/JRS/ALAT Official Clinical Practice Guidelines (2022 Edition), and the Chinese Expert Consensus on the Diagnosis and Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis, the disease staging evaluation of IPF is stable phase or acute exacerbation.
Measured: Evaluate at baseline.
Gender, age and physiologic variables (GAP)stage
Recording the GAP stage of IPF patients. GAP stage is a risk stratification method that quantifies the three core parameters of patients: gender, age, and physiological parameters, by calculating the total score and conducting risk stratification.
Measured: Evaluate at baseline.
Pulmonary function classification
Recording the pulmonary function classification of IPF patients. According to The Expert Consensus on the Diagnostic Criteria for Adult Lung Function in China, pulmonary function classification is divided into mild, moderate, and severe grades.
Measured: Evaluate at baseline.
Natural course
Recording the natural course of IPF patient. According to international research, the natural course of IPF can be divided into stable, slow progression, rapid progression, and recurrent acute exacerbation. The specific criteria are as follows: 1.stable: FVC annual decline<0.13L; 2. stable slow progression: FVC annual decline 0.13L-0.21L; 3. Rapid progress: FVC annual decline>0.21L; 4. Recurrent acute exacerbations: Annual number of acute exacerbations ≥ 1.
Measured: Evaluate at baseline.
The Traditional Chinese Medicine(TCM) Syndromes
Evaluate traditional Chinese medicine syndromes by collecting patients' symptoms, signs, and tongue pulse information.
Measured: Evaluate at baseline.
6 Six Minute Walk Distance(6MWD)
6MWD will be applied to evaluate the exercise capacity. The higher values indicate the better exercise capacity.
Measured: Evaluate at baseline.
The 30 - second sit - to - stand test(30s STS)
The 30 second sitting and standing test will be used to evaluate lower limb strength and cardiopulmonary function.
Measured: Evaluate at baseline.
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 scored on a 1-5 scale. The higher the score, the worse the quality of life.
Measured: Evaluate at baseline.
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 at baseline.
Dyspnea
Dyspnea will be assessed by modified Medical Research Council(mMRC) scores. A score of 0-4 will be givenaccording to the degree of immediate dyspnea. A higher score indicates a worse condition.
Measured: Evaluate at baseline.
C-reactive protein (CRP)
The CRP level will be detected by ELISA technology.
Measured: Evaluate at baseline.
Krebs Von den Lungen-6（KL-6）
The KL-6 level will be detected by ELISA technology.
Measured: Evaluate at baseline.
The pulmonary artery systolic pressure(PASP)
The PASP will be measured byechocardiogram.
Measured: Evaluate at baseline.
The diameter of the pulmonary artery
The diameter of the pulmonary artery will be measured byechocardiogram.
Measured: Evaluate at baseline.
Forced vital capacity (FVC)
FVC will be applied to assess pulmonary function.
Measured: Evaluate at baseline.
FVC as the percentage of the predicted value (FVC%)
FVC% will be applied to assess pulmonary function.
Measured: Evaluate at baseline.
Diffusing capacity of the lungs for carbon monoxide (DLCO)
DLCO will be applied to assess pulmonary function.
Measured: Evaluate at baseline.
DLCO as the percentage of the predicted value (DLCO%)
DLCO% will be applied to assess pulmonary function.
Measured: Evaluate at baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start15 Sep 2025 (estimated)
- Primary completion30 Sep 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 2,864 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
- NCT07178392
- Sponsor's protocol ID
- Characteristics of IPF
- Status last verified
- Sep 2025
- First submitted
- 29 Jun 2025
- Last updated
- 17 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 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Disease-syndrome Characteristics of Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT07178392
- Acronym / sponsor ID
- Characteristics of IPF
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Keywords
- Idiopathic Pulmonary Fibrosis, TCM, Epidemiological investigation, characteristics
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,864 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
- 15 Sep 2025 (estimated)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Nov 2028 (estimated)
- First posted
- 17 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 previous registration records, aims to explore the syndrome patterns, disease characteristics, and their interrelationships of IPF at different stages, grades, and in its natural course, thus providing a multidimensional interpretation of the syndrome patterns and characteristics of IPF.
Detailed description
This study, based on previous registration records, uses a cross-sectional survey design to collect demographic information, disease-related data, syndrome data, and auxiliary examination data from 2864 IPF patients in China. It aims to elucidate the syndrome types, disease characteristics, and the interrelationships between them of IPF at different stages, grades, and in its natural course.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants fill out the questionnaire | – | –Participants fill out the questionnaire |
Who may qualify
- Ages
- 18 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 ≥ 18 years old;
- Voluntarily participate in this study and sign an informed consent form.
Key exclusion criteria (2 listed)
- Patients with confusion, dementia, consciousness disorders, and various mental illnesses;
- Those 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.
Primary outcome
Disease Stage
Time frame: Evaluate at baseline.
Recording the disease staging of IPF patients. According to the Adult Idiopathic Pulmonary Fibrosis (Revised Edition) and Progressive Pulmonary Fibrosis: ATS/ERS/JRS/ALAT Official Clinical Practice Guidelines (2022 Edition), and the Chinese Expert Consensus on the Diagnosis and Treatment of Acute Exacerbation of Idiopathic Pulmonary Fibrosis, the disease staging evaluation of IPF is stable phase or acute exacerbation.
Gender, age and physiologic variables (GAP)stage
Time frame: Evaluate at baseline.
Recording the GAP stage of IPF patients. GAP stage is a risk stratification method that quantifies the three core parameters of patients: gender, age, and physiological parameters, by calculating the total score and conducting risk stratification.
Pulmonary function classification
Time frame: Evaluate at baseline.
Recording the pulmonary function classification of IPF patients. According to The Expert Consensus on the Diagnostic Criteria for Adult Lung Function in China, pulmonary function classification is divided into mild, moderate, and severe grades.
Natural course
Time frame: Evaluate at baseline.
Recording the natural course of IPF patient. According to international research, the natural course of IPF can be divided into stable, slow progression, rapid progression, and recurrent acute exacerbation. The specific criteria are as follows: 1.stable: FVC annual decline<0.13L; 2. stable slow progression: FVC annual decline 0.13L-0.21L; 3. Rapid progress: FVC annual decline>0.21L; 4. Recurrent acute exacerbations: Annual number of acute exacerbations ≥ 1.
The Traditional Chinese Medicine(TCM) Syndromes
Time frame: Evaluate at baseline.
Evaluate traditional Chinese medicine syndromes by collecting patients' symptoms, signs, and tongue pulse information.
6 Six Minute Walk Distance(6MWD)
Time frame: Evaluate at baseline.
6MWD will be applied to evaluate the exercise capacity. The higher values indicate the better exercise capacity.
The 30 - second sit - to - stand test(30s STS)
Time frame: Evaluate at baseline.
The 30 second sitting and standing test will be used to evaluate lower limb strength and cardiopulmonary function.
A Tool to Assess Quality of life (ATAQ-IPF) total scores
Time frame: Evaluate at baseline.
ATAQ-IPF is currently a specialized scale for evaluating the quality of life, consisting of 13 dimensions and 74 items, with each item scored on a 1-5 scale. The higher the score, the worse the quality of life.
St. George's respiratory questionnaire (SGRQ) total scores
Time frame: Evaluate at baseline.
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.
Dyspnea
Time frame: Evaluate at baseline.
Dyspnea will be assessed by modified Medical Research Council(mMRC) scores. A score of 0-4 will be givenaccording to the degree of immediate dyspnea. A higher score indicates a worse condition.
C-reactive protein (CRP)
Time frame: Evaluate at baseline.
The CRP level will be detected by ELISA technology.
Krebs Von den Lungen-6（KL-6）
Time frame: Evaluate at baseline.
The KL-6 level will be detected by ELISA technology.
The pulmonary artery systolic pressure(PASP)
Time frame: Evaluate at baseline.
The PASP will be measured byechocardiogram.
The diameter of the pulmonary artery
Time frame: Evaluate at baseline.
The diameter of the pulmonary artery will be measured byechocardiogram.
Forced vital capacity (FVC)
Time frame: Evaluate at baseline.
FVC will be applied to assess pulmonary function.
FVC as the percentage of the predicted value (FVC%)
Time frame: Evaluate at baseline.
FVC% will be applied to assess pulmonary function.
Diffusing capacity of the lungs for carbon monoxide (DLCO)
Time frame: Evaluate at baseline.
DLCO will be applied to assess pulmonary function.
DLCO as the percentage of the predicted value (DLCO%)
Time frame: Evaluate at baseline.
DLCO% will be applied to assess pulmonary function.
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 17 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 17 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?
Disease Stage (time frame: Evaluate at baseline.). The study lists 18 primary outcomes in all. 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 17 Sep 2025.