Idiopathic Pulmonary FibrosisNCT03711435
Traditional Chinese Medicine(TCM) Syndrome Classification of Idiopathic Pulmonary Fibrosis(IPF) and Metabolomics
An observational study of Idiopathic Pulmonary Fibrosis, run by Xuzhou Traditional Chinese Medicine Hospital at 1 site in China.
Trial summary
The pathogenesis of idiopathic pulmonary interstitial fibrosis is complex, and there is no specific biomarkers, the treatment effect is not such useful. Currently, it is discovered that Chinese medicine treatment may be effective. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2018to 5 Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: IPF patients in XUZHOU
Who may be able to join
- Case group inclusion criteria
- According to the diagnostic criteria published in 2015, the New Guidelines for the Diagnosis and Treatment of Idiopathic Pulmonary Fibrosis, jointly developed by the American Thoracic Society, the European Respiratory Society, the Japanese Respiratory Society, and the Latin American Thoracic Society;
- aged 50 to 85 years old;
- Control group inclusion criteria:
- Health people match on the age (±3 years old) and gender with case group with 1:1 rate at the same time.
Who cannot join
- Case group exclusion criteria:
- Those with severe heart, liver, kidney and other organ dysfunction or suffering from blood diseases;
- with malignant tumors;
- Severely infected people;
- Pregnant and lactating women;
- mental illness, serious obstacles and those who are unwilling to cooperate;
Show all 13Show fewer
- Control group exclusion criteria:
- Those with severe heart, liver, kidney and other organ dysfunction or blood disease;
- With malignant tumors;
- Chest X-ray or chest low-dose CT suggesting intra-pulmonary interstitial fibrosis;
- With chronic pulmonary diseases such as pulmonary interstitial disease, chronic obstructive pulmonary disease, and bronchial asthma;
- With connective tissue disease and those with a history of exposure to occupational diseases;
- Mental illness, serious obstacles and unwilling to cooperate.
Trial locations and contacts
1 site in 1 country.
China1 site
Xuzhou Traditional Chinese Medicine Hospital
Xuzhou, Jiangsu, 210029
About this study
Official title: Study on TCM Syndrome Classification of Idiopathic Pulmonary Fibrosis Based on Metabolomics
The pathogenesis of idiopathic pulmonary interstitial fibrosis is complex, and there is no specific biomarkers, the treatment effect is not such useful. Currently, it is discovered that Chinese medicine treatment may be effective. The investigators select patients with idiopathic pulmonary interstitial fibrosis and healthy controls, use metabolomics to study the biological characteristics of idiopathic pulmonary interstitial fibrosis, screen biomarkers of IPF, and label different TCM syndromes of IPF, explore the biological nature of IPF TCM syndromes, find the biological changes that occur during the development and progression of IPF and explore the metabolite marker clusters of IPF. Furthermore, the results of this study may find its diagnostic significance for IPF and Looking for potential targets for future treatment of IPF.
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Idiopathic Pulmonary Fibrosis, Metabolomics, Chinese medicine
- 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 |
|---|---|---|
| Training set | The training set is composed of 30 IPF patients and 15 controls. The group is designed to identify differential metabolites between IPF and control groups. | |
| Validation set | The validation set is composed of 15 IPF patients and 15 controls. The group is designed to validate differential metabolites identified in the previous groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
biomarkers detected in metabolites
Metabolomics of serum based on mass spectrometry.It is non-targeted metabolomics.The study is to find the target metabolite to distinguish IPF.
Measured: 1 year
Secondary outcomes (4)
High-resolution chest CT total score (CT-Tot)
High-resolution chest CT total score (CT-Tot), which includes the grid shadow and the honeycomb lung. The score range is 0-5, and the larger the score, the more serious the disease.
Measured: 1 year
Six Minute Walk Test(6MWT)
The six-minute walk test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface.It is a simple objective indicator for evaluating cardiopulmonary function
Measured: 1 year
Pulmonary function Pulmonary function
Pulmonary function including forced vital capacity(FVC),forced expiratory volume at one second(FEV1),diffusion capacity of lung for carbon monoxide(DLCO)
Measured: 1 year
St. George's Respiratory Questionnaire
St. George's Respiratory Questionnaire is measuring impaired health and perceived well-being ('quality of life') in airways disease. the score is 0 to 100，the higher the score is，the worse life quality the patients has.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2018
- Study start20 Oct 2018
- Primary completion5 Feb 2020
- Study completion5 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary FibrosisStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xuzhou Traditional Chinese Medicine Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- YING MS ZHAO, PHD, Principal investigator, Xuzhou Traditional Chinese Medicine Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03711435
- Sponsor's protocol ID
- XZTCM2018LSY-013
- Status last verified
- Jul 2022
- First submitted
- 7 Oct 2018
- Last updated
- 25 Jul 2022
- Results posted
- No
- Individual data sharing
- Undecided: Other researchers may contact us with email
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on TCM Syndrome Classification of Idiopathic Pulmonary Fibrosis Based on Metabolomics
- ClinicalTrials.gov ID
- NCT03711435
- Acronym / sponsor ID
- XZTCM2018LSY-013
- Conditions
- Idiopathic Pulmonary Fibrosis
- Keywords
- Idiopathic Pulmonary Fibrosis, Metabolomics, Chinese medicine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Xuzhou Traditional Chinese Medicine HospitalUniversity, hospital or other
- Study start
- 20 Oct 2018 (actual)
- Primary completion
- 5 Feb 2020 (actual)
- Study completion
- 5 Feb 2020 (actual)
- First posted
- 18 Oct 2018 (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.
The pathogenesis of idiopathic pulmonary interstitial fibrosis is complex, and there is no specific biomarkers, the treatment effect is not such useful. Currently, it is discovered that Chinese medicine treatment may be effective. The investigators select patients with idiopathic pulmonary interstitial fibrosis and healthy controls, use metabolomics to study the biological characteristics of idiopathic pulmonary interstitial fibrosis, screen biomarkers of IPF, and label different TCM syndromes of IPF, explore the biological nature of IPF TCM syndromes, find the biological changes that occur during the development and progression of IPF and explore the metabolite marker clusters of IPF. Furthermore, the results of this study may find its diagnostic significance for IPF and Looking for potential targets for future treatment of IPF.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training set | – | –The training set is composed of 30 IPF patients and 15 controls. The group is designed to identify differential metabolites between IPF and control groups. |
| Validation set | – | –The validation set is composed of 15 IPF patients and 15 controls. The group is designed to validate differential metabolites identified in the previous groups. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- IPF patients in XUZHOU
Key inclusion criteria (5 listed)
- Case group inclusion criteria
- Health people match on the age (±3 years old) and gender with case group with 1:1 rate at the same time.
Key exclusion criteria (13 listed)
- Case group exclusion criteria:
- Those with severe heart, liver, kidney and other organ dysfunction or blood disease;
- With malignant tumors;
- Chest X-ray or chest low-dose CT suggesting intra-pulmonary interstitial fibrosis;
- With chronic pulmonary diseases such as pulmonary interstitial disease, chronic obstructive pulmonary disease, and bronchial asthma;
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
biomarkers detected in metabolites
Time frame: 1 year
Metabolomics of serum based on mass spectrometry.It is non-targeted metabolomics.The study is to find the target metabolite to distinguish IPF.
4 secondary outcomes
High-resolution chest CT total score (CT-Tot)
Time frame: 1 year
Six Minute Walk Test(6MWT)
Time frame: 1 year
Pulmonary function Pulmonary function
Time frame: 1 year
St. George's Respiratory Questionnaire
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
- Individual participant dataSharing planned: Undecided. Other researchers may contact us with email
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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. This study is not recruiting at the moment.
YING MS ZHAO, PHD principal investigator
Xuzhou Traditional Chinese Medicine Hospital
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, run by Xuzhou Traditional Chinese Medicine Hospital 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 5 inclusion and 13 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: finished, as of the sponsor's last update on 25 Jul 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
biomarkers detected in metabolites (time frame: 1 year). 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 25 Jul 2022.