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Trial record 13 of 317 for:    "Pulmonary Fibrosis, Idiopathic"

Traditional Chinese Medicine(TCM) Syndrome Classification of Idiopathic Pulmonary Fibrosis(IPF) and Metabolomics

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ClinicalTrials.gov Identifier: NCT03711435
Recruitment Status : Recruiting
First Posted : October 18, 2018
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Xuzhou Traditional Chinese Medicine Hospital

Brief 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. 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.

Condition or disease Intervention/treatment
Idiopathic Pulmonary Fibrosis Diagnostic Test: Metabolomics

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Study on TCM Syndrome Classification of Idiopathic Pulmonary Fibrosis Based on Metabolomics
Estimated Study Start Date : October 20, 2018
Estimated Primary Completion Date : October 31, 2019
Estimated Study Completion Date : October 31, 2019


Group/Cohort Intervention/treatment
control group Diagnostic Test: Metabolomics
we test the two group with metabolomics for serum, urine,stool and saliva,the case group with TCM Syndrome,and other diagnostic tests
Other Names:
  • Pulmonary function
  • Six Minute Walk Test
  • CT scan

case group Diagnostic Test: Metabolomics
we test the two group with metabolomics for serum, urine,stool and saliva,the case group with TCM Syndrome,and other diagnostic tests
Other Names:
  • Pulmonary function
  • Six Minute Walk Test
  • CT scan




Primary Outcome Measures :
  1. IPF biomarkers in metabolites [ Time Frame: 1 year ]
    Metabolomics of serum,urine,stool and saliva based on mass spectrometry.It is non-targeted metabolomics.The study is to find the target metabolite to distinguish IPF.


Secondary Outcome Measures :
  1. Pulmonary function Pulmonary function [ Time Frame: 1 year ]
    Pulmonary function including forced vital capacity(FVC),forced expiratory volume at one second(FEV1),diffusion capacity of lung for carbon monoxide(DLCO)

  2. Six Minute Walk Test(6MWT) [ Time Frame: 1 year ]
    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

  3. High-resolution chest CT total score (CT-Tot) [ Time Frame: 1 year ]
    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.

  4. St. George's Respiratory Questionnaire [ Time Frame: 1 year ]
    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.


Biospecimen Retention:   Samples With DNA
blood;urine;stool;saliva


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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
IPF patients in XUZHOU
Criteria

Inclusion Criteria:

  • Case group inclusion criteria

    1. 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;
    2. 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.

Exclusion Criteria:

  • Case group exclusion criteria:

    1. Those with severe heart, liver, kidney and other organ dysfunction or suffering from blood diseases;
    2. with malignant tumors;
    3. Severely infected people;
    4. Pregnant and lactating women;
    5. mental illness, serious obstacles and those who are unwilling to cooperate;

Control group exclusion criteria:

  1. Those with severe heart, liver, kidney and other organ dysfunction or blood disease;
  2. With malignant tumors;
  3. Chest X-ray or chest low-dose CT suggesting intra-pulmonary interstitial fibrosis;
  4. With chronic pulmonary diseases such as pulmonary interstitial disease, chronic obstructive pulmonary disease, and bronchial asthma;
  5. With connective tissue disease and those with a history of exposure to occupational diseases;
  6. Mental illness, serious obstacles and unwilling to cooperate.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03711435


Contacts
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Contact: YING MS ZHAO, PHD 08618205211881 njmuzy@126.com

Locations
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China, Jiangsu
Xuzhou Traditional Chinese Medicine Hospital Recruiting
Xuzhou, Jiangsu, China, 210029
Contact: YING MS ZHAO, PHD    08618205211881    njmuzy@126.com   
Contact: CONGHAI MR FAN    086051667663519    418580219@qq.com   
Sub-Investigator: Xianmei MS Zhou, PHD         
Principal Investigator: Ying MS Zhao, PHD         
Sub-Investigator: Qi MR Wu, PHD         
Sub-Investigator: Yingzi MS Li         
Sub-Investigator: Huiqing MS Ding         
Sub-Investigator: He MR Zhang         
Sub-Investigator: Ke MR Lv         
Sponsors and Collaborators
Xuzhou Traditional Chinese Medicine Hospital
Investigators
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Principal Investigator: YING MS ZHAO, PHD Xuzhou Traditional Chinese Medicine Hospital

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Responsible Party: Xuzhou Traditional Chinese Medicine Hospital
ClinicalTrials.gov Identifier: NCT03711435     History of Changes
Other Study ID Numbers: XZTCM2018LSY-013
First Posted: October 18, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Other researchers may contact us with email

Keywords provided by Xuzhou Traditional Chinese Medicine Hospital:
Idiopathic Pulmonary Fibrosis
Metabolomics
Chinese medicine

Additional relevant MeSH terms:
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Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial