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NCT Number: NCT03711435

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

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Xuzhou Traditional Chinese Medicine Hospital

Xuzhou, Jiangsu, 210029, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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;

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  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. 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)

  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.

Sponsors and collaborators

Lead sponsor

Xuzhou Traditional Chinese Medicine Hospital

Other

Registry information

Official study title

Study on TCM Syndrome Classification of Idiopathic Pulmonary Fibrosis Based on Metabolomics

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 18, 2018
Registry last updated
Jul 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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