Clinical trial NCT03711435: Traditional Chinese Medicine(TCM) Syndrome Classification of Idiopathic Pulmonary Fibrosis(IPF) and Metabolomics
Official title: Study on TCM Syndrome Classification of Idiopathic Pulmonary Fibrosis Based on Metabolomics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Idiopathic Pulmonary Fibrosis
Metabolomics
Chinese medicine
Lead sponsor: Xuzhou Traditional Chinese Medicine Hospital
Sponsor class: OTHER
First posted: 2018-10-18
Enrollment: 75
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: IPF patients in XUZHOU

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.


Eligibility 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.

Primary outcomes:
measure: biomarkers detected in metabolites
timeFrame: 1 year
Secondary outcomes:
measure: High-resolution chest CT total score (CT-Tot)
timeFrame: 1 year
measure: Six Minute Walk Test(6MWT)
timeFrame: 1 year
measure: Pulmonary function Pulmonary function
timeFrame: 1 year
measure: St. George's Respiratory Questionnaire
timeFrame: 1 year
Other outcomes:
Locations:
city: Xuzhou
country: China
facility: Xuzhou Traditional Chinese Medicine Hospital
state: Jiangsu
Study officials:
affiliation: Xuzhou Traditional Chinese Medicine Hospital
name: YING MS ZHAO, PHD
role: PRINCIPAL_INVESTIGATOR
References: