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

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Xuzhou, Jiangsu, China, 210029
      • Xuzhou Traditional Chinese Medicine Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 83 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

IPF patients in XUZHOU

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	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)	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.	1 year

Collaborators and Investigators

• Sponsor: Xuzhou Traditional Chinese Medicine Hospital
• Investigators: Principal Investigator: YING MS ZHAO, PHD, Xuzhou Traditional Chinese Medicine Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 20, 2018
• Primary Completion (Actual): February 5, 2020
• Study Completion (Actual): February 5, 2020

Study Registration Dates

• First Submitted: October 7, 2018
• First Submitted That Met QC Criteria: October 17, 2018
• First Posted (Actual): October 18, 2018

Study Record Updates

• Last Update Posted (Actual): July 25, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Metabolomics; Idiopathic Pulmonary Fibrosis; Chinese medicine
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: XZTCM2018LSY-013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Other researchers may contact us with email