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

NCT ID: NCT03711435

Last Updated: 2022-07-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-20
• Study Completion Date: 2020-02-05

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.

Conditions

Idiopathic Pulmonary Fibrosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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;

Health people match on the age (±3 years old) and gender with case group with 1:1 rate at the same time.

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;

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xuzhou Traditional Chinese Medicine Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

YING MS ZHAO, PHD

Role: PRINCIPAL_INVESTIGATOR

Xuzhou Traditional Chinese Medicine Hospital

Locations

Xuzhou Traditional Chinese Medicine Hospital

Xuzhou, Jiangsu, China

Countries

China

Other Identifiers

XZTCM2018LSY-013

Identifier Type: -

Identifier Source: org_study_id