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

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03711435
• Other study ID #: XZTCM2018LSY-013
• Status: Completed
• Start date: October 20, 2018
• Est. completion date: February 5, 2020

Study information

• Verified date: July 2022
• Source: Xuzhou Traditional Chinese Medicine Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: February 5, 2020
• Est. primary completion date: February 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Locations

Country	Name	City	State
China	Xuzhou Traditional Chinese Medicine Hospital	Xuzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Xuzhou Traditional Chinese Medicine Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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