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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03711435

Enrollment

Registered

2018-10-18

Start date

2018-10-20

Completion date

2020-02-05

Last updated

2022-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic Pulmonary Fibrosis, Metabolomics, Chinese medicine

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to 85 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
biomarkers detected in metabolites	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

Measure	Time frame	Description
High-resolution chest CT total score (CT-Tot)	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.
Six Minute Walk Test(6MWT)	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
Pulmonary function Pulmonary function	1 year	Pulmonary function including forced vital capacity(FVC),forced expiratory volume at one second(FEV1),diffusion capacity of lung for carbon monoxide(DLCO)
St. George's Respiratory Questionnaire	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.

Countries

China

Outcome results