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Construction and validation of an early warning model for progressive pulmonary fibrosis based on Chinese medicine evidence characteristics

Construction and validation of an early warning model for progressive pulmonary fibrosis based on Chinese medicine evidence characteristics

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400085801
Enrollment
Unknown
Registered
2024-06-19
Start date
2024-06-19
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

Progressive pulmonary fibrosis

Interventions

Gold Standard:According to the "Diagnosis Criteria for Traditional Chinese Medicine Syndrome of Diffuse Interstitial Pulmonary Disease (2012 Edition)", two or more physicians with professional titles
Index test:Using logistic regression analysis to screen for risk factors of progressive pulmonary fibrosis, R language software was used to construct a Nomogram warning model.

Sponsors

Xiyuan Hospital, China Academy of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 90 Years

Inclusion criteria

Inclusion criteria: (1) Retrospective study inclusion criteria ? medical records in line with the diagnosis of interstitial lung disease (code: J84.901) ? age=18 years old and =90 years old, gender is not limited; ? complete data recorded in the medical record; ? relevant data can be traced. (2) Prospective study inclusion criteria ?Meet the diagnostic criteria of fibrotic interstitial lung disease; ?Age =18 years old and =90 years old, gender is not limited; ?Voluntary participation and signing of informed consent.

Exclusion criteria

Exclusion criteria: (1) Exclusion criteria for retrospective studies ? Medical records consistent with the diagnosis of idiopathic pulmonary fibrosis (code: J84.110);? Patients with worsening dyspnea symptoms caused by other diseases clearly identified in the medical record, such as heart failure, acute lung infection, pulmonary embolism, etc.; ? Explicit rejection of medical records for use in those who explicitly rejected the use of medical records for scientific research. (2) Prospective study exclusion criteria ? patients with a clear diagnosis of idiopathic pulmonary fibrosis; ? patients with worsening dyspnea symptoms caused by other diseases, such as heart failure, acute lung infection, pulmonary embolism, etc; ? Combined with other serious diseases of vital organs, such as acute stroke shock, respiratory arrest; ? malignant tumors,blood system diseases, serious liver and kidney function abnormality.

Design outcomes

Primary

MeasureTime frame
Clinical symptoms and signs, including cough, sputum, dyspnea, activity tolerance etc. as well as TCM symptoms including tongue and pulse.;Laboratory findings included routine blood tests, blood biochemistry, blood gas analysis, tumor markers, immunological indicators, KL-6, and lymphocyte subsets.;Results of chest imaging and pulmonary function tests including FVC% and DLCO%.;Chinese medicine evidence;area undercurve;C-index;Decision Curve Analysis;

Secondary

MeasureTime frame
General information including name, sex, age, occupation, smoking history, disease classification and disease duration;Past history and allergies;Therapeutic conditions include N-acetylcysteine, pirfenidone, and nidanib, glucocorticoids and immunosuppressants, etc., as well as Chinese medicine therapeutic prescriptions and proprietary Chinese medicines, etc.;

Countries

China

Contacts

Public ContactFan Maorong

Xiyuan Hospital, China Academy of Traditional Chinese Medicine

1620245324@qq.com+86 135 8913 3829

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026