Clinical trial
REspiratory diSEAse cohoRt Studies of CHinese Medicine for CAP (RESEARCH- CAP)
Name
TCM for CAP Cohort
Description
The purpose of this study is to evaluate the clinical efficacy and safety of dialectical treatment in the patients with CAP after discharge in a prospective cohort study: one is the Traditional Chinese Medicine (TCM) cohort, which has been evaluated and has certain effects; The other is a non traditional Chinese medicine queue.
Trial arms
Trial start
2024-04-01
Estimated PCD
2025-12-01
Trial end
2026-03-01
Status
Not yet recruiting
Treatment
TCM
CAP patients diagnosed with Qi Deficiency Phlegm Dampness Syndrome or Qi Yin Deficiency Phlegm Heat Syndrome after discharge, with traditional Chinese medicine treatment as the exposure factor, will be included in the Traditional Chinese Medicine cohort. Patients who continuously take traditional Chinese medicine (modified by Bu Fei Jian Pi Hua Tan Fang or modified by Yi Qi Yang Yin Qing Fei Fang) for more than 2 months per year, or those who intermittently take medicine for more than 3 months of the total time of the year will be classified.
Arms:
TCM cohort
Size
1078
Primary endpoint
Rehospitalization rate
The Rehospitalization rate within a one-year follow-up period
Eligibility criteria
Selection Criteria:
* CAP patients who meet the diagnostic criteria are discharged within 7 days;
* Willing to receive treatment and able to take medication orally;
* Sign an informed consent form.
Exclusion Criteria:
* Patients with confusion, consciousness disorders, dementia, and various mental illnesses;
* Patients with neuromuscular diseases and long-term bed rest who are at risk of aspiration;
* Patients infected with HIV infection or other immunodeficiency diseases;
* Participants in clinical trials of other drugs;
* Known to be allergic to treatment drugs.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'The biological sample bank includes serum samples, plasma samples, urine samples, stool samples.'}, 'enrollmentInfo': {'count': 1078, 'type': 'ESTIMATED'}}
Updated at
2024-04-09
1 organization
1 product
1 indication
Organization
Henan University of Traditional Chinese MedicineProduct
TCMIndication
Community Acquired Pneumonia