Viewing Study NCT06220019



Ignite Creation Date: 2024-05-06 @ 8:01 PM
Last Modification Date: 2024-10-26 @ 3:18 PM
Study NCT ID: NCT06220019
Status: NOT_YET_RECRUITING
Last Update Posted: 2024-04-09
First Post: 2024-01-05

Brief Title: REspiratory diSEAse cohoRt Studies of CHinese Medicine for Pneumonia RESEARCH-Pneumonia
Sponsor: Henan University of Traditional Chinese Medicine
Organization: Henan University of Traditional Chinese Medicine

Study Overview

Official Title: REspiratory diSEAse cohoRt Studies of CHinese Medicine for Pneumonia RESEARCH-Pneumonia
Status: NOT_YET_RECRUITING
Status Verified Date: 2024-09
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The purpose of this study is to evaluate the clinical efficacy and safety of dialectical treatment in the patients with pneumonia 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
Detailed Description: The incidence hospitalization rate and mortality associated with pneumonia are significant contributing to a substantial disease burden Post-discharge follow-up and intervention strategies for pneumonia patients are often insufficient leaving patients vulnerable to readmission or mortality due to recurrent pneumonia and related complications In clinical practice there is a predominant focus on the amelioration of clinical symptoms during hospitalization with limited attention to ongoing outpatient interventions aimed at reducing readmission rates Consequently there is a pressing need for cohort studies on pneumonia

This study is a multicenter prospective cohort study involving adult patients discharged after pneumonia treatment Approximately 5000 patients will be enrolled with follow-up assessments conducted every three months over the course of one year After one year patients will be stratified into two cohorts based on the duration of Traditional Chinese medicine TCM treatment received eg continuous treatment for two months or intermittent treatment for three months per year One cohort will consist of patients receiving TCM while the other will include those who did not receive TCM The primary endpoint is the rate of hospital readmission while secondary outcomes include treatment satisfaction physician-reported outcomes patient-reported outcomes quality of life nutritional status incidence of acute upper respiratory tract infections and survival This study aims to evaluate the clinical efficacy and safety of TCM in the management of adult pneumonia patients following discharge

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None