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TCM Syndrome Differentiation Treatment on Discharged Elderly Patients With CAP

Community-acquired Pneumonia Clinical Trial

Official title:
TCM Syndrome Differentiation Treatment on Reducing the Rehospitalization Rate of Discharged Elderly Patients With CAP:A Multi-center, Randomized, Double-blind Controlled Trial

Clinical Trial Summary

This study is to evaluate the efficacy and safety of TCM syndrome differentiation treatment on the rehospitalization rate of discharged elderly patients with community acquired pneumonia(CAP)and to explore its mechanism.

Clinical Trial Description

The incidence and mortality of elderly patients with CAP are on a rising trend, especially the mortality of those over 65 years old are the highest. The elderly patients with CAP have more complications and drug resistance, which makes it difficult to treat and have heavy burden on the society. The discharged elderly patients with CAP are still facing the risk of readmission or even death due to recurrent pneumonia or other reasons. Research reports showed that TCM syndrome differentiation treatment had a certain role in improving the condition of discharged elderly patients with CAP. Our previous exploratory studies suggested that TCM syndrome differentiation treatment on the discharged elderly patients with CAP had good clinical efficacy and safety. This is a multi-center, randomized, double-blind, placebo controlled trial to evaluate the efficacy and safety of TCM syndrome differentiation on the rehospitalization rate of discharged elderly patients with CAP and to explore its mechanism. 292 patients will be randomly assigned in a 1:1 ratio to experimental group or control group for 2 months treatment and 6 months follow-up.The experimental group will be given by Bu Fei Jian Pi Hua Tan granule or Yi Qi Yang Yin Qing Fei granule based on TCM syndrome differentiation. The primary outcomes are rehospitalization rate. The secondary outcomes include mortality, assessment of disease severity(CURB65 scores),quality of life (SF-36), treatment satisfaction(ESQ-CAP),Clinician Reported Outcome for CAP,Patient Reported Outcome for CAP,nutritional status (MNA-SF). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04702074
Study type Interventional
Source Henan University of Traditional Chinese Medicine
Contact Ming-hang Wang, Doctor
Phone 0371-66248624
Email wmh@163.com
Status Not yet recruiting
Phase N/A
Start date January 15, 2021
Completion date December 30, 2022
View Details
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