Ignite Creation Date:
2024-05-06 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 1:53 PM
Study NCT ID:
NCT04702074
Status:
UNKNOWN
Last Update Posted:
2021-01-08
First Post:
2021-01-01
Brief Title:
TCM Syndrome Differentiation Treatment on Discharged Elderly Patients With CAP
Sponsor:
Henan University of Traditional Chinese Medicine
Organization:
Henan University of Traditional Chinese Medicine
Study Overview
Official Title:
TCM Syndrome Differentiation Treatment on Reducing the Rehospitalization Rate of Discharged Elderly Patients With CAPA Multi-center Randomized Double-blind Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
NOT_YET_RECRUITING
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:
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 pneumoniaCAPand to explore its mechanism
Detailed 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 11 ratio to experimental group or control group for 2 months treatment and 6 months follow-upThe 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 severityCURB65 scoresquality of life SF-36 treatment satisfactionESQ-CAPClinician Reported Outcome for CAPPatient Reported Outcome for CAPnutritional status MNA-SF
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 11 ratio to experimental group or control group for 2 months treatment and 6 months follow-upThe 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 severityCURB65 scoresquality of life SF-36 treatment satisfactionESQ-CAPClinician Reported Outcome for CAPPatient Reported Outcome for CAPnutritional status MNA-SF
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None