TCM Syndrome Differentiation Treatment on Discharged Elderly Patients With CAP

Not Applicable

• Conditions: Community-acquired Pneumonia
• Interventions: Drug: Traditional Chinese medicine granules; Drug: Traditional Chinese medicine granules placebo

• Registration Number: NCT04702074
• Lead Sponsor: Henan University of Traditional Chinese Medicine

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 pneumonia(CAP)and 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 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 Timeline

• Status Verified: 2021-01
• Study First Submitted: 2021-01-01
• Study First Submitted QC: 2021-01-07
• Last Update Submitted: 2021-01-07
• Study First Posted: 2021-01-08
• Last Update Posted: 2021-01-08
• Study Start: 2021-01-15
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 292

Inclusion Criteria

1. A confirmed diagnosis of discharged elderly patients with CAP within 1 weeks;
2. Syndrome differentiation meets criteria of syndrome of the lung and spleen qi deficiency and unclean phlegm dampness, Syndrome of qi and yin deficiency and unclean phlegm heat;
3. Age including or above 65 years old;
4. Voluntary treatment, oral medication;
5. With informed consent signed.

Exclusion Criteria

1. A confirmed diagnosis of discharged elderly patients with severe CAP;
2. Patients with unconscious, dementia or mental disorders;
3. Patients with hydrothorax, bronchiectasis, active pulmonary tuberculosis, pulmonary abscess, chronic obstructive pulmonary disease of GOLD D;
4. Patients with aspiration risk of severe neuromuscular disorders and long-term bedridden;
5. Patients with tumor, severe cardiovascular disease and severe liver and kidney diseases;
6. Participants in clinical trials of other drugs;
7. People who are allergic to the treatment drugs.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional Chinese medicine granules	Traditional Chinese medicine granules	The experimental group will be given Bu Fei Jian Pi Hua Tan granule or Yi Qi Yang Yin Qing Fei granule based on TCM syndrome differentiation.
Traditional Chinese medicine granules placebo	Traditional Chinese medicine granules placebo	The control group will be given Bu Fei Jian Pi Hua Tan granule placebo or Yi Qi Yang Yin Qing Fei granule placebo based on TCM syndrome differentiation.

Primary Outcome Measures

Name	Time	Method
Rehospitalization rate	up to month 8.	Rehospitalization and causes of rehospitalization during the study period will be recorded.

Secondary Outcome Measures

Name	Time	Method
ESQ-CAP	Before treatment, the month 1,2 of treatment period and month 3, 6 of follow-up period.	The efficacy satisfaction questionnaire for CAP (ESQ-CAP) will be used to assess clinical efficacy. The higher scores will indicate the better outcomes.
Mortality	the month1,2 of treatment period and month3, 6 of follow-up period.	Deaths and causes of death during the study period will be recorded.
CURB65 score	Before treatment, the month 2 of treatment period and month 6 of follow-up period.	CURB65 score will be assessd the severity of discharged elderly patients with CAP. 0-1 points: in principle, outpatient treatment is enough; 2 points: hospitalization or out of hospital treatment under strict follow-up; 3-5 points: hospitalization. The higher scores will indicate the worse outcomes.
MNA-SF	Before treatment, the month 2 of treatment period and month 3, 6 of follow-up period.	MNA-SF will be used to evaluate the nutritional status.The higher scores will indicate the better nutritional status.
CAP-PRO	Before treatment, the month 1,2 of treatment period and month 3, 6 of follow-up period.	Patient Reported Outcome for CAP scale(CAP-PRO) will be used to evaluate clinical efficacy .The lower scores will indicate the better outcomes.
CAP-CRO	Before treatment, the month 1,2 of treatment period and month3, 6 of follow-up period.	Clinician Reported Outcome for CAP scale(CAP-CRO)will be used to evaluate clinical efficacy . The lower scores will indicate the better outcomes.
SF-36	Before treatment, the month 1,2 of treatment period and month 3, 6 of follow-up period.	SF-36 will be used to evaluate quality of life with a total of 0-100. The higher scores will indicate the better quality of life.

Trial Locations

Locations (1)

the First Affiliated Hospital of Henan University of Chinese Medicine; 🇨🇳 Zhengzhou, China