An interventional study of Traditional Chinese medicine granules and Traditional Chinese medicine granules placebo in Community-acquired Pneumonia, sponsored by Henan University of Traditional Chinese Medicine. Status unknown at 1 site in China. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2021-01-08.
Sponsored by Henan University of Traditional Chinese Medicine · Not applicable, Interventional, and Treatment
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.
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).
2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.
This study's planned enrollment of 292 is above the median of 106 across 1,247 interventional studies indexed under Pneumonia.
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Exclusion Criteria:
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.
Drug: Traditional Chinese medicine granules
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.
Drug: Traditional Chinese medicine granules placebo
Bu Fei Jian Pi Hua Tan granule for syndrome of the lung and spleen qi deficiency and unclean phlegm dampness. Yi Qi Yang Yin Qing Fei granule for syndrome of qi and yin deficiency and unclean phlegm heat. Traditional Chinese medicine granules will be administered twice daily for 2 months.
Bu Fei Jian Pi Hua Tan granule placebo for syndrome of the lung and spleen qi deficiency and unclean phlegm dampness. Yi Qi Yang Yin Qing Fei granule placebo for Syndrome of qi and yin deficiency and unclean phlegm heat. Traditional Chinese medicine granules placebo will be administered twice daily for 2 months. The appearance, weight, color and odor of the preparation are the same as those of experimental group. The granule placebo consists of dextrin, bitter and 5% of the Traditional Chinese medicine granules .
Rehospitalization rate
Rehospitalization and causes of rehospitalization during the study period will be recorded.
Time frame: up to month 8.
Mortality
Deaths and causes of death during the study period will be recorded.
Time frame: the month1,2 of treatment period and month3, 6 of follow-up period.
CURB65 score
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.
Time frame: Before treatment, the month 2 of treatment period and month 6 of follow-up period.
MNA-SF
MNA-SF will be used to evaluate the nutritional status.The higher scores will indicate the better nutritional status.
Time frame: Before treatment, the month 2 of treatment period and month 3, 6 of follow-up period.
CAP-PRO
Patient Reported Outcome for CAP scale(CAP-PRO) will be used to evaluate clinical efficacy .The lower scores will indicate the better outcomes.
Time frame: Before treatment, the month 1,2 of treatment period and month 3, 6 of follow-up period.
CAP-CRO
Clinician Reported Outcome for CAP scale(CAP-CRO)will be used to evaluate clinical efficacy . The lower scores will indicate the better outcomes.
Time frame: Before treatment, the month 1,2 of treatment period and month3, 6 of follow-up period.
SF-36
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.
Time frame: Before treatment, the month 1,2 of treatment period and month 3, 6 of follow-up period.
ESQ-CAP
The efficacy satisfaction questionnaire for CAP (ESQ-CAP) will be used to assess clinical efficacy. The higher scores will indicate the better outcomes.
Time frame: Before treatment, the month 1,2 of treatment period and month 3, 6 of follow-up period.
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Henan University of Traditional Chinese Medicine