This study evaluates the integrated traditional Chinese and Western medicine in the treatment of severe community acquired pneumonia in adults. Half of participants will receive traditional Chinese and Western medicine in combination, while the other half will receive a placebo traditional Chinese and Western medicine.
Improving the care of patients with community-acquired pneumonia (CAP) has been the focus of many different organizations. Such efforts at improvement in care are warranted, because CAP, especially severe CAP remains the leading cause of death in the world. Despite advances in antimicrobial therapy, rates of mortality due to severe CAP have not decreased significantly since penicillin became routinely available. traditional Chinese Medicine, has been used for thousands of years in treating pneumonia. To date, it has become popular and widely practiced in many countries around the world. In the past decades, Evidences from both clinicians and patients suggest that there is some beneficial effect of TCM on severe CAP. At present, there are many therapies available for patients with severe CAP, it is difficult for us to identify the most suitable therapy. Thus, this study aims to compare the efficacy of combination conventional drug and TCM to the conventional drug and placebo, and then determine which one is the better therapy, providing a scientific basis for clinical decision. This is a multi-center, randomized, controlled trial to compare the efficacy of two therapies for patients with severe CAP. 198 subjects will be randomly assigned to one therapies (conventional drug, and the combination of conventional drug and TCM) for 28 days treatment. After the treatment period, subjects in two arms will be followed up for 12 weeks. The primary outcomes will include treatment failure, and secondary outcomes Time to clinical stability, length hospital stays, in-hospital mortality, SOFA questionnaire, quality of life (CAP-PRO ) and health economics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
198
All patients were treated with antibiotics according to international guidelines. The Experimental group will receive TCM according to the TCM syndrome. qingfeijieduhuatan granule (Sanjiu Medical \& Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for phlegm-heat obstructing in the lung syndrome in 28 treatment days. zaoshihuatanxiefei granule (Sanjiu Medical \& Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for pulmonary stagnation of phlegm syndrome in 28 treatment days. qingxinkaiqiao granule (Sanjiu Medical \& Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for Pathogenic heat trapping the pericardium syndrome in 28 treatment days. shenmai injection（Sichuan chuanda west China Pharmaceutical Co., Ltd.）,15ml/ ampulla, 10～60ml each time (when needed), for yin exhausted syndrome in 28 treatment days. shenfu injection（Sanjiu Medical \& Pharmaceutical Co., Ltd.）,10ml/ ampulla, 50～100ml each time (when needed), for yang exhausted syndrome in 28 treatment days.
All patients were treated with antibiotics according to international guidelines. The control group will receive TCM placebo according to the TCM syndrome. placebo qingfeijieduhuatan granule (Sanjiu Medical \& Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for phlegm-heat obstructing in the lung syndrome every day in 28 treatment days. placebo zaoshihuatanxiefei granule (Sanjiu Medical \& Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for pulmonary stagnation of phlegm syndrome every day in 28 treatment days. placebo qingxinkaiqiao granule (Sanjiu Medical \& Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for Pathogenic heat trapping the pericardium syndrome every day in 28 treatment days.
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, China
Treatment failure
The primary efficacy outcome was the rate of treatment failure, which includes treatment failure that occurred.
Time frame: up to 28 days.
time to clinical stability
Clinical stability
Time frame: up to 28 days.
length hospital stays
length hospital stays will be recorded.
Time frame: up to 28 days.
in-hospital mortality
in-hospital mortality will be recorded.
Time frame: up to 28 days.
SOFA questionnaire
Clinical symptom assessment questionnaire of severe CAP
Time frame: Change from baseline SOFA score at day 0、7、14、28 of the treatment phase.
CAP -CRO
CAP doctor reported outcome scale will be used to assess symptoms.
Time frame: Change from baseline CAP -CRO score at day 0、7、14、28 of the treatment phase.at week 4, week 8, week 12 of the follow-up phase.
Health economics
Cost of the treatment phase will be recorded.
Time frame: up to 28 days.
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