NCT03185923

Effect of Traditional Chinese Medicine on Outcomes in Patients With Severe Pneumonia

A Randomized Controlled Trial of Integrated Traditional Chinese and Western Medicine in the Treatment of Severe Community Acquired Pneumonia

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 198 (estimated)
• Sponsor: Henan University of Traditional Chinese Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Community-Acquired Infections

Interventions

Type	Name	Description
DRUG	TCM plus conventional drug	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.
DRUG	TCM placebo plus conventional drug	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.

Timeline

• Start date: 2017-06-20
• Primary completion: 2019-12-31
• Completion: 2020-12-31
• First posted: 2017-06-14
• Last updated: 2017-06-14

Locations

1 site across 1 country: China