Efficacy and safety of a sequential treatment with clearing heat and eliminating phlegm and tonifying Qi and activating blood circulation in treating acute ischemic stroke: study protocol for a randomized controlled trial

OBJECTIVE:To investigate the short-term efficacy and safety outcomes following a sequential treatment with clearing heat and eliminating phlegm(CHEP)formula and tonifying Qi and activating blood circulation(TQABC)formula in patients with acute ischemic stroke(AIS)within a 72 h time window.METHODS:In this randomized,multicenter,doubleblinded,placebo-controlled trial,500 participants will be randomly assigned in a ratio of 1∶1 to the CHEP+TQABC group or control group.In addition to guidelinebased standard medical care,participants in the treatment group will receive the CHEP formula for the first 5 consecutive days followed by the TQABC formula for another 10 consecutive days,while those in the control group will receive CHEP formula placebo and TQABC formula placebo consecutively.The primary outcome measure will be the comparison of the change in the National Institutes of Health Stroke Scale score from baseline to 15 days after randomization.The secondary outcome measures will include the scores on the modified Rankin Scale,Barthel Index,Patient-Reported Outcomes,TCM symptom pattern(Zheng-hou)evaluation Scale,and the incidence of in-hospital complications.Safety assessment will include the physical examination,laboratory detection,any adverse events or serious adverse events,and the proportion of any complications during hospitalization.DISCUSSION:The results of this study will provide objective and scientific data with which to assess the efficacy and safety of a sequential treatment based on“integrating disease and symptom pattern”for patients with AIS.

Research Progress on the Pharmacological Mechanisms of Chinese Medicines that Tonify Qi and Activate Blood Against Cerebral Ischemia/Reperfusion Injury

Cerebral ischemia-reperfusion injury(CIRI) refers to a pathological phenomenon that aggravates the injury after the restoration of blood perfusion and oxygen supply to the cerebral ischemia-induced tissues and organs, with a relatively high incidence. The traditional Chinese medicine(TCM) believes that Qi deficiency and blood stasis are the cause of CIRI. Therefore, Chinese medicine for tonifying Qi and activating blood is regarded as an important choice for the treatment of CIRI. In recent years, it has been found that many Chinese herbal medical ingredients and compound Chinese medicine(CCM) have significant anti-CIRI effects, and their mechanisms of action mainly include improving brain blood supply, neuroprotection, regulating signal pathways such as TLR4/HO-1/Bcl-2, protecting mitochondrial function, regulating related protein levels, and regulating oxidative molecule levels. This article summarizes and introduces the pharmacological mechanisms of Tonifying-Qi and activating-blood Chinese medicine and CCM which have the function of anti-CIRI. Our goal is to provide effective reference for further researches on the cerebral protection of related TCMs or compounds and their clinical application.