[Translation] Safety and efficacy of Tribulus saponin capsules in the treatment of cerebral infarction (stroke meridians) in the recovery period (wind phlegm stasis syndrome), an open, multicenter phase IV clinical trial
(1)通过Ⅳ期临床试验研究,评价蒺藜皂苷胶囊治疗脑梗死(中风病中经络)恢复期(风痰瘀阻证)的安全性及有效性,重点观察可能出现的不良反应,包括不良反应类型、不良反应发生率及不良反应的临床表现及程度; (2)并探索其其治疗脑梗死(中风病中经络)恢复期(风痰瘀阻证)可能的作用机理。
[Translation] (1) To evaluate the safety and efficacy of Tribulus terrestris saponin capsules in the treatment of patients in the recovery period (wind-phlegm-stasis syndrome) of cerebral infarction (stroke meridians) through a Phase IV clinical trial, with a focus on observing possible adverse reactions, including the type of adverse reactions, the incidence of adverse reactions, and the clinical manifestations and severity of adverse reactions; (2) To explore its possible mechanism of action in the treatment of patients in the recovery period (wind-phlegm-stasis syndrome) of cerebral infarction (stroke meridians).