School of Pharmaceutical Science and Technology, Tianjin University, Tianjin, China.
School of Chinese Medicine Engineering, Tianjin University of Traditional Chinese Medicine, Tianjin, China.
BMJ Open. 2017 Nov 8;7(11):e015983. doi: 10.1136/bmjopen-2017-015983.
After stroke, hemiplegia, dysphasia and facial paralysis can manifest during the convalescent period. Currently, no Chinese patent medicine (CPM) is previously reported to cure each of these symptoms primarily, and thus, there are no relevant instructions for the use of CPM. This study presents a new approach based on comparative effectiveness research to distinguish the curative effects of three CPMs that are often used in stroke convalescence to determine the ideal medicine for the treatment of each symptom.
In this multicentre and double-blind clinical trial, stratified randomisation is used to group the patients according to their primary symptoms (hemiplegia, dysphasia and facial paralysis). Three strata will be enrolled, with 80 eligible participants included in each stratum. Each stratum will be randomly and equally divided into four groups, and each group will receive one of the following treatments: Naoxuekang, Xinnaoshutong (XNST), Xuesaitong (XST) or placebo. This study will include two stages: the initial treatment period (30 days) and a follow-up period (180 days). Three replicates for each data point will be completed during this trial. The first visit will occur on day 0 after enrolment, the second visit on day 30±2 and the third visit on day 210±5. The Delphi technique is adopted to achieve index weighting, which ensures that the evaluation outcome is patient oriented. The weighted index value will be computed as the final measurement index of the outcome.
This study has been approved by the Medical Ethics Committee of Tianjin University of Traditional Chinese Medicine (registration number TJUTCM-EC20160007). The results will be offered for publication in peer-reviewed journals.
This trial was registered with the Chinese Clinical Trial Registry (ChiCTR-IOR-17010397). The date of registration was 11 January 2017.
中风后恢复期可出现偏瘫、失语、面瘫等症状，目前尚无一种中成药能主要针对这些症状进行治疗，因此也没有相关的中成药使用说明。本研究采用基于比较疗效研究的新方法，区分三种常用于中风恢复期的中成药的疗效，以确定治疗每种症状的理想药物。
本多中心、双盲临床试验采用分层随机分组，根据主要症状（偏瘫、失语、面瘫）将患者分组。将招募 3 个分层，每个分层纳入 80 名合格参与者。每个分层将随机平均分为 4 组，每组接受以下治疗之一：脑心康、心脑舒通（XNST）、血塞通（XST）或安慰剂。本研究将包括两个阶段：初始治疗期（30 天）和随访期（180 天）。在试验过程中完成 3 次数据点的重复测量。第一次就诊在入组后第 0 天进行，第二次就诊在第 30±2 天进行，第三次就诊在第 210±5 天进行。采用德尔菲技术进行指标加权，确保评价结果以患者为中心。加权指标值将作为最终的疗效测量指标。
本研究已获得天津中医药大学医学伦理委员会的批准（注册号 TJUTCM-EC20160007）。研究结果将发表在同行评议的期刊上。
该试验在中国临床试验注册中心（ChiCTR-IOR-17010397）注册。注册日期为 2017 年 1 月 11 日。
