Xie Le, Xie Yao, Mao Guo, Jiang Junlin, Yao Ting, Fang Rui, Yue Zenghui, Li Yingchen, Wu Dahua
Neurology Department, Hunan Academy of Chinese Medicine Affiliated Hospital, Changsha, Hunan, 410006, PR China.
College of Integrated Traditional Chinese and Western Medicine, Hunan University of Chinese Medicine, Changsha, Hunan, 410208, PR China.
Contemp Clin Trials Commun. 2022 Aug 17;29:100975. doi: 10.1016/j.conctc.2022.100975. eCollection 2022 Oct.
Stroke is the first leading cause of mortality and disability worldwide, and post-stroke spasticity (PSS) is the common complication of stroke. Sangdantongluo Granule (Z20210481000), a modern patent Chinese medicine, is widely used in clinical practice to treat PSS. Whereas, there is limited evidence of effectiveness for Sangdantongluo Granule to treat PSS. This study will evaluate the clinical efficacy and safety of Sangdantongluo granule in the treatment of PSS.
and Analysis This multicenter, randomized, double-blind and placebo-controlled study will recruit 132 participants in China who develops PSS 15 days-90 days after stroke. Participants will be randomly assigned in an equal ratio to receive either Sangdantongluo granule or placebo for 2 months twice a day orally. The primary measure is the Modified Ashworth Scale (MAS), Secondary outcome measures include Composite Spasticity Scale (CSS), Simplified Fugl-Meyer Motor Scale (S-FM), National Institute of Health stroke scale (NIHSS), Modified Rankin Scale (mRS), Modified Barther Index (MBI), and Surface electromyography. Adverse events will be supervised throughout the trial. SPSS V. 26.0 statistical software will be used for statistical analysis. Enrolment will be started in April 2022.
The trial and protocol were approved by the Ethics Committee of Hunan Academy of Chinese Medicine Affiliated Hospital (No. [202102]20). We will report the results of this trial in a peer-reviewed journal.
ClinicalTrials.gov ChiCTR2100044544. Registered on 23 March 2021.
中风是全球致死和致残的首要原因，中风后痉挛（PSS）是中风常见的并发症。桑丹通络颗粒（Z20210481000）是一种现代专利中药，在临床实践中广泛用于治疗PSS。然而，关于桑丹通络颗粒治疗PSS有效性的证据有限。本研究将评估桑丹通络颗粒治疗PSS的临床疗效和安全性。
本多中心、随机、双盲和安慰剂对照研究将在中国招募132名中风后15天至90天发生PSS的参与者。参与者将按等比例随机分配，每天口服两次桑丹通络颗粒或安慰剂，持续2个月。主要测量指标是改良Ashworth量表（MAS），次要结局指标包括综合痉挛量表（CSS）、简化Fugl-Meyer运动量表（S-FM）、美国国立卫生研究院卒中量表（NIHSS）、改良Rankin量表（mRS）、改良Barthel指数（MBI）和表面肌电图。在整个试验过程中对不良事件进行监测。将使用SPSS V. 26.0统计软件进行统计分析。入组将于2022年4月开始。
该试验和方案已获得湖南中医药大学附属医院伦理委员会批准（编号[202102]20）。我们将在同行评审期刊上报告本试验的结果。
ClinicalTrials.gov ChiCTR2100044544。于2021年3月23日注册。
