A randomized double-blind controlled study protocol on the efficacy and safety of Sangdantongluo granule in the treatment of post-stroke spasticity

Le Xie; Yao Xie; Guo Mao; Junlin Jiang; Ting Yao; Rui Fang; Zenghui Yue; Yingchen Li; Dahua Wu

doi:10.1016/j.conctc.2022.100975

A randomized double-blind controlled study protocol on the efficacy and safety of Sangdantongluo granule in the treatment of post-stroke spasticity

Contemp Clin Trials Commun. 2022 Aug 17:29:100975. doi: 10.1016/j.conctc.2022.100975. eCollection 2022 Oct.

Authors

Le Xie¹, Yao Xie¹, Guo Mao¹, Junlin Jiang¹, Ting Yao¹, Rui Fang², Zenghui Yue³, Yingchen Li¹, Dahua Wu¹

Affiliations

¹ Neurology Department, Hunan Academy of Chinese Medicine Affiliated Hospital, Changsha, Hunan, 410006, PR China.
² College of Integrated Traditional Chinese and Western Medicine, Hunan University of Chinese Medicine, Changsha, Hunan, 410208, PR China.
³ College of Acupuncture ＆; Moxibustion and Tui-na, Hunan University of Chinese Medicine, Changsha, Hunan, 410208, PR China.

Abstract

Introduction: 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.

Methods: 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.

Ethics and dissemination: 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.

Trial registration: ClinicalTrials.gov ChiCTR2100044544. Registered on 23 March 2021.

Keywords: Sangdantongluo granule; Spasticity; Stroke; Traditional Chinese medicine.