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STUDY PROTOCOL article

Front. Med.
Sec. Geriatric Medicine
Volume 11 - 2024 | doi: 10.3389/fmed.2024.1507278
This article is part of the Research Topic Inflammation in the Elderly: Therapeutic Drugs and Strategies View all 5 articles

Efficacy and safety of Xiongzhitongluo granules in the treatment of Acute ischemic stroke: study protocol for a randomized controlled trial

Provisionally accepted
Hongxi Liu Hongxi Liu 1Yunmeng Chen Yunmeng Chen 1Xiao Liang Xiao Liang 1Yue LIU Yue LIU 1Lina Miao Lina Miao 1Di Zhao Di Zhao 1,2Yunfan Zhang Yunfan Zhang 1,2Jingjing Wei Jingjing Wei 1Yunling Zhang Yunling Zhang 1*
  • 1 Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China
  • 2 School of Traditional Chinese Medicine, Beijing University of Chinese Medicine, Beijing, China

The final, formatted version of the article will be published soon.

    Introduction Acute ischemic stroke (AIS) poses a significant risk to human health. Intravenous thrombolysis and mechanical thrombectomy are essential treatments for AIS, offering substantial benefits for neurological recovery and brain protection. However, their efficacy is often limited by stringent time constraints and contraindications, restricting accessibility for certain patient populations. Investigating novel therapeutic strategies is, therefore, crucial. Our team developed Xiongzhitongluo granules specifically for AIS and is conducting a randomized controlled trial (RCT) to validate their effectiveness.This multi-center, randomized, double-blind, placebo-controlled clinical trial includes 120 participants randomly allocated to the intervention or placebo group. Participants will receive a 14-day treatment alongside routine medications and will be monitored at multiple time points: days 1, 3, 5, 7, 14, 30, 60, and 90. The primary outcome is the change in the National Institutes of Health Stroke Scale (NIHSS) score from baseline to day 14. Secondary outcomes include the Scandinavian Stroke Scale (SSS), Barthel Index (BI), modified Rankin Scale (mRS), Brief Mini-Mental State Examination (MMSE), and traditional Chinese medicine (TCM) symptom assessment. Safety evaluations will include vital signs and laboratory tests. Data will be recorded using Epidata V3.1 and analyzed with SPSS 26.0.

    Keywords: Acute ischemic stroke, Xiongzhitongluo granules, Randomized controlled study, Traditional Chinese Medicine, study protocol, efficacy and safety

    Received: 07 Oct 2024; Accepted: 03 Dec 2024.

    Copyright: © 2024 Liu, Chen, Liang, LIU, Miao, Zhao, Zhang, Wei and Zhang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.

    * Correspondence: Yunling Zhang, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing, China

    Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.