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

## TL;DR

This study is testing a new treatment called Xiongzhitongluo granules for acute ischemic stroke in a clinical trial to see if it is effective and safe.

## Contribution

The paper introduces a novel herbal treatment for acute ischemic stroke and outlines a rigorous trial to assess its efficacy and safety.

## Key findings

- The trial will measure changes in stroke severity using the NIHSS score over 14 days.
- Safety will be evaluated through vital signs and lab tests during the study period.
- Results will also assess neurological recovery using multiple standardized scales.

## Abstract

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.

This study received approval from the Ethics Committee of Xiyuan Hospital, China Academy of Chinese Medical Sciences (2021XLA102-2). Written informed consent was obtained from all participants.

https://clinicaltrials.gov/, identifier, ChiCTR2200061859.