中药复方HH333预防小血管病所致缺血性卒中患者复发性卒中的临床疗效与安全性：多中心、双盲、随机、前瞻性、试点临床试验方案

Clinical Efficacy and Safety of the Herbal Prescription, HH333, in Preventing Recurrent Stroke in Patients With Ischemic Stroke Induced by Small-Vessel Disease: Protocol for Multicenter, Double-Blind, Randomized, Prospective, Pilot Clinical Trial.

作者信息

Lee Han-Gyul, Kwon Seungwon, Jung Woo-Sang, Moon Sang-Kwan, Kim Cheol-Hyun, Choi Dong-Jun

机构信息

Department of Cardiology and Neurology, College of Korean Medicine, Kyung Hee University Medical Center, Kyung Hee University, Seoul, Republic of Korea.

Department of Internal Medicine and Neuroscience, College of Korean Medicine, Wonkwang University Gwangju Medical Center, Wonkwang University, Gwangju, Republic of Korea.

出版信息

JMIR Res Protoc. 2025 May 13;14:e70953. doi: 10.2196/70953.

DOI:10.2196/70953

PMID:40358993

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12117272/

Abstract

BACKGROUND

Patients with ischemic stroke are at high risk of recurrence, making preventive care an important factor. Current antiplatelet therapy for recurrence prevention treatment has several limitations. Recent retrospective observational studies suggested that HH333, an herbal prescription, has an inhibitory effect on stroke recurrence in small-vessel diseases.

OBJECTIVE

This study aims to propose a protocol for evaluating the efficacy and safety of HH333 in patients with ischemic stroke induced by small-vessel disease.

METHODS

In this multicenter, double-blind, randomized, prospective, pilot clinical trial, 236 patients from 3 university Korean medicine hospitals in South Korea with ischemic stroke caused by small-vessel disease will be recruited and randomly assigned to either the HH333 or the placebo group. Both patients and investigators will be blinded to prevent access to the allocation results. The HH333 group will take 2 capsules of HH333 once daily for 720 days, whereas the placebo group will take HH333 placebo capsules in the same manner. Efficacy will be assessed using the recurrence rate of ischemic stroke, which will be assessed on days 30, 90, 180, 270, 360, 450, 540, 630, 720, and 750 after starting the medication. The effects on quality of life and fatigue with the Fatigue Severity Scale (FSS), Fatigue Assessment Scale (FAS), and Korean Patient Health Questionnaire (K-PHQ-9), functional improvement with Korean National Institutes of Health Stroke Scale (K-NIHSS), modified Rankin Scale (mRS), Korean modified Barthel Index (K-mBI), and Korean Montreal Cognitive Assessment (K-MoCA) and Pattern Identification also will be evaluated on days 0, 90, 180, 270, 360, 450, 540, 630, and 720 after starting the medication. Safety will be evaluated by performing blood and urine tests and electrocardiography on days 30, 90, 180, 270, 360, 450, 540, 630, and 720 after starting the medication.

RESULTS

Recruitment for the study started on May 22, 2024, and is scheduled to end on November 30, 2026. As of November 13, 2024, a total of 12 participants have been randomized.

CONCLUSIONS

The protocol will provide a detailed process for a clinical trial evaluating the efficacy of preventing recurrent ischemic stroke caused by small-vessel disease and improving neurologic symptoms and the safety of HH333 in ischemic stroke. The results of this study provide a basis for alternative treatments to prevent and treat ischemic stroke.

TRIAL REGISTRATION

Clinical Research Information Service KCT0009431; https://tinyurl.com/y2ctvje8.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/70953.

摘要

背景

缺血性中风患者复发风险高，因此预防性护理是一个重要因素。目前用于预防复发的抗血小板治疗存在若干局限性。最近的回顾性观察研究表明，草药方剂HH333对小血管疾病中的中风复发具有抑制作用。

目的

本研究旨在提出一个评估HH333对小血管疾病所致缺血性中风患者疗效和安全性的方案。

方法

在这项多中心、双盲、随机、前瞻性、试点临床试验中，将招募来自韩国3所大学韩医医院的236例小血管疾病所致缺血性中风患者，并随机分配至HH333组或安慰剂组。患者和研究人员均将设盲，以防止知晓分配结果。HH333组患者将每日服用2粒HH333，共720天，而安慰剂组将以相同方式服用HH333安慰剂胶囊。疗效将通过缺血性中风复发率进行评估，在开始用药后的第30、90、180、270、360、450、540、630、720和750天进行评估。还将在开始用药后的第0、90、180、270、360、450、540、630和720天，使用疲劳严重程度量表（FSS）、疲劳评估量表（FAS）和韩国患者健康问卷（K-PHQ-9）评估对生活质量和疲劳的影响，使用韩国国立卫生研究院卒中量表（K-NIHSS）、改良Rankin量表（mRS）、韩国改良Barthel指数（K-mBI）和韩国蒙特利尔认知评估（K-MoCA）以及模式识别评估功能改善情况。安全性将在开始用药后的第30、90、180、270、360、450、540、630和720天通过进行血液和尿液检查以及心电图检查来评估。