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Randomized controlled study of Huanglian Jiedu Decoction in treating acute ischemic apoplexy syndrome

注册号：

Registration number：

ITMCTR2025001076

最近更新日期：

Date of Last Refreshed on：

2025-05-29

注册时间：

Date of Registration：

2025-05-29

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

黄连解毒汤治疗急性缺血性中风火热证的随机对照研究

Public title：

Randomized controlled study of Huanglian Jiedu Decoction in treating acute ischemic apoplexy syndrome

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于河间学派火热论的黄连解毒汤及其有效组分调控“中枢-外周”免疫互作治疗急性缺血性中风的多组学联动研究

Scientific title：

Multi-omics linkage study of Huanglian Jiedu Decoction and its effective components regulating "central-peripheral" immune interaction in the treatment of acute ischemic stroke based on the fiery theory of Hejian School

研究课题的正式科学名称简写：

Scientific title acronym：

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

兰芯

研究负责人：

王庆国

Applicant：

Xin Lan

Study leader：

Qingguo Wang

申请注册联系人电话：

Applicant telephone：

13398129126

研究负责人电话：

Study leader's telephone：

13601183429

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

Laci_97@163.com

研究负责人电子邮件：

Study leader's E-mail：

542775038@qq.com

申请单位网址(自愿提供)：

Study leader's website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website
(voluntary supply)：

申请注册联系人通讯地址：

北京市房山区良乡高教园区或阳光南大街与白杨东路交叉口东北角

研究负责人通讯地址：

北京市朝阳区北三环东路11号

Applicant address：

No. Yangguang South Street (at the northeast corner of the intersection with Baiyang East Road) Liangxiang Higher Education Park Fangshan District Beijing China

Study leader's address：

11 Beisanhuan Dong Lu Chaoyang District Beijing

申请注册联系人邮政编码：

Applicant postcode：

102401

研究负责人邮政编码：

Study leader's postcode：

100029

申请人所在单位：

北京中医药大学中医学院

Applicant's institution：

Beijing University of Chinese Medicine

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

CZX2023-KY-035

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

河北省沧州中西医结合医院伦理委员会

Name of the ethic committee：

Ethics Committee of Cangzhou Hospital of Integrated Chinese and Western Medicine Hebei Province

伦理委员会批准日期：

Date of approved by ethic committee：

2023/4/10 0:00:00

伦理委员会联系人：

董庆敏

Contact Name of the ethic committee：

Qingmin Dong

伦理委员会联系地址：

河北省沧州市黄河路31号沧州中西医结合医院

Contact Address of the ethic committee：

CangZhou Hospital of Integrated Traditional Chinese and Western Medicine No. 31 Huanghe Road Cangzhou City Hebei Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 317 207 6696

伦理委员会联系人邮箱：

Contact email of the ethic committee：

heartwing1985@163.com

研究实施负责（组长）单位：

河北省沧州中西医结合医院

Primary sponsor：

Cangzhou Hospital of Integrated Chinese and Western Medicine Hebei Province

研究实施负责（组长）单位地址：

河北省沧州市黄河路31号

Primary sponsor's address：

No. 31 Huanghe Road Cangzhou City Hebei Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京市

市(区县)：

北京市

Country：

China

Province：

Beijing

City：

单位(医院)：

北京中医药大学

具体地址：

北京市朝阳区北三环东路11号

Institution
hospital：

Beijing University of Chinese Medicine

Address：

11 Beisanhuan East Road Chaoyang District Beijing

经费或物资来源：

国家自然科学基金-区域创新发展联合基金

Source(s) of funding：

National Natural Science Foundation of China-Regional Joint Fund for Innovative Development

研究疾病：

急性缺血性中风

研究疾病代码：

Target disease：

acute ischemic stroke

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段：

Study phase：

其它

Others

研究目的：

通过随机对照研究，采用宏观疗效指标及微观指标（包含影像组学数据和生化指标）相结合的方式，综合评价黄连解毒汤对急性缺血性中风火热证患者免疫炎症机制的作用。

Objectives of Study：

Through a randomized controlled study the effects of Huanglian Jiedu Decoction on the immune inflammation mechanism of acute ischemic stroke patients with fiery syndrome were comprehensively evaluated by combining macroscopic efficacy indicators and microscopic indicators (including image omics data and biochemical indicators).

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

（1）符合西医急性缺血性脑卒中的诊断标准； （2）符合中医缺血性中风，中经络，急性期，内火证的诊断标准； （3）发病72h内入院； （4）就诊时，美国国立卫生研究院卒中量表（NIHSS）评分为 6分≤NIHSS≤20分的患者； （5）年龄≤75岁； （6）患者或其法定代理人能够并愿意签署知情同意书。

Inclusion criteria

(1) Meet the diagnostic criteria of Western medicine for acute ischemic stroke; (2) It meets the diagnostic criteria of ischemic stroke middle meridian acute phase and internal fire syndrome of TCM; (3) Hospital admission within 72 hours of onset; (4) Patients with a National Institutes of Health Stroke Scale (NIHSS) score of 6 ≤NIHSS≤20 at the time of presentation; (5) Age less than 75 years old; (6) The patient or his legal representative is able and willing to sign the informed consent.

排除标准：

（1）昏迷患者； （2）计划或已经进行过溶栓、血管内治疗者； （3）因血液病、颅内占位、脑外伤等原因所继发的脑卒中； （4）过敏体质、对试验药物或其中相关成分过敏者； （5）经西医基础治疗其血压仍＜90/60mmHg或＞220/120mmHg者； （6）严重肝肾功能不全（定义为血清肌酐浓度、丙氨酸转氨酶(ALT)或天冬氨酸转氨酶(AST)值高于正常上限2倍）； （7）有出血倾向者或３个月内发生过严重出血者； （8）心血管系统、肝脏、肾脏或血液系统的严重原发疾病、免疫缺陷疾病、肿瘤、精神病、认知障碍者； （9）其他疾病导致运动功能障碍者（如严重骨关节病、类风湿性关节炎、免疫系统疾病等）； （10）自身免疫疾病患者、目前正在或者近期使用免疫制剂治疗者及存在影响免疫功能的其他疾病者； （11）因其他危及生命的疾病（如晚期癌症）而预期寿命不超过3个月; （12）正在参加其他临床试验或参加其他药物临床试验结束未超过３个月者； （13）孕妇和哺乳期妇女；

Exclusion criteria：

(1)Coma patients; (2) Those who plan or have already undergone thrombolytic or intravascular therapy; (3) secondary stroke due to blood diseases intracranial space occupation brain trauma and other reasons; (4) Allergic constitution allergic to the test drug or related ingredients; (5) Patients whose blood pressure is still < 90/60mmHg or > 220/120mmHg after basic treatment with Western medicine; (6) Severe hepatic and renal insufficiency (defined as serum creatinine concentration alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values greater than 2 times the upper limit of normal); (7) Those who have a tendency to bleed or have experienced severe bleeding within 3 months; (8) serious primary diseases of the cardiovascular system liver kidney or blood system immune deficiency diseases tumors mental disorders cognitive disorders; (9) Motor dysfunction caused by other diseases (such as severe osteoarthropathy rheumatoid arthritis immune system diseases etc.); (10) Patients with autoimmune diseases those who are currently or recently using immune agents for treatment and those who have other diseases affecting immune function; (11) A life expectancy of no more than 3 months due to other life-threatening diseases (such as advanced cancer); (12) Those who are participating in other clinical trials or participating in other drug clinical trials less than 3 months after completion; (13) Pregnant and lactating women;

研究实施时间：

Study execute time：

从From 2024-03-01

至To      2025-12-31

征募观察对象时间：

Recruiting time：

从From 2024-03-01

至To      2025-12-31

干预措施：

Interventions：

组别：

试验组

样本量：

60

Group：

Experimental group

Sample size：

干预措施：

在西医常规治疗和标准护理康复的基础上，增加口服黄连解毒颗粒（药物为黄连9g，黄芩6g，黄柏6g，栀子9g，1日2次，1次1袋，疗程为14d）。

干预措施代码：

Intervention：

On the basis of conventional treatment and standard nursing rehabilitation in western medicine, the oral administration of Huanglian Jiedu Decoction was added (the drugs were Huanglian 9g, Scutellaria baicalensis 6g, cypress 6g, gardenia 9g, 2 times a day, 1 time 1 bag, the course of treatment was 14d).

Intervention code：

组别：

对照组

样本量：

60

Group：

contrast group

Sample size：

干预措施：

在西医常规治疗和标准护理康复的基础上，同时口服黄连解毒颗粒模拟剂（1日2次，1次1袋，疗程为14d）

干预措施代码：

Intervention：

Alongside conventional Western medicine therapy and standard rehabilitative care patients received an oral placebo mimicking Huanglian Jiedu Granules administered in parallel (twice daily 1 sachet per dose) for 14 days.

Intervention code：

样本总量 Total sample size ： 120

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

沧州市

市(区县)：

Country：

China

Province：

Hebei Province

City：

单位(医院)：

河北省沧州中西医结合医院

单位级别：

三甲医院

Institution/hospital：

Cangzhou Hospital of Integrated Chinese and Western Medicine Hebei Province

Level of the institution：

Tertiary Class A Hospital

测量指标：

Outcomes：

指标中文名：

神经功能及生存质量评分

指标类型：

次要指标

Outcome：

Neurologic function and quality of survival scores

Type：

Secondary indicator

测量时间点：

在入组时及发病后的5d、14d、30d和3个月

测量方法：

采用Barthel指数（BI）评分评价两组治疗前后自理能力; 采用改良Rankin量表（mRS量表）对患者症状和生活能力限制情况进行评定; 采用美国国立卫生研究院卒中量表（NIHSS）评分评估较基线的变化值。

Measure time point of outcome：

Neurological and functional outcomes were evaluated at enrollment, and at 5, 14, and 30 days post-onset, as well as 3 months post-intervention.

Measure method：

The Barthel index (BI) score was used to evaluate the self-care ability of the two groups before and after treatment. The modified Rankin scale (mRS) was used to evaluate the symptoms and limitations of life ability. The National Institutes of Health Stroke Scale (NIHSS) score was used to evaluate the change from baseline.

指标中文名：

影像学检测

指标类型：

次要指标

Outcome：

Imaging test

Type：

Secondary indicator

测量时间点：

在入组时及发病后的5d、14d、30d和3个月，进行颅脑MRI检查

测量方法：

T1加权成像（T1WI）、T2加权成像（T2WI）、液体衰减反转恢复（FLAIR）、扩散加权成像（DWI）和ASL。计算梗死面积、水肿体积、血脑屏障完整性与血流动力学参数）。

Measure time point of outcome：

Cranial MRI was performed at the time of enrollment and at 5d, 14d, 30d, and 3 months after the onset of the disease

Measure method：

T1-weighted imaging (T1WI), T2-weighted imaging (T2WI), fluid-attenuated inversion recovery (FLAIR), diffusion-weighted imaging (DWI), and ASL. calculated infarct area, edema volume, blood-brain barrier integrity, and hemodynamic parameters).

指标中文名：

生物标志物（血常规、尿常规、生化、外周血淋巴细胞亚群、炎性因子）

指标类型：

次要指标

Outcome：

Biomarkers (blood routine, urine routine, biochemistry, peripheral blood lymphocyte subsets, inflammatory factors)

Type：

Secondary indicator

测量时间点：

在入组时及发病后的5d、14d、30d和3个月

测量方法：

流式细胞仪检测外周血淋巴细胞亚群（CD4+ T、CD8+ T及CD4+T细胞亚群；ELISA检测T淋巴细胞分泌因子（IFN-γ、IL-4、TGF-β、IL-17A）；ELISA检测血脑屏障相关指标（MMP-9、LFA-1、ICAM-1）。

Measure time point of outcome：

At enrollment and at 5d, 14d, 30d, and 3 months after the onset of the disease

Measure method：

Flow cytometry for peripheral blood lymphocyte subsets (CD4+ T, CD8+ T and CD4+ T cell subsets; ELISA for T lymphocyte secreted factors (IFN-γ, IL-4, TGF-β, IL-17A); ELISA for blood-brain-barrier related indicators (MMP-9, LFA-1, ICAM-1).

指标中文名：

中医中风病症状和证候评分

指标类型：

次要指标

Outcome：

TCM apoplexy symptom and syndrome score

Type：

Secondary indicator

测量时间点：

在入组时及发病后的5d、14d、30d和3个月

测量方法：

参照《中风病诊断与疗效评定标准（试行）》和《缺血性中风证候要素诊断量表编制及方法学探讨》，进行中医症状体征评分及证候评判

Measure time point of outcome：

At enrollment and at 5d, 14d, 30d, and 3 months after the onset of the disease

Measure method：

Referring to the “Diagnostic and Efficacy Assessment Criteria for Stroke Disease (Trial)” and “Compilation of Diagnostic Scale for Ischemic Stroke Symptoms and Elements and Exploration of Methodology”, the scoring of Chinese medicine symptoms and signs and the evaluation of symptoms were conducted

指标中文名：

心脑血管事件的发生率

指标类型：

次要指标

Outcome：

Incidence of cardiovascular events

Type：

Secondary indicator

测量时间点：

随访时间内发生包括卒中或心肌梗死的复发率

测量方法：

Measure time point of outcome：

Recurrence rate including stroke or myocardial infarction during follow-up time

Measure method：

指标中文名：

死亡率

指标类型：

次要指标

Outcome：

mortality rate

Type：

Secondary indicator

测量时间点：

随访时间内因任何原因死亡的发生率

测量方法：

Measure time point of outcome：

Incidence of death from any cause during the follow-up period

Measure method：

指标中文名：

美国国立卫生研究院卒中量表（NIHSS）

指标类型：

主要指标

Outcome：

National Institutes of Health Stroke Scale (NIHSS)

Type：

Primary indicator

测量时间点：

在患者入组当天及发病后的14d，对患者进行神经功能缺损评分

测量方法：

采用美国国立卫生研究院卒中量表（NIHSS）对进行评分, 包括语言、感觉、意识水平等多个项目, 总分42分, 分值与神经缺损程度呈正相关。

Measure time point of outcome：

Neurological deficit scores were assessed in patients on the day of enrollment and at 14 days post-onset.

Measure method：

Neurological function was assessed using the National Institutes of Health Stroke Scale (NIHSS), which evaluates domains including language, sensation, and level of consciousness. The total score ranges from 0 to 42, with higher scores indicating greater neurological impairment.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

尿液

组织：

Sample Name：

urine

Tissue：

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note：

标本中文名：

粪便

组织：

Sample Name：

faeces

Tissue：

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note：

征募研究对象情况：

正在进行

Recruiting

年龄范围：

最小 0 岁
Min age years
最大 75 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男女均可

Both

随机方法（请说明由何人用什么方法产生随机序列）：

随机设计：试验采用统计软件中文版SPSS 26.0(Statistical Product and Service Solutions26.0)进行随机分组。

Randomization Procedure (please state who generates the random number sequence and by what method)：

Randomized design: The Chinese version of Statistical software SPSS 26.0(Statistical Product and Service Solutions26.0) was used for randomization.

盲法：

本试验采用双盲法设计，随机编码和分组表由上海交通大学基础医学院生物统计学教研室教授负责编制，该表(盲底)采用不透光信封密封，封口处盖章，存放于主研究单位药物临床研究基地。按试验全程用药/人份包装，无法从药剂外观和人份包装外标记识别两组药物；由北京中医药大学统计学教研室教授及助手三人按随机编码表和序号在人份包装外贴序号标识。

Blinding：

This experiment was designed by double-blind method. The random coding and grouping tables were compiled by professors in the Department of Biostatistics School of Basic Medicine Shanghai Jiao Tong University. The tables (blind bottom) were sealed with opaque envelopes and sealed at the seal and stored in the drug clinical research base of the main research unit. The two groups of drugs could not be identified from the appearance of the drug and the marks outside the package of the drug according to the package of the drug/person portion. Three professors and assistants from the Department of Biostatistics of Shanghai Jiao Tong University will paste the serial number label on the outside of the package according to the random coding table and serial number.

是否共享原始数据：

IPD sharing：

是

Yes

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

Laci_97@163.com

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Laci_97@163.com

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

数据的收集和管理课题组将本研究的各项数据采集量表制成网络问卷，受试者在签署知情同意书后在临床研究者的指导下完成问卷填写。独立的数据研究者在移动终端收集数据，并将数据记录于CRF表中，此过程与受试者无直接交流。数据研究者负责保存研究数据，严格保兄护受试者的隐私。本研究的数据收集与管理定期接受沧州中西医结合医院伦理委基线资料员会的审查。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Data collection and management The research group made various data collection scales of this study into an online questionnaire and the subjects completed the questionnaire under the guidance of clinical investigators after signing the informed consent letter. Independent data investigators collect data on mobile terminals and record the data in CRF tables without direct communication with subjects. The data researcher is responsible for preserving the study data and strictly protecting the privacy of the subjects. The data collection and management of this study were regularly reviewed by the baseline data Committee of the Ethics Committee of Cangzhou Integrated Traditional Chinese and Western Medicine Hospital.

数据管理委员会：

Data Managemen Committee：

暂未确定

Not yet

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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