电针辅助药物治疗复发缓解型多发性硬化的循证评价及机制研究

注册号:

Registration number:

ITMCTR2025000257

最近更新日期:

Date of Last Refreshed on:

2025-02-13

注册时间:

Date of Registration:

2025-02-13

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

电针辅助药物治疗复发缓解型多发性硬化的循证评价及机制研究

Public title:

The Evidence-Based Evaluation and Mechanism Study of Electroacupuncture-Assisted Pharmacotherapy in Relapsing-Remitting Multiple Sclerosis

注册题目简写:

English Acronym:

研究课题的正式科学名称:

电针辅助药物治疗复发缓解型多发性硬化的循证评价及机制研究

Scientific title:

The Evidence-Based Evaluation and Mechanism Study of Electroacupuncture-Assisted Pharmacotherapy in Relapsing-Remitting Multiple Sclerosis

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:

胡学谦

研究负责人:

杨莎

Applicant:

HuXueQian

Study leader:

YangSha

申请注册联系人电话:

Applicant telephone:

13390709843

研究负责人电话:

Study leader's telephone:

13550358408

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:

1726198218@qq.com

研究负责人电子邮件:

Study leader's E-mail:

yangsha@cdutcm.edu.cn

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:

四川省成都市温江区柳台大道1166号

研究负责人通讯地址:

四川省成都市青羊区下汪家拐街19、21号

Applicant address:

No. 1166 Liutai Avenue Wenjiang District Chengdu City

Study leader's address:

No. 19 and 21 Xiwangjiaguai Street Qingyang District Chengdu City Sichuan Province

申请注册联系人邮政编码:

Applicant postcode:

研究负责人邮政编码:

Study leader's postcode:

申请人所在单位:

成都中医药大学

Applicant's institution:

Chengdu University of Traditional 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:

(2024)科研伦审第(03)号

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

成都中医药大学第三附属医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of The -Third Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2024/12/1 0:00:00

伦理委员会联系人:

李雪梅

Contact Name of the ethic committee:

Li Xue Mei

伦理委员会联系地址:

四川省成都市青羊区下汪家拐街19、21号

Contact Address of the ethic committee:

No. 19 and 21 Xiwangjiaguai Street Qingyang District Chengdu City Sichuan Province

伦理委员会联系人电话:

Contact phone of the ethic committee:

18408203942

伦理委员会联系人邮箱:

Contact email of the ethic committee:

2573624048@qq.com

研究实施负责(组长)单位:

成都中医药大学第三附属医院

Primary sponsor:

he Third Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

四川省成都市青羊区下汪家拐街19、21号

Primary sponsor's address:

No. 19 and 21 Xiwangjiaguai Street Qingyang District Chengdu City Sichuan 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):

四川省

市(区县):

成都市

Country:

China

Province:

Sichuan Province

City:

Chengdu City

单位(医院):

四川省中医药管理局

具体地址:

四川省成都市永兴巷15号5楼

Institution
hospital:

Sichuan Provincial Administration of Traditional Chinese Medicine

Address:

5th Floor No. 15 Yongxing Alley Chengdu City Sichuan Province

经费或物资来源:

四川省中医药管理局科学技术研究专项课题

Source(s) of funding:

Special Research Project on Science and Technology of Sichuan Provincial Administration of Traditional Chinese Medicine

研究疾病:

复发-缓解型多发性硬化症

研究疾病代码:

Target disease:

Relapsing-Remitting Multiple Sclerosis

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:

评价电针结合西药治疗复发缓解型多发性硬化(RRMS)的临床疗效及探讨针刺治疗MS“神经-内分泌-免疫网络”的可能机制,形成高质量循证医学证据支持的中西医结合治疗多发性硬化的临床实践指南,为针刺治疗多发性硬化提供重要的基础。

Objectives of Study:

Evaluate the clinical efficacy of electroacupuncture combined with Western medicine in the treatment of Relapsing-Remitting Multiple Sclerosis (RRMS) and explore the possible mechanisms of acupuncture in modulating the "neuro-endocrine-immune network" in MS. The aim is to establish high-quality evidence-based medicine to support clinical practice guidelines for the integrated Chinese and Western medicine treatment of multiple sclerosis, providing a solid foundation for acupuncture treatment of multiple sclerosis.

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)所有纳入患者符合2017年改版的用于MS诊断的McDonald标准及2018年中国专家多发性硬化诊断共识。所有患者排除其它免疫性疾病及应激性疾病,均为缓解期(复发缓解型)。 (2)20岁≤年龄≤60岁,男女均可。 (3)3年内被医生记录发作大于2次及近期至少发作在1年之内的患者。 (4)扩展残疾状态量表(Expanded disability status scale,EDSS)评分<=5分者。 (5)MRI特征性表现为白质内多发长T1、长T2异常信号脑内病灶直径常<10cm,一般为0.3~10cm散在分布干脑室周围,胼眠体,脑干与小脑,少数在灰白质交界处。脑室旁病灶呈椭圆形或线条形,其长轴与头颅矢状位垂直。脊髓多发性硬化病灶以颈胸段多见,形态多样,多为散在小点状,斑块状,圆形或椭圆形,少数为不规则片状,部分病灶可融合。 (6)受试者无金属假牙、心脏起搏器等异物。 (7)具有一定的理解和阅读能力,能够正确理解量表的相关内容并做出回答。 (8)依从性好,愿意配合研究,患者签署知情同意书。 (9)获取知情同意书过程符合GCP的相关规定。 注:同时符合上述9项的患者,方可纳入本研究。

Inclusion criteria

(1) All included patients meet the 2017 revised McDonald criteria for MS diagnosis and the 2018 Chinese expert consensus on multiple sclerosis diagnosis. Patients with other autoimmune diseases or stress-related disorders are excluded and all are in remission (Relapsing-Remitting type). (2) Age between 20 and 60 years both males and females are eligible. (3) Patients who have had more than 2 documented relapses in the past 3 years and at least one relapse within the past year. (4) Expanded Disability Status Scale (EDSS) score ≤ 5. (5) MRI shows characteristic features with multiple long T1 and long T2 abnormal signals in the white matter with lesions typically < 10 cm in diameter generally ranging from 0.3 to 10 cm. These lesions are scattered around the periventricular area corpus callosum brainstem and cerebellum with a few located at the gray-white matter junction. Periventricular lesions are oval or linear with their long axis perpendicular to the sagittal plane of the skull. Spinal cord lesions are commonly found in the cervical and thoracic segments with various shapes such as scattered small dots plaques round or oval shapes and a few irregular or plate-like lesions some of which may merge. (6) Subjects with metal dentures pacemakers or other foreign objects are excluded. (7) Subjects must have adequate understanding and reading ability capable of correctly understanding the relevant content of the scales and providing answers. (8) Good compliance and willingness to cooperate with the study with patients signing the informed consent form. (9) The informed consent process must comply with the relevant Good Clinical Practice (GCP) regulations. Note: Only patients who meet all the above 9 criteria will be included in this study.

排除标准:

(1)原发进展型、继发进展型或进行性复发型MS患者; (2)对本研究中的任何药物具有过敏史及对针刺疗法不能耐受的患者; (3)在6个月内应用过疾病修饰药物治疗的患者;任何有临床意义的历史疾病或其他重大原发病和精神类疾病的患者(①HIV感染或活动性甲肝或梅毒感染;具有免疫缺陷的病史或体征;②治疗未能充分控制的癫痫;③临床上有明显的心脏疾病,如:未控制的心律失常、未控制的心绞痛、心肌病、或未控制的充血性心力衰竭;④有严重抑郁或自杀企图的病史或目前有自杀倾向者;⑤恶性肿瘤疾病病史、乙型肝炎病史患者等)。 (4)妊娠或哺乳期患者,或近3个月内有妊娠计划的患者。 (5)后期诊断为其他脱髓鞘疾病(如急性播散性脑脊髓炎、视神经脊髓炎谱系疾病、抗髓鞘少突胶质细胞糖蛋白免疫球蛋白G抗体相关疾病、脱髓鞘假瘤和脊髓炎等);脑血管病(多发腔隙性脑梗死、血管畸形和烟雾病等);感染性疾病、结缔组织病、肉芽肿性疾病、肿瘤类疾病、遗传代谢性疾病。 注:凡符合上述任何1项的患者,即予以排除。

Exclusion criteria:

(1) Patients with primary progressive secondary progressive or progressive-relapsing multiple sclerosis (MS). (2) Patients with a history of allergies to any medications used in this study or those who cannot tolerate acupuncture therapy. (3) Patients who have been treated with disease-modifying drugs within 6 monthsPatients with any clinically significant history of diseases or other major primary diseases or psychiatric disorders including: ① HIV infection or active hepatitis A or syphilis infection; history or signs of immunodeficiency; ② Epilepsy that is not adequately controlled by treatment; ③ Clinically significant heart disease such as uncontrolled arrhythmia uncontrolled angina cardiomyopathy or uncontrolled congestive heart failure; ④ A history of severe depression or suicide attempts or currently having suicidal tendencies; ⑤ History of malignancy hepatitis B or other major diseases like connective tissue diseases granulomatous diseases tumors or genetic metabolic disorders. (4) Pregnant or breastfeeding women or patients who plan to become pregnant within the last 3 months. (5) Later diagnosis of other demyelinating diseases (such as acute disseminated encephalomyelitis neuromyelitis optica spectrum disorder myelin oligodendrocyte glycoprotein IgG antibody-associated disease demyelinating pseudotumor or myelitis) cerebrovascular diseases (such as multiple lacunar cerebral infarcts vascular malformations or moyamoya disease) infectious diseases connective tissue diseases granulomatous diseases tumor diseases or genetic metabolic diseases. Note: Any patient who meets any one of the above criteria will be excluded from the study.

研究实施时间:

Study execute time:

From 2024-01-01

To      2025-12-31

征募观察对象时间:

Recruiting time:

From 2025-02-17

To      2025-10-31

干预措施:

Interventions:

组别:

电针组

样本量:

70

Group:

Electroacupuncture Group

Sample size:

干预措施:

电针+常规西药治疗

干预措施代码:

Intervention:

Electroacupuncture+Conventional Western medicine treatment

Intervention code:

组别:

电针对照组

样本量:

70

Group:

Electroacupuncture Control Group

Sample size:

干预措施:

假针+常规西药治疗

干预措施代码:

Intervention:

Sham Acupuncture+Conventional Western medicine treatment

Intervention code:

样本总量 Total sample size : 140

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

四川省

市(区县):

成都市

Country:

China

Province:

Sichuan Province

City:

Chengdu City

单位(医院):

成都中医药大学第三附属医院

单位级别:

二级医院

Institution/hospital:

The Third Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

Level of the institution:

Second-level Hospital

测量指标:

Outcomes:

指标中文名:

运动诱发电位(MEP)

指标类型:

次要指标

Outcome:

Motor Evoked Potential (MEP)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

扩展残疾状态量表(EDSS)

指标类型:

主要指标

Outcome:

Expanded Disability Status Scale(EDSS)

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体感诱发电位(SEP)

指标类型:

次要指标

Outcome:

Somatosensory evoked potential

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

汉密尔顿焦虑量表(HAMA)

指标类型:

次要指标

Outcome:

Hamilton Anxiety Scale(HAMA)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

汉密尔顿抑郁量表(HAMD)

指标类型:

次要指标

Outcome:

Hamilton Depression Scale

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

头颅磁共振(MRI)

指标类型:

次要指标

Outcome:

Magnetic ResonanceImaging(MRI))

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规+CRP

指标类型:

次要指标

Outcome:

blood routine examination+CRP

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

九孔柱测试(9-HPT)

指标类型:

次要指标

Outcome:

9-Hole Peg Test(9-HPT)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

符号数字模式测试(SDMT)

指标类型:

次要指标

Outcome:

The Symbol Digit Modalities Test (SDMT)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

12项多发性硬化步行功能量表(MSWS-12)

指标类型:

次要指标

Outcome:

The 12-Item MS Walking ScaleMSWS-12

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

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:

尚未开始

Not yet recruiting

年龄范围:

最小 20
Min age years
最大 60
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):

由计算机网络为基础的中央随机系统产生随机编码,试验采用动态区组随机化分组

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

The random codes are generated by a central random system based on computer networks and the experiment adopts dynamic block randomization for grouping.

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

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):

2026年1月 纸质公开

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

January2026 Public on paper

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:

数据采集以量表的形式,原始量表在试验结束时提交至伦理委员会

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

Data collection was in the form of scales and the original scales were submitted to the ethics committee at the end of the trial

数据管理委员会:

Data Managemen Committee:

Yes

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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