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针灸治疗儿童抽动障碍与芍麻止痉颗粒的效果比较研究

注册号：

Registration number：

ITMCTR2025000987

最近更新日期：

Date of Last Refreshed on：

2025-05-15

注册时间：

Date of Registration：

2025-05-15

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

针灸治疗儿童抽动障碍与芍麻止痉颗粒的效果比较研究

Public title：

A Comparative Study on the Efficacy of Acupuncture for Tic Disorders in Children and Shaoma Zhijing Granules

注册题目简写：

English Acronym：

研究课题的正式科学名称：

针灸治疗儿童抽动障碍与芍麻止痉颗粒的效果比较研究

Scientific title：

A Comparative Study on the Efficacy of Acupuncture for Tic Disorders in Children and Shaoma Zhijing Granules

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：

王庭钰

研究负责人：

于海波

Applicant：

Tingyu Wang

Study leader：

Haibo YU

申请注册联系人电话：

Applicant telephone：

13698026950

研究负责人电话：

Study leader's telephone：

13480752834

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：

2968055640@qq.com

研究负责人电子邮件：

Study leader's E-mail：

2934804419@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：

广东省深圳市福华路1号

研究负责人通讯地址：

广东省深圳市福华路1号

Applicant address：

No. 1 Fuhua Road Shenzhen City Guangdong Province

Study leader's address：

No. 1 Fuhua Road Shenzhen City Guangdong 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：

深圳市中医院

Applicant's institution：

Shenzhen Traditional Chinese Medicine Hospital

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：

K2024-093-01

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：

深圳市中医院广州中医药大学第四临床医学院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the Fourth Clinical Medical College of Guangzhou University of Chinese Medicine Shenzhen Traditional Chinese Medicine Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2024/9/24 0:00:00

伦理委员会联系人：

邓容

Contact Name of the ethic committee：

Rong Deng

伦理委员会联系地址：

广东省深圳市福华路1号

Contact Address of the ethic committee：

No. 1 Fuhua Road Shenzhen City Guangdong Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

0755-88600579

伦理委员会联系人邮箱：

Contact email of the ethic committee：

szszyyll@126.com

研究实施负责（组长）单位：

深圳市中医院

Primary sponsor：

Shenzhen Traditional Chinese Medicine Hospital

研究实施负责（组长）单位地址：

深圳市中医院

Primary sponsor's address：

Shenzhen Traditional Chinese Medicine Hospital

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

深圳市

市(区县)：

Country：

Province：

City：

单位(医院)：

深圳市中医院

具体地址：

广东省深圳市福华路1号

Institution
hospital：

Shenzhen Traditional Chinese Medicine Hospital

Address：

No. 1 Fuhua Road Shenzhen City Guangdong Province

经费或物资来源：

课题项目经费5万元，药品由天士力提供

Source(s) of funding：

The funding for the research project amounts to RMB 50000 and the pharmaceuticals are provided by Tasly Pharmaceutical Group Co. Ltd.

研究疾病：

抽动障碍

研究疾病代码：

Target disease：

Tic disorder

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：

通过耶鲁综合抽动严重程度量表（YGTSS）以及中医症状评分表，观察 1、“健 脾益肾三针组穴”针法对儿童抽动障碍的影响，并观察其治疗儿童抽动障碍的疗效， 初步探讨其可能的机制，以期为治疗儿童抽动障碍提供一种新的、安全、可行的治疗 方案及思路；2、芍麻止痉颗粒治疗儿童抽动障碍的真实世界研究。

Objectives of Study：

Through the Yale Global Tic Severity Scale (YGTSS) and the Traditional Chinese Medicine Symptom Rating Scale this study aims to: 1. Observe the impact of the acupuncture method of "Jianpi Yishen Three - point Acupoints" on tic disorders in children evaluate its therapeutic effect on treating tic disorders in children and preliminarily explore its possible mechanisms. The goal is to provide a new safe and feasible treatment plan and approach for the treatment of tic disorders in children. 2. Conduct a real - world study on the treatment of tic disorders in children with Shaoma Zhijing Granules.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

参照《美国精神疾病诊断与统计手册》第 5 版（DSM-5）中儿童抽动障碍诊断标准。 （1）短暂性抽动障碍的诊断标准 ①一种或多种运动性和（或）发声性抽动，表现为突然的、快速的、反复性的、非节 律性的及刻板的动作或发声； ②自首发抽动以来，抽动的病程少于 1 年； ③18 岁以前起病； ④抽动症状不是由某些药物（如可卡因）或内科疾病（如亨廷顿舞蹈病或病毒感染后 脑炎）所致； ⑤不符合慢性运动性或发声性抽动障碍或图雷特（Tourette）综合症的诊断标准。 （2）慢性运动性或发声性抽动障碍的诊断标准 ①一种或多种运动性抽动或发声性抽动，但在病程中仅有一种抽动形式出现； ②自从首发抽动以来，抽动频率可以增多和减少，病程在 1 年以上； ③18 岁以前起病； ④抽动症状不是由某些药物（如可卡因）或内科疾病（如亨廷顿舞蹈病或病毒感染后 脑炎）所致； ⑤不符合 Tourette 综合征的诊断标准。 （3）Tourette 综合征的诊断标准 ①具有多种运动性抽动及一种或多种发生性抽动，而不必在同一时间出现； ②自首发抽动以来，抽动的频率可以增多和减少，病程在 1 年以上； ③18 岁以前起病； ④抽动症状不是由某些药物（如可卡因）或内科疾病（如亨廷顿舞蹈病或病毒感染后 脑炎）所致。 入选标准 （1）符合上述诊断标准； （2）年龄在 5—18 岁之间（包含 5 岁，不包含 18 岁）； （3）性别不限； （4）自愿参加本课题研究，患儿及其监护人完全理解研究内容并愿意签署知情同意 书； （5）愿意服从分组治疗计划，配合完成所有疗程者； （6）加入课题一个月前未服用相关西药、除芍麻止痉颗粒外的中成药物或行相关治 疗者。

Inclusion criteria

Refer to the diagnostic criteria for tic disorders in children in the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM - 5). (1) Diagnostic criteria for transient tic disorder ① One or more motor and/or vocal tics manifested as sudden rapid repetitive non - rhythmic and stereotyped movements or vocalizations. ② Since the onset of the first tic the duration of the tics is less than 1 year. ③ Onset before the age of 18. ④ The tic symptoms are not caused by certain drugs (such as cocaine) or medical diseases (such as Huntington's disease or post - viral encephalitis). ⑤ Does not meet the diagnostic criteria for chronic motor or vocal tic disorder or Tourette syndrome. (2) Diagnostic criteria for chronic motor or vocal tic disorder ① One or more motor tics or vocal tics but only one type of tic appears during the course of the illness. ② Since the onset of the first tic the frequency of tics can increase or decrease and the duration of the illness is more than 1 year. ③ Onset before the age of 18. ④ The tic symptoms are not caused by certain drugs (such as cocaine) or medical diseases (such as Huntington's disease or post - viral encephalitis). ⑤ Does not meet the diagnostic criteria for Tourette syndrome. (3) Diagnostic criteria for Tourette syndrome ① There are multiple motor tics and one or more vocal tics which do not have to occur simultaneously. ② Since the onset of the first tic the frequency of tics can increase or decrease and the duration of the illness is more than 1 year. ③ Onset before the age of 18. ④ The tic symptoms are not caused by certain drugs (such as cocaine) or medical diseases (such as Huntington's disease or post - viral encephalitis). Inclusion criteria (1) Meet the above - mentioned diagnostic criteria. (2) Aged between 5 and 18 years old (including 5 years old but excluding 18 years old). (3) Gender is not restricted. (4) Voluntarily participate in this research project. The children and their guardians fully understand the content of the research and are willing to sign the informed consent form. (5) Willing to comply with the group treatment plan and cooperate to complete all treatment courses. (6) Have not taken relevant western medicines Chinese patent medicines other than Shaoma Zhijing Granules or undergone relevant treatments one month before joining the research project.

排除标准：

（1）孤独症谱系障碍、全面发育迟缓/智力发育障碍或明显躯体及神经精神异常； （2）合并有心、脑、肝、肾或造血系统等严重疾病，或经医生判断存在有临床意义 的肝肾功能异常、心电图异常； （3）合并药源性不自主运动、其他锥体外系病变、肝豆状核变性、小舞蹈症、癫痫 肌痉挛发作等病变； （4）由寰枢关节紊乱导致的儿童抽动障碍应排除； （5）患儿依从性不高，不能配合本研究的治疗方法者； （6）同时参加了其他药物的临床试验者； （7）既往针灸晕针或过敏史者。

Exclusion criteria：

(1) Autism spectrum disorder, global developmental delay/intellectual developmental disorder, or obvious physical and neuropsychiatric abnormalities. (2) Complicated with serious diseases of the heart, brain, liver, kidneys, or hematopoietic system, or having clinically significant abnormalities in liver and kidney functions or electrocardiogram as judged by a doctor. (3) Complicated with drug - induced involuntary movements, other extrapyramidal disorders, Wilson's disease, chorea minor, epileptic myoclonic seizures and other disorders. (4) Children with tic disorders caused by atlanto - axial joint disorder should be excluded. (5) Children with poor compliance who cannot cooperate with the treatment methods of this study. (6) Those who are simultaneously participating in clinical trials of other drugs. (7) Those with a history of fainting during acupuncture or acupuncture - related allergies in the past.

研究实施时间：

Study execute time：

从From 2025-03-01

至To      2026-06-30

征募观察对象时间：

Recruiting time：

从From 2025-03-01

至To      2026-06-30

干预措施：

Interventions：

组别：

芍麻组

样本量：

33

Group：

Shaoma Group

Sample size：

干预措施：

口服芍麻止痉颗粒

干预措施代码：

Intervention：

Take Shaoma Zhijing Granules orally.

Intervention code：

组别：

针刺组

样本量：

33

Group：

Acupuncture Group

Sample size：

干预措施：

针刺

干预措施代码：

Intervention：

Acupuncture

Intervention code：

样本总量 Total sample size ： 66

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

深圳市

市(区县)：

Country：

Province：

City：

单位(医院)：

深圳市中医院

单位级别：

深圳市中医院

Institution/hospital：

Level of the institution：

测量指标：

Outcomes：

指标中文名：

中医症状评分

指标类型：

次要指标

Outcome：

Score of Traditional Chinese Medicine Symptoms

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

共患病评估

指标类型：

次要指标

Outcome：

Assessment of Comorbidity

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

耶鲁综合抽动严重程度量表的减分率

指标类型：

主要指标

Outcome：

The reduction rate of scores on the Yale Global Tic Severity Scale

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

治疗有效（YGTSS 量表总分的减分率≥30%）所需要的时间

指标类型：

次要指标

Outcome：

The time required for effective treatment (the reduction rate of the total score of the YGTSS scale is ≥30%)

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：

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 5 岁
Min age years
最大 17 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）：

本课题采用随机数字表随机对事先准备好的信封编号，能有效将信封随机排列，再根据患儿就诊的先后顺序分发信封，故能做到每个患儿得到的信封皆是随机的，具体方法：从随机数表第一列的第一行顶部，从上到下，由左往右，截取共306个随机三位数。再将随机数字一信封一数字的填上预先准备好的306个信封封面。然后将这些信封按照获得的随机数字由小及大进行排序（当两个信封随机数字相同时，规定先出现的随机数字为小，后出现为大。医生按照患者就诊时间的先后顺序将排序好的信封从前往后一人一信封交予患者，患儿信封记录的“A”者进入“健脾益肾三针组穴”针法组，信封记录“B”者进入“芍麻组”。

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

In this research project the pre - prepared envelopes are numbered using a random number table. This method can effectively arrange the envelopes randomly. Then the envelopes are distributed according to the order of the children's visits ensuring that each child gets a randomly assigned envelope. The specific method is as follows: Starting from the top of the first row in the first column of the random number table moving from top to bottom and then from left to right a total of 306 random three - digit numbers are intercepted. Then these random numbers are written one by one on the covers of the 306 pre - prepared envelopes with one number corresponding to one envelope. Next these envelopes are sorted in ascending order according to the obtained random numbers. When two envelopes have the same random number it is stipulated that the earlier - appearing random number is considered smaller and the later - appearing one is larger. The doctor distributes the sorted envelopes to the patients one by one in the order of their visits. If the letter A is recorded on a child's envelope the child will be assigned to the Jianpi Yishen Three - point Acupoints acupuncture group; if the letter B is recorded the child will be assigned to the Shaoma group.

盲法：

Blinding：

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）：

预计2026-6-30，将在ResMan平台上公开原始数据。

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

It is expected that the original data will be made public on the ResMan platform on June 30, 2026.

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：

本试验的 CRF 采用纸质表格与电子表格相结合的形式。纸质 CRF 用于现场数据记录，包含患者的人口学信息、疾病诊断信息、治疗方案及疗效评估等内容。电子 CRF 为纸质 CRF 的数字化版本，便于数据录入和整理。研究人员在患者每次访视时填写纸质 CRF，随后由数据录入员将数据录入到电子 CRF 中。填写完成的纸质 CRF 将存放在试验中心的专用档案室，按照编号顺序排列，由专人负责管理。电子 CRF 数据存储在本地服务器的加密数据库中，定期备份至移动硬盘，异地保存。 本实验将使用 ResMan 作为本次试验的 EDC 系统，研究人员在患者就诊或检查时，通过 ResMan 系统的 Web 界面实时录入 CRF 中的数据。系统会根据预设的逻辑规则对录入数据进行实时校验，如发现数据异常或不符合逻辑，会立即弹出提示框，要求录入人员进行核实和修正。数据录入完成后，由数据管理员进行审核，审核通过的数据将被锁定，无法随意修改，确保数据的真实性和可靠性”。

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

The Case Record Form (CRF) for this trial combines the use of paper - based forms and electronic spreadsheets. The paper - based CRF is used for on - site data recording and includes information such as the patient's demographic details disease diagnosis information treatment plans and efficacy evaluations. The electronic CRF is a digital version of the paper - based CRF which facilitates data entry and organization. During each patient visit researchers fill out the paper - based CRF. Subsequently data entry clerks input the data into the electronic CRF. The completed paper - based CRFs will be stored in a dedicated archive room at the trial center arranged in numerical order and managed by a dedicated staff member. The data from the electronic CRF will be stored in an encrypted database on a local server and regularly backed up to an external hard drive for off - site storage. This experiment will use ResMan as the Electronic Data Capture (EDC) system for this trial. When patients come for consultations or examinations researchers can enter the data from the CRF in real - time through the web interface of the ResMan system. The system will perform real - time validation of the entered data according to pre - set logical rules. If any data anomalies or illogical entries are detected a prompt box will immediately pop up asking the data entry personnel to verify and correct the data. After the data entry is completed the data will be reviewed by the data administrator. Once the data is approved it will be locked and cannot be modified at will ensuring the authenticity and reliability of the data.

数据管理委员会：

Data Managemen Committee：

无

No

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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