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Clinical efficacy evaluation of Jingxin Zhidong formula in the treatment of moderate and severe Tic Disorder

注册号：

Registration number：

ITMCTR2100004402

最近更新日期：

Date of Last Refreshed on：

2020-11-02

注册时间：

Date of Registration：

2020-11-02

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

静心止动方治疗中重度抽动障碍临床疗效评价

Public title：

Clinical efficacy evaluation of Jingxin Zhidong formula in the treatment of moderate and severe Tic Disorder

注册题目简写：

English Acronym：

研究课题的正式科学名称：

静心止动方治疗难治性抽动障碍临床疗效评价及影响因素的logistic分析

Scientific title：

Clinical efficacy evaluation of Jingxin Zhidong formula in the treatment of moderate and severe Tic Disorder and the logistic analysis of influencing factors

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：

ChiCTR2000039601 ; ChiMCTR2100004402

申请注册联系人：

范菲

研究负责人：

韩斐

Applicant：

Fei Fan

Study leader：

Fei Han

申请注册联系人电话：

Applicant telephone：

+86 15001052585

研究负责人电话：

Study leader's telephone：

+86 13693134383

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：

360636336@qq.com

研究负责人电子邮件：

Study leader's E-mail：

hanfei@gamyy.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：

北京市西城区北线阁5号

研究负责人通讯地址：

北京市西城区北线阁5号

Applicant address：

5 Beixiange, Xicheng District, Beijing, China

Study leader's address：

5 Beixiange, Xicheng District, Beijing, China

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：

中国中医科学院广安门医院

Applicant's institution：

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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：

2013EC053

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：

中国中医科学院广安门医院伦理委员会

Name of the ethic committee：

The Ethics Committee of Guang'anmen Hospital, China Academy of Chinese Medical Sciences

伦理委员会批准日期：

Date of approved by ethic committee：

2013/3/26 0:00:00

伦理委员会联系人：

乔洁

Contact Name of the ethic committee：

Jie Qiao

伦理委员会联系地址：

北京市西城区北线阁5号

Contact Address of the ethic committee：

5 Beixiange, Xicheng District, Beijing, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

中国中医科学院广安门医院

Primary sponsor：

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

研究实施负责（组长）单位地址：

北京市西城区北线阁5号

Primary sponsor's address：

5 Beixiange, Xicheng District, Beijing, China

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(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

中国中医科学院广安门医院

具体地址：

西城区北线阁5号

Institution
hospital：

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Address：

5 Beixiange, Xicheng District

经费或物资来源：

“首都临床特色应用研究”专项

Source(s) of funding：

Capital Clinical Characteristic application research special project

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：

1.采用随机、双盲的临床研究方法，YGTSS 评分的疗效评判方法，评价最新西药阿立哌唑及中药静心止动方治疗 TD 在改善抽动动作及精神、情绪方面的疗效。通过对临床疗效的确认，肯定我课题组对 TD 的中医病机——心神不安、肝风动摇的认识，使中医对 TD 病机的认识从肝风动摇上升到心神不安的境界，以推动中医对 TD 病机的认识。并努力宣传介绍 TD 中医心神不安、肝风动摇的深层次的病机，及静心止动方的方药组成、功能及主治，提高中医治疗 TD 的整体水平。 2.采用 logistic 回归的研究方法，对中、西药治疗 TD 过程中的一些影响因素进行分析，其中主要包括：相关社会信息处理模式、家庭管理、情绪管理、遗传疾病、外感及病程等影响因素进行调查，同时对中西药治疗 TD 后包括饮食、睡眠、惊吓、外感、体质等方面的症状进行评分比较，以弥补 YGTSS 评分对中药治疗 TD 疗效评判的不足之处，凸显中药治疗 TD 的优势，完善中药治疗 TD 的疗效评价方法。

Objectives of Study：

1. A randomized, double-blind clinical study method and the efficacy evaluation method of YGTSS score were used to evaluate the efficacy of aripiprazole, the latest western medicine, and Jing Xin Zhi Dong formula in the treatment of TD in reduce tics, as well as improving mental and emotional effects.Through the confirmation of the formulas clinical efficacy, the pathogenesis of uneasiness and liver wind shaking will be confirmed, and the understanding of TD in TCM will be promoted. Efforts should be made to publicize and introduce TD's uneasiness, the underlying pathogenesis of liver wind shaking, and the composition of prescriptions, functions and indications of Jingxin Zhidong formula, so as to improve the overall level of TCM treatment of TD. 2. Logistic regression was used to analyze some influencing factors in the process of TD treatment with TCM and Western medicine, mainly including:relevant social information processing model, family management, emotion management, genetic diseases, exogenous diseases etc. At the same time, the scores of TCM and Western medicine after TD treatment, including diet, sleep, shock, external sensation, physique and other aspects were compared, so as to make up for the deficiency of YGTSS score in the evaluation of TCM treatment of TD efficacy, highlight the advantages of TCM treatment of TD, and improve the evaluation method of TCM treatment of TD efficacy.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

2014 年 1 月～2015 年 12 月在广安门医院儿科就诊的 TD 患儿，年龄 8～11 岁，均符合2000 年美国《精神疾病诊断统计手册》第四版修订本(DSM-Ⅳ-TR)关于儿童抽动障碍中慢性抽动（CTD）或抽动秽语综合症（TS）诊断标准及中医辨证标准(头面肢体抽动，眨眼噘嘴，洁喉清嗓，或皱眉耸鼻，或嘴角抽动，或喉中痰鸣，或异声秽语等，抽动症状反复发作，时轻时重,兼见脾气急躁易怒，或胆小易紧张，或多疑，或易委屈，或易兴奋，或入睡慢，或眠不实，纳食可，大便调，舌淡红或红，苔薄白或白，脉弦或滑或弦滑。) 病程 1 年以上，耶鲁综合抽动严重程度量表（the Yale Global Tic Severity Scale Modified，YGTSS）评分 40～70 分之间（难治性抽动障碍目前无明确诊断标准，拟耶鲁综合抽动严重程度量表评分 40～70分之间者为难治性抽动障碍），未使用过中、西药或就诊前 6 个月内未使用过中、西药。 所有入组患儿皆由家长签署获得广安门医院医学伦理委员会批准的知情同意书。

Inclusion criteria

1. Children with TD who visited the Department of Pediatrics of Guang'anmen Hospital from January 2014 to December 2015; 2. Aged 8-11 years; 3. All meet the requirements of 2000 DSM - Ⅳ - TR diagnostic criteria and TCM syndrome differentiation criteria for children with tic disorder (head and body twitch, blinking and pouting, throat cleaning, or frowning and nose shrugging, or corner twitch, or sputum in throat, or abnormal voice, etc.) were discussed When heavy, and see temper irritable, or timid, easy to nervous, or suspicious, or easy to be wronged, or easy to excited, or sleep slowly, or sleep not solid, take food can, stool regulation, tongue light red or red, thin white or white fur, pulse string or slippery string.) 4. The course of disease is more than one year, the Yale Global Tic Severity Scale modified (YGTSS) score is between 40 and 70 (there is no clear diagnostic criteria for refractory tic disorder, the Yale Global Tic Severity Scale modified (YGTSS) score between 40 and 70 is refractory tic disorder), no use of Chinese and Western medicine or 6 months before treatment There was no use of Chinese and Western medicine in three months. 5. All the children were signed by their parents and obtained the informed consent from the medical ethics committee of Guang'anmen Hospital.

排除标准：

排除有肝豆状核变性、风湿性舞蹈病、儿童偏头痛、癫痫、精神发育迟滞、精神 分裂症等病史者； 有遗传代谢病史者； 有严重躯体疾病者； 有心律失常及肝肾功能异常者； 有药物过敏史者； 患儿及其家长不同意参加治疗者。

Exclusion criteria：

1. Patients with hepatolenticular degeneration, rheumatic chorea, migraine in children, epilepsy and mental retardation; 2. Patients with history of schizophrenia, etc; 3. Patients with history of genetic metabolism; 4. Patients with severe physical diseases; 5. Patients with arrhythmia and abnormal liver and kidney function; 6. Patients with history of drug allergy; 7. Children and their parents do not agree to participate in the treatment.

研究实施时间：

Study execute time：

从From 2014-01-01

至To      2015-12-31

征募观察对象时间：

Recruiting time：

从From 2014-01-01

至To      2015-12-31

干预措施：

Interventions：

组别：

阿立哌唑组

样本量：

60

Group：

Aripiprazole group

Sample size：

干预措施：

给予阿立哌唑片加安慰剂治疗12周

干预措施代码：

Intervention：

Aripiprazole tablets and a placebo were administered for 12 weeks

Intervention code：

组别：

静心止动方组

样本量：

60

Group：

Jingxin Zhidong formula group

Sample size：

干预措施：

给予静心止动方加安慰剂治疗12周

干预措施代码：

Intervention：

Jingxin Zhidong formula and a placebo were administered for 12 weeks

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)：

北京

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

中国中医科学院广安门医院

单位级别：

三级甲等

Institution/hospital：

Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

中医证候评分量表评分

指标类型：

次要指标

Outcome：

TCM syndrome rating scale score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

不良反应量表评分

指标类型：

次要指标

Outcome：

Adverse reaction scale score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

YGTSS量表评分

指标类型：

主要指标

Outcome：

YGTSS score

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

TESS量表评分

指标类型：

副作用指标

Outcome：

TESS scale score

Type：

Adverse events

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：

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：

征募研究对象情况：

结束

Completed

年龄范围：

最小 岁
Min age years
最大 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）：

委托中国中医科学院广安门医院临床疗效评价中心完成。120 例 TD 分为中药组 60 例，西药组 60 例；通过SAS6.12 软件的PROC PLAN程序产生受试者所接受处理的1：1 随机分配，即列出药物编号所对应的治疗分配，按受试者的就诊顺序发放相应编号的药。

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

The center for clinical Efficacy evaluation of Guang 'anmen Hospital, China Academy of Chinese Medical Sciences was commissioned. The 120 cases of TD children were divided into two groups, 60 cases in the Jing Xin Zhi Dong formula group and 60 cases in the Aripiprazole group.

盲法：

双盲

Blinding：

Double blind

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）：

临床试验公共管理平台(http://www.medresman.org.cn)

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

Clinical Trial Management Public Platform(http://www.medresman.org.cn)

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：

一、病例记录表。将研究内容设计为病例临床观察表，统一印刷。研究者如实记录观察表内的各项内容，确保内容的真实可靠，临床观察表作为原始资料不得更改。 二、将数据上传至ResMan平台。将收集到的所有数据输入电脑，用 SPSS13.0 软件包建立数据库并进行分析，计数资料用 x2 检验、秩和检验，计量资料比较用单因素方差分析，多组比较采用 q 检验，logistic 回归分析比较YGTSS评分与危险因素的定量关系。组间比较 P<0.05 为有统计学显著意义的差别。以上工作由中国中医科学院广安门医院临床疗效评价中心完成。

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

1、 Case record form. The research content was designed as clinical observation table of cases and printed uniformly. The researcher truthfully recorded the contents of the observation form to ensure the authenticity and reliability of the contents. The clinical observation form, as the original data, shall not be changed. 2、 Upload data to resman platform. All the data collected were input into the computer, and the database was established and analyzed by SPSS13.0 software package. The counting data were analyzed by x2 test and rank sum test. The measurement data were compared by one-way ANOVA. The multiple groups were compared by Q test. The quantitative relationship between YGTSS score and risk factors was compared by logistic regression analysis. The difference between groups was statistically significant (P < 0.05). The above work was completed by the clinical efficacy evaluation center of Guang'anmen Hospital, Chinese Academy of traditional Chinese medicine.

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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