中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR1900027251
最近更新日期： Date of Last Refreshed on：	2019-11-06 22:03:48
注册时间： Date of Registration：	2019-11-06 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	慧之素治疗孤独谱系障碍（ASD）多中心、开放、自身前后对照临床试验
Public title：	A multicenter, open, self-controlled clinical trial for Huizhisu in the treatment of ASD
注册题目简写：
English Acronym：
研究课题的正式科学名称：	慧之素治疗孤独谱系障碍（ASD）多中心、开放、自身前后对照临床试验
Scientific title：	A multicenter, open, self-controlled clinical trial for Huizhisu in the treatment of ASD
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：	戚艳杰	研究负责人：	郑毅
Applicant：	Yanjie Qi	Study leader：	Yi Zheng
申请注册联系人电话： Applicant telephone：	+86 13426215603	研究负责人电话： Study leader's telephone：	+86 010-58303181
申请注册联系人传真： Applicant Fax：		研究负责人传真： Study leader's fax：	+86 010-58303181
申请注册联系人电子邮件： Applicant E-mail：	qijie416@126.com	研究负责人电子邮件： Study leader's E-mail：	dr.zheng@tom.com
申请单位网址(自愿提供)： Applicant 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：	北京市西城区安康胡同5号	研究负责人通讯地址：	北京市西城区安康胡同5号
Applicant address：	5 Ankang Hutong, Xicheng District, Beijing	Study leader's address：	5 Ankang Hutong, Xicheng District, Beijing
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：	首都医科大学附属北京安定医院
Applicant's institution：	Beijing Anding Hospital Affiliated to Capital Medical University
研究负责人所在单位：	首都医科大学附属北京安定医院
Affiliation of the Leader：	Beijing Anding Hospital Affiliated to Capital Medical University

是否获伦理委员会批准：	是
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	（2019）科研第（83）号-2019103FS-2	伦理委员会批件附件： Approved file of Ethical Committee：	查看附件View
批准本研究的伦理委员会名称：	首都医科大学附属北京安定医院伦理委员会
Name of the ethic committee：	Ethics Committee of Beijing Anding Hospital Affiliated to Capital Medical University
伦理委员会批准日期： Date of approved by ethic committee：	2019-09-25 00:00:00
伦理委员会联系人：	贾京津
Contact Name of the ethic committee：	Jinjing Jia
伦理委员会联系地址：	北京市西城区德外安康胡同5号，北京安定医院3号楼2层
Contact Address of the ethic committee：	Second Floor, Building 3, Beijing Anding Hospital, 5 Ankang Hutong, Dewai, Xicheng District, Beijing
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：

首都医科大学附属北京安定医院

Primary sponsor：

Beijing Anding Hospital Affiliated to Capital Medical

研究实施负责（组长）单位地址：

北京市西城区安康胡同5号北京安定医院

Primary sponsor's address：

5 Ankang Hutong, Xicheng District, Beijing

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)：	首都医科大学附属北京安定医院	具体地址：	西城区安康胡同5号
Institution hospital：	Beijing Anding Hospital Affiliated to Capital Medical	Address：	5 Ankang Hutong, Xicheng District

经费或物资来源：

政府经费

Source(s) of funding：

Government Funding

研究疾病：

孤独症

Target disease：

Autistic Spectrum Disorder

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

探索性研究/预试验

Study phase：

0

研究设计：

单臂

Study design：

Single arm

研究目的：

以多中心，自身前后对照，评价慧之素（米糠，大豆提取物）用于治疗孤独谱系障碍（ASD）的有效性和安全性。

Objectives of Study：

To evaluate the efficacy and safety of huizhisu (rice bran, soybean extract) in the treatment of ASD.

药物成份或治疗方案详述：

受试者服用慧之素A <12岁，剂量为2g/d(1g/包),分两次服用；12岁以上剂量4g/d,分两次服用，早2g晚2g。之后按此恒定剂量直至治疗期结束。

Description for medicine or protocol of treatment in detail：

The subjects took Huizhisu A<12 years old, the dose was 2g/D (1g/bag), twice; the subjects over 12 years old, 4g/D, twice, 2g earlier and 2g later. Then press this constant dose until the end of the treatment period.

纳入标准：

Inclusion criteria

排除标准：

1.有较严重的心、肝、肾、青光眼、前列腺肥大、内分泌等内科疾病；或有癫痫、精神发育迟滞等神经精神疾病；
2.诊断双相障碍、抑郁症、精神分裂症等精神病性障碍的受试者；诊断为脆性 X 染色体综合症的受试者；
3.根据病史或常规精神状况检查结果，存在重大自杀风险；既往出现过癫痫发作的受试者；具有严重头部外伤或中风病史；具有任何不稳定性医学病症病史或目前患病的受试者（如先天性心脏病，心律失常或癌症），研究者判断，在试验过程中，将处于重大不良事件（AE）风险之下，或者会干扰安全性和有效性评估；
4.研究者认为有临床意义的辅助检查和实验室检查异常；
5.入选前3个月内参加过其他药物临床试验；
6.对慧之素中的任何成分过敏；
7.同时接受系统心理治疗；
8.入组前2周使用过单胺氧化酶抑制剂(MAOI)、抗精神病药、抗抑郁药、心境稳定剂；
9.患有能够明显增强交感系统活动的躯体疾病（如分泌儿茶酚胺神经肿瘤），或每天服用拟交感神经活动的药物（如舒喘灵，吸入性气雾剂，假毛果芸香碱）；
10.研究者认为有其它的共患疾病或正在服用的药物可能会干扰慧之素的安全应用；
11.在研究的任何阶段，需要服用试验药物以外的精神药物，包括研究者认为有中枢神经系统活性的保健品[如褪黑素（脑白金）]；
12.怀疑或确有酒精、药物滥用病史；
13.明确或怀疑怀孕的女性；
14.研究者认为受试者和/或受试者的父母或监护人不能够充分理解此项研究或遵循研究的要求。

Exclusion criteria：

1. There are serious internal diseases such as heart, liver, kidney, glaucoma, prostate hypertrophy, endocrine, etc., or neuropsychiatric diseases such as epilepsy, mental retardation, etc.;
2. Subjects with bipolar disorder, depression, schizophrenia and other mental disorders, and subjects with fragile X-chromosome syndrome;
3. According to the results of medical history or routine mental state examination, there is a significant risk of suicide; the subjects who have had epilepsy before; the subjects who have had severe head injury or stroke; the subjects who have any history of unstable medical disease or are currently ill (such as congenital heart disease, arrhythmia or cancer), the researcher judges that they will be in a major adverse event during the test Under the risk of component (AE), or it may interfere with safety and effectiveness assessment;
4. The researchers think that there are clinical significance of auxiliary examination and laboratory examination abnormalities;
5. Participated in clinical trials of other drugs within 3 months before selection;
6. Be allergic to any component in huizhisu;
7. Receive systematic psychotherapy at the same time;
8. Monoamine oxidase inhibitors (MAOI), antipsychotics, antidepressants and mood stabilizers were used two weeks before admission;
9. Have physical diseases that can significantly enhance sympathetic system activity (such as catecholamine secreting neurotumor), or take drugs that mimic sympathetic activity (such as shuchuanling, inhaled aerosol, pseudopilocarpine) every day;
10. The researchers believe that there are other common diseases or drugs that may interfere with the safe use of huizhisu;
11. At any stage of the study, psychoactive drugs other than the investigational drugs are required, including health care products [such as melatonin (brain platinum)] that the researchers believe have central nervous system activity;
12. Suspect or have a history of alcohol or drug abuse;
13. Women with definite or suspected pregnancy;
14. In the opinion of the investigator, the subjects and / or their parents or guardians could not fully understand the study or follow the requirements of the study.

研究实施时间：

Study execute time：

从 From 2019-11-05 00:00:00至 To 2021-11-05 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2019-11-05 00:00:00 至 To 2020-11-05 00:00:00

干预措施：

Interventions：

组别：	治疗组	样本量：	60
Group：	Treatment Group	Sample size：	60
干预措施：	慧之素治疗	干预措施代码：
Intervention：	Huizhisu Treatment	Intervention code：

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)：	首都医科大学附属北京安定医院	单位级别：	三级甲等专科医院
Institution hospital：	Beijing Anding Hospital Affiliated to Capital Medical University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	ABC量表的总分及治疗前后的变化	指标类型：	主要指标
Outcome：	The total score of ABC scale and the changes before and after treatment	Type：	Primary 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：

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：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：

最小 Min age	6	岁 years
最大 Max age	16	岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

本研究为自身前后对照的探索性研究，不对被试进行分组对照，对于符合入组标准，且自愿参加试验的被试进行随机选取。

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

This study is an exploratory study of its own before and after control. No group control is conducted for the subjects. The subjects who meet the enrollment criteria and voluntarily participate in the test are randomly selected.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：	N/A
Blinding：	N/A
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

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）：	项目组根据研究进程择期选择具体方式公开原始数据
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Accroding to the progress of the research, raw research data should be made freely available to all researchers in specific ways.
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：	研究者根据受试者的原始观察记录，将数据及时、完整、正确、清晰地载入病例报告表。监查员根据药物临床试验管理规范（GCP）要求对试验进行监查。经监查员检查后的病例报告表，由监查员核查签字后，及时送交临床试验数据管理员。数据管理员录入数据采用二次录入。数据管理员与主要研究者一起，按病例报告表中各指标数值的范围和相互关系拟定数据的范围检查和逻辑检查内容，并编写相应的计算机程序。数据库命名要规范、易读、易查找，并保证其正确、安全和保密。在录入过程中如发现问题，采用疑问表形式及时通知监查员，要求研究者做出回答。原始病例报告表在按要求完成数据录入和核查后可按编号顺序归档保存，并填写检索目录等以备查考。电子数据文件分类保存并有多个备份，防止损坏。所有文件传输均有专门记录及相应签名，并按GCP的规定妥善保存。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	According to the original observation records of the subjects, the researchers recorded the data in the case report form in a timely, complete, correct and clear manner. The supervisor shall monitor the test according to the requirements of GCP. The case report form checked and signed by the supervisor shall be submitted to the clinical trial data manager in time. The data entered by the data administrator adopts secondary entry. The data manager, together with the main researchers, formulates the scope inspection and logic inspection contents of the data according to the scope and interrelation of the index values in the case report form, and compiles the corresponding computer program. The naming of database should be standard, easy to read, easy to find, and ensure its correctness, security and confidentiality. If any problem is found in the input process, the supervisor shall be informed in time in the form of question form, and the researcher shall be required to answer. The original case report form can be filed and saved in the order of number after data entry and verification as required, and the retrieval catalogue can be filled in for reference. Electronic data files are classified and saved with multiple backups to prevent damage. All documents shall be transferred with special records and corresponding signatures, and shall be properly kept in accordance with the provisions of GCP.
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2019-11-06 22:03:48