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多中心随机双盲安慰剂平行对照观察恒清Ⅰ号方 治疗血管性痴呆临床疗效
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注册号:

Registration number:

ChiCTR1900023170 

最近更新日期:

Date of Last Refreshed on:

2019-05-15 

注册时间:

Date of Registration:

2019-05-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

多中心随机双盲安慰剂平行对照观察恒清Ⅰ号方 治疗血管性痴呆临床疗效 

Public title:

Vascular dementia treatment with Hengqing I formula: A multicenter randomized double-blind parallel place-controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

多中心随机双盲安慰剂平行对照观察恒清Ⅰ号方 治疗血管性痴呆临床疗效 

Scientific title:

Vascular dementia treatment with HengqingⅠformula: A multicenter randomized double-blind parallel place-controlled trial 

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:

孟胜喜 

研究负责人:

孟胜喜 

Applicant:

Shengxi Meng 

Study leader:

Shengxi Meng 

申请注册联系人电话:

Applicant telephone:

+86 18930170565 

研究负责人电话:

Study leader's telephone:

+86 18930170565 

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:

mengsx163@163.com 

研究负责人电子邮件:

Study leader's E-mail:

mengsx163@163.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:

上海市徐汇区宜山路600号 

研究负责人通讯地址:

上海市徐汇区宜山路600号 

Applicant address:

600 Yishan Road, Xuhui District, Shanghai, China 

Study leader's address:

600 Yishan Road, Xuhui District, Shanghai, China  

申请注册联系人邮政编码:

Applicant postcode:

200233 

研究负责人邮政编码:

Study leader's postcode:

200233 

申请人所在单位:

上海市第六人民医院 

Applicant's institution:

Shanghai Sixth People's Hospital 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

上海市第六人民医院 

Primary sponsor:

Shanghai Sixth People's Hospital 

研究实施负责(组长)单位地址:

上海市徐汇区宜山路600号 

Primary sponsor's address:

600 Xuhui District, Shanghai, 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):

上海市

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市第六人民医院

具体地址:

上海市徐汇区宜山路600号

Institution
hospital:

Shanghai Sixth People's Hospital

Address:

600 Yishan Road, Xuhui District, Shanghai

经费或物资来源:

上海市科委 

Source(s) of funding:

Project of Shanghai science and technology commission 

研究疾病:

血管性痴呆 

Target disease:

vascular dementia 

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:

研究目的:

通过多中心、随机、双盲、安慰剂对照的RTC研究方法验证中药复方恒清Ⅰ号方治疗血管性痴呆的临床疗效,并进一步探讨其作用机制。 

Objectives of Study:

Through a multicenter, randomized, double-blind, placebo-controlled RTC research methods validation of traditional Chinese medicine compound constant qing fang Ⅰ to treat vascular dementia clinical curative effect, and further explore its action mechanism. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

血管性痴呆的诊断采用美国《精神病诊断和统计手册》(DSM-Ⅳ-R,1994)血管性痴呆的诊断标准。须同时具备下列2条: 痴呆:首先通过临床检查和神经心理学评价的手段,确定患者认知水平较先前有明显下降,包括:①记忆缺陷(无法学习新的信息、或者无法回忆先前掌握的信息);②认知领域两项或两项以上障碍:失语、失用(不能执行动作,即使患者不存在运动功能障碍)、失 认(不能认识或识别物体,即使患者不存在感觉功能障碍)、执行管理功能的障碍(即计划、组织、抽象、安排次序等);③上述两种缺陷障碍并不是由脑血管病变本身导致,但也已经非常严重,影响了患者的日常生活、活动能力。 脑血管病:①经神经系统检查证实,患者存在由脑血管病造成的局灶性体征,包括偏瘫、偏盲、感觉障碍、中枢性面瘫、病理征等;②无局灶性体征,但是有影像学检查(头颅CT或MRI)证实的脑血管病证据,如多发的大血管梗塞或单个关键部位的梗塞,以及多发基 底节和脑白质腔隙性梗塞,或广泛的脑室周围白质损害,或上述病变共存。 上述这两种损害具有因果关系,即存在以下的关系:①在确诊卒中3个月内出现认知障碍等痴呆症状;②或出现突然的认知功能衰退,或其认知障碍呈现波动样、阶梯样损害。 (1)符合上述痴呆诊断标准及轻、中度临床诊断;(2)脑血管病发病时间明确,影像学支持梗塞和出血诊断,在发病3个月内出现痴呆,并持续3个月;(3)Hachinski缺血积分(HDS评分标准(3))≥7分。(4)除外其他原因引起的痴呆。 

Inclusion criteria

The diagnosis of vascular dementia by American psychiatric diagnostic and statistical manual (DSM-IV- R, 1994) diagnostic criteria of vascular dementia. Eligible participants should meet both the following items: Dementia: Firstly, pass through clinical examination and neuropsychological evaluation means, to determine the cognitive level of patients with a significant decline in the previous, including: (1) memory defects (unable to learn new information, or unable to recall previously mastered information); (2) cognitive field of two or more disorders: aphasia, apraxia (can not perform action, even if the patient does not have motor dysfunction), loss Recognize (cannot recognize or recognize objects, even if the patient does not have sensory dysfunction), executive management dysfunction (that is, planning, organization, abstraction, order, etc.); (3) the above two kinds of defects are not caused by cerebrovascular disease itself, but also has been very serious, affecting the patient's daily life, activity ability. Cerebrovascular disease: (1) confirmed by the nervous system examination, the patient has focal signs caused by cerebrovascular disease, including hemiplegia, blindness, sensory disorders, central facial paralysis, pathological signs; (2) no focal signs, but there is imaging examination (head CT or MRI) confirmed evidence of cerebrovascular disease, such as multiple large blood vessel infarction or a single key location of the infarction, as well as multiple base Basal ganglia and lacunar white matter infarcts, or extensive periventricular white matter damage, or coexistence of these lesions. The above two kinds of damage have causal relationship, that is, the existence of the following relationship:(2) or a sudden decline in cognitive function, or its cognitive impairment shows fluctuations like, ladder like damage. (1) meet the above criteria for diagnosis of dementia and mild to moderate clinical diagnosis; (2) the onset time of cerebrovascular disease was clear, imaging supported the diagnosis of infarction and hemorrhage, and dementia appeared within 3 months and lasted for 3 months; (3) Hachinski ischemia score (HDS score standard (3)) >=7; (4) except for dementia caused by other reasons. 

排除标准:

(1)早老性痴呆(AD)或其他类型痴呆及重度VD患者;(2)合并严重心、肺、肾功能障碍者,重症糖尿病及精神病史者;(3)近期曾系统接受过中、西医治疗者。 

Exclusion criteria:

(1) patients with alzheimer's disease (AD) or other types of dementia and severe VD; (2) patients with severe cardiac, pulmonary and renal dysfunction, severe diabetes mellitus and a history of mental illness; (3) those who have received systematic treatment of Chinese and western medicine in near past. 

研究实施时间:

Study execute time:

From2019-03-30To 2022-03-30 

干预措施:

Interventions:

组别:

治疗组

样本量:

157

Group:

Experimental group

Sample size:

干预措施:

恒清Ⅰ号方

干预措施代码:

Intervention:

Hengqing I formula

Intervention code:

组别:

安慰剂对照组

样本量:

157

Group:

Placebo control group

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

Placebo

Intervention code:

组别:

尼莫地平组

样本量:

157

Group:

Nimodipine group

Sample size:

干预措施:

尼莫地平

干预措施代码:

Intervention:

Nimodipine tablet

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市第六人民医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai Sixth People's Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

蒙特利尔认知量表

指标类型:

主要指标 

Outcome:

MoCA 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:

长谷川智力量表

指标类型:

主要指标 

Outcome:

Hasegawa dementia scale, HDS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Hachinski缺血量表评分

指标类型:

主要指标 

Outcome:

HIS

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

简易精神状态量表

指标类型:

主要指标 

Outcome:

Minimum Mental State Examination, MMSE

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

ADAS-Cog量表

指标类型:

主要指标 

Outcome:

ADAS-Cog 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:

日常生活自理能力量表

指标类型:

主要指标 

Outcome:

Activity of Daily Living Scale, ADL

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清总胆固醇

指标类型:

次要指标 

Outcome:

serum total cholesterol

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

甘油三酯

指标类型:

次要指标 

Outcome:

triglyceride

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

高密度脂蛋白胆固醇

指标类型:

次要指标 

Outcome:

high density lipoprotein cholesterol

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

低密度脂蛋白胆固醇

指标类型:

次要指标 

Outcome:

low density lipoprotein cholesterin

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血管性痴呆中医辨证量表

指标类型:

次要指标 

Outcome:

SDSVD

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:

标本中文名:

尿

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:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

本试验采用中央随机方法。由第三方统计人员根据随机化方案事先设计好随机化参数,利用 SAS 软件模拟产生随机分配表,由与试验无关人员完成药物的编盲。编盲过程形成编盲记录保存。

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

The central randomization method was used in this study.The randomization parameters were designed by the third party statisticians according to the randomization scheme, and the random distribution table was generated by SAS software simulation.The process of codification and blindness forms the process of codification an

盲法:

Blinding:

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

原始数据公开时间:

The time of sharing IPD:

即时公开/Real time access

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):

采用网络平台于试验结束后共享原始数据

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

The network platform was used to share the original data after the test

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:

采用病例记录表(Case Record Form, CRF)进行数据采集和管理

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

Case Record Form (CRF) was used for data collection and management

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-05-15
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