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Identify Characteristics of Similar Chinese Patent Medicine for Stroke
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注册号:

Registration number:

ChiCTR-IOR-17010397 

最近更新日期:

Date of Last Refreshed on:

2017-12-03 

注册时间:

Date of Registration:

2017-01-11 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

治疗中风病相似中成药的特征辨析 

Public title:

Identify Characteristics of Similar Chinese Patent Medicine for Stroke 

研究课题的正式科学名称:

治疗中风病相似中成药的特征辨析的随机对照临床试验 

Scientific title:

Identify Characteristics of Similar Chinese Patent Medicine for Stroke: a Randomized 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:

陈慧玲 

研究负责人:

陈慧玲 

Applicant:

Huiling Chen 

Study leader:

Huiling Chen 

申请注册联系人电话:

Applicant telephone:

+86 18522601370 

研究负责人电话:

Study leader's telephone:

+86 18522601370 

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:

373380535@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

373380535@qq.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:

天津市南开区鞍山西道312号 

研究负责人通讯地址:

天津市南开区鞍山西道312号 

Applicant address:

School of Chinese Medicine engineering, Tianjin University of Traditional Chinese Medicine, 312 Anshanxi Road, Nankai District, Tianjin 300193, China 

Study leader's address:

School of Chinese Medicine engineering, Tianjin University of Traditional Chinese Medicine, 312 Anshanxi Road, Nankai District, Tianjin 300193, 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:

天津中医药大学 

Applicant's institution:

Tianjin University of Traditional Chinese Medicine 

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:

20160007 

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:

天津中医药大学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Tianjin University of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-03-03 

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:

天津中医药大学 

Primary sponsor:

Tianjin University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

天津市南开区鞍山西道312号 

Primary sponsor's address:

Tianjin University of Traditional Chinese Medicine, 312 Anshanxi Road, Nankai District, Tianjin 300193, 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):

天津

市(区县):

Country:

China

Province:

Tianjin

City:

单位(医院):

天津中医药大学第一附属医院

具体地址:

鞍山西道310号

Institution
hospital:

First Affiliated hospital Tianjin University of TCM

Address:

310 Anshanxi Road, Nankai District, Tianjin

国家:

中国

省(直辖市):

天津

市(区县):

Country:

China

Province:

Tianjin

City:

单位(医院):

天津中医药大学第二附属医院

具体地址:

天津市河北区真理道88号

Institution
hospital:

Second Affiliated Hospital of Tianjin University of TCM

Address:

88 Zhenli Road, Hebei District,Tianjin

国家:

中国

省(直辖市):

天津

市(区县):

Country:

China

Province:

Tianjin

City:

单位(医院):

天津中医药大学附属保康医院

具体地址:

天津市南开区玉泉路80号

Institution
hospital:

Baokang Hospital of Tianjin University of TCM

Address:

80 Yuquan Road, Nankai District, Tianjin

国家:

中国

省(直辖市):

天津

市(区县):

Country:

China

Province:

Tianjin

City:

单位(医院):

天津中医药大学附属南开医院

具体地址:

天津市南开区

Institution
hospital:

NanKan Affiliated Hospital of Tianjin University of TCM

Address:

Nankai District,Tianjin

经费或物资来源:

国家自然科学基金青年科学基金项目 

Source(s) of funding:

National Natural Science Foundation of China  

研究疾病:

脑卒中 

Target disease:

STROKE 

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:

其它 

Study phase:

Other 

研究目的:

研究目的:中风恢复期的主要症状为偏瘫、舌蹇语涩、面瘫。目前,没有相关的使用说明针对治疗上述某一种症状哪种中成药效果最好。本研究试图建立一个基于CER的新方法,它区分了通常用于中风恢复期功效相似的三种中成药,辨析出针对某个症状某种药效果最好。 

Objectives of Study:

The main symptoms of stoke convalescent include hemiplegia, dysphasia and facial paralysis. At present, no CPM is particularly used to treat each of the symptoms above and there are no relevant instructions. This study is trying to set up a new approach based on CER, which distinguishes the curative effects of the three CPMs that are often used in stroke convalescence and to point out the symptom(s) on which each medicine has the best effect. 

药物成份或治疗方案详述:

脑血康胶囊主要成份为水蛭,经临床观察,安全有效,不良反应少。中华人民共和国药典标注出血者及孕妇禁用。心脑舒通胶囊的主要成分为蒺藜甾体总皂甙,经临床试验,未出现明显不良反应。中华人民共和国药典标注的不良反应为:偶有口干和胃部不适。禁忌症为:颅内出血后尚未完全止血者忌用。有出血史或低粘症者慎用。血塞通胶囊主要成分为三七总皂苷Notoginseng total saponin,经临床验证,不良反应较轻,未影响正常用药。中华人民共和国药典标注孕妇及过敏体质者慎用。 

Description for medicine or protocol of treatment in detail:

Naoxuekang capsule (NXK) [6] is manufactured by Shandong HaoFu pharmaceutical co., Ltd. NXK, and the main ingredient of which is leech, is proved to be safe, effective and with less adverse reactions by clinical observation [7]. According to Pharmacopoeia of the Peoples Republic of China, it is forbidden to be given to pregnant women and bleeding persons [8]. Xinnaoshutong capsule (XNST) [9] is manufactured by Jilin Aodong Taonan Pharmaceutical Co., Ltd. XNST, and the main ingredient of which is Steroidal saponins of Tribulus terrestris, leads to no obvious adverse reactions in clinical trials [10]. According to Pharmacopoeia of the Peoples Republic of China, it occasionally leads to adverse reactions such as dry mouth and stomach upset. It is forbidden to give the medicine to patients who have intracranial hemorrhage, while patients with a history of bleeding or blood-low-viscosity-syndrome should be given the medicine cautiously [11]. Xuesaitong capsule (XST) [12] is manufactured by Kunming Shenghuo Pharmaceutical (Group) Co., Ltd. According to clinical trials, XST, and the main ingredient of which is Panax Notoginseng Saponins, leads to minor adverse reactions and can be given to patients normally [13]. According to Pharmacopoeia of the People’s Republic of China, it is forbidden to be given to pregnant women and allergic people [14]. These three CPMs are frequently used in the treatment of stroke, hemiplegia, facial distortion, dysphasia, dark purplish tongue with ecchymosis, as well as cephalophyma or cerebral thrombosis with the symptoms above that are caused by encephalorrhagia with high blood pressure [8,11,14]. 

研究设计:

随机平行对照试验 

Study design:

Randomized parallel controlled trial 

纳入标准:

1.年龄介于30-65岁之间; 2.首次发病; 3.参照2010年中华医学会神经病学分会脑血管病学组急性缺血性脑卒中诊治指南撰写组制定的《中国急性缺血性中风诊治指南2010》诊断为缺血性卒中;局灶性神经功能缺损,少数为全面神经功能缺损,脑CT或MRI有梗死病灶,脑CT或MRI排除脑出血和其他病变; 4. 本研究选择中医临床诊断为中风中经络患者; 5. NIHSS量表评分在6-10分之间; 6.发病后四周至八周,病情稳定,已进入疾病恢复期; 7.签署知情同意书; 8.以上的纳入标准适用于试验组与对照组。 

Inclusion criteria

1. Patients aged 30 to 65 years old; 2. The first onset of stroke; 3. Diagnosis of unilateral, non-recurring, subacute stroke of ischemic and lacunar type, as defined by the International Classification of Diseases (ICD-10) through computed omography or magnetic resonance imaging conducted by neurologists; 4. Meet the TCM pattern diagnosis of stroke in meridian syndrome; 5. Patients should have a score between 6 and 20 according to National Institutes of Health Stroke Scale (NIHSS); 6. Four weeks to eight weeks after onset of stroke; 7. Provision of signed informed consent. 

排除标准:

1.过敏体质及对本药已知成分过敏者; 2. 合并肝、肾、造血系统等严重原发性疾病及精神病、恶性肿瘤者、真红细胞增多症等; 3. 病人有其它并发症; 4.合并未控制的Ⅲ级高血压(收缩压≥180mmHg和、或舒张压≥110mmHg); 5.空腹血糖值<2.8或>16.8mmol/l或有严重的糖尿病并发症; 6.肝功能的ALT或AST值超过正常值上限的1.5倍; 7.肾功能障碍与血清肌酐值超过正常值上限的1.5倍; 8.有活动性消化性溃疡或其他出血性疾病的患者; 9.目前或在过去90天内参加其他临床试验的患者。 

Exclusion criteria:

1. Patients with a known history of allergy or suspected allergy to the medicines used in the study; 2. Patients who suffered from serious heart, liver or kidney-related diseases, blood coagulation dysfunction or severe mental disorders; 3. Patients with other complications; 4. Uncontrolled NYHA class III hypertension (systolic blood pressure ≥180 mmHg and/or diastolic blood pressure ≥110 mmHg); 5. Fasting blood glucose <2.8 or >16.8 mmol/l or with severe complications due to diabetes (e.g., diabetic gangrene, or peripheral neuropathy); 6. Liver function impairment with the value of ALT or AST over 1.5-fold the upper limit of normal range; 7. Renal dysfunction with the value of serum creatinine over 1.5-fold the upper limit of normal range; 8. Patients with active peptic ulcers or other hemorrhagic diseases; 9. Patients who participate in other clinical trials, either currently or within the past 90 days. 

研究实施时间:

Study execute time:

From2018-07-01To 2020-07-01 

干预措施:

Interventions:

组别:

1

样本量:

60

Group:

1

Sample size:

干预措施:

脑血康胶囊

干预措施代码:

Intervention:

Naoxuekang capsule

Intervention code:

组别:

2

样本量:

60

Group:

2

Sample size:

干预措施:

心脑舒通胶囊

干预措施代码:

Intervention:

Xinnaoshutong capsule

Intervention code:

组别:

3

样本量:

60

Group:

3

Sample size:

干预措施:

血塞通胶囊

干预措施代码:

Intervention:

Xuesetong capsule

Intervention code:

组别:

4

样本量:

60

Group:

4

Sample size:

干预措施:

placebo

干预措施代码:

Intervention:

placebl

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津中医药大学第一附属医院 

单位级别:

三甲 

Institution
hospital:

First Affiliated hospital Tianjin University of TCM  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津中医药大学第二附属医院 

单位级别:

三甲 

Institution
hospital:

Second Affiliated hospital Tianjin University of TCM  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津中医药大学附属保康医院 

单位级别:

二甲 

Institution
hospital:

Baokang Affiliated hospital Tianjin University of TCM  

Level of the institution:

Secondary A hospital 

国家:

中国 

省(直辖市):

天津 

市(区县):

 

Country:

China 

Province:

Tianjin 

City:

 

单位(医院):

天津中医药大学附属南开医院 

单位级别:

三甲 

Institution
hospital:

Nankai Affiliated hospital Tianjin University of TCM  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

NIHSS

指标类型:

主要指标 

Outcome:

NIHSS

Type:

Primary indicator 

测量时间点:

0,30±2day,210±5day

测量方法:

Measure time point of outcome:

0,30+/-2day, 210+/-5day

Measure method:

指标中文名:

WHOQOL-BREF

指标类型:

主要指标 

Outcome:

WHOQOL-BREF

Type:

Primary indicator 

测量时间点:

0,30±2day, 210±5day

测量方法:

Measure time point of outcome:

0, 30+/-2days, 210+/-5days

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

尚未开始

Pending

年龄范围:

Participant age:

最小 Min age 30 years
最大 Max age 65 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):

参与试验患者的随机化将由独立的数据中心使用交互式系统完成随机数将由该数据中心生成

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

Randomization of the trial patients will be finished using an independent data center with an interactive voice response system, and the random number will be generated by this data center.

盲法:

试验药品将先被编码,然后由专门指派的人员放入统一的容器中,这些专门指派的人员将不参加这项试验。此外,药物的安排会被放在不透明信封中,由试验管理委员会保管。脑血康、心脑舒通、血塞通的原始胶囊壳将被替换为统一的胶囊壳,安慰剂使用相同的胶囊壳,其内容物为淀粉。该项工作由天津中医药大学附属药厂完成。因

Blinding:

The test medicine will be coded firstly, and then put in indistinguishable containers by specially assigned personnel who will not participate in this trial. In addition, medicine assignments will be located in opaque envelopes and are kept confidential by the trial management board. The original capsule shells of NXK, XNST and XST were exchanged for the new uniform capsule shells, which was conducted by the Pharmaceutical Factory of Tianjin University of TCM. The placebo was put into the same capsule shells, the content of which was amylum. Thus, the volunteers, doctors, participating nurses, trial coordinators, statisticians and outcome assessors will be blinded to treatment assignment.

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

公开发表

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

publication

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:

数据管理将遵循国际GCDMP标准。

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

The data management of the trial follows Good Clinical Data Management Practice (GCDMP)

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2017-01-11
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