PGLA线体穴位埋线治疗中风后胃肠道功能紊乱临床研究

注册号:

Registration number:

AMCTR-IPR-19000261 

注册号获得时间:

Date of releasing the registration number:

2019/3/13 12:30:06 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

PGLA线体穴位埋线治疗中风后胃肠道功能紊乱临床研究 

Public title:

Clinical study of PGLA line acupoint embedding therapy for gastrointestinal dysfunction after stroke 

研究课题的正式科学名称:

PGLA线体穴位埋线治疗中风后胃肠道功能紊乱临床研究 

Scientific title:

Clinical study of PGLA line acupoint embedding therapy for gastrointestinal dysfunction after stroke 

研究课题代号(代码):

Study subject ID:

2017122 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

尹丽丽 

研究负责人:

尹丽丽 

Applicant:

Yin Lili 

Study leader:

Yin Lili 

申请注册联系人电话:

Applicant telephone:

13752362670 

研究负责人电话:

Study leader's telephone:

13752362670 

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:

kintelili@163.com 

研究负责人电子邮件:

Study leader's E-mail:

kintelili@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:

天津市南开区鞍山西道314号 

研究负责人通讯地址:

天津市南开区鞍山西道314号 

Applicant address:

No. 314, Anshan West Road, Nankai District, Tianjin 

Study leader's address:

No. 314, Anshan West Road, Nankai District, Tianjin 

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:

天津中医药大学第一附属医院 

Applicant's institution:

The First Affiliated Hospital of 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:

TYLL2018[K]字013 

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:

天津中医药大学第一附属医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-02-13 

研究实施负责(组长)单位:

天津中医药大学第一附属医院 

Primary sponsor:

The First Affiliated Hospital of 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314号 

Primary sponsor's address:

No. 314, Anshan West Road, Nankai District, Tianjin 

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

市(区县):

Country:

China

Province:

Tiānjīn shì 3/5000 Tianjin

City:

单位(医院):

天津中医药大学第一附属医院

具体地址:

天津市南开区鞍山西道314号

Institution
hospital:

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Address:

No. 314, Anshan West Road, Nankai District, Tianjin

经费或物资来源:

天津市卫生和计划生育委员会中医中西医结合科研课题 

Source(s) of funding:

Tianjin Health and Family Planning Commission Chinese Medicine and Western Medicine Research Project 

研究疾病:

中风后胃肠道功能紊乱 

Target disease:

Gastrointestinal dysfunction after stroke 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional 

研究所处阶段:

I期临床试验 

Study phase:

Phase I 

研究目的:

以中风后胃肠道功能紊乱患者为观察对象,采用PGLA线体穴位埋线方法,以胃肠激素(胃动素和胃泌素),胃肠道症状分级评分量表(GSRS),美国国立卫生研究院卒中量表(NIHSS)为观察指标,研究穴位埋线治疗中风后胃肠道功能紊乱的临床疗效。 

Objectives of Study:

Patients with gastrointestinal dysfunction after stroke were observed, using PGLA line acupoint embedding method, gastrointestinal hormone (motilin and gastrin), Gastrointestinal Symptom Rating Scale (GSRS), US National Institute of Health Stroke Scale (NIHSS) is an observational index to study the clinical efficacy of acupoint catgut implantation for the treatment of gastrointestinal dysfunction after stroke. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

1.符合中风病诊断标准; 2.符合胃肠道功能紊乱诊断标准; 3.病程发病1周至3月; 4.年龄在40~75岁,男女均可; 5.受试者同意,并签署知情同意书。 

Inclusion criteria

1. Meet the diagnostic criteria for stroke; 2. Meet the diagnostic criteria for gastrointestinal dysfunction; 3. The course of disease is from 1 week to 3 months; 4. Age is 40 to 75 years old, both men and women; 5. Subject agrees and signs Informed consent form. 

排除标准:

1.蛛网膜下腔出血,腔隙性脑梗死等其他脑血管病; 2.脑卒中后神志障碍,如嗜睡,昏迷不能回答问题,执行指令者;或严重失语,无言语或听力理解能力者; 3.排除消化道器质性疾病,如器质性肠梗阻,消化性溃疡,食管炎,消化道恶性肿瘤,入院前1周内服用过影响胃肠动力或胃酸分泌的药物,如抗胆碱药,解痉止痛药及其他促胃肠动力药; 4.合并严重心功能不全,肝肾功能严重异常和造血系统疾病,精神病患者; 5.妊娠或准备妊娠妇女,哺乳期妇女。 

Exclusion criteria:

1. Subarachnoid hemorrhage, lacunar infarction and other cerebrovascular diseases; 2. Post-stroke mental disorders, such as lethargy, coma can not answer questions, executive instructions; or severe aphasia, no speech or listening comprehension; 3. Excluding gastrointestinal organic diseases, such as organic intestinal obstruction, peptic ulcer, esophagitis, digestive tract malignant tumors, taking drugs that affect gastrointestinal motility or gastric acid secretion, such as anticholinergic drugs, within 1 week before admission. Antispasmodic and other gastrointestinal motility drugs; 4. Combined with severe cardiac insufficiency, severe liver and kidney function and hematopoietic system diseases, mental patients; 5. Pregnant or pregnant women, lactating women. 

研究实施时间:

Study execute time:

From2017-10-01To 2019-09-30 

干预措施:

Interventions:

组别:

治疗组

样本量:

40

Group:

therapy group

Sample size:

干预措施:

穴位埋线

干预措施代码:

Intervention:

Acupoint embedding

Intervention code:

组别:

对照组

样本量:

40

Group:

Duìzhào zǔ 3/5000 Control group

Sample size:

干预措施:

假穴位埋线

干预措施代码:

Intervention:

Sham acupoint embedding

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 

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:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine  

Level of the institution:

Third-class hospital 

测量指标:

Outcomes:

指标中文名:

胃动素

指标类型:

主要指标 

Outcome:

Wèi dòng sù 3/5000 Motilin

Type:

Primary indicator 

指标中文名:

胃泌素

指标类型:

主要指标 

Outcome:

Gastrin

Type:

Primary indicator 

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:

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 40 years
最大 Max age 75 years

随机方法(请说明由何人用什么方法产生随机序列):

本课题组统计人员采用SPSS统计软件生成随机序列

性别:

男女均可

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

The random sequences will be generate in SPSS statistical software by statisticians of this research group.

Gender:

Both

盲法:

Blinding:

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

发表文章

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

Essay published

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

纸质病例报告表收集数据后录入EXCLL表格

The repository and management of the data(Please specify what repository will be used for management of the metadata):

Collects data in case report forms(CRF),then enters the EXCLL form.

创建人:

Creater Name:

 2019-01-18
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