芒针治疗中风后消化不良的临床疗效研究

注册号:

Registration number:

AMCTR-IOR-17000117 

注册号获得时间:

Date of releasing the registration number:

2018/3/15 10:25:25 

注册号状态:

补注册  

Registration Status:

1008002 Retrospective registration  

注册题目:

芒针治疗中风后消化不良的临床疗效研究 

Public title:

Clinical efficacy research of elongated needle in the treatment of indigestion after stroke 

研究课题的正式科学名称:

芒针治疗中风后消化不良的临床疗效研究 

Scientific title:

Clinical efficacy research of elongated needle in the treatment of indigestion after stroke 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

ChiCTR-INR-17013012 

申请注册联系人:

齐荣霞 

研究负责人:

牛红月 

Applicant:

Rongxia Qi 

Study leader:

Hongyue Niu 

申请注册联系人电话:

Applicant telephone:

+86 13032275018 

研究负责人电话:

Study leader's telephone:

+86 13820689368 

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:

1362354832@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

nhy1966@sina.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:

314 Anshan Road West, Nankai District, Tianjin, China 

Study leader's address:

314 Anshan Road West, Nankai District, Tianjin, 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:

天津中医药大学第一附属医院 

Applicant's institution:

First Hospital Affiliated to 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:

TYLL2016[K]字019 

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:

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 First Hospital Affiliated to Tianjin University of TCM 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-12-26 

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:

First Hospital Affiliated to 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:

314 Anshan Road West, Nankai District, Tianjin, 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:

天津市南开区鞍山西道314号

Institution
hospital:

First Hospital Affiliated to Tianjin University of Traditional Chinese Medicine

Address:

314 Anshan Road West, Nankai District, Tianjin, China

经费或物资来源:

国家中医药管理局国家中医临床研究基地业务建设科研专项 

Source(s) of funding:

Special project for scientific research and construction of national TCM clinical research base of State Administration 

研究疾病:

中风后消化不良 

Target disease:

Post-stroke dyspepsia 

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:

其它 

Study phase:

Other 

研究目的:

(1)验证针刺治疗中风后消化不良的临床疗效 (2)发掘芒针治疗中风后消化不良的优势 

Objectives of Study:

(1) to verify the clinical efficacy of acupuncture in the treatment of post-stroke dyspepsia; (2) to explore the superiority of Awn Needle in the treatment of indigestion after stroke. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

①符合以上中风的中西医诊断标准及消化不良餐后不适综合征的诊断标准; ②年龄在40~70岁之间(包括40周岁和70周岁); ③中风后消化不良,病程2-4周内; ④意识清楚,查体合作,无失语及严重认知障碍; ⑤患者及家属知情同意并签署知情同意书者。 

Inclusion criteria

1. the diagnostic criteria of TCM and Western medicine for the above stroke and the postprandial discomfort syndrome of dyspepsia; 2. The age ranged from 40~70 to 70 years old (including 40 years of age and one year old); 3. The course of Dyspepsia after stroke within 2-4 weeks; 4. Clear awareness, physical examination, no aphasia and severe cognitive impairment; 5. Patients and their families understand informed consent and sign it. 

排除标准:

①消化不良之上腹疼痛综合征; ②2周内接受过其他消化不良治疗者或正参加其他临床试验者; ③合并有严重消化性溃疡,便潜血阳性,胃粘膜有重度异型增生,或器质性病变者; ④处于重度焦虑抑郁状态,有自杀倾向的患者; ⑤合并严重心脏疾患、肝功能障碍(ALT、AST高于正常值上限1.5倍)、肾功能不全(Cr超出正常值上限,BUN高于正常值上限的1.2倍)、造血系统及代谢系统等严重疾病; ⑥不能配合治疗者; ⑦妊娠和哺乳期妇女; ⑧过敏体质或对多种药物过敏者。 

Exclusion criteria:

1. Dyspeptic epigastric pain syndrome; 2. patients who had been treated with other dyspeptic symptoms within 2 weeks or were enrolled in other clinical trials; 3. The patients with severe peptic ulcer, positive fecal occult blood, severe dysplasia of gastric mucosa, or organic lesions; 4. patients with severe anxiety and depression and suicidal tendency; 5. The patients with severe heart disease, liver dysfunction (ALT AST, 1.5 times higher than the upper limit of normal) and renal insufficiency (Cr beyond the upper limit of the normal value of BUN, 1.2 times higher than the upper limit of the normal value), a serious disease of hematopoietic system and metabolic system etc.; 6. We can not cooperate with the procedure; 7. The pregnant and lactating women; 8. The allergic or allergy to drugs. 

研究实施时间:

Study execute time:

From2016-01-01To 2018-12-31 

干预措施:

Interventions:

组别:

芒针组

样本量:

60

Group:

Awn needle group

Sample size:

干预措施:

芒针针刺

干预措施代码:

Intervention:

Elongated needle acupuncture

Intervention code:

组别:

毫针组

样本量:

60

Group:

Filiform needle group

Sample size:

干预措施:

毫针针刺

干预措施代码:

Intervention:

Filiform needle acupunture

Intervention code:

组别:

药物组

样本量:

60

Group:

medicine group

Sample size:

干预措施:

口服药物

干预措施代码:

Intervention:

Oral drug treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

消化不良中医症状分级量化表

指标类型:

主要指标 

Outcome:

Quantization table of TCM symptom classification of dyspepsia

Type:

Primary indicator 

指标中文名:

胃泌素释放肽前体

指标类型:

次要指标 

Outcome:

pro-gastrin-releasing peptide

Type:

Secondary indicator 

指标中文名:

胃动素

指标类型:

附加指标 

Outcome:

motilin

Type:

Additional indicator 

采集人体标本:

Collecting sample(s)
from participants:

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 0 years
最大 Max age 0 years

随机方法(请说明由何人用什么方法产生随机序列):

电脑生成随机数字表,研究者根据患者就诊顺序,随机分组

性别:

男女均可

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

Computer generated random number table, the patients were randomly assigned according to the order of them.

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):

通过网络平台(中国临床试验注册中心,www.chictr.org.cn)

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

www.chictr.org.cn

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):

1.通过CRF表进行记录; 2.通过SPSS软件计算。

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

1. Through the CRF table records; 2. Calculated by SPSS software.

创建人:

Creater Name:

 2017-10-18
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