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痛泻要方靶向miR-144调控肠道黏膜通透性治疗肝郁脾虚型肠易激综合征分子机制研究
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注册号:

Registration number:

ChiCTR1900021785 

最近更新日期:

Date of Last Refreshed on:

2019-03-09 

注册时间:

Date of Registration:

2019-03-09 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

痛泻要方靶向miR-144调控肠道黏膜通透性治疗肝郁脾虚型肠易激综合征分子机制研究 

Public title:

Molecular Mechanism of Tongxie Yaofang Targeting MiR-144 Regulating Intestinal Mucosal Permeability in Treating Irritable Bowel Syndrome of Liver Depression and Spleen Deficiency 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

痛泻要方靶向miR-144调控肠道黏膜通透性治疗肝郁脾虚型肠易激综合征分子机制研究 

Scientific title:

Molecular Mechanism of Tongxie Yaofang Targeting MiR-144 Regulating Intestinal Mucosal Permeability in Treating Irritable Bowel Syndrome of Liver Depression and Spleen Deficiency 

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:

侯秋科 

研究负责人:

侯秋科 

Applicant:

Qiuke Hou 

Study leader:

Qiuke Hou 

申请注册联系人电话:

Applicant telephone:

+86 13332842458 

研究负责人电话:

Study leader's telephone:

+86 13332842458 

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:

houqiuke@126.com 

研究负责人电子邮件:

Study leader's E-mail:

houqiuke@126.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:

广东省广州市白云区机场路16号广州中医药大学第一附属医院 

研究负责人通讯地址:

广东省广州市白云区机场路16号广州中医药大学第一附属医院 

Applicant address:

16 Airport Road, Baiyun District, Guangzhou, Guangdong, China 

Study leader's address:

16 Airport Road, Baiyun District, Guangzhou, Guangdong, 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:

广州中医药大学第一附属医院 

Applicant's institution:

First Affiliated Hospital of Guangzhou 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:

ZYYECK[2018]125 

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:

广州中医药大学第一附属医院伦理委员会 

Name of the ethic committee:

Ethics Committee of the First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-02-28 

伦理委员会联系人:

黎老师 

Contact Name of the ethic committee:

Mrs Li 

伦理委员会联系地址:

广东省广州市白云区机场路16号广州中医药大学第一附属医院 

Contact Address of the ethic committee:

16 Airport Road, Baiyun District, Guangzhou, Guangdong 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 020 36588667 

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:

广州中医药大学第一附属医院 

Primary sponsor:

Guangzhou University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

广东省广州市云区机场路16号广州中医药大学第一附属医院 

Primary sponsor's address:

16 Airport Road, Baiyun District, Guangzhou, Guangdong 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东省

市(区县):

广州市

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广州中医药大学第一附属医院

具体地址:

云区机场路16号

Institution
hospital:

Guangzhou University of Traditional Chinese Medicine

Address:

16 Airport Road, Baiyun District

经费或物资来源:

国家自然科学基金 

Source(s) of funding:

National Natural Science Foundation 

研究疾病:

肠易激综合征 

Target disease:

Irritable bowel syndrome 

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:

通过临床验证痛泻要方治疗肝郁脾虚型IBS-D 的疗效及安全性,以及检测痛泻要方治疗前后IBS患者肠道黏膜组织标本中miR-144 和靶基因OCLN、ZO-1 的表达水平差异。 

Objectives of Study:

To clarify the clinical efficacy and safty of tong-xie-yao-fang and to evaluate the expression of mir-144 and ocln,zo-1 in the intestinal mucosa of IBS-D patients before and after treatment by tong-xie-yao-fang.  

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:

⑴ 符合IBS诊断标准,入选前两周内未进行过其他治疗; ⑵ 年龄在18-70岁之间; ⑶ 近1月内腹痛、腹泻症状呈发作性且平均发作次数在>2天/周; ⑷ 患者知情同意并愿意接受相应治疗。 

Inclusion criteria

1. Diagnosis of IBS-D according to ROME IV; 2. Diagnosis of diarrhea syndrome with liver stagnation and spleen deficiency according to TCM; 3. Aged 18 to 70 years; 4. Able to understand and sign a written informed consent. 

排除标准:

⑴ 炎症性肠病、消化道出血及肠道肿瘤者; ⑵ 有消化系统器质性病变(如慢性胰腺炎、肝硬化等),或有影响消化道动力的全身疾病(例如:甲亢、糖尿病、慢性肾功能不全、精神和神经系统病变等); ⑶ 伴有心肝肾等主要脏器严重病变者、造血系统疾病以及肿瘤等患者;对心电图检查有明显异常者,须排除相关病变,谨慎入组。 ⑷ 试验前1周服用对该病有治疗作用的药物。 ⑸ 有生育意向的育龄期妇女、孕妇及哺乳期妇女; ⑹ 有神经系统及精神疾病史; ⑺ 对所用药物有过敏史者; ⑻ 正在参加其他临床试验的受试者。 

Exclusion criteria:

1. Patients with inflammatory bowel disease, gastrointestinal bleeding, gastrointestinal tumors or a history of previous abdominal surgery; 2. Systemic organ diseases such as hyperthyroidism, diabetes, chronic renal impairment effect gastrointestinal motility; 3. Patients with serious primary diseases of the heart, liver, kidney, blood system or endocrine system, and patients with tumors or AIDS; 4. History of usage of other medication for IBS-D during the last week and patients taking any medication for other diseases which would impact the trial; 5. Pregnant and lactating women or women who plan to have baby; 6. Patients who are allergic to the trial medicine; 7. Patients with neurological disease, mental illness; 8. Patients who have participated in other clinical studies. 

研究实施时间:

Study execute time:

From2019-03-01To 2021-12-01 

征募观察对象时间:

Recruiting time:

From2019-05-01To 2021-05-31 

干预措施:

Interventions:

组别:

痛泻要方组

样本量:

60

Group:

Experimental group

Sample size:

干预措施:

痛泻要方

干预措施代码:

Intervention:

Tong-Xie Yao-fang

Intervention code:

组别:

对照组

样本量:

60

Group:

Control group

Sample size:

干预措施:

中药安慰剂

干预措施代码:

Intervention:

Place of Tong-Xie Yao-fang

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东省 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

广州中医药大学第一附属医院 

单位级别:

三甲医院 

Institution
hospital:

Guangzhou University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

IBS病情严重程度调查表

指标类型:

主要指标 

Outcome:

Irritable Bowel Syndromes Symptom Severity Score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

大便性状评分

指标类型:

主要指标 

Outcome:

Bristol stool form scale

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:

肠道黏膜

组织:

Sample Name:

Intestinal mucosa

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):

运用SAS9.2统计软件采用分层、区组随机方法,按病例分配数及随机比例生成随机数字分组表。试验组与对照组按1:1的比例用分层区组随机化方法产生随机编码。

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

Use SAS software to generate a random number sequence by stratified block randomization and 1:1 rate.

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

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):

临床试验预计将在2021年12月完成,原始数据将在2022年6月前以Excel上传至该网站

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

The clinical trial is expected to be completed in December 2021, and the original data will be uploaded to the site in Excel by June 2022.

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:

为了使试验遵循研究设计和标准指南并确保数据的准确性,所有临床医生,研究助理,数据管理员和药物管理者将在试验开始前接受关于试验特定过程的严格培训。 收集数据后,应立即安全地保存原始表格和证据。 数据输入和管理将由两名个人数据管理员完成。 数据输入完成后,将记录在病历记录表中。 只有经本研究领导批准的人才能访问所有数据。

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

In order to make the trial follow the study design and the standard guidelines and to ensure the accuracy of the data, all clinicians, research assistants, data administrators, and drug managers will get strict training regarding the trial-specific process before the trial begins. The original forms and evidences should be kept safely immediately when the data are collected. Data input and management will be completed by two individual data administrators. Once the data input is completed, it will be recorded in the CRF. Only those who have been approved by the leader of this study will have access to all data.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2019-03-09
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