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罗云坚教授调肠克敏方治疗肠易激综合征的嵌入式随机对照研究
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注册号:

Registration number:

ChiCTR-IOR-17010600 

最近更新日期:

Date of Last Refreshed on:

2017-02-09 

注册时间:

Date of Registration:

2017-02-09 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

罗云坚教授调肠克敏方治疗肠易激综合征的嵌入式随机对照研究 

Public title:

A patent Chinese medicine TiaoChang KeMin Granule prepared by Professor Yunjian Luo for the Treatment of Irritable Bowel Syndrome: A Randomized Controlled Trial Embeded with Multiple Factors 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

罗云坚教授调肠克敏方治疗肠易激综合征的嵌入式随机对照研究 

Scientific title:

A patent Chinese medicine TiaoChang KeMin Granule prepared by Professor Yunjian Luo for the Treatment of Irritable Bowel Syndrome: A Randomized Controlled Trial Embeded with Multiple Factors 

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:

李倩 

研究负责人:

杨小波 

Applicant:

Li Qian 

Study leader:

Yang Xiaobo 

申请注册联系人电话:

Applicant telephone:

+86 13929504679 

研究负责人电话:

Study leader's telephone:

+86 13825012636 

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:

liqiantcm2012@163.com 

研究负责人电子邮件:

Study leader's E-mail:

yangxiaobomd@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:

中国广东省广州市越秀区大德路111号 

研究负责人通讯地址:

中国广东省广州市越秀区大德路111号 

Applicant address:

111 Dade Road, Yuexiu District, Guangzhou, Guangdong, China 

Study leader's address:

111 Dade Road, Yuexiu District, Guangzhou, Guangdong, China 

申请注册联系人邮政编码:

Applicant postcode:

510120 

研究负责人邮政编码:

Study leader's postcode:

510120 

申请人所在单位:

广州中医药大学第二附属医院 

Applicant's institution:

The Second Affiliated Hospital of Guangzhou University of 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:

B2016-132-01 

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:

广东省中医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Guangdong Provincial Hospital of Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-12-09 

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:

广州中医药大学第二附属医院 

Primary sponsor:

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine 

研究实施负责(组长)单位地址:

中国广东省广州市越秀区大德路111号 

Primary sponsor's address:

111 Dade Road, Yuexiu District, Guangzhou, Guangdong, 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):

广东

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

广州中医药大学第二附属医院

具体地址:

中国广东省广州市越秀区大德路111号

Institution
hospital:

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine

Address:

111 Dade Road, Yuexiu District, Guangzhou, Guangdong, China

经费或物资来源:

广东省省级科技计划项目 

Source(s) of funding:

Science and Technology Planning Project of Guangdong Province 

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:

其它 

Study phase:

N/A 

研究目的:

1. 明确调肠克敏颗粒治疗腹泻型肠易激综合征的有效性、安全性,尤其是预防复发优势,形成高级别证据; 2. 对调肠克敏颗粒治疗肠易激综合征进行适应症的优化、细化,以期提高治疗的特异性,为提高中医临床研究效率及效能探索形成一种新的研究模式。 

Objectives of Study:

1. To assess the efficacy and safety of TCKM granule for the treatment of irritable bowel syndrome, especially in reducing IBS symptoms recurrence; 2. To investigate what patient and disease characteristics may predict successful outcome from the treatment with TCKM granule, by doing which the indication of IBS treated with TCKM granule may be optimized. 

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:

(1)符合IBS-D西医诊断标准; (2)签署知情同意; (3)患者年龄在18-75岁之间,性别不限; (4)基线期IBS-SSS积分>75分。 

Inclusion criteria

(1) Patients meeting diagnosis of IBS-D; (2) Patients providing signed informed consent; (3) Male or female aged 18 to 75 years; (4) Patients reporting a Irritable Bowel Syndromes Symptom Severity Score (IBS-SSS) of >75. 

排除标准:

(1)有报警征象者; (2)确诊存在胃肠道器质性病变者,如炎症性肠病; (3)确诊为感染性肠炎、甲状腺功能亢进者或其他影响胃肠道转运或功能的疾病; (4)心理测量量表SAS标准分>50分或SDS标准分>53分,或合并其他精神疾病者; (5)曾有可能引起与IBS类似症状的腹部手术者(不包括胆囊、阑尾、息肉切除术); (6)研究过程中不能或不愿意停止使用影响干预措施有效性评估的药物; (7)妊娠、哺乳期妇女或3个月内计划妊娠者; (8)合并严重疾病,如严重的心、脑、肝、肾等系统疾病,以及恶性肿瘤; (9)近3个月内曾参加其它临床试验者; (10)研究者认为不适合本研究的其他情况。 

Exclusion criteria:

(1) Patients with alarm symptoms; (2) Patients with history or current evidence of inflammatory bowel disease; (3) Patients with history or current evidence of concurrent enteric infection, hyperthyroidism or other diseases causing diarrhea and abdominal pain; (4) Patients who report a anxiety score of > 50 on Self-rating Anxiety Scale (SAS) or a depression score of > 53 on Self-rating Depression Scale (SDS), or patients with other psychiatric disorders; (5) Patients with a history of gastrointestinal surgery causing similar syndromes with IBS; (6) Patients who are unable or unwilling to stop taking medication affecting the assessments of experimental drug efficacy and safety; (7) Patients who are pregnancy, breast feeding, or plan to conceive within 3 months; (8) Patients with concurrent serious diseases, such as cancer, serious cardiovascular, respiratory, hepatic, renal, or neurological disease; (9) Patients who are participating or have participated in another clinical trial within the previous 3 months; (10) Patients who are in researchers opinion unsuitable for this trial. 

研究实施时间:

Study execute time:

From2017-03-01To 2018-05-31 

干预措施:

Interventions:

组别:

治疗组

样本量:

72

Group:

intervention group

Sample size:

干预措施:

调肠克敏颗粒剂+基础治疗

干预措施代码:

Intervention:

TiaoChangKeMin granule + health education

Intervention code:

组别:

安慰剂组

样本量:

72

Group:

placebo group

Sample size:

干预措施:

安慰剂+基础治疗

干预措施代码:

Intervention:

placebo + health education

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

广州中医药大学第二附属医院 

单位级别:

三级甲等 

Institution
hospital:

The Second Affiliated Hospital of Guangzhou University of Chinese Medicine  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

明显缓解

指标类型:

主要指标 

Outcome:

AR

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

完全缓解时间

指标类型:

次要指标 

Outcome:

time to relief

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

首次复发间隔时间

指标类型:

次要指标 

Outcome:

time to first relapse

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总体复发次数

指标类型:

次要指标 

Outcome:

total relapse times

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

腹痛(程度)

指标类型:

次要指标 

Outcome:

severity of abdominal pain

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

腹部不适(程度)

指标类型:

次要指标 

Outcome:

severity of abdominal discomfort

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

腹胀(程度)

指标类型:

次要指标 

Outcome:

severity of abdominal distension

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

排便频率

指标类型:

次要指标 

Outcome:

stool frequency

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

粪便性状

指标类型:

次要指标 

Outcome:

stool consistency

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

排便急迫感

指标类型:

次要指标 

Outcome:

urgency

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

排便不尽感

指标类型:

次要指标 

Outcome:

feelings of incomplete evacuation

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

粘液便

指标类型:

次要指标 

Outcome:

mucus

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

长期有效性

指标类型:

次要指标 

Outcome:

long-term efficacy

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肠易激综合征症状严重程度评分

指标类型:

次要指标 

Outcome:

IBS-SSS

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肠易激综合征生活质量评分

指标类型:

次要指标 

Outcome:

IBS-QOL

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

患者的焦虑、抑郁评分

指标类型:

次要指标 

Outcome:

HADS

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:

尿液

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:

stool

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 18 years
最大 Max age 75 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):

由广东省中医院统计学专业人员采用SPSS 18.0软件和SAS 9.2软件,完成程序编写和随机化的操作。

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

Programing and randomization operations will be performed by an independent statistician from Guangdong Provincial Hospital of Chinese Medicine,using SPSS 18.0 and SAS 9.2 software.

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):

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):

试验完成后6个月内公开,上传至本网站ResMan。

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

IPD will be public accessable via ResMan Within six months after the trial complete on this website.

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:

EXCEL和SPSS数据库。

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

EXCEL and SPSS detabase will be used.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2017-02-09
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