今天是:2019-11-21 星期四

张毅医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。 国医大师颜德馨“消渴方”对早期2型糖尿病脾虚血瘀证的临床有效性研究
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注册号:

Registration number:

ChiCTR1900026782 

最近更新日期:

Date of Last Refreshed on:

2019-10-22 

注册时间:

Date of Registration:

2019-10-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

张毅医师:该研究尚未获得伦理委员会批准。请于批准后再开始纳入参试者,并与我们联系上传批件。 国医大师颜德馨“消渴方”对早期2型糖尿病脾虚血瘀证的临床有效性研究 

Public title:

A research for the clinical validity of Diabetes decoction which was set up by national medical master professor Yan Dexin and was used for treating type 2 diabetes with spleen-deficiency and blood-stasis syndrome in the early period 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

国医大师颜德馨“消渴方”对早期2型糖尿病脾虚血瘀证的临床有效性研究 

Scientific title:

A research for the clinical validity of Diabetes decoction which was set up by national medical master professor Yan Dexin and was used for treating type 2 diabetes with spleen-deficiency and blood-stasis syndrome in the early period 

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:

张毅 

研究负责人:

张毅 

Applicant:

Zhang Yi 

Study leader:

Zhang Yi 

申请注册联系人电话:

Applicant telephone:

+86 18116070306 

研究负责人电话:

Study leader's telephone:

+86 18116070306 

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:

zhangyizhongyi001@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zhangyizhongyi001@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:

上海市静安区芷江中路274号 

研究负责人通讯地址:

上海市静安区芷江中路274号 

Applicant address:

274 Middle Zhijiang Road, Jing'an District, Shanghai, China 

Study leader's address:

274 Middle Zhijiang Road, Jing'an District, Shanghai, 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:

上海市中医医院 

Applicant's institution:

Shanghai Traditional Chinese Medicine Hospital 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

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:

上海市中医医院 

Primary sponsor:

Shanghai Traditional Chinese Medicine Hospital 

研究实施负责(组长)单位地址:

上海市静安区芷江中路274号 

Primary sponsor's address:

274 Middle Zhijiang Road, Jing'an District, Shanghai, 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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市中医医院

具体地址:

静安区芷江中路274号

Institution
hospital:

Shanghai Traditional Chinese Medicine Hospital

Address:

274 Middle Zhijiang Road, Jing'an District

经费或物资来源:

上海申康医院发展中心 

Source(s) of funding:

Shanghai shenkang hospital development center 

研究疾病:

2型糖尿病 

Target disease:

Type 2 diabetes 

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:

1)评价国医大师颜德馨“消渴方”对于早期2型糖尿病脾虚血瘀证的临床有效性。 2)基于TNF-α及IL-6等炎症指标,初步探索“消渴方”治疗早期2型糖尿病脾虚血瘀证的作用机制。 

Objectives of Study:

1)To evaluate clinical validity of Diabetes decoction which was set up by national medical master professor Yan Dexin and was used for treating type 2 diabetes with spleen-deficiency and blood-stasis syndrome in the early period. 2) Based on TNF-α, IL-6 and other inflammatory indicators, to explore the mechanism of xiaoke decoction in treating type 2 diabetes with spleen-deficiency and blood-stasis syndrome in the early period. 

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)空腹血糖< 13.8mmol/L,糖化血红蛋白(HbA1c)< 9.0%,体质量指数BMI> 23kg/m2,胰岛素抵抗指数(HOMA-IR)> 2.8。 (2)年龄35-75岁之间,男女不限。 (3)确诊后的2型糖尿病初发患者或病程< 3年;接受磺脲类和双胍类血糖药物治疗超过3个月以上,磺脲类及双胍类药物稳定剂量至少1个月以上,受试期间不能使用胰岛素治疗及其他影响糖脂代谢的药物。 (4)属于中医消渴病脾虚血瘀型患者。 (5)签署知情同意书并自愿参与研究。 

Inclusion criteria

1. FBG< 13.8mmol/L, HbA1c< 9.0%, BMI> 23kg/m2, HOMA-IR> 2.8. 2. Aged 35-75 years. 3. Patients with newly diagnosed type 2 diabetes or whose course of disease is less than 3 years received sulfonylureas and guanidine blood glucose drugs for more than 3 months and the stable dose of sulfonylureas and guanidine drugs for at least 1 month were not allowed to use insulin therapy or other drugs that affect glucose and lipid metabolism during the test period 4. Spleen-deficiency and blood-stasis syndrome. 5. Signed informed consent and volunteered to participate in the study. 

排除标准:

(1)有严重心脏病史:心肌梗死、不稳定型心绞痛、慢性心功能不全等的患者。 (2)有严重糖尿病慢性并发症,有明确的肝、肾疾病,其他内分泌疾病的患者。 (3)近期内有急性传染病及糖尿病的急性并发症的患者。 (4)重度高血压:收缩压>160mmHg和/或舒张压>100mmHg。 (5)研究者评估认为不适合纳入本研究的患者。 

Exclusion criteria:

1. A history of severe heart disease. 2. There are serious chronic complications of diabetes. 3. Recent acute infectious disease and acute complications of diabetes. 4. Severe hypertension. 5. The researchers evaluated it is inappropriate for inclusion. 

研究实施时间:

Study execute time:

From2019-12-01To 2022-12-01 

干预措施:

Interventions:

组别:

治疗组

样本量:

120

Group:

Trantment Group

Sample size:

干预措施:

中药

干预措施代码:

Intervention:

Chinese medicine

Intervention code:

组别:

对照组

样本量:

120

Group:

Control Group

Sample size:

干预措施:

阿格列汀

干预措施代码:

Intervention:

Alogliptin

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

上海市中医医院 

单位级别:

三甲 

Institution
hospital:

Shanghai Traditional Chinese Medicine Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

空腹血糖

指标类型:

主要指标 

Outcome:

FBG

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

餐后2小时血糖

指标类型:

主要指标 

Outcome:

PBG

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

糖化血红蛋白

指标类型:

主要指标 

Outcome:

HbAlc

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总胆固醇

指标类型:

主要指标 

Outcome:

TC

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

甘油三酯

指标类型:

主要指标 

Outcome:

TG

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

空腹胰岛素

指标类型:

主要指标 

Outcome:

FIns

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胰岛素抵抗指数

指标类型:

主要指标 

Outcome:

HOMA-IR

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:

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

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

随机数表法

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

random number table

盲法:

未说明

Blinding:

Not stated

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:

即时公开/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):

2022年12月1日http://www.chictr.org.cn/index.aspx

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

2022.12.1 http://www.chictr.org.cn/index.aspx

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:

CRF

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

CRF

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-10-22
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