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Clinical research of Qidan Dihuang granule combined with ACEI/ARB on patients with early-stage diabetic nephropathy
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注册号:

Registration number:

ChiCTR-TRC-12002756 

最近更新日期:

Date of Last Refreshed on:

2015-12-21 

注册时间:

Date of Registration:

2012-10-30 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

芪丹地黄颗粒联合ACEI/ARB对糖尿病肾病Ⅲ期的临床疗效研究 

Public title:

Clinical research of Qidan Dihuang granule combined with ACEI/ARB on patients with early-stage diabetic nephropathy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

糖尿病肾病个体化综合治疗方案的优化研究 

Scientific title:

Optimization of treatment protocols for diabetic nephropathy 

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:

肖雅 

研究负责人:

罗仁 

Applicant:

Ya Xiao 

Study leader:

Ren Luo 

申请注册联系人电话:

Applicant telephone:

+86 13631307882 

研究负责人电话:

Study leader's telephone:

+86 13503049569 

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:

xiaoya0527@126.com 

研究负责人电子邮件:

Study leader's E-mail:

luoren41671@yahoo.com.cn 

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:

广州大道北1838号南方医科大学南方医院中医科 

研究负责人通讯地址:

广州大道北1838号南方医科大学南方医院中医科 

Applicant address:

1838 Guangzhou avenue north, GuangZhou, Guangdong, China 

Study leader's address:

1838 Guangzhou avenue north, 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:

南方医科大学 

Applicant's institution:

Southern Medical University 

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:

[2011]伦审字(140)号 

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:

南方医科大学南方医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Southern Hospital of Southern Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2012-06-20 

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:

南方医科大学南方医院 

Primary sponsor:

Southern Hospital of Southern Medical University 

研究实施负责(组长)单位地址:

广州大道北1838号南方医科大学 

Primary sponsor's address:

1838 Guangzhou avenue north, GuangZhou, Guangdong, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

广东省“211工程”三期建设重点学科建设项目;国家中医临床研究基地业务建设科研专项 

Source(s) of funding:

Leading Academic Discipline Project of 211 Project of Guangdong Province;The bases construction of national TCM clinical research 

研究疾病:

糖尿病肾病 

Target disease:

diabetic nephropathy 

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:

评价芪丹地黄颗粒联合ACEI/ARB治疗糖尿病肾病Ⅲ期的临床疗效及安全性 

Objectives of Study:

Evaluation of clinical efficacy and safety of qi dan di huang granule combined with ACEI/ARB in the treatment of early-stage diabetic nephropathy 

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2型糖尿病诊断标准; (2)符合Ⅲ期糖尿病肾病标准,即尿微量白蛋白排泄率为 20一 200μg/min(30一300mg/24h); (3)年龄18-80岁; (4)已进行饮食控制、运动疗法,或饮食控制 + 运动疗法 +降糖西药治疗1周后,HbA1c≤12.5%,空腹血糖≤7.8mmol/L或餐后2小时血糖<11 mmol/L者; (5)估算eGFR值为80~120ml/min(按照改良MDRD公式计算) (6)自愿签署知情同意书者。 

Inclusion criteria

(1) Patients included in the study were diagnosed with type 2 diabetes mellitus; (2) Patients included in the study were diagnosed with early-stage diabetic nephropathy; (3) The age of patients are between 18-80 years; (4) HbA1c<=12.5%, fasting plasma glucose<=7.8mmol/L or 2-hour postprandial blood glucose <11mmol/L after diet control, exercise therapy or taking hypoglycemic medicine for one week; (5) The value of eGFR is between 80 and 120ml/min (according to the modified MDRD formula); (6) Patients voluntarily signed the informed consent. 

排除标准:

(1)不符合上述早期糖尿病肾病诊断标准者; (2)合并冠心病、心肌梗死、重度心率失常,肝、肾、造血系统等严重并发症及严重精神障碍者(高血压患者血压超过160/90mmHg;ALT升高超过正常值上限1.5倍;BUN、Cr高于正常范围者。); (3)空腹血浆甘油三酯水平>l0mmol/L(>886mg/d1)者; (4)2型糖尿病合并糖尿病酮症酸中毒或糖尿病高渗性昏迷者; (5)近期内(4周内)有各种感染者; (6)年龄<18周岁,或>80周岁者; (7)妊娠或哺乳期妇女; (8)对试验药物过敏者; (9)正在参加其他药物临床试验的受试者; (10)研究人员认为其他原因不适合临床实验者。 

Exclusion criteria:

(1) Patients did not meet the diagnostic criteria of early diabetic nephropathy; (2) Patients suffered from coronary heart disease, myocardial infarction, severe mental disorders,severe arrhythmia and other serious complications of liver, kidney and hematopoietic system (blood pressure was over 160/90mmHg; the ALT rised above 1.5 times of the upper limit of normal value; BUN and Cr were above the normal range); (3) Fasting plasma triglyceride was above l0mmol/L(>886mg/d1); (4) Patients with type 2 diabetes mellitus were diagnosed with diabetic ketoacidosis or diabetic hyperosmolar coma; (5) Patients had a variety of infections in 4 weeks; (6) The age of patients is younger than 18 years, or older than 80 years; (7) Patients were pregnant or lactating women; (8) Patients were allergic to the test drug; (9) Patients were subjects of clinical trials of other drugs; (10) The researchers thought the patients were not suitable for clinical subjects for other reasons. 

研究实施时间:

Study execute time:

From2011-06-01To 2014-06-01 

征募观察对象时间:

Recruiting time:

From2011-06-01To 2013-12-31 

干预措施:

Interventions:

组别:

观察组

样本量:

66

Group:

Observation Group

Sample size:

干预措施:

芪丹地黄颗粒联合ACEI/ARB

干预措施代码:

Intervention:

Qidan Dihuang granule combined with ACEI/ARB

Intervention code:

组别:

对照组

样本量:

66

Group:

Control Group

Sample size:

干预措施:

ACEI/ARB

干预措施代码:

Intervention:

ACEI/ARB

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):

南方医院 

单位级别:

三甲医院 

Institution
hospital:

Nanfang Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

24小时尿微量白蛋白排泄率

指标类型:

主要指标 

Outcome:

Urine microalbumin excretion rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

空腹血糖

指标类型:

次要指标 

Outcome:

fasting blood glucose

Type:

Secondary 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:

次要指标 

Outcome:

2-hour postprandial blood glucose

Type:

Secondary 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:

次要指标 

Outcome:

Glycosylated hemoglobin

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血脂

指标类型:

次要指标 

Outcome:

blood lipids

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:

尿液

组织:

中段尿

Sample Name:

urine

Tissue:

Middle urine

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:

血液

组织:

静脉血

Sample Name:

blood

Tissue:

venous blood

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:

血液

组织:

静脉血

Sample Name:

blood

Tissue:

venous blood

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 80 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):

随机数字表法

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

Random number table

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

No

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):

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

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:

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

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2012-10-30
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