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糖肾方(配方颗粒)干预气阴两虚夹瘀证2型糖尿病肾病多中心、随机、双盲、安慰剂平行对照临床研究
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注册号:

Registration number:

ChiCTR-TRC-10000843 

最近更新日期:

Date of Last Refreshed on:

2015-06-13 

注册时间:

Date of Registration:

2010-04-15 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

糖肾方(配方颗粒)干预气阴两虚夹瘀证2型糖尿病肾病多中心、随机、双盲、安慰剂平行对照临床研究 

Public title:

The Effect of Tangshen Formula on Patients with Type 2 diabetic Kidney Disease of both Qi and Yin deficiency syndrone: a Multicentre Randomized Placebo-Controlled Trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中医防治慢性肾功能衰竭临床方法的系统生物学研究 

Scientific title:

Systems biological research of Traditional Chinese Medicine for prevention and treatment of chronic renal failure 

研究课题代号(代码):

Study subject ID:

2005CB523503 

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:

付桂香 

研究负责人:

李平 

Applicant:

Guixiang Fu 

Study leader:

Ping Li 

申请注册联系人电话:

Applicant telephone:

+86 010 84205662 

研究负责人电话:

Study leader's telephone:

+86 010 64227163 

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:

fgx203@yahoo.cn 

研究负责人电子邮件:

Study leader's E-mail:

lp8675@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:

北京市朝阳区樱花东路2号中日友好医院临床医学研究所 

研究负责人通讯地址:

北京市朝阳区樱花东路2号中日友好医院临床医学研究所 

Applicant address:

Institute of Clinical medical science of Beijing China-Japan Friendship hospital. No. 2, East Yinghua road, Chaoyang district, Beijing, China 

Study leader's address:

Institute of Clinical medical science of Beijing China-Japan Friendship hospital. No. 2, East Yinghua road, Chaoyang district, Beijing, China 

申请注册联系人邮政编码:

Applicant postcode:

100029 

研究负责人邮政编码:

Study leader's postcode:

100029 

申请人所在单位:

中日友好医院 

Applicant's institution:

China-Japan Friendship hospital 

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:

2006-059 

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:

中日友好医院伦理委员会 

Name of the ethic committee:

Ethic committee of China-Japan Friendship hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2006-11-15 

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:

中日友好医院 

Primary sponsor:

China-Japan Friendship hospital 

研究实施负责(组长)单位地址:

北京市朝阳区樱花东路2号 

Primary sponsor's address:

No. 2, East Yinghua road, Chaoyang district, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

国家科技部

具体地址:

国家科技部

Institution
hospital:

Ministry of Science and Technology of China

Address:

Ministry of Science and Technology of China

经费或物资来源:

国家重点基础研究发展计划973计划 

Source(s) of funding:

National Key project of basic research—programm 973 grant 

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:

通过随机、对照临床试验,观察糖肾方治疗2型糖尿病肾病的疗效,并进行相关系统生物学评价。 

Objectives of Study:

To evaluate the efficacy and safety of Tangshen Formula in treating diabetic nephropathy, which is further made by systemic biology analysis 

药物成份或治疗方案详述:

黄芪、生地、制大黄、三七、卫矛、山茱萸、枳壳 

Description for medicine or protocol of treatment in detail:

seven herbs Huangqi, Shengdi, Zhidahuang, Sanqi, Weimao, Shanzhuyu, Zhiqiao 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(1)符合西医糖尿病肾病诊断标准、中医消渴病诊断标准和中医气阴两虚夹瘀辨证标准; (2)符合1999年WHO诊断标准与分型标准 ①糖尿病分型属于2型者; ②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,空腹血糖≤7.8mmol/L和餐后2小时血糖<11mmol/L者; ③年龄25-70岁; ④有早期糖尿病:UAER>20μg/min ⑤ GFR:60-130ml/min;24小时尿蛋白定量<2.0g; ⑥有④和/或⑤; (3)收缩压小于140mmHg,舒张压小于90mmHg,正在服用降压药或未服用者均可; (4)已签署知情同意书者。 

Inclusion criteria

1. Consistent with TCM diagnostic criterion of diabetes and syndrome differentiation criterion of Qi and Yin deficiency with blood stasis; 2. Consistent with WHO diagnostic criterion of diabetes: (1) type 2 diabetes; (2) fasting blood glucose level<=7.8mmol/L and HbA1c<=7.5%; (3) age between 25-75; (4) early stage of diabetic nephroapthy: urinary albuminuria excration rate >20ug/min; (5) glomerular filtration rate 60-130ml/min; 24 hour urinary protein<2.0g; (6) (4) and/or (5) 3. Systolic blood pressure<140mmHg, diastolic blood pressure<90mmHg, taking or not taking hypotensive drugs; 4. those who have signed informed consent. 

排除标准:

(1)不符合中医消渴病的诊断辨证标准者; (2)入组时,空腹血糖>7.8mmol/L或HbA1c>7.5%者; (3)既往有心肌梗塞,现有心绞痛或心衰或大血管事件一次以上; (4)所有在近期内发生心血管事件者; (5)需激光治疗的视网膜病变; (6)其他继发性高血压者; (7)有严重并发病如脑血管病、原发性肾脏疾和可引起尿蛋白阳性疾病、血液系统疾病、 糖尿病周围神经病变以外各种神经病变、各种其他内分泌代谢疾病、精神障碍患者。 (8)空腹血浆甘油三酯水平>l0mmol/L(>886mg/d1)者。转氨酶升高至正常范围上限(ULN)2倍以上者; (9)既往3个月内用皮质激素、β-阻滞剂、噻唑类利尿剂及烟酸等药物治疗者; (10)近期内(4周内)有各种感染者; (11)妊娠或哺乳期妇女,对试验药物过敏者; (12)不合作者(不能配合饮食控制,或不按规定用药而影响疗效者); (13)对本研究了解不充分、不愿参加者,或依从性差者。 

Exclusion criteria:

1. Those that do not consistent with the diagnostic criteria of diabetes in TCM; 2. With Fasting blood glucose (FBG) >7.8mmol/L or HbA1c>7.5%; 3. With myocardial infarction history, current vagina pectoris or other vascular event more than once; 4. With recent cardiovascular event; 5. With retinopathy requiring laser treatment; 6. With secondary hypertension; 7. Complicated with cerebrovascular disease, primary kidney disease, other diseases with positive urinary protein, blood disease, enuropathies except for diabetic periphery neuropathy, other endocrine and metabolic disease and mental disorder; 8. Fasting serum TG>10 mmol/L(>886mg/dl) and transaminase elevated over 2 above the upper limit normal; 9. Received drugs such as cortisone, beta-blocker, thiazole diauretics and nicacid within 3 months; 10. Recent infection within 4 weeks; 11. Women in pregnancy or lactation and those who are allergic with the herbal medicine; 12. Those who do not coordinate, i.e. those who do not take dietary management or drugs as ordered; 13. Those who do not fully understand this research procedure or do not consent to participate or those who are with poor compliance. 

研究实施时间:

Study execute time:

From2005-11-01To 2010-10-31 

干预措施:

Interventions:

组别:

安慰剂组

样本量:

59

Group:

control group

Sample size:

干预措施:

西医基础治疗加中药安慰剂

干预措施代码:

Intervention:

basic treatment of western medicine plus placebo

Intervention code:

组别:

糖肾方组

样本量:

122

Group:

treatment group

Sample size:

干预措施:

西医基础治疗加糖肾方为主的中医治疗

干预措施代码:

Intervention:

basic treatment of western medicine plus Tangshen Formula

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中日友好医院 

单位级别:

三甲 

Institution
hospital:

China-Japan Friendship hospital  

Level of the institution:

Tertiary A Hopital 

测量指标:

Outcomes:

指标中文名:

尿微量白蛋白排泄率和24小时尿蛋白定量

指标类型:

主要指标 

Outcome:

Urinary albumine excretion rate (UAER) and 24-hour

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肾功能

指标类型:

次要指标 

Outcome:

renal function parameters serum creatinine blood urinary nitrogen and estimated glomerular filtration

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 lipid profiler

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规、肝功能和心电图

指标类型:

副作用指标 

Outcome:

blood routine test, liver function parameters, electrocardiogarph

Type:

Adverse events 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医证候疗效

指标类型:

附加指标 

Outcome:

TCM syndrome effect

Type:

Additional 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:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 25 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):

计算机软件

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

computer software

盲法:

患者 是 研究者 是

Blinding:

patients: blinding observers: 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:

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):

中日友好医院临床医学研究所

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

Institute of Clinical medical science Beijing China-Japan Friendship hospital,

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:

中日友好医院临床医学研究所, 加拿大UBC大学

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

Institute of Clinical medical science Beijing China-Japan Friendship hospital, UBC in Canada

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2010-04-15
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