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A prospective, double-blind, randomized controlled trial of TCM syndrome differentiation combined with andis classification in the treatment of stage IV diabetic kidney disease of spleen kidney qi deficiency type
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注册号:

Registration number:

ChiCTR2000037506 

最近更新日期:

Date of Last Refreshed on:

2020-10-19 

注册时间:

Date of Registration:

2020-08-28 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

中医辨证联合ANDIS分型治疗脾肾气虚型IV期糖尿病肾脏疾病的前瞻性、双盲、随机对照的临床研究 

Public title:

A prospective, double-blind, randomized controlled trial of TCM syndrome differentiation combined with andis classification in the treatment of stage IV diabetic kidney disease of spleen kidney qi deficiency type 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中医辨证联合ANDIS分型治疗脾肾气虚型IV期糖尿病肾脏疾病的前瞻性、双盲、随机对照的临床研究 

Scientific title:

A prospective, double-blind, randomized controlled trial of TCM syndrome differentiation combined with andis classification in the treatment of stage IV diabetic kidney disease of spleen kidney qi deficiency type 

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:

ChiMCTR2000003821 

申请注册联系人:

张先闻 

研究负责人:

张先闻 

Applicant:

Zhang Xianwen 

Study leader:

Zhang Xianwen 

申请注册联系人电话:

Applicant telephone:

+86 13564567339 

研究负责人电话:

Study leader's telephone:

+86 13564567339 

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:

zxw0202@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zxw0202@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:

上海浦东新区上南路1000弄 

研究负责人通讯地址:

上海浦东新区上南路1000弄 

Applicant address:

Lane 1000th, Shangnan Road, Pudong New Area, Shanghai, China 

Study leader's address:

Lane 1000th, Shangnan Road, Pudong New Area, 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:

上海中医药大学附属龙华医院 

Applicant's institution:

Longhua Hospital Shanghai 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:

2020LHSB056 

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:

上海中医药大学附属龙华医院医学伦理委员会 

Name of the ethic committee:

Medical ethics committee of Longhua Hospital Affiliated to Shanghai University of traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-08-14 

伦理委员会联系人:

陈晓云 

Contact Name of the ethic committee:

Chen Xiaoyun 

伦理委员会联系地址:

上海宛平南路725号 

Contact Address of the ethic committee:

725 Wanping Road South, Xuhui District, Shanghai, China 

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:

上海中医药大学附属龙华医院 

Primary sponsor:

Longhua Hospital Shanghai University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

上海宛平南路725号 

Primary sponsor's address:

725 Wanping Road South, Xuhui 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):

上海中医药大学附属龙华医院

具体地址:

上海宛平南路725号

Institution
hospital:

Longhua Hospital Shanghai University of Traditional Chinese Medicine

Address:

725 Wanping Road South, Xuhui 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:

糖尿病肾脏疾病 

Target disease:

Diabetic kidney disease 

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:

本研究整合中医辨证论治及西医ANDIS研究建立的糖尿病分型方法,根据ANDIS研究建立的糖尿病分型方法对患者预后的预测作用,有针对性、预防性的对系列中药处方进行优化,并采用前瞻、随机、对照的研究方法,开展12周临床观察,客观评价中药优化方案的临床疗效。 

Objectives of Study:

This study integrated the traditional Chinese medicine syndrome differentiation and treatment and Western medicine andis research established diabetes classification method, according to the prediction effect of diabetes classification method established by andis research on the prognosis of patients, targeted, preventive series of traditional Chinese medicine prescription optimization, and using prospective, randomized, controlled research methods, carried out 12 weeks of clinical observation, objective evaluation of the clinical treatment of Chinese medicine optimization program Effect. 

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)临床诊断为脾肾气虚型DKD IV期患者 (2)性别不限、年龄18-75岁; (3)患者知情同意并签署知情同意书。 

Inclusion criteria

(1) The clinical diagnosis of DKD stage IV was spleen kidney qi deficiency type; (2) Aged 18 to 75 years old; (3) The patients were informed and signed the informed consent. 

排除标准:

(1)尿沉渣提示活动性血尿; (2)短期内肾功能迅速下降; (3)急性感染及糖尿病急性并发症(糖尿病酮症酸中毒、高血糖高渗状态)者; (4)严重心、脑、肝、肾不全等器质性疾病者,恶性肿瘤及精神疾病患者; (5)妊娠或哺乳期妇女。;  

Exclusion criteria:

(1) Urinary sediment indicates active hematuria; (2) The renal function decreased rapidly in a short time; (3) Acute infection and acute complications of diabetes (diabetic ketoacidosis, hyperglycemia and hyperosmolarity); (4) Severe heart, brain, liver, kidney and other organic diseases, malignant tumor and mental disease patients; (5) Pregnant or lactating women. 

研究实施时间:

Study execute time:

From2020-10-01To 2022-09-30 

征募观察对象时间:

Recruiting time:

From2020-10-01To 2022-07-31 

干预措施:

Interventions:

组别:

试验组

样本量:

144

Group:

Experimental group

Sample size:

干预措施:

健脾益肾方

干预措施代码:

Intervention:

Jianpi Yishen prescription

Intervention code:

组别:

对照组

样本量:

144

Group:

Control group

Sample size:

干预措施:

Conventional treatment

干预措施代码:

Intervention:

Conventional treatment

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):

上海中医药大学附属龙华医院 

单位级别:

三甲医院 

Institution
hospital:

Longhua Hospital Shanghai University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

肾小球滤过率

指标类型:

主要指标 

Outcome:

Glomerular filtration rate

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 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):

统计学专家使用SPSS软件,按区组随机法(4例为一个区组),1:1分组

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

The statistical experts used SPSS software to divide the patients into groups according to the random method (4 cases in one block)

盲法:

未说明

Blinding:

Not stated

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

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):

发表文章或学术会议报告

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

Publish articles or academic conference reports

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:

病例记录表

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

Case Record Form, CRF

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2020-08-28
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