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抑囊方治疗多囊肾CKD3-4期的临床研究
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注册号:

Registration number:

ChiCTR-INR-16009914 

最近更新日期:

Date of Last Refreshed on:

2016-11-18 

注册时间:

Date of Registration:

2016-11-18 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

抑囊方治疗多囊肾CKD3-4期的临床研究 

Public title:

Clinical Study on Treatment of Polycystic Kidney CKD3 - 4 with Yinang Decoction 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

抑囊方治疗多囊肾CKD3-4期的临床研究 

Scientific title:

Clinical Study on Treatment of Polycystic Kidney CKD3 - 4 with Yinang Decoction 

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:

吴燕升 

研究负责人:

高建东 

Applicant:

Wu Yansheng 

Study leader:

Gao Jiandong 

申请注册联系人电话:

Applicant telephone:

+86 13262982823 

研究负责人电话:

Study leader's telephone:

+86 18101819551 

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:

wuyansheng0704@163.com 

研究负责人电子邮件:

Study leader's E-mail:

gaojiandong@hotmail.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:

上海市张衡路528号 

研究负责人通讯地址:

上海市张衡路528号5B病区医生办公室 

Applicant address:

528 Zhangheng Road, Shanghai 

Study leader's address:

528 Zhangheng Road, Shanghai 

申请注册联系人邮政编码:

Applicant postcode:

201203 

研究负责人邮政编码:

Study leader's postcode:

201203 

申请人所在单位:

上海中医药大学附属曙光医院 

Applicant's institution:

Shuguang Hospital Affiliated to 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:

2016-kykt-08 

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曙光医院伦理委员会 

Name of the ethic committee:

Ethics committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine 

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:

上海中医药大学附属曙光医院 

Primary sponsor:

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

上海市张衡路528号 

Primary sponsor's address:

528 Zhangheng Road, Shanghai 

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曙光医院

具体地址:

上海市张衡路528号

Institution
hospital:

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Address:

528 Zhangheng Road, Shanghai

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

第二军医大学附属长征医院

具体地址:

上海市凤阳路415号

Institution
hospital:

Changzheng Hospital Affiliated to Second Military Medical University

Address:

415 Fengyang Road, Shanghai

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上海市中医医院

具体地址:

上海市芷江中路274号

Institution
hospital:

Shanghai Municipa Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Address:

274Middle Zhijiang Road, Shanghai

经费或物资来源:

上海申康医院发展中心,专科疾病临床“五新”转化项目 

Source(s) of funding:

Shenkang Hospital Development Center,Shanghai, specialist disease clinical  

研究疾病:

多囊肾慢性肾脏病3-4期 

Target disease:

Polycystic Kidney disease CKD3 - 4 

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:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

在已授权专利抑囊方延缓多囊肾进展的小样本临床研究和多年临床实践的基础上,进一步开展多中心、前瞻性、随机临床验证研究开发具有中医临床优势的安全、有效的治疗多囊肾的新药,证实中药复合物抑囊方能够有效改善多囊肾CKD3-4期患者临床症状,并且能够有效改善患者血压、肾功能、肾小管功能和尿微量蛋白指标,抑制囊肿生长,提高患者生存质量,延长患者进入透析的时间和寿命。抑囊方具有形成临床新药并推广至市场的巨大潜力,为多囊肾的治疗和新药推广应用提供科学依据。 

Objectives of Study:

On the basis of authorized patent Yinangfang delay progression of polycystic kidney small sample clinical research and years of clinical practice, further multicenter, prospective, randomized clinical, research and development of TCM clinical advantages, the drug is safe and effective in the treatment of polycystic kidney, confirmed that the medicine compound capsule can effectively inhibiting the clinical symptoms improve the polycystic kidney patients with CKD3-4, and can effectively improve the patient's blood pressure, renal function, renal function and urinary protein index, inhibition of cyst growth, improve the quality of life of patients, prolong the life of patients in time and dialysis. The Yinangfang has the great potential to form a new drug and to promote the market, which provides scientific basis for the treatment of polycystic kidney disease and the application of new drug. 

药物成份或治疗方案详述:

三棱10g,莪术10g,猫爪草30g ,皂角刺6g,玉米须15g,泽兰15g,骨碎补10g,黄芪30g,党参30g ,当归10g,赤芍15g,白芍10g,蛇莓10g,蛇舌草15g,王不留行15g,炒芥子15g ,车前子15g,虎杖10,积雪草30g,制大黄10g。 

Description for medicine or protocol of treatment in detail:

Angelica 10g, Radix Paeoniae Rubra 10g, Radix Paeoniae Rubra 10g, Radix Paeoniae Rubra 10g, Rhizoma Zingiberis 10g, Radix Angelicae Sinensis 10g, Radix Paeoniae Rubra 10g, Radix Paeoniae Rubra 10g, Rhizoma Zingiberis 10g, Radix Astragali 30g , Hedyotis 15g, Vaccaria 15g, fried mustard 15g, Plantago 15g, Polygonum cuspidatum 10, Centella asiatica 30g, rhubarb 10g. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

①符合多囊肾诊断标准; ②年龄18-75岁; ③未行肾脏替代治疗; ④无心血管、肝和造血系统等严重原发性疾病; ⑤肾功能15ml/min≤GFR<60ml/min。 

Inclusion criteria

1. meet the diagnostic criteria for polycystic kidney disease; 2. aged 18-75 years; 3. no renal replacement therapy; 4. no cardiovascular, liver and hematopoietic system and other serious primary disease; 5. renal function 15ml/min; ≤GFR <60ml/min. 

排除标准:

①不符合多囊肾诊断标准; ②年龄小于18岁或大于75岁; ③就诊或入院检查前已行肾脏替代疗法; ④妊娠或哺乳期妇女; ⑤合并有心血管、肝和造血系统等严重原发性疾病; ⑥精神病患者或不能清晰表达不适症状者; ⑦同时参加其他临床药物试验者; ⑧肾功能GFR<15ml/min或GFR>60ml/min。 

Exclusion criteria:

1. do not meet the diagnostic criteria for polycystic kidney disease; 2. less than 18 years of age or greater than 75 years of age; 3. Renal replacement therapy was performed prior to admission or admission 4. pregnant or lactating women; 5. combined with cardiovascular, liver and hematopoietic system and other serious primary disease; 6. patients with mental illness or can not clearly express the symptoms; 7. also participate in other clinical drug test. 

研究实施时间:

Study execute time:

From2016-09-30To 2018-12-31 

干预措施:

Interventions:

组别:

基础治疗组

样本量:

36

Group:

Baseline treatment group

Sample size:

干预措施:

注意休息,避免剧烈的体力,活动和腹部撞伤

干预措施代码:

Intervention:

Attention to rest, avoid intense physical activity and abdominal bruises

Intervention code:

组别:

基础治疗+抑囊方治疗的治疗组

样本量:

36

Group:

Basic treatment + Yinang Decoction treatment group

Sample size:

干预措施:

对症支持治疗加抑囊方中药治疗

干预措施代码:

Intervention:

Symptomatic support treatment plus Yinang Decoction Chinese medicine 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曙光医院 

单位级别:

三级甲等医院 

Institution
hospital:

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

China 

Province:

Shanghai 

City:

 

单位(医院):

第二军医大学附属长征医院 

单位级别:

三级甲等医院 

Institution
hospital:

Changzheng Hospital Affiliated to Second Military Medical University  

Level of the institution:

Tertiary A hospital 

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上海市中医医院 

单位级别:

三级甲等医院 

Institution
hospital:

Shanghai Municipa Hospital Affiliated to Shanghai University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

中医临床症状积分

指标类型:

主要指标 

Outcome:

Chinese medicine clinical symptom score

Type:

Primary indicator 

测量时间点:

0月、3个月、6个月各记录1次

测量方法:

Measure time point of outcome:

Each record in the 0 months, the third months, the sixth months

Measure method:

指标中文名:

肾脏囊肿体积

指标类型:

主要指标 

Outcome:

cyst volume, cyst volume /kidney volume

Type:

Primary indicator 

测量时间点:

患者入组前6个月,做一次肾脏MRI,半年后评价囊肿生长速率再进行入组。入组以后每半年记录一次肾脏MRI cyst volume、cyst volume /kidney volume。

测量方法:

肾脏磁共振

Measure time point of outcome:

6 months before patients brought into the group, they receive kidney MRI for the first time. After half a year, patients are decided whether to be brought into the group according to the growth rate of cysts. Their kidney MRI cyst volume, cyst volume /kidney volume are recorded every six months

Measure method:

Kidney MRI

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:

0月、3个月、6个月各记录1次

测量方法:

CKD-EPI公式计算

Measure time point of outcome:

Each record in the 0 months, the third months, the sixth months

Measure method:

CKD-EPI formula calculation

指标中文名:

肾功能

指标类型:

主要指标 

Outcome:

Renal function

Type:

Primary indicator 

测量时间点:

0月、3个月、6个月各记录1次

测量方法:

自动生化分析仪

Measure time point of outcome:

Each record in the 0 months, the third months, the sixth months

Measure method:

Automatic biochemical analyzer

指标中文名:

尿微量蛋白

指标类型:

主要指标 

Outcome:

Urinary microprotein

Type:

Primary indicator 

测量时间点:

0月、6个月各记录1次

测量方法:

自动生化分析仪

Measure time point of outcome:

Each record in the 0 months, the sixth months

Measure method:

Automatic biochemical analyzer

指标中文名:

血压

指标类型:

主要指标 

Outcome:

blood pressure

Type:

Primary indicator 

测量时间点:

0月、3个月、6个月各记录1次

测量方法:

手动血压计

Measure time point of outcome:

Each record in the 0 months, the third months, the sixth months

Measure method:

Manual blood pressure

指标中文名:

电解质

指标类型:

主要指标 

Outcome:

Electrolytes

Type:

Primary indicator 

测量时间点:

0月、3个月、6个月各记录1次

测量方法:

自动生化分析仪

Measure time point of outcome:

Each record in the 0 months, the third months, the sixth months

Measure method:

Automatic biochemical analyzer

指标中文名:

血常规

指标类型:

副作用指标 

Outcome:

Blood routine

Type:

Adverse events 

测量时间点:

0月、6个月各记录1次

测量方法:

血液分析仪

Measure time point of outcome:

Each record in the 0 months, the sixth months

Measure method:

Blood analyzer

指标中文名:

尿常规

指标类型:

副作用指标 

Outcome:

Urine routine

Type:

Adverse events 

测量时间点:

0月、6个月各记录1次

测量方法:

尿液分析仪

Measure time point of outcome:

Each record in the 0 months, the sixth months

Measure method:

Urine analyzer

指标中文名:

肝功能

指标类型:

副作用指标 

Outcome:

liver function

Type:

Adverse events 

测量时间点:

0月、6个月各记录1次

测量方法:

自动生化分析仪

Measure time point of outcome:

Each record in the 0 months, the sixth months

Measure method:

Automatic biochemical analyzer

指标中文名:

心电图

指标类型:

副作用指标 

Outcome:

Electrocardiogram

Type:

Adverse events 

测量时间点:

0月、6个月各记录1次

测量方法:

心电图机

Measure time point of outcome:

Each record in the 0 months, the sixth months

Measure method:

ECG machine

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:

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):

根据样本量测算,共收集72例患者,患者随机入组的随机化方案,取区组4,共18个区组,采用SPSS18.0软件编程制定该随机化方案,根据软件分组结果将患者随机分入基础治疗组或基础治疗加抑囊方治疗组组中。

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

According to the estimation of sample size, a total of 72 patients were randomized, randomized scheme, the block of 4, a total of 18 groups, using SPSS18.0 software programming to develop the software. According to the randomization scheme, grouping results were randomly divided into basic treatment group or

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):

2019年6月公开原始数据

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

In June 2019, open the raw data

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:

原始数据记录,病例报告表,采用excel和SPSS

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

Original data records, case report form, using the excel and SPSS

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-11-18
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