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Effect of Qingshen Granules on serum wnt1, β-catenin, type I collagen and type III collagen protein in chronic renal failure patients with Damp-heat Syndrome
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注册号:

Registration number:

ChiCTR-INR-17011057 

最近更新日期:

Date of Last Refreshed on:

2017-04-04 

注册时间:

Date of Registration:

2017-04-04 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

清肾颗粒对慢性肾衰竭湿热证患者血清Wnt1、β-链蛋白、Ⅰ型胶原和Ⅲ型胶原蛋白的干预作用  

Public title:

Effect of Qingshen Granules on serum wnt1, β-catenin, type I collagen and type III collagen protein in chronic renal failure patients with Damp-heat Syndrome 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

清肾颗粒对慢性肾衰竭湿热证患者血清Wnt1、β-链蛋白、Ⅰ型胶原和Ⅲ型胶原蛋白的干预作用 

Scientific title:

Effect of Qingshen Granules on serum wnt1, β-catenin, type I collagen and type III collagen protein in chronic renal failure patients with Damp-heat Syndrome 

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:

张磊 

研究负责人:

王亿平 

Applicant:

Lei Zhang 

Study leader:

Yiping Wang 

申请注册联系人电话:

Applicant telephone:

+86 15105513650 

研究负责人电话:

Study leader's telephone:

+86 13075580986 

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:

zhang0551lei@163.com 

研究负责人电子邮件:

Study leader's E-mail:

wypwyp54@aliyun.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:

安徽省合肥市梅山路117号 

研究负责人通讯地址:

安徽省合肥市梅山路117号 

Applicant address:

117 Meishan Road, Shushan District, Hefei, Anhui, China 

Study leader's address:

117 Meishan Road, Shushan District, Hefei, Anhui, China 

申请注册联系人邮政编码:

Applicant postcode:

230031 

研究负责人邮政编码:

Study leader's postcode:

230031 

申请人所在单位:

安徽中医药大学第一附属医院 

Applicant's institution:

the First Affiliated Hospital of Anhui 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:

2017AH-05 

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:

安徽中医药大学第一附属医院医学伦理委员会 

Name of the ethic committee:

Ethics Committee of the First Affiliated Hospital of Anhui University of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-02-21 

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:

安徽中医药大学第一附属医院 

Primary sponsor:

the First Affiliated Hospital of Anhui University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

安徽省合肥市梅山路117号 

Primary sponsor's address:

117 Meishan Road, Shushan District, Hefei, Anhui, 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):

安徽省

市(区县):

合肥市

Country:

China

Province:

Anhui

City:

Hefei

单位(医院):

安徽中医药大学第一附属医院

具体地址:

安徽省合肥市梅山路117号

Institution
hospital:

First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Address:

117 Meishan Road, Shushan District, Hefei, Anhui, China

经费或物资来源:

自筹经费 

Source(s) of funding:

Self financing 

研究疾病:

慢性肾衰竭 

Target disease:

chronic renal failure 

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:

为延缓肾脏纤维化的进程提供了一条新的治疗方法 

Objectives of Study:

Providing a new treatment method to delay the process of renal fibrosis 

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年龄18~70岁; ②符合慢性肾脏病(CKD)3~5期,未行肾脏替代治疗; ③符合中医湿热证的诊断标准者; ④血压<140/90mmHg、血钾<5.5mmol/L、血红蛋白≥80g/L、感染得到控制,病情稳定2周以上; ⑤签署知情同意书。 

Inclusion criteria

1. Aged from 18 to 70 years old; 2. Accord with the diagnostic criteria of chronic kidney disease (CKD) from 3 to 5, without renal replacement therapy; 3. Accord with the diagnostic criteria of damp-heat syndrome of TCM; 4. The blood pressure is less than 140/90mmHg, potassium less than 5.5mmol/L, hemoglobin more than 80g/L,infection controled,state of illness is stable for more than 2 weeks; 5. Signed informed consent. 

排除标准:

①孕妇或哺乳期患者; ②无法合作者,如精神病患者; ③合并有活动期恶性肿瘤,肝硬化失代偿期或造血系统等严重原发性疾病; ④合并有感染性疾病患者;存在急性尿路梗阻性疾病,需行外科手术治疗; ⑤严重的心律失常、严重心力衰竭,NYHA分级Ⅲ级及以上者(纽约心脏协会分级Ⅲ、Ⅳ级的证据),或入选前3月内有心肌梗死或脑血管事件; ⑥确诊为糖尿病肾病的患者; ⑦正在使用皮质类固醇、非类固醇类抗炎药或免疫抑制剂; ⑧已知对该研究中某种药物过敏者; ⑨正在参加其他临床试验的患者。 

Exclusion criteria:

1. Pregnant and lactating patients; 2. A person who is unable to cooperate, such as a psychotic; 3. Combined with active malignant tumor, liver cirrhosis, decompensated or hematopoietic system and other serious primary diseases; 4. Patients with infectious diseases, acute urinary tract obstruction, surgical treatment; 5. Severe arrhythmia, severe heart failure, grade NYHA or above (New York Heart Association grade III, IV),or in the first 3 months of suffering from myocardial infarction or cerebrovascular events; 6. Patients diagnosed with diabetic nephropathy; 7. Corticosteroids, non steroidal anti-inflammatory drugs or immunosuppressive agents are being used; 8. Known to be allergic to certain drugs in the study; 9. Patients participating in other clinical trials. 

研究实施时间:

Study execute time:

From2017-05-01To 2018-03-01 

征募观察对象时间:

Recruiting time:

From2017-05-01To 2018-03-01 

干预措施:

Interventions:

组别:

治疗组

样本量:

35

Group:

treatment group

Sample size:

干预措施:

清肾颗粒+西医基础治疗+中药灌肠

干预措施代码:

Intervention:

Basic treatment of Western Medicine+Enema with TCM+Qingshen Granules

Intervention code:

组别:

对照组

样本量:

35

Group:

control group

Sample size:

干预措施:

西医基础治疗+中药灌肠

干预措施代码:

Intervention:

Basic treatment of Western Medicine+Enema with TCM

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

安徽省 

市(区县):

合肥市 

Country:

China 

Province:

Anhui 

City:

Hefei 

单位(医院):

安徽中医药大学第一附属医院 

单位级别:

综合性三甲医院 

Institution
hospital:

the First Affiliated Hospital of Anhui University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

估算肾小球滤过率

指标类型:

主要指标 

Outcome:

eGFR

Type:

Primary indicator 

测量时间点:

干预治疗后每四周一次

测量方法:

公式计算

Measure time point of outcome:

After intervention treatment 1 times every 4 weeks

Measure method:

Formula calculation

指标中文名:

血肌酐

指标类型:

次要指标 

Outcome:

serum creatinine

Type:

Secondary indicator 

测量时间点:

干预治疗后每四周一次

测量方法:

酶联免疫吸附测定

Measure time point of outcome:

After intervention treatment 1 times every 4 weeks

Measure method:

enzyme-linked immuno sorbent assay

指标中文名:

尿素氮

指标类型:

次要指标 

Outcome:

Urea nitrogen

Type:

Secondary indicator 

测量时间点:

干预治疗后每四周一次

测量方法:

酶联免疫吸附测定

Measure time point of outcome:

After intervention treatment 1 times every 4 weeks

Measure method:

enzyme-linked immuno sorbent assay

指标中文名:

血清电解质

指标类型:

次要指标 

Outcome:

Serum electrolyte

Type:

Secondary indicator 

测量时间点:

干预治疗后每四周一次

测量方法:

酶联免疫吸附测定

Measure time point of outcome:

After intervention treatment 1 times every 4 weeks

Measure method:

enzyme-linked immuno sorbent assay

指标中文名:

24小时尿蛋白定量

指标类型:

次要指标 

Outcome:

24 hour urine protein quantitation

Type:

Secondary indicator 

测量时间点:

干预治疗后每四周一次

测量方法:

酶联免疫吸附测定

Measure time point of outcome:

After intervention treatment 1 times every 4 weeks

Measure method:

enzyme-linked immuno sorbent assay

指标中文名:

甲状旁腺素

指标类型:

次要指标 

Outcome:

Parathyroid hormone

Type:

Secondary indicator 

测量时间点:

治疗前和疗程结束后

测量方法:

酶联免疫吸附测定

Measure time point of outcome:

Before and after treatment

Measure method:

enzyme-linked immuno sorbent assay

指标中文名:

中医症候

指标类型:

次要指标 

Outcome:

TCM Syndrome

Type:

Secondary indicator 

测量时间点:

治疗前和疗程结束后

测量方法:

症候评价量表

Measure time point of outcome:

Before and after treatment

Measure method:

Symptom rating scale

指标中文名:

血清Wnt1

指标类型:

附加指标 

Outcome:

serum wnt1

Type:

Additional indicator 

测量时间点:

治疗前和疗程结束后

测量方法:

ELISA法

Measure time point of outcome:

Before and after treatment

Measure method:

ELISA

指标中文名:

血清β-catenin蛋白水平

指标类型:

附加指标 

Outcome:

serum β-catenin

Type:

Additional indicator 

测量时间点:

治疗前和疗程结束后

测量方法:

ELISA法

Measure time point of outcome:

Before and after treatment

Measure method:

ELISA

指标中文名:

血清I型胶原蛋白

指标类型:

附加指标 

Outcome:

serum type I collagen protein

Type:

Additional indicator 

测量时间点:

治疗前和疗程结束后

测量方法:

ELISA法

Measure time point of outcome:

Before and after treatment

Measure method:

ELISA

指标中文名:

血清Ⅲ型胶原蛋白

指标类型:

附加指标 

Outcome:

serum type Ⅲcollagen protein

Type:

Additional indicator 

测量时间点:

治疗前和疗程结束后

测量方法:

ELISA法

Measure time point of outcome:

Before and after treatment

Measure method:

ELISA

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 70 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):

依据随机数字表法,随机分为治疗组和对照组各35例。

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

According to the random number table method, the patients were randomly divided into treatment group and control group, 35 cases in each group.

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

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):

网络平台,中国临床试验注册中心

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

Website,Chinese Clinical Trial Registry,http://www.chictr.org.cn/registry.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:

采用纸质病例观察表获得数据,采用EXCEL表进行双录入

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

The data were obtained by case observation table, and the EXCEL table was used to record the data

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:

 2017-04-04
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