关于风邪实质与慢性肾炎蛋白尿关系的临床研究

注册号:

Registration number:

ITMCTR2024000832

最近更新日期:

Date of Last Refreshed on:

2024-12-17

注册时间:

Date of Registration:

2024-12-17

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

关于风邪实质与慢性肾炎蛋白尿关系的临床研究

Public title:

A clinical study on the relationship between the essence of wind evil and proteinuria in chronic nephritis

注册题目简写:

English Acronym:

研究课题的正式科学名称:

关于风邪实质与慢性肾炎蛋白尿关系的临床研究

Scientific title:

A clinical study on the relationship between the essence of wind evil and proteinuria in chronic nephritis

研究课题的正式科学名称简写:

Scientific title acronym:

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:

俞涌飞

研究负责人:

周恩超

Applicant:

Yongfei Yu

Study leader:

Enchao Zhou

申请注册联系人电话:

Applicant telephone:

13771489081

研究负责人电话:

Study leader's telephone:

13851572603

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:

yongfeiyumarch@126.com

研究负责人电子邮件:

Study leader's E-mail:

zhouenchao@njucm.edu.cn

申请单位网址(自愿提供):

Study leader's 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:

江苏省南京市汉中路155号

研究负责人通讯地址:

江苏省南京市汉中路155号

Applicant address:

155 Hanzhong Road Nanjing Jangsu China

Study leader's address:

155 Hanzhong Road Nanjing Jiangsu China

申请注册联系人邮政编码:

Applicant postcode:

210000

研究负责人邮政编码:

Study leader's postcode:

210000

申请人所在单位:

南京中医药大学附属医院(江苏省中医院)

Applicant's institution:

The Affiliated Hospital of Nanjing University of Traditional Chinese Medicine (Jiangsu Provincial Hospital of Traditional Chinese Medicine)

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

2022NL-213-02

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

南京中医药大学附属医院(江苏省中医院)伦理委员会

Name of the ethic committee:

Ethics Committee of the Affiliated Hospital of Nanjing University of Traditional Chinese Medicine (Jiangsu Provincial Hospital of Traditional Chinese Medicine).

伦理委员会批准日期:

Date of approved by ethic committee:

2023/1/6 0:00:00

伦理委员会联系人:

王卯

Contact Name of the ethic committee:

Mao Wang

伦理委员会联系地址:

江苏省南京市汉中路155号

Contact Address of the ethic committee:

155 Hanzhong Road Nanjing Jangsu China

伦理委员会联系人电话:

Contact phone of the ethic committee:

025-86560515

伦理委员会联系人邮箱:

Contact email of the ethic committee:

llwyhbgs@qq.com

研究实施负责(组长)单位:

南京中医药大学附属医院(江苏省中医院)

Primary sponsor:

The Affiliated Hospital of Nanjing University of Traditional Chinese Medicine (Jiangsu Provincial Hospital of Traditional Chinese Medicine)

研究实施负责(组长)单位地址:

江苏省南京市汉中路155号

Primary sponsor's address:

155 Hanzhong Road Nanjing Jangsu 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):

江苏省

市(区县):

南京市

Country:

China

Province:

Jiangsu

City:

Nanjing

单位(医院):

南京中医药大学附属医院(江苏省中医院)

具体地址:

江苏省南京市汉中路155号

Institution
hospital:

The Affiliated Hospital of Nanjing University of Traditional Chinese Medicine (Jiangsu Provincial Hospital of Traditional Chinese Medicine)

Address:

155 Hanzhong Road Nanjing Jangsu China

经费或物资来源:

江苏省研究生实践创新计划

Source(s) of funding:

Jiangsu Leading Talents Project of Traditional Chinese Medicine

研究疾病:

慢性肾炎

研究疾病代码:

Target disease:

Chronic nephritis

Target disease code:

研究类型:

Study type:

观察性研究

Observational study

研究设计:

Study design:

连续入组

Sequential

研究所处阶段:

Study phase:

探索性研究/预试验

Pilot clinical trial

研究目的:

通过风邪证候评分表,研究风邪与慢性肾炎蛋白尿的相关性,并探寻能够反映风邪的物质基础。

Objectives of Study:

Through the Wind Pathogenic Syndrome Scoring Table and Kidney Essence Deficiency Scoring Table we studied the correlation between wind pathogenic syndrome and proteinuria in chronic nephritis and explored the material basis that reflects wind pathogenic syndrome.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

1. 符合慢性肾炎诊断标准,以蛋白尿为主要表现; 2. 年龄在18~75岁之间,性别不限。 3. 尿蛋白定量≦3.5g/24h; 4.通过CKD-EPI公式计算eGFR>60ml/min/1.73m2; 5. 知情同意,志愿受试。获得知情同意书过程应符合GCP规定。

Inclusion criteria

1. Meet the diagnostic criteria for chronic nephritis with proteinuria as the main manifestation; 2. Aged between 18 and 75 years with no gender restrictions; 3. Urine protein quantification ≤3.5g/24h; 4.Using the CKD-EPI formula eGFR is calculated to be greater than 60 ml/min/1.73m². 5. Informed consent voluntary participation. The process of obtaining informed consent should comply with GCP regulations.

排除标准:

1. 继发性慢性肾脏病,包括系统性红斑狼疮、高血压肾损害、糖尿病肾病、痛风性肾病以及药物性肾损害等; 2. 合并有心、脑、肝、肺等严重的基础疾病、造血系统疾患、或伴有恶性肿瘤等消耗性疾病; 3. 急性肾衰竭或肾移植术后; 4. 目前正在使用激素或免疫抑制剂治疗者; 5. 由于智力或行为障碍不能给予充分知情同意者。 6. 怀疑或确有酒精、药物滥用病史。 7. 伴有严重的精神疾患或正处在妊娠期、哺乳期者; 8. 正在参加其他药物临床试验的患者。

Exclusion criteria:

1. Secondary chronic kidney disease including systemic lupus erythematosus hypertension-related kidney damage diabetic nephropathy gouty nephropathy and drug-induced nephropathy; 2. Patients with severe underlying diseases such as heart brain liver and lung diseases hematological disorders or malignant tumors and other debilitating diseases; 3. Acute renal failure or post-renal transplantation; 4. Patients currently receiving treatment with steroids or immunosuppressants; 5. Patients who cannot provide adequate informed consent due to intellectual or behavioral disabilities; 6. Patients with a history of alcohol or drug abuse; 7. Patients with severe mental disorders or those who are pregnant or breastfeeding; 8. Patients who are currently participating in other drug clinical trials.

研究实施时间:

Study execute time:

From 2023-01-06

To      2024-12-31

征募观察对象时间:

Recruiting time:

From 2023-01-06

To      2024-12-31

干预措施:

Interventions:

组别:

慢性肾炎组

样本量:

150

Group:

Chronic nephritis group

Sample size:

干预措施:

干预措施代码:

Intervention:

none

Intervention code:

样本总量 Total sample size : 150

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

江苏省

市(区县):

南京市

Country:

China

Province:

Jiangsu

City:

Nanjing

单位(医院):

南京中医药大学附属医院(江苏省中医院)

单位级别:

三甲

Institution/hospital:

The Affiliated Hospital of Nanjing University of Traditional Chinese Medicine (Jiangsu Provincial Hospital of Traditional Chinese Medicine)

Level of the institution:

grade A tertiary hospital

测量指标:

Outcomes:

指标中文名:

风邪证候评分

指标类型:

主要指标

Outcome:

Wind-evil syndrome score

Type:

Primary indicator

测量时间点:

入组一周以内

测量方法:

Measure time point of outcome:

within one week after the test

Measure method:

指标中文名:

血清组学

指标类型:

附加指标

Outcome:

Seromics

Type:

Additional indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿微量蛋白/尿肌酐

指标类型:

次要指标

Outcome:

urine microprotein/urine creatinine serum

Type:

Secondary indicator

测量时间点:

入组前后2周以内

测量方法:

Measure time point of outcome:

Within 2 weeks before and after test

Measure method:

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:

入组前后2周以内

测量方法:

Measure time point of outcome:

Within 2 weeks before and after test

Measure method:

指标中文名:

24h尿蛋白定量

指标类型:

次要指标

Outcome:

24-hour urine protein

Type:

Secondary indicator

测量时间点:

入组前后2周以内

测量方法:

Measure time point of outcome:

Within 2 weeks before and after test

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

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:

标本中文名:

血液

组织:

Sample Name:

Boold

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:

正在进行

Recruiting

年龄范围:

最小 18
Min age years
最大 75
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

无需随机

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

No need to be random

盲法:

Blinding:

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):

EXCEL和SPSS数据库

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

EXCEL and SPSS database

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:

采用病例记录表进行采集和管理

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

Case record form was used for collection and management.

数据管理委员会:

Data Managemen Committee:

暂未确定

Not yet

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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