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评价尿毒清颗粒延缓慢性肾脏病(CKD3-4期)进展的多中心、随机、双盲、安慰剂对照的临床试验
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注册号:

Registration number:

ChiCTR-TRC-12002448 

最近更新日期:

Date of Last Refreshed on:

2015-09-24 

注册时间:

Date of Registration:

2012-08-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

评价尿毒清颗粒延缓慢性肾脏病(CKD3-4期)进展的多中心、随机、双盲、安慰剂对照的临床试验 

Public title:

Effects of Niaoduqing Particles in preventing the progression of stage 3-4 chronic kidney disease: a multicenter, double-blind, randomized, placebo-controlled trial 

研究课题的正式科学名称:

评价尿毒清颗粒延缓慢性肾脏病(CKD3-4期)进展的有效性及安全性的多中心、随机、双盲、安慰剂对照的临床试验 

Scientific title:

A prospective, multi-Center, double-blind, randomized, placebo-controlled study to assess the safety andefficacy of Niaoduqing Particles in preventing the progression of stage 3-4 chronic kidney disease 

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:

张利 

研究负责人:

陈香美 

Applicant:

Li Zhang 

Study leader:

Xiangmei Chen 

申请注册联系人电话:

Applicant telephone:

+86 1368157581 

研究负责人电话:

Study leader's telephone:

+86 10 66395462 

申请注册联系人传真 :

Applicant Fax:

+86 10 68130297 

研究负责人传真:

Study leader's fax:

+86 10 68130297 

申请注册联系人电子邮件:

Applicant E-mail:

zhangl301@hotmail.com 

研究负责人电子邮件:

Study leader's E-mail:

xmchen301@126.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:

北京市海淀区复兴路28号 

研究负责人通讯地址:

北京市海淀区复兴路28号 

Applicant address:

28 Fuxing Road, Haidian District, Beijing 

Study leader's address:

28 Fuxing Road, Haidian District, Beijing 

申请注册联系人邮政编码:

Applicant postcode:

100853 

研究负责人邮政编码:

Study leader's postcode:

100853 

申请人所在单位:

中国人民解放军总医院 

Applicant's institution:

Chinese General Hospital of PLA 

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:

2012032-02 

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:

中国人民解放军总医院医学伦理委员会 

Name of the ethic committee:

Ethic committee of Chinese General Hospital of PLA 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-05-27 

研究实施负责(组长)单位:

中国人民解放军总医院 

Primary sponsor:

Chinese General Hospital of PLA 

研究实施负责(组长)单位地址:

北京市海淀区复兴路28号 

Primary sponsor's address:

28 Fuxing Road, Haidian District, Beijing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

康臣药业(内蒙古)有限责任公司 

Source(s) of funding:

CONSUN PHARMACEUTICAL GROUP (Inner Mongolia) 

研究疾病:

慢性肾脏病 

Target disease:

Chronic 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:

上市后药物 

Study phase:

Post-market 

研究目的:

评价尿毒清颗粒改善肾功能,延缓慢性肾脏病(CKD4期)进展的有效性及安全性 

Objectives of Study:

To assess the safety andefficacy of Niaoduqing Particles on patients with stage 4 chronic kidney disease. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照试验 

Study design:

Randomized parallel controlled trial 

纳入标准:

1.年龄18-70岁,性别不限,门诊或住院病人均可; 2.西医诊断为CKD 3-4期 CKD分期标准,CKD3-4期(肾功能中重度下降),eGFR20~45ml/(ml/min/1.73m2); 3.中医辨证属脾虚湿浊或脾虚血瘀证者; 中医辨证分型标准 本虚证: 脾肾气虚证 主要症状:倦怠乏力,腰酸膝软,夜尿清长; 次要症状:面色萎黄或少华,脘腹胀满,食少纳呆,大便稀溏。 (具备以上二项主要症状,或一项主要症状,二项次要症状即可做出诊断) 标实证: 湿浊证: 主要症状:恶心呕吐,水肿; 次要症状:口中粘腻,肢体困重,大便粘滞。 血瘀证: 主要症状:腰痛固定或刺痛,口唇舌紫暗、有瘀斑点; 次要症状:面色晦暗,肌肤甲错,肢体麻木。 (具备以上一项主要症状或二项次要症状即可诊断); 4.高血压能够有效控制,血压≤140/90mmHg; 5.自愿签署知情同意书参加试验。 

Inclusion criteria

1. Male or female 18-70 years of age; 2. Patients with chronic kidney disease in stage 3-4 (GFR20-45ml/(ml/min/1.73m2)); 3. According to syndrome differentiation of Traditional Chinese Medicine (TCM) it belongs to damp filth anddeficient spleen or spleen deficiency andblood stasis; Standards for Syndrome Differentiation Typing of TCM; Primary Deficiency Syndrome: Both Spleen Qi andKidney Qi Deficiency Syndrome; The main symptoms: weakness, fatigue, lumbus andknees debility, cool andincreased nocturia; The minor symptoms: pale complexion, abdominal distension, anorexia, thin sloopy stool. (It could be diagnosed with more than two major symptoms, or a major symptom andtwo minor symptoms) The secondary excess syndrome: Damp Pathogen Syndrome: The main symptoms: nausea, vomiting, edema; The minor symptoms: greasy mouth, heavy sensation in limbs, sticky stools; Blood Stasis Syndrome: The main symptoms: fixed or stabbing pain of low back, dark purple mouth lips andtongue with ecchymosis or point. The minor symptoms: blackish complexion, coarse skins, Limb Numbness. (It could be diagnosed with the main symptoms of more than one or two minor symptoms) 4. Hypertension can be effectively controlled, blood pressure <=140/90mmHg; 5. Signed the informed consent form prior to the study participation. 

排除标准:

1、过敏体质或对多种药物过敏者; 2、肾病综合征、狼疮性肾炎等免疫性疾病; 3、入组前1个月内曾使用尿毒清颗粒; 4、入组前1个月内及试验期间使用含大黄的或影响肾功能的中药和中成药、活性碳、吸附剂等; 5、入组前3个月内及试验期间使用激素和免疫抑制剂(包括雷公藤多苷片); 6、拟行肾脏替代治疗者; 7、合并有感染性疾病包括尿路感染、非感染性炎症疾病或近期有急性感染; 8、存在影响药物吸收的严重消化道疾病,如活动性溃疡、慢性腹泻、胃肠道术后等; 9、合并有心、脑、肝和造血系统等严重原发性疾病; 10、存在急性尿路梗阻性疾病,需行外科手术治疗。 11、无法合作者,如精神病患者。 12、妊娠或哺乳期妇女。 13、酒精、药物滥用史者。 14、正在参加另外一项临床试验者。 15、其他:研究者认为不应入组者。 

Exclusion criteria:

Allergic constitution or allergic to multiple drugs; Nephritic syndrome, lupus nephritis andother autoimmune diseases; Previous treatment with Niaoduqing particles within one month; Previous treatment with herb or traditional Chinese patent medicines andsimple preparations which contains rhubarb or something affect renal function, activated carbon andadsorbent etc. in recent month or during the trial period; Previous treatment with glucocorticoid or immunosuppressive agents (including tripterygium glycosides tablet) within three months or during the trial period; Proposes to perform renal replacement; Infectious diseases, including urinary tract infections, non-infectious inflammatory disease or acute infection recently; Serious gastrointestinal disease which affect drug absorption, such as active ulcer, chronic diarrhea, post gastrointestinal surgery etc. Severe cardiovascular, brain, liver, or hematopoietic system disease. Acute urinary tract obstruction, need surgical treatment. Can not be partners, such as the mentally ill. Women in pregnancy or lactation; With alcohol or drug abuse; Enrolled in other trials; Any other conditions that researchers think not suitable for this experiment. 

研究实施时间:

Study execute time:

FromTo 2013-12-31 

干预措施:

Interventions:

组别:

治疗组

样本量:

150

Group:

treated group

Sample size:

干预措施:

尿毒清颗粒温开水冲服,每日四次,每次一袋,最后一次服用2袋

干预措施代码:

Intervention:

Taking Niaoduqing particles with warm boiled water, 1 bag, tid, 2 bags,qn

Intervention code:

组别:

对照组

样本量:

150

Group:

controlled group

Sample size:

干预措施:

安慰剂温开水冲服,每日4次,每次一袋,最后一次服用2袋

干预措施代码:

Intervention:

Taking placebo with warm boild water,1 bag,tid, 2 bags, qn

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):

海淀区 

Country:

China 

Province:

Beijing 

City:

haidian district 

单位(医院):

中国人民解放军总医院 

单位级别:

三甲 

Institution
hospital:

Chinese PLA General Hospital  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

吉林省 

市(区县):

长春市 

Country:

China 

Province:

Jilin Province 

City:

Changchun 

单位(医院):

吉林大学附属二院 

单位级别:

三甲 

Institution
hospital:

The second hospital of jilin university  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

辽宁省 

市(区县):

大连市 

Country:

China 

Province:

Liaoning Province 

City:

Dalian 

单位(医院):

大连医科大学第一附属医院 

单位级别:

三甲 

Institution
hospital:

The First Affiliated Hospital of Dalian Medical University  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

广东省 

市(区县):

广州市 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

广东省中医院 

单位级别:

三甲 

Institution
hospital:

Guangdong Province Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

西城区 

Country:

China 

Province:

Beijing 

City:

xicheng district 

单位(医院):

中国中医科学院广安门医院等 

单位级别:

三甲 

Institution
hospital:

Guang’anmen Hospital, China Academy of Chinese Medical Sciences  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

血肌酐和肾小球滤过率

指标类型:

主要指标 

Outcome:

serum creatitine and eGFR

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胱抑素C

指标类型:

主要指标 

Outcome:

cystatin

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

24小时尿蛋白定量

指标类型:

次要指标 

Outcome:

24h urinary protein excretion

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿白蛋白/尿肌酐比值

指标类型:

次要指标 

Outcome:

urinary albumin/ urinary creatintine

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

贫血指标

指标类型:

次要指标 

Outcome:

biochemical indices of anemia

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血尿素氮

指标类型:

次要指标 

Outcome:

blood urea nitrogen

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

超敏C反应蛋白

指标类型:

次要指标 

Outcome:

hs-CRP

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

丙二醛

指标类型:

次要指标 

Outcome:

MDA

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

超氧化物歧化酶

指标类型:

次要指标 

Outcome:

Superoxide dismutase (SOD)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿白介素-6

指标类型:

次要指标 

Outcome:

urinary IL-6

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿中性粒细胞明胶酶相关性脂质运载蛋白

指标类型:

次要指标 

Outcome:

urinary NGAL

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

脾虚湿浊的表现

指标类型:

附加指标 

Outcome:

symptoms of damp filth and deficient spleen

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

脾虚血瘀的表现

指标类型:

附加指标 

Outcome:

symptoms of spleen deficiency and blood stasis

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

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:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血电解质

指标类型:

副作用指标 

Outcome:

serum electrolytes

Type:

Adverse events 

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:

副作用指标 

Outcome:

biochemical indices of lipid level

Type:

Adverse events 

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:

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:

结束

Completed

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):

由专业统计人员应用SAS9.2软件进行分层区组随机化

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

Stratified randomization will be done by the Professional statisticians using SAS9.2

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:

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):

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

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:

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

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2012-08-15
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