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中医药抗病毒治疗艾滋病临床研究
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注册号:

Registration number:

ChiCTR-INR-17010324 

最近更新日期:

Date of Last Refreshed on:

2017-01-04 

注册时间:

Date of Registration:

2017-01-04 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

中医药抗病毒治疗艾滋病临床研究 

Public title:

Clinical study of Chinese medicine antiviral therapy for AIDS 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

艾滋病急性药物性肝损伤(气血亏虚、肝胆湿热证)中医诊疗方案临床研究 

Scientific title:

Clinical Study on TCM Diagnosis and Treatment Scheme of Acute Drug-Induced Liver Injury by Anti-AIDS Drugs (Gan-Dan Damp-Heat Syndrome and Qi-Blood Deficiency 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:

李鑫 

研究负责人:

李鑫 

Applicant:

Li Xin 

Study leader:

Li Xin 

申请注册联系人电话:

Applicant telephone:

+86 13910908996 

研究负责人电话:

Study leader's telephone:

+86 13910908996 

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:

leaxin@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

leaxin@sina.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:

北京朝阳区京顺东街8号 

研究负责人通讯地址:

北京朝阳区京顺东街8号 

Applicant address:

8 East Jingshun Road, Chaoyang District, Beijing 

Study leader's address:

8 East Jingshun Road, Chaoyang District, Beijing 

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:

首都医科大学附属北京地坛医院 

Applicant's institution:

Beijing Ditan Hospital Capital Medical University 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

Name of the ethic committee:

 

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:

首都医科大学附属北京地坛医院 

Primary sponsor:

Beijing Ditan Hospital Capital Medical University 

研究实施负责(组长)单位地址:

北京朝阳区京顺东街8号 

Primary sponsor's address:

8 East Jingshun Road, Chaoyang District, Beijing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京市

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

首都医科大学附属北京地坛医院

具体地址:

北京朝阳区京顺东街8号

Institution
hospital:

Beijing DiTan Hospital Capital Medical University

Address:

8 East Jingshun Road, Chaoyang District, Beijing

经费或物资来源:

中国中医科学院 

Source(s) of funding:

China Academy Chinese medical Science 

研究疾病:

艾滋病急性药物性肝损伤(气血亏虚、肝胆湿热证) 

Target disease:

Acute Drug-Induced Liver Injury by Anti-AIDS Drugs (Gan-Dan Damp-Heat Syndrome and Qi-Blood Deficiency Syndrome) 

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:

主要目的:验证中医药分型治疗艾滋病急性药物性肝损伤方案的临床疗效及安全性。评价益气养血、清热利湿法治疗艾滋病药物性肝损伤(气血亏虚、肝胆湿热证)的疗效,优化中医药治疗艾滋病急性药物性肝损伤治疗方案。 次要目的:在获取参芪肝康胶囊治疗艾滋病急性药物性肝损伤疗效基础上,探讨其对艾滋病患者的免疫功能及生存质量的影响。 

Objectives of Study:

Main objective: To verify the clinical efficacy and safety of traditional Chinese medicine in the treatment of acute drug-induced liver injury by anti-AIDS drugs. Evaluation of Nourishing Qi, clearing heat and removing dampness in the treatment of drug-induced liver injury (Gan-Dan Damp-Heat Syndrome and Qi-Blood Deficiency Syndrome) curative effect, optimization of Chinese medicine treatment of AIDS treatment of acute drug-induced liver injury. Secondary objective: To explore the effect of the immune function and quality of life of AIDS patients with acute drug induced liver injury. 

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符合HIV/AIDS诊断标准者; ②年龄18-65岁,男女均可; ③符合药物性肝损伤诊断标准,且具备以下条件: 病程小于3个月 ALT或AST<5 ULN TBil <2.5 ULN INR<1.5 PTA≥60% 嗜酸性粒细胞<5% ④符合中医气血亏虚、肝胆湿热表现症候者; ⑤自愿参加随机对照研究,签署知情同意书,可规律随访。 

Inclusion criteria

1. Compliance with HIV/AIDS diagnostic criteria; 2. Aged 18-65 years old, male or female; 3. In accordance with the diagnostic criteria for drug-induced liver injury, and meet the following conditions: (1) Course of disease is less than 3 months; (2) ALT or AST < 5 ULN; (3) TBil < 2.5 ULN; (4) INR < 1.5; (5) PTA = 60%; (6) Eosinophils < 5%; 4. In accordance with the Gan-Dan Damp-Heat Syndrome and Qi-Blood Deficiency Syndrome performance; 5. The voluntary randomized controlled study, signed informed consent, can be regular follow-up. 

排除标准:

①小于18岁或大于65岁; ②急性及亚急性肝衰竭患者,或重度肝损伤患者; ③HAV、HBV、HCV、HEV、EBV、CMV感染、脂肪肝(酒精性、非酒精性)、肝硬化、肝癌、自身免疫性肝病、胆汁淤积性疾病、遗传代谢性肝病等其他非药物因素导致的肝损伤患者; ④心功能不全、低血压、休克、各种非药物性因素引起的血管闭塞性疾病; ⑤妊娠期及哺乳期妇女,或者准备妊娠妇女; ⑥存在智力或语言障碍者,精神病患者; ⑦正参加其他临床试验者; ⑧过敏体质者; ⑨研究者认为不适宜参加试验的其他情况。 

Exclusion criteria:

1. Patients with acute or subacute liver failure or severe liver injury; 2. The HAV, HBV, HCV, HEV, EBV, CMV infection and fatty liver (alcoholic and non-alcoholic), cirrhosis, liver cancer, autoimmune liver disease, cholestatic disease and genetic metabolic liver disease and other non drug factors of liver injury; 3. The heart failure, hypotension, shock, non drug induced factors of vascular occlusive disease; 4. The pregnancy and breast-feeding women, or ready for pregnant women; 5. The patients with the disorders of the intelligence or language, psychiatric patients; 6. Patients attending other clinical trials; 7. The allergy; 8. The investigators think the situation is not suitable for other researchers in the study. 

研究实施时间:

Study execute time:

From2015-05-01To 2020-05-31 

征募观察对象时间:

Recruiting time:

From2017-09-01To 2019-01-01 

干预措施:

Interventions:

组别:

治疗组

样本量:

100

Group:

Treatment group

Sample size:

干预措施:

参芪肝康胶囊

干预措施代码:

Intervention:

Intervention code:

组别:

对照组

样本量:

100

Group:

Control group

Sample size:

干预措施:

复方甘草酸苷胶囊

干预措施代码:

Intervention:

Compound Glycyrrhizin Capsules

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 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

首都医科大学附属北京地坛医院 

单位级别:

三级甲等医院 

Institution
hospital:

Beijing DiTan Hospital Capital Medical University  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

肝功能生化指标

指标类型:

主要指标 

Outcome:

liver function test

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医证候积分

指标类型:

主要指标 

Outcome:

TCM syndrome scores

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 65 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):

通过SPSS软件产生两组120例受试者所接受处理(治疗组和对照组)的随机安排,即列出流水号为001~120所对应的治疗分配表,研究者从数据管理单位取得患者的随机号。

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

Have accepted two groups of 120 subjects with SPSS software (treatment group and control group) randomly arranged, which lists the serial number is 001 ~ 120 corresponding to the treatment allocation table, researchers have a random number with the data management unit.

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):

试验完成后6个月内公开

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

The dada will be disclosed within six months after completion of the study.

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:

本课题设计有临床专用CRF表,专人进行纸质记录,保存于研究者处。

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

Each patient is required to fill one CRF table, all the CRF tables saved by researchers.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2017-01-04
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