Today is 2014-07-29

A Study of the Clinical Manifestation and the Therapy of Chronic Hepatitis B Combining Traditional Chinese with Western Medicine

注册号:

Registration number:

ChiCTR-TRC-09000594 

注册号获得时间:

Date of releasing the registration number:

2010/06/26 

注册号状态:

预注册 

Registration Status:

Prospective registration 

注册题目:

慢性乙型肝炎证侯规律及中西医结合治疗方案研究(ALT1~2×ULN) 

Public title:

A Study of the Clinical Manifestation and the Therapy of Chronic Hepatitis B Combining Traditional Chinese with Western Medicine 

研究课题的正式科学名称:

慢性乙型肝炎证侯规律及中西医结合治疗方案研究(ALT1~2×ULN) 

Scientific title:

A Randomized clinical trial of Lingmao granules compared with Entecavir for Chronic hepatitis B 

研究课题代号(代码):

Study subject ID:

2008ZX10005-006 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

周振华 

研究负责人:

高月求 

Applicant:

Zhenhua Zhou 

Study leader:

Yueqiu Gao 

申请注册联系人电话:

Applicant telephone:

+86 15800586832 

研究负责人电话:

Study leader's telephone:

+86 13795388789 

申请注册联系人传真 :

Applicant Fax:

+86 21 53823660 

研究负责人传真:

Study leader's fax:

+86 21 53823660 

申请注册联系人电子邮件:

Applicant E-mail:

jinghua1220@163.com 

研究负责人电子邮件:

Study leader's E-mail:

gaoyueqiu@hotmail.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

http://www.sgyy.cn/ 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

http://www.sgyy.cn/ 

申请注册联系人通讯地址:

上海卢湾区普安路185号 

研究负责人通讯地址:

上海卢湾区普安路185号 

Applicant address:

NO.185, Pu'an Road, Luwan District, Shanghai City, China 

Study leader's address:

NO.185, Pu'an Road, Luwan District, Shanghai City 

申请注册联系人邮政编码:

Applicant postcode:

200021 

研究负责人邮政编码:

Study leader's postcode:

200021 

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:

2009-N095-01 

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:

上海中医药大学附属曙光医院伦理委员会 

Name of the ethic committee:

Ethic Committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medici 

伦理委员会批准日期:

Date of approved by ethic committee:

2009/04/20 

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:

上海卢湾区普安路185号 

Primary sponsor's address:

NO.185, Pu'an Road, Luwan District, Shanghai City 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

省(直辖市):

市(区县):

Country:

Province:

City:

单位(医院):

卫生部

具体地址:

北京市海淀区双清路83号

Institution
hospital:

Ministry of Public Health

Address:

No. 83, Shuangqing Road, Haiding District, Beijing

经费或物资来源:

国家卫生部 

Source(s) of funding:

Ministry of Public Health 

研究疾病:

慢性乙型肝炎 

Target disease:

Chronic Hepatitis B 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional 

研究所处阶段:

上市后药物 

Study phase:

Post-market 

研究目的:

1、研发中医四诊信息结构化数据采集平台。 2、构建慢性乙型肝炎(ALT1~2×ULN)证候数字化判识模式。 3、明确慢性乙型肝炎(ALT1~2×ULN)中医证候分布规律。 4、初步形成疗效确切的可供推广应用的慢性乙型肝炎(ALT1~2×ULN)中西医结合、中医辨证治疗方案。 5、建立慢性乙型肝炎临床数据库、血清库、病理库。 

Objectives of Study:

1.To establish an information-structured, data- collection platform of four diagnostic methods. 2.To build a digital sub-consciousness mode of Clinical Manifestation. 3.To research the Clinical Manifestation Distribution of Chronic Hepatitis B. 4.To form an treatment protocol of combined TCM with Western medicine for Chronic Hepatitis B. 5.To create the clinical data base, serum and pathology database of Chronic Hepatitis B. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

①年龄18-65周岁。 ②符合慢性乙型肝炎的诊断标准未进行西药抗病毒治疗者。 ③1×ULN≤ALT<2×ULN。 ④近1个月内未应用过保肝降酶中西药物。 ⑤签订知情同意书。 

Inclusion criteria

1. Male and female aged 18 to 65 years old. 2. Diagnosed as Chronic Hepatitis B, have not been treated with anti-viral treatment in western medicine. 3.1×ULN≤ALT<2×ULN. 4. Patients who have not been treated with Chinese and western medicine to reduce transaminase in the latest month. 5. Able and willing to provide signed informed consent. 

排除标准:

①慢性乙型肝炎ALT>2×ULN。 ②慢性重型肝炎和肝硬化。 ③合并其它嗜肝病毒感染的肝炎。 ④伴有心、肾、肺、内分泌、血液、代谢及胃肠道严重原发病者;或精神病患者。 ⑤孕妇或哺乳期妇女。 ⑥过敏体质或多种药过敏的患者。 

Exclusion criteria:

1. Chronic Severe Hepatitis and Liver Cirrhosis. 2. Hepatitis infected with other type of hepatovirus. 3. Patients who have serious primary disease in heart, kidney, lung, endocrine system, blood, metabolism, or gastrointestinal tract. 4. Patients with mental disease. 5. Pregnant or lactating women. 6. allergic to drug. 

研究实施时间:

Study execute time:

From2008-12-1To 2010-12-31 

干预措施:

Interventions:

组别:

抗病毒中药安慰剂组

样本量:

150

Group:

Group A

Sample size:

干预措施:

恩替卡韦片 0.5mg/次,1次/日+灵猫颗粒1 1包/2次/日 冲服,治疗12个月,随访6个月

干预措施代码:

Intervention:

Entecavir 0.5mg orally taken once daily for 12 months, and Lingmao Granules 1 one package orally taken twice daily for 12 months (six-month follow-up)

Intervention code:

组别:

非抗病毒中药治疗组

样本量:

150

Group:

Group B

Sample size:

干预措施:

恩替卡韦片 0.5mg/次,1次/日+灵猫颗粒2 1包/2次/日 冲服,治疗12个月,随访6个月

干预措施代码:

Intervention:

Entecavir 0.5mg orally taken once daily for 12 months, and Lingmao Granules 2 one package orally taken twice daily for 12 months (six-month follow-up)

Intervention code:

组别:

非抗病毒中药安慰剂组

样本量:

150

Group:

Group C

Sample size:

干预措施:

灵猫颗粒1 1包/2次/日 冲服,治疗12个月,随访6个月

干预措施代码:

Intervention:

Lingmao Granules 1 one package orally taken twice daily for 12 months (six-month follow-up)

Intervention code:

组别:

抗病毒中药治疗组

样本量:

150

Group:

Group D

Sample size:

干预措施:

灵猫颗粒2 1包/2次/日 冲服,治疗12个月,随访6个月

干预措施代码:

Intervention:

Lingmao Granules 2 one package orally taken twice daily for 12 months (six-month follow-up)

Intervention code:

组别:

总数

样本量:

600

Group:

Total

Sample size:

干预措施:

干预措施代码:

Intervention:

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 

Institution
hospital:

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine 

Level of the institution:

Tertiary 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龙华医院 

单位级别:

三级甲等 

Institution
hospital:

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine 

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国中医科学院西苑医院 

单位级别:

三级甲等 

Institution
hospital:

Xiyuan Hospital of China Academy 

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

山东 

市(区县):

 

Country:

China 

Province:

Shandong 

City:

 

单位(医院):

山东中医药大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

 

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

山西 

市(区县):

 

Country:

China 

Province:

Shanxi 

City:

 

单位(医院):

山西中医药研究院附属医院 

单位级别:

三级甲等 

Institution
hospital:

 

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

安徽 

市(区县):

 

Country:

China 

Province:

Anhui 

City:

 

单位(医院):

安徽中医学院第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

 

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

湖北 

市(区县):

 

Country:

China 

Province:

Hubei 

City:

 

单位(医院):

湖北省中医院 

单位级别:

三级甲等 

Institution
hospital:

 

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

浙江 

市(区县):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江省中医院 

单位级别:

三级甲等 

Institution
hospital:

 

Level of the institution:

Tertiary hospital 

国家:

中国 

省(直辖市):

河南 

市(区县):

 

Country:

China 

Province:

Henan 

City:

 

单位(医院):

河南中医药大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

 

Level of the institution:

Tertiary hospital 

测量指标:

Outcomes:

指标中文名:

Outcome:

HBV DNA

指标中文名:

肝脏穿刺

Outcome:

Liver Biopsy

指标中文名:

肝功能

Outcome:

Liver Function index

指标中文名:

B超

Outcome:

Liver morphological change

指标中文名:

乙肝全套

Outcome:

HBV antigen and antibody complete set test

指标中文名:

慢性乙型肝炎生存质量量表

Outcome:

Quality of life scale for Chronic Hepatitis B

采集人体标本:

Collecting sample(s)
from participants:

未填写任何采集标本。

No sample added。

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 65 years

随机方法(请说明由何人用什么方法产生随机序列):

随机数字表

性别:

男女均可

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

randomization table

Gender:

Both

盲法:

患者 是 研究者 是

Blinding:

Researcher: Yes Patient: Yes

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

Organizer institution (leader institution):

资料收集汇总单位:

上海中医药大学附属曙光医院

Data collection Institution:

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

资料管理单位:

上海中医药大学附属曙光医院

Data management Institution:

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

资料分析单位:

上海中医药大学附属曙光医院

Data analysis Institution:

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

创建人:

Creater Name:

周振华 2009/11/16 0:00:00
Return to list