今天是:2019-04-22 星期一

凉血地黄汤治疗痔疮出血随机、对照、 双盲、双模拟、多中心临床研究
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注册号:

Registration number:

ChiCTR1900022531 

最近更新日期:

Date of Last Refreshed on:

2019-04-15 

注册时间:

Date of Registration:

2019-04-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

凉血地黄汤治疗痔疮出血随机、对照、 双盲、双模拟、多中心临床研究 

Public title:

Traditional Chinese medicine (Liang-Xue-Di-Huang Decoction ) for hemorrhoid hemorrhage: a randomized, controlled, double blind, double simulation and multi-center trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中医肛肠病学—凉血地黄汤治疗痔疮出血随机、对照、 双盲、双模拟、多中心临床研究 

Scientific title:

traditional chinese colo-proctology—Traditional Chinese medicine (Liang-Xue-Di-Huang Decoction ) for hemorrhoid hemorrhage: a randomized, controlled, double blind, double simulation and multi-center trial 

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:

周青 

研究负责人:

陈玉根 

Applicant:

Qing Zhou 

Study leader:

Yugen Chen 

申请注册联系人电话:

Applicant telephone:

+86 13601401869 

研究负责人电话:

Study leader's telephone:

+86 13701409418 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

025-86626161 

申请注册联系人电子邮件:

Applicant E-mail:

13601401869@163.com 

研究负责人电子邮件:

Study leader's E-mail:

chenyg666@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:

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, Jiangsu, China 

Study leader's address:

155 Hanzhong Road, Nanjing, Jiangsu, China 

申请注册联系人邮政编码:

Applicant postcode:

210029 

研究负责人邮政编码:

Study leader's postcode:

210029 

申请人所在单位:

南京中医药大学附属医院 

Applicant's institution:

Affiliated Hospital of Nanjing University of 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:

2019NL-158-02 

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:

南京中医药大学附属医院 

Name of the ethic committee:

Affiliated Hospital of Nanjing University of Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-01-10 

伦理委员会联系人:

吴静 

Contact Name of the ethic committee:

Jing Wu 

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, Jiangsu, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 025-86560515 

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:

南京中医药大学附属医院 

Primary sponsor:

Affiliated Hospital of Nanjing University of 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, Jiangsu, 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

具体地址:

汉中路155号

Institution
hospital:

Affiliated Hospital of Nanjing University of Chinese Medicine

Address:

155 Hanzhong Road

经费或物资来源:

国家中医药管理局名医验方评价与转化重点研究室 

Source(s) of funding:

key laboratory of prescription evaluation and transformation,State administration of Traditional Chinese Medicine 

研究疾病:

痔疮 

Target disease:

hemorrhoid 

研究疾病代码:

I84.200 

Target disease code:

I84.200 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

1. 评价凉血地黄汤用于痔疮出血的有效性。 2. 评价凉血地黄汤用于痔疮出血的安全性。 

Objectives of Study:

1. To evaluate the effectiveness of Liang-Xue-Di-Huang Decoction in hemorrhoid hemorrhage. 2. To evaluate the safety of Liang-Xue-Di-Huang Decoction for hemorrhoid hemorrhage. 

药物成份或治疗方案详述:

凉血地黄汤,出自清朝《外科大成》卷二,由当归一钱五分(4.5g),生地二钱(6g),赤芍一钱(3g),黄连(炒)二钱(6g),枳壳一钱(3g),黄芩(炒黑)一钱(3g),槐角(炒黑)三钱(9g),地榆(炒黑)二钱(6g),荆芥(炒黑)一钱(3g),升麻五分(1.5g),天花粉八分(2.4g),甘草五分(1.5g),生侧柏二钱(6g)组成,合计饮片54.9g。为每日总剂量,午餐和晚餐后1-2小时服用,连续7天。功效:清热燥湿,凉血止血。治湿热侵入直肠,血络损伤,痔疮肿痛出血。 

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. 符合内痔I期、Ⅱ期、Ⅲ期诊断标准; 2. 符合《中医病证诊断疗效标准》风伤肠络或湿热下注证:内痔出血呈喷射状或点滴而下,血色鲜红者; 3. 签署知情同意书的患者。 

Inclusion criteria

1. Comply with hemorrhoids stage I, stage Ⅱ, Ⅲ diagnosis standards; 2. Comply with "Traditional Chinese Medicine Disease and Syndrome Diagnosis and Curative Effect Standard" wind injury intestinal or damp-heat staining syndrome:hemorrhoid hemorrhage was jet or drip down, blood color red; 3. Patients who signed the informed consent form. 

排除标准:

1. 伴有严重肝肾、心脑肺功能不全、凝血功能异常; 2. 既往病史或肛门镜肠镜高度提示IBD患者; 3. 伴有炎性外痔; 4. 嵌顿性痔; 5. 合并肛周脓肿、肛瘘、直肠息肉、肠道肿瘤或肠道感染性疾病者; 6. 筛选前1个月、研究期间及研究结束后6个月有妊娠计划的患者; 7. 妊娠或哺乳期妇女; 8. 对试验药物及其成分过敏者; 9. 研究者认为不适合入组的其他患者。 

Exclusion criteria:

1. Accompanied by severe liver and kidney, heart and brain lung dysfunction, coagulation dysfunction; 2. Previous medical history or colonoscopy highly suggested IBD patients; 3. Accompanied by inflammatory external hemorrhoids; 4. Acute haemorrhoidal episodess; 5. Patients with perianal abscess, anal fistula, rectal polyp, intestinal tumor or intestinal infectious disease; 6. Patients with pregnancy plan in the first 1 month, during the study and 6 months after the study were screened; 7. Pregnant or lactating women; 8. Those who are allergic to the test drugs and their ingredients; 9. Other patients considered unsuitable for enrollment by the researchers. 

研究实施时间:

Study execute time:

From2019-04-14To 2020-08-01 

干预措施:

Interventions:

组别:

1

样本量:

120

Group:

1

Sample size:

干预措施:

凉血地黄汤单煎剂+地奥司明片模拟剂

干预措施代码:

Intervention:

Liang-Xue-Di-Huang Decoction + Diosmin Tablet Simulant

Intervention code:

组别:

2

样本量:

120

Group:

2

Sample size:

干预措施:

口服地奥司明片+血地黄汤单煎模拟剂

干预措施代码:

Intervention:

Diosmin Tablet + Liang-Xue-Di-Huang Decoction Simulant

Intervention code:

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 

Country:

China 

Province:

Jiangsu 

City:

Nanjing 

单位(医院):

南京中医药大学附属医院 

单位级别:

三级甲等中医医院 

Institution
hospital:

Affiliated Hospital of Nanjing University of Chinese Medicine  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

江苏省 

市(区县):

苏州市 

Country:

China 

Province:

Jiangsu 

City:

Suzhou 

单位(医院):

苏州市中医医院 

单位级别:

Jiangsu 

Institution
hospital:

Suzhou Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

江苏省 

市(区县):

常州市 

Country:

China 

Province:

Jiangsu 

City:

Changzhou 

单位(医院):

苏州市中医医院 

单位级别:

三级甲等中医医院 

Institution
hospital:

Changzhou Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

江苏省 

市(区县):

常州市(武进区) 

Country:

China 

Province:

Jiangsu 

City:

Changzhou(Wujin) 

单位(医院):

常州市武进中医医院 

单位级别:

三级乙等中医医院 

Institution
hospital:

Wujin Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary B 

国家:

中国 

省(直辖市):

江苏省 

市(区县):

淮安市(盱眙县) 

Country:

China 

Province:

Jiangsu 

City:

Huanan(Xuyi) 

单位(医院):

盱眙县中医院 

单位级别:

三级乙等中医医院 

Institution
hospital:

Xuyi Hospital of Traditional Chinese Medicine  

Level of the institution:

Tertiary B 

测量指标:

Outcomes:

指标中文名:

痔疮出血评分

指标类型:

主要指标 

Outcome:

French bleeding score

Type:

Primary indicator 

测量时间点:

服药1周后

测量方法:

表格式问卷

Measure time point of outcome:

After take the medicine for one week

Measure method:

FORM INTERROGATORIES

指标中文名:

痔核脱垂评分

指标类型:

次要指标 

Outcome:

goligher prolapse score

Type:

Secondary indicator 

测量时间点:

服药1周后

测量方法:

表格式问卷

Measure time point of outcome:

After take the medicine for one week

Measure method:

FORM INTERROGATORIES

指标中文名:

生活质量评分

指标类型:

次要指标 

Outcome:

quality-of-life score

Type:

Secondary indicator 

测量时间点:

服药1周后

测量方法:

表格式问卷

Measure time point of outcome:

After take the medicine for one week

Measure method:

FORM INTERROGATORIES

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

Sample Name:

Blood

Tissue:

no

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:

no

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 years
最大 Max age 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):

采用区组随机化方法。按中心进行分层,借助SAS统计软件,给定种子数产生《中心编码随机数字表》,随机分成凉血地黄汤单煎颗粒剂组与地奥司明片组(两组的比例为1:1),受试者根据随机编号进行入组。

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

Block randomization was used.Stratification was carried out according to the center. With the help of SAS statistical software, the random number table of central coding was generated for a given number of seeds. The subjects were randomly divided into Liang-Xue-Di-Huang decoction group and diosmine tablet group (t

盲法:

双盲

Blinding:

Double blind

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):

医路临床科研信息化管理系统,http://edc.medroad.cn/sci/main/edc/edc-sjcj?time=Sat%20Feb%2023%202019%2009:57:06%20GMT+0800%20(%E4%B8%AD%E5%9B%BD%E6%A0%87%E5%87%86%E6%97%B6%E9%97%B4)

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

Medroad, http://edc.medroad.cn/sci/main/edc/edc-sjcj?time=Sat%20Feb%2023%202019%2009:57:06%20GMT+0800%20(%E4%B8%AD%E5%9B%BD%E6%A0%87%E5%87%86%E6%97%B6%E9%97%B4)

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:

http://edc.medroad.cn/sci/main/edc/edc-sjcj?time=Sat%20Feb%2023%202019%2009:57:06%20GMT+0800%20(%E4%B8%AD%E5%9B%BD%E6%A0%87%E5%87%86%E6%97%B6%E9%97%B4)

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

http://edc.medroad.cn/sci/main/edc/edc-sjcj?time=Sat%20Feb%2023%202019%2009:57:06%20GMT+0800%20(%E4%B8%AD%E5%9B%BD%E6%A0%87%E5%87%86%E6%97%B6%E9%97%B4)

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-04-15
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