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芒针刺白环俞、会阳治疗慢性前列腺炎 (气滞血瘀证)的临床研究
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注册号:

Registration number:

ChiCTR-ICR-15006138 

最近更新日期:

Date of Last Refreshed on:

2015-03-24 

注册时间:

Date of Registration:

2015-03-24 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

芒针刺白环俞、会阳治疗慢性前列腺炎 (气滞血瘀证)的临床研究 

Public title:

The clinical curative effect of long needle acupuncture "Baihuanshu", "Huiyang" acupoints in the treatment of qi stagnation and blood stasis syndrome for chronic prostatitis 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

芒针刺白环俞、会阳治疗慢性前列腺炎 (气滞血瘀证)的临床研究 

Scientific title:

The clinical curative effect of long needle acupuncture "Baihuanshu", "Huiyang" acupoints in the treatment of qi stagnation and blood stasis syndrome for chronic prostatitis 

研究课题代号(代码):

Study subject ID:

上海市卫计委科研项目20134164 

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:

周敏杰 

研究负责人:

应荐 

Applicant:

Zhou Minjie 

Study leader:

Ying Jian 

申请注册联系人电话:

Applicant telephone:

+86 13917528510 

研究负责人电话:

Study leader's telephone:

+86 181117366678 

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:

zhouminjie19881109@163.com 

研究负责人电子邮件:

Study leader's E-mail:

yingjian03@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:

上海市宛平南路650号气功研究所210室 

研究负责人通讯地址:

上海市宛平南路650号气功研究所210室 

Applicant address:

Room 210, No. 650 Qigong Institute, Wanping Road, Shanghai 

Study leader's address:

Room 210, No. 650 Qigong Institute, Wanping Road, Shanghai 

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:

上海市气功研究所 

Applicant's institution:

Shanghai Qigong Institute 

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:

2014LCSY31 

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龙华医院医学伦理委员会 

Name of the ethic committee:

Shanghai University of Traditional Chinese Medicine, Longhua Hospital Medical Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-07-09 

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:

上海市气功研究所 

Primary sponsor:

Shanghai Qigong Institute 

研究实施负责(组长)单位地址:

上海市宛平南路650号气功研究所210室 

Primary sponsor's address:

Room 210, No. 650 Qigong Institute, Wanping Road, Shanghai 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市气功研究所

具体地址:

上海市宛平南路650号气功研究所210室

Institution
hospital:

Shanghai Qigong Institute

Address:

Room 210, No. 650 Qigong Institute, Wanping Road, Shanghai

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

具体地址:

宛平南路725号

Institution
hospital:

Longhua Hospital, Shanghai University of Traditional Chinese Medicine

Address:

725 Wan Ping Road, Shanghai

国家:

省(直辖市):

市(区县):

Country:

Province:

City:

单位(医院):

具体地址:

Institution
hospital:

Address:

经费或物资来源:

上海市卫计委科研项目(课题编号:20134164) 

Source(s) of funding:

Shanghai Municipal Health Bureau topic (number 20134164) 

研究疾病:

慢性前列腺炎 

Target disease:

chronic prostatitis 

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:

观察芒针刺白环俞、会阳治疗慢性前列腺炎(气滞血瘀证)的临床疗效。 

Objectives of Study:

The clinical curative effect of long needle acupuncture white ring shu, hui yang therapy in the treatment of qi stagnation and blood stasis syndrome for chronic prostatitis. 

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符合慢性前列腺炎诊断标准者; ②病程超过3个月者; ③年龄20-50岁男性患者; ④心、肝、肾功能基本正常; ⑤自愿受试并签署知情同意书。 

Inclusion criteria

1. meet diagnostic criteria for chronic prostatitis; 2. course of more than three months persons; 3. male patients aged 20-50 years old; 4. heart, liver and kidney function was normal; 5. voluntary test and signed informed consent. 

排除标准:

①急性前列腺炎患者; ②泌尿系感染,尿道炎患者; ③单纯的前列腺增生症患者; ④前列腺癌患者; ⑤泌尿系统结石、附睾炎、腹沟疝、精索静脉曲张、直肠结肠疾病,腰椎疾病等原因导致的下腹部、会阴、腰骶等部位不适者; ⑥合并有严重的心、肝、肾和造血系统疾病; ⑦精神病患者,需要专科治疗者。 

Exclusion criteria:

1. acute prostatitis patients; 2. urinary tract infections, urethritis patients; 3. simple benign prostatic hyperplasia; 4. prostate cancer patients; 5. urinary tract stones, epididymitis, groin hernia, varicocele, colorectal disease, spinal disease and other causes of lower abdominal, perineal, lumbar discomfort and other parts; 6. with severe heart, liver, kidney and hematopoietic system diseases; 7. psychiatric patients, who require specialist treatment. 

研究实施时间:

Study execute time:

From2015-04-01To 2016-04-01 

干预措施:

Interventions:

组别:

试验Ⅰ组

样本量:

36

Group:

Experimental group

Sample size:

干预措施:

毫针针刺+针剌

干预措施代码:

Intervention:

filiform needle + acupuncture

Intervention code:

组别:

对照

样本量:

36

Group:

Control

Sample size:

干预措施:

针灸治疗组

干预措施代码:

Intervention:

acupuncture

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):

上海市气功研究所 

单位级别:

三乙 

Institution
hospital:

Shanghai Qigong Institute  

Level of the institution:

Tertiary B hospital 

测量指标:

Outcomes:

指标中文名:

白细胞

指标类型:

主要指标 

Outcome:

White Blood Cell

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

红细胞

指标类型:

主要指标 

Outcome:

Red Blood Cell

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

卵磷脂

指标类型:

主要指标 

Outcome:

Lecithin

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:

前列腺液

组织:

前列腺

Sample Name:

Prostatic fluid

Tissue:

Prostate

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 22 years
最大 Max age 50 years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

专人通过Microsoft Office Excel 2007 得到随机数字表

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

A special person to get through Microsoft Office Excel 2007 random number table

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-based 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:

 2015-03-24
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