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香槟方促进围手术期术后胃肠功能快速康复的研究
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注册号:

Registration number:

ChiCTR-TRC-14004156 

最近更新日期:

Date of Last Refreshed on:

2018-06-13 

注册时间:

Date of Registration:

2014-01-03 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

香槟方促进围手术期术后胃肠功能快速康复的研究 

Public title:

Clinical trial on the effectiveness of Chinese herbal Xiangbin Fang on the recovery from gastrointestinal function after abdominal surgery 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中医药促进围手术期术后胃肠功能快速康复的研究 

Scientific title:

Research on Chinese Traditional Medicine for Fast Recovery of Postoperative Gastrointestinal Function 

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:

蒋志 

研究负责人:

陈志强 

Applicant:

Jiang Zhi 

Study leader:

Chen Zhiqiang 

申请注册联系人电话:

Applicant telephone:

+86 15011937399 

研究负责人电话:

Study leader's telephone:

+86 020 81887233 

申请注册联系人传真 :

Applicant Fax:

+86 020 81874903 

研究负责人传真:

Study leader's fax:

+86 020 87351873 

申请注册联系人电子邮件:

Applicant E-mail:

2000jiangzhi@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zhi57@163.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:

广东省广州市越秀区大德路111号广东省中医院 

研究负责人通讯地址:

广东省广州市越秀区大德路111号广东省中医院 

Applicant address:

111 Dade Road, Yuexiu District, Guangzhou, Guangdong Province, China 

Study leader's address:

111 Dade Road, Yuexiu District, Guangzhou, Guangdong Province, China 

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:

广州中医药大学第二附属医院 

Applicant's institution:

The 2nd Affiliated Hospital of Guangzhou 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:

B2012-64-01 

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:

广东省中医院伦理委员会 

Name of the ethic committee:

IRB of Guangdong Provincial Hospital of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2012-11-30 

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:

广东省中医院 

Primary sponsor:

Guangdong Provincial Hospital of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

广东省广州市越秀区大德路111号 

Primary sponsor's address:

111 Dade Road, Yuexiu District, Guangzhou, Guangdong, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

广东省财政厅“产业技术研究与开发” 

Source(s) of funding:

Research and development of industrial technology by Department of Finance of Guangdong Province 

研究疾病:

腹部中等及以上手术 

Target disease:

medium and large size abdominal surgery 

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:

探索性研究/预试验 

Study phase:

研究目的:

观察中药香槟方对腹部术后胃肠功能的作用,同时观察槟榔颗粒对妇科术后患者胃肠功能的作用。 

Objectives of Study:

To observe the effectiveness of Chinese herbal Xiangbin Fang on the recovery from gastrointestinal function after abdominal surgery and investigate the effect of areca particles on gastrointestinal function after gynecologic surgery. 

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:

(一)中药香槟方对腹部术后胃肠功能的作用:1)外科腹腔镜结直肠癌根治术后;妇科腹腔镜全子宫切除术后患者。 2)年龄:40 ~ 75 岁之间; 胃肠外科:40-80岁之间; 3)手术时间1~4 小时者。 4)麻醉时间1.5~4.5 小时者。 5)中医证型属于气滞气虚者。 6)知情同意者。 (二)槟榔颗粒对妇科术后患者胃肠功能的作用:1)妇科术后患者40~75岁;2)胃肠外科:40-80岁之间;3)手术时间:手术时间为0.5-5小时者;4)麻醉时间:1.0-6.5小时者;5)中医证型属于气虚气滞,腑气不通者;6)知情同意者。 

Inclusion criteria

Part one: 1) Patients with gastric and colorectal cancerHysteromyoma hysterectomy after surgery; 2) Aged from 40 to 75 years old; Gastroenterological surgery patients aged from 40 to 80 years old; 3) The duration of operation is with 1 to 4 hours; 4) The anesthesia time is within 1.5 to 4.5 hours; 5) The TCM syndrome is identified as qi stagnation fu-organ stuff; 6) Willing to sign an informed consent document. Part two: 1) patients underwent gynecologic surgery, age 40~75 years; 2) Gastroenterological surgery patients aged from 40 to 80 years old; 3) The duration of operation is with 0.5 to 5 hours; 4) The anesthesia time is within 1 to 5 hours; 5) The TCM syndrome is identified as qi stagnation fu-organ stuff; 6) Willing to sign an informed consent document. 

排除标准:

1)恶性肿瘤晚期出现恶液质、极度衰弱者。 2)恶性肿瘤需行扩大根治术者。 3)有心血管、肝、肾、脑、肺等严重合并疾病者。 4)高血压、糖尿病,药物控制效果不佳者。 5)有精神疾病者。 6)对治疗药物过敏者。 7)孕妇或哺乳期者。 8)重度营养不良患者,血清白蛋白<21g/L;前白蛋白<0.10g/L。 9)再次腹部手术并肠粘连严重者。 10)术中出血量超过400 毫升者,术中或术后需输血者。 11)术后6 小时内出现严重并发症者,或术后转ICU 者,如多脏器功能不全 12) 急诊手术者。 13)术后必须使用对胃肠功能有明显影响的药物或治疗者。 14)目前正在参加或在本研究前1 个月内参加过其它临床试验的患者。 15)研究者认为不宜进行此项临床研究者 

Exclusion criteria:

1) Advanced malignant tumor cachexia, extremely weak; 2) Patients of malignant tumor who needs extended radical operation; 3) patients combined with cardiovascular, liver, kidney, brain, lung and other serious diseases; 4) Bad drug control of Hypertension, diabetes; 5) Patients with mental disease; 6) Patients with allergies to the intervention; 7) Pregnant or breast-feeding women; 8) Severe malnutrition, serum albumin<21g/L, prealbumin< 0.1g/L; 9) Re-abdominal surgery and severe intestinal adhesion; 10) Blood loss more than 400 milliliters during the surgery; 11) Occuring serious complications within 6 hours after the surgery, e.g. multiple organ dysfunction; 12) Emergency surgery; 13) Prokinetic drugs must be taken after operation; 14) Patient participating other clinical study or having participated other clinical study in the last one month; 15) Patient considered inappropriate to participate the study by clinical investigators. 

研究实施时间:

Study execute time:

From2014-01-01To 2016-12-31 

干预措施:

Interventions:

组别:

A (香槟方)

样本量:

210

Group:

A (Xiangbin Fang)

Sample size:

干预措施:

安慰剂组

干预措施代码:

Intervention:

placebo

Intervention code:

组别:

B (香槟方)

样本量:

210

Group:

B Xiangbin Fang

Sample size:

干预措施:

中药香槟方治疗

干预措施代码:

Intervention:

Oral Xiangbin Fang

Intervention code:

组别:

A (槟榔颗粒)

样本量:

50

Group:

A (Xiangbin granule)

Sample size:

干预措施:

槟榔颗粒

干预措施代码:

Intervention:

Xiangbin granule

Intervention code:

组别:

B (安慰剂)

样本量:

50

Group:

B (placebo)

Sample size:

干预措施:

安慰剂

干预措施代码:

Intervention:

placebo

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

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:

三级甲等 

Institution
hospital:

Guangdong Provincial Hospital of Chinese Medicine  

Level of the institution:

Tertiary-A hospital 

测量指标:

Outcomes:

指标中文名:

术后肠鸣音恢复正常时间

指标类型:

主要指标 

Outcome:

time to first bowel sounds

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后排气恢复正常时间

指标类型:

主要指标 

Outcome:

time to first flatus

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后排便恢复正常时间

指标类型:

主要指标 

Outcome:

time to first defecation

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胃肠动力学指标

指标类型:

主要指标 

Outcome:

Gastrointestinal dynamics

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胃肠激素

指标类型:

主要指标 

Outcome:

gastrointestinal hormone

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

使用后保存 

说明

Fate of sample:

Preservation after use 

Note:

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 45 years
最大 Max age 75 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):

计算机软件

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

computer software

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):

广东省中医院

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

Guangdong Provincial Hospital of Chinese Medicine

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:

广州中医药大学DME中心

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

DME center of Guangzhou University of Traditional Chinese Medicine

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2014-01-03
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