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Clinic test for termination unwanted early pregnancy by kidney bean lectin(KBL)
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注册号:

Registration number:

ChiCTR1800018469 

最近更新日期:

Date of Last Refreshed on:

2018-09-20 

注册时间:

Date of Registration:

2018-09-20 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

芸豆凝集素用于终止人体早期非愿意妊娠的试验 

Public title:

Clinic test for termination unwanted early pregnancy by kidney bean lectin(KBL)  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

芸豆凝集素终止人体早期非愿意妊娠的试验研究 

Scientific title:

Experimental study for the termination of early pregnancy by kidney bean lectin(KBL) 

研究课题代号(代码):

Study subject ID:

H201504-1 

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:

王敏康 

研究负责人:

王敏康 

Applicant:

Min-Kang Wang 

Study leader:

Min-Kang Wang 

申请注册联系人电话:

Applicant telephone:

+86 13888011251 

研究负责人电话:

Study leader's telephone:

+86 13888011251 

申请注册联系人传真 :

Applicant Fax:

+86 0871-65910909 

研究负责人传真:

Study leader's fax:

+86 0871-65910909 

申请注册联系人电子邮件:

Applicant E-mail:

wangmk1998@163.com 

研究负责人电子邮件:

Study leader's E-mail:

wangmk1998@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

www.kzbio.net 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

www.kzbio.net 

申请注册联系人通讯地址:

昆明市呈贡区雨花片区1号,云南师范大学生命科学学院 

研究负责人通讯地址:

昆明市呈贡区雨花片区1号,云南师范大学生命科学学院 

Applicant address:

1 Yuhua Community, Chenggong District, Kunmin, Yunnan, China 

Study leader's address:

1 Yuhua Community, Chenggong District, Kunmin, Yunnan, China 

申请注册联系人邮政编码:

Applicant postcode:

650500 

研究负责人邮政编码:

Study leader's postcode:

650500 

申请人所在单位:

云南师范大学生命科学学院 

Applicant's institution:

School of Life Sciences,Yunnan Normal 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:

云南师范大学 

Primary sponsor:

Yunnan Normal University 

研究实施负责(组长)单位地址:

昆明市呈贡区雨花片区1号 

Primary sponsor's address:

1 Yuhua Community, Chenggong District, Kunmin, Yunnan, 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):

云南省

市(区县):

昆明市呈贡区

Country:

China

Province:

Yunnan

City:

Chenggong,Kunming

单位(医院):

云南师范大学

具体地址:

昆明市呈贡区雨花片区1号

Institution
hospital:

Yunnan Normal University

Address:

1 Yuhua Community, Chenggong District, Kunmin, Yunnan, China

国家:

中国

省(直辖市):

云南省

市(区县):

昆明市

Country:

China

Province:

Yunnan

City:

Kunming

单位(医院):

昆明圣爱中医馆

具体地址:

云南省昆明市西山区东寺街88号

Institution
hospital:

Kunming Sheng Ai Hospital of TCM

Address:

88 Dongsi Street, Xishan District, Kunming, Yunnan

经费或物资来源:

国家自然科学基金 

Source(s) of funding:

National Natural Science Foundation of China 

研究疾病:

人体早期非愿意妊娠终止 

Target disease:

Termination of unwtanted early pregnancy. 

研究疾病代码:

N/A 

Target disease code:

N/A 

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:

芸豆凝集素是一种来源于菜豆属芸豆(Phaseolus vulgaris L.)的糖蛋白,分子量大约32KD。以往的研究表明,芸豆植物凝集素可在小鼠模型上终止早中晚期妊娠。但还缺乏灵长类特别是人的临床试验资料。我们的相关基础研究显示在小鼠妊娠中期给予芸豆植物凝集素可引起孕酮水平的降低。形态学研究显示其主要作用部位为胎盘(合体)滋养层细胞,也包含部分胎膜. 进行人体试验对其安全性和有效性检验是临床或人体应用的前提,具有重要的理论意义和临床价值。  

Objectives of Study:

Kidney bean lectin(KBL)originating from the kidney bean (Phaseolus vulgaris L.) is a glycoprotein with MW about 32KD. Previous studies have shown that KBL can terminate early, middle and late pregnancy in a mouse model. But there are no primate or clinical trials data. If it is also effective for use in humans to terminate unwanted pregnancy, it will be a new choice for women with a wide application time and few side effects. Many studies have proved that the binding of galectin-1 (Gal-1) to extracellular matrix components plays many important roles in the process of embryo implantation, the process of decidualization and the formation of the placenta. The safety and efficacy of human trials is the premise for clinical or human application, and has important theoretical and clinical value for KBL.  

药物成份或治疗方案详述:

药物成分为芸豆凝集素(Red kidney bean lectin),为云南师范大学生命科学学院动物生理学实验室采用相关技术提取。经双缩脲法测定浓度,最后以生理盐水配制,0.22μm微孔滤膜过滤,室温保存待用。使用浓度为5mg/ml。 给药方式:常规外阴及阴道消毒,然后采取膀胱截石位,扩阴器扩张阴道,宫颈钳固定子宫颈口侧边,采用90mm长,外径为2mm的一次性塑料直肠给药管经宫颈口插入子宫腔,缓慢推入4ml 总剂量为20mg的RKBL生理盐水,给药时间是9:40。注射后即退出给药管。试验者卧床休息。大约48小时后阴道给以60mg 米索前列醇片60mg,大约3小时后孕囊排出。 

Description for medicine or protocol of treatment in detail:

Red KBL (RKBL) was extracted and prepared at the School of Life Sciences, Yunnan Normal University. The concentration of RKBL was determined by the biuret method and agglutination activity was tested according to the Sigma-Aldrich standard (http://www.sigmaaldrich.com/catalog/product/). The lowest concentration to agglutinate a 2% suspension of human erythrocytes was 7.8-15.6μg. The RKBL solution was prepared with saline at a concentration of 5mg/ml, filtered by 0.22μm microporous membrane, and kept in a refrigerator at 4℃ before using. Routine skin and vaginal disinfection was carried out, and the patient volunteer then took the bladder lithotomy position. The vagina was dilated and?a cervical clamp was fixed to place. Then a disposable plastic rectal drug delivery pipe was inserted through the cervix and into the uterine cavity, to slowly deliver 20 mg/4 ml of KBL. 60 mg misoprostol were administrated vaginally about 48h later. The gestational sac was discharged 3h later.  

研究设计:

单病例随机对照研究 

Study design:

N of 1 Trial 

纳入标准:

1.有早孕反应; 2.B超检查确诊 

Inclusion criteria

1. There are early pregnancy reactions; 2. Confirmed by ultrasound B examination. 

排除标准:

无 

Exclusion criteria:

No 

研究实施时间:

Study execute time:

From2015-04-08To 2015-04-18 

征募观察对象时间:

Recruiting time:

From2015-03-30To 2015-05-27 

干预措施:

Interventions:

组别:

Case

样本量:

1

Group:

Case

Sample size:

干预措施:

宫腔内一次性注射芸豆凝集素20mg

干预措施代码:

Intervention:

one time Intrauterine injection of kidney bean lectin 20mg

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

云南省 

市(区县):

昆明市 

Country:

China 

Province:

Yunnan 

City:

Kunming 

单位(医院):

昆明圣爱中医馆 

单位级别:

二级 

Institution
hospital:

Kunming Sheng Ai Hospital of TCM  

Level of the institution:

Scond 

测量指标:

Outcomes:

指标中文名:

孕囊排除与否

指标类型:

主要指标 

Outcome:

whether or not discharge gestational sac

Type:

Primary indicator 

测量时间点:

给以芸豆凝集素后

测量方法:

肉眼观察

Measure time point of outcome:

after administration KBL

Measure method:

Naked eye observation

指标中文名:

性激素6项检测

指标类型:

主要指标 

Outcome:

Tests for 6 items of sex hormones

Type:

Primary indicator 

测量时间点:

应用芸豆凝集素后不同时间间隔

测量方法:

电化学发光法

Measure time point of outcome:

Different interval after administration KBL

Measure method:

electrochemical luminescence assay

指标中文名:

血液生化指标

指标类型:

主要指标 

Outcome:

Analysis of blood biochemical indexes

Type:

Primary indicator 

测量时间点:

给以凝集素后不同时间间隔

测量方法:

仪器检测

Measure time point of outcome:

Different interval after administration KBL

Measure method:

Instrument detection

指标中文名:

血液生化指标

指标类型:

主要指标 

Outcome:

Analysis of blood biochemical indexes

Type:

Primary indicator 

测量时间点:

给以凝集素后不同时间间隔

测量方法:

仪器检测

Measure time point of outcome:

Different interval after administration KBL

Measure method:

Instrument detection

指标中文名:

血常规检测

指标类型:

次要指标 

Outcome:

Blood routine examination

Type:

Secondary indicator 

测量时间点:

给以凝集素后不同时间间隔

测量方法:

仪器检测

Measure time point of outcome:

Different interval after administration KBL

Measure method:

Instrument detection

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

血液

Sample Name:

Blood

Tissue:

Blood

人体标本去向

使用后销毁 

说明

检测后由检测机构处理

Fate of sample:

Destruction after use 

Note:

After testing, it is handled by the testing institution.

标本中文名:

孕囊

组织:

孕囊

Sample Name:

gestation sac

Tissue:

gestation sac

人体标本去向

使用后保存 

说明

冷冻保持一年

Fate of sample:

Preservation after use 

Note:

Freeze for one year

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 24 years
最大 Max age 24 years

性别:

女性

Gender:

Female

随机方法(请说明由何人用什么方法产生随机序列):

非随机

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

Non-randomization

盲法:

Blinding:

No

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

此前未公开

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

Previously undisclosed

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:

两者都有

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

We have both data

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2018-09-20
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