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针刺治疗中重度经前期紧张综合症临床疗效评价及其疗效机制研究
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注册号:

Registration number:

ChiCTR1900024093 

最近更新日期:

Date of Last Refreshed on:

2019-06-25 

注册时间:

Date of Registration:

2019-06-25 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

针刺治疗中重度经前期紧张综合症临床疗效评价及其疗效机制研究 

Public title:

Study for mechanism and efficacy of acupuncture in the treatment of severe premenstrual syndrome 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

针刺治疗中重度经前期紧张综合症临床疗效评价及其疗效机制研究 

Scientific title:

Study for mechanism and efficacy of acupuncture in the treatment of severe premenstrual syndrome 

研究课题代号(代码):

Study subject ID:

国家中医药管理局(JDZX2015056) 

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:

匡洪影 

研究负责人:

匡洪影 

Applicant:

Hongying Kuang 

Study leader:

Hongying Kuang 

申请注册联系人电话:

Applicant telephone:

+86 13766860387 

研究负责人电话:

Study leader's telephone:

+86 13766860387 

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:

hyk20042@sina.com 

研究负责人电子邮件:

Study leader's E-mail:

hyk20042@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:

黑龙江省哈尔滨市香坊区和平路26号 

研究负责人通讯地址:

黑龙江省哈尔滨市香坊区和平路26号 

Applicant address:

26 Heping Road, Xiangfang District, Harbin, Heilongjiang, China 

Study leader's address:

26 Heping Road, Xiangfang District, Harbin, Heilongjiang, 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:

黑龙江中医药大学附属第一医院 

Applicant's institution:

First Affiliated Hospital of Heilongjiang 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:

HZYLLKY201600802 

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:

黑龙江中医药大学附属第一医院伦理委员会 

Name of the ethic committee:

Ethics Committee, First Affiliated Hospital of Heilongjiang University of Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2016-08-15 

伦理委员会联系人:

赵楠 

Contact Name of the ethic committee:

Nan Zhao 

伦理委员会联系地址:

黑龙江省哈尔滨市香坊区和平路26号 

Contact Address of the ethic committee:

26 Heping Road, Xiangfang District, Harbin, Heilongjiang, China 

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:

黑龙江中医药大学附属第一医院 

Primary sponsor:

First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

黑龙江省哈尔滨市香坊区和平路26号 

Primary sponsor's address:

26 Heping Road, Xiangfang District, Harbin, Heilongjiang, 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):

黑龙江省

市(区县):

哈尔滨市

Country:

China

Province:

Heilongjiang

City:

Harbin

单位(医院):

黑龙江中医药大学附属第一医院

具体地址:

黑龙江省哈尔滨市香坊区和平路26号

Institution
hospital:

First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine,Heilongjiang Province

Address:

26 Heping Road, Xiangfang District, Harbin, Heilongjiang, China

经费或物资来源:

国家中医药管理局科技司 

Source(s) of funding:

State Administration of Traditional Science and Technology Division 

研究疾病:

妇儿病 

Target disease:

Women and children's disease 

研究疾病代码:

2015M01 

Target disease code:

2015M01 

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:

1、评价针刺治疗中重度经前期紧张综合症临床疗效。 2、探讨评价针刺治疗中重度经前期紧张综合症的疗效机制。 

Objectives of Study:

1. Evaluation of acupuncture in the treatment of severe premenstrual syndrome clinical efficacy. 2. To investigate the efficacy evaluation of stress syndrome mechanism of acupuncture treatment of moderate to severe premenstrual. 

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.年龄介于18-35岁之间,符合西医中重度经前期紧张综合症诊断标准女性。 2.月经周期规律,为28-35天 。 3.有读写能力。 4.自愿参加本试验研究,签署知情同意书。 5.连续2个月经周期DRSP经前5天总得分大于等于130分。 

Inclusion criteria

1. Women aged between 18 and 35, who met the diagnostic criteria of moderate and severe premenstrual tension syndrome; 2. The regularity of menstrual cycle is 28-35 days; 3. Ability to read and write; 4. Voluntarily to be involved in the study and sign the informed consent; 5. The total score of DRSP in the first five days of two consecutive menstrual cycles is greater than or equal to 130 points. 

排除标准:

1.患有其他严重心脑肾疾病及高血压,糖尿病等。 2.近六个月接受经前期紧张综合征的治疗。 3.近一个月接受其他药物治疗。 4.预期在方案研究期间,需中断治疗1个月经周期以上的受试者。不能按要求参加随访(电话或者邮件等方式随访)。 5.近一个月内参加其他临床研究者。 6.近六个月接受精神疾病类药物治疗或其他影响本试验研究的药物治疗。 7.妊娠受试者,或计划妊娠受试者。 8.盆腔超声有任何器质性病变者。 9.有精神疾病病史。 10.近一个月服用止痛药物。 11.近6个月接受过针刺治疗。 12.目前有酗酒、药物滥用病史、自杀未遂及患有严重人格障碍受试者。酗酒的定义是> 14 杯/周或暴饮。 

Exclusion criteria:

1. With serious heart, brain and kidney diseases, hypertension, diabetes and so on; 2. Recent six months of treatment for premenstrual tension syndrome; 3. Recent month received other medication; 4. It is anticipated that during the study period, the treatment of subjects with more than one menstrual cycle will be discontinued. Can not attend follow-up as required (telephone or e-mail follow-up); 5. Participate in other clinical researchers in the past month; 6. Recent six months received psychiatric drugs or other medications that affected the study; 7. Pregnant subjects or planned pregnant subjects; 8. Pelvic ultrasound has any organic lesions; 9. Have a history of mental illness; 10. Take analgesics in the past month; 11. Acupuncture treatment has been given in the past six months; 12. There are subjects with alcohol abuse, drug abuse history, attempted suicide and severe personality disorders. Alcohol abuse is defined as > 14 cups per week or binge drinking. 

研究实施时间:

Study execute time:

From2017-04-01To 2019-12-31 

干预措施:

Interventions:

组别:

电针组

样本量:

40

Group:

EA group

Sample size:

干预措施:

电针

干预措施代码:

Intervention:

EA

Intervention code:

组别:

对照组

样本量:

40

Group:

Control group

Sample size:

干预措施:

安慰针

干预措施代码:

Intervention:

Sham accpunture

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

黑龙江省 

市(区县):

哈尔滨市 

Country:

China 

Province:

Heilongjiang 

City:

Harbin City 

单位(医院):

黑龙江中医药大学附属第一医院 

单位级别:

三级甲等 

Institution
hospital:

First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine,Heilongjiang Province  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

DRSP评分

指标类型:

主要指标 

Outcome:

DRSP Rating

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清激素指标

指标类型:

主要指标 

Outcome:

Serum hormone index

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

神经递质指标

指标类型:

主要指标 

Outcome:

Neurotransmitter indices

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

使用后销毁 

说明

Fate of sample:

Destruction 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 years
最大 Max age 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):

随机分组

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

Randomization Procedure

盲法:

未说明

Blinding:

Not stated

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):

随信索取; ResMan

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

Provided based on requirement; ResMan

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:

病例记录表

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

CRF

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-06-25
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