今天是:2022-08-12 星期五

桂枝茯苓丸治疗热灼血瘀型原发性痛经的随机对照研究
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注册号:

Registration number:

ChiCTR2000034118 

最近更新日期:

Date of Last Refreshed on:

2020-06-25 

注册时间:

Date of Registration:

2020-06-24 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

桂枝茯苓丸治疗热灼血瘀型原发性痛经的随机对照研究 

Public title:

A randomized controlled study on the treatment of primary dysmenorrhea with heat burning blood stasis by Guizhi Fuling Wan 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

新制桂枝茯苓丸治疗热灼血瘀型原发性痛经的随机对照研究 

Scientific title:

A randomized controlled study on the treatment of primary dysmenorrhea with heat burning blood stasis by Guizhi Fuling Wan 

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:

ChiMCTR2000003429 

申请注册联系人:

付先芸 

研究负责人:

李晨劼 

Applicant:

Xianyun Fu 

Study leader:

Chenjie Li 

申请注册联系人电话:

Applicant telephone:

+86 13972031404 

研究负责人电话:

Study leader's telephone:

+86 13085157861 

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:

dinnar1@163.com 

研究负责人电子邮件:

Study leader's E-mail:

179073543@qq.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:

湖北省宜昌市西陵区大学路8号 

研究负责人通讯地址:

湖北省宜昌市西陵区大学路8号 

Applicant address:

8 University Road, Xiling District, Yichang, Hubei, China 

Study leader's address:

8 University Road, Xiling District, Yichang, Hubei, 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:

三峡大学 

Applicant's institution:

Three Gorges University 

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:

2020001 

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:

宜昌市第二人民医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Yichang Second People's Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-06-05 

伦理委员会联系人:

刘发军 

Contact Name of the ethic committee:

Fajun Liu 

伦理委员会联系地址:

湖北省宜昌市西陵区西陵一路21号 

Contact Address of the ethic committee:

21 First Xiling Road, Xiling District, Yichang, Hubei, 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:

宜昌市第二人民医院 

Primary sponsor:

Yichang Second People's Hospital 

研究实施负责(组长)单位地址:

湖北省宜昌市西陵区西陵一路21号 

Primary sponsor's address:

21 First Xiling Road, Xiling District, Yichang, Hubei, 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):

湖北

市(区县):

宜昌

Country:

China

Province:

Hubei

City:

Yichang

单位(医院):

宜昌市第二人民医院

具体地址:

西陵区西陵一路21号

Institution
hospital:

Yichang Second People's Hospital

Address:

21 First Xiling Road, Xiling District

经费或物资来源:

国家自然科学基金(编号81973897)资助 

Source(s) of funding:

Supported by the National Natural Science Foundation of China (No. 81973897) 

研究疾病:

原发性痛经 

Target disease:

Primary dysmenorrhea 

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:

1.采用双盲随机对照研究验证新制桂枝茯苓丸对热灼血瘀证型原发性痛经的疗效; 1.通过肠道菌群组学的方法揭示新制桂枝茯苓丸治疗热灼血瘀证型原发性痛经潜在机制。 

Objectives of Study:

1. To verify the efficacy of Guizhi Fuling Wan for primary dysmenorrhea with heat burning blood stasis syndrome; 1. To reveal the potential mechanism of Guizhi Fuling Wan in the treatment of primary dysmenorrhea with heat burning blood stasis syndrome by methods of enterobacteriaceae. 

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:

符合以下7项者,可纳入研究,若有任何一项不符合,则患者不能进入研究: 1. 年龄16-30岁; 2. 根据原发性痛经共识指南诊断原发性痛经; 3. 未产妇; 4. (自述疼痛)6个月至15年; 5. 平均疼痛强度40或更大(100毫米视觉模拟评分法VAS ),至少连续3个月经周期; 6. 中医辩证为热灼血瘀证患者; 7. 患者本人签署或由其直系亲属代签知情同意书。 

Inclusion criteria

Those who meet the following 7 items can be included in the study. If there is any inconformity, the patient cannot enter the study 1. Patients aged 16-30 years; 2. To diagnose patients with primary dysmenorrhea according to the consensus guideline of primary dysmenorrhea; 3. No parturient; 4. Self described pain duration: from 6 months to 15 years; 5. Patients with an average pain intensity of 40 or more (VAS by 100 mm visual analogue scale) and at least three consecutive menstrual cycles; 6. Patients with syndrome of heat burning and blood stasis; 7. The informed consent shall be signed by the patient himself or by his immediate relatives. 

排除标准:

如果以下任何一项符合,则患者不能进入研究 1. 半年内不能完成本研究治疗方案的患者; 2. 继发性痛经(如子宫内膜异位症或子宫腺肌症所致); 3. 月经周期不规律(超出21-35天的典型范围) 4. 近半年有妊娠计划的妇女; 5. 有精神障碍及智能障碍不能配合问卷调查者; 6. 合并有严重的心血管疾病、肝肾功能损害者、心理疾病或者危及生命的情况; 7. 正在使用镇痛药物; 8. 曾经参与或正在参与其它临床试验者。 

Exclusion criteria:

Patients cannot enter the study if any of the following are met: 1. Patients who can not complete the treatment plan of this study within half a year; 2. Patients with secondary dysmenorrhea (such as endometriosis or adenomyosis); 3. Patients with irregular menstrual cycle (beyond the typical range of 21-35 days); 4. Women with pregnancy plan in the past half year; 5. Patients with mental disorders and mental disorders who can not cooperate with the questionnaire survey; 6. Patients with serious cardiovascular disease, liver and kidney function damage, psychological disease or life-threatening situation; 7. Patients who are using analgesics; 8. Patients who have participated in or are participating in other clinical trials. 

研究实施时间:

Study execute time:

From2020-09-12To 2022-12-31 

征募观察对象时间:

Recruiting time:

From2020-09-12To 2022-06-01 

干预措施:

Interventions:

组别:

试验组

样本量:

64

Group:

experimental group

Sample size:

干预措施:

桂枝茯苓丸口服

干预措施代码:

Intervention:

Guizhi Fuling Wan for oral administration

Intervention code:

组别:

对照组

样本量:

64

Group:

control group

Sample size:

干预措施:

安慰剂口服

干预措施代码:

Intervention:

placebo for oral administration

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖北 

市(区县):

宜昌 

Country:

China 

Province:

Hubei 

City:

Yichang 

单位(医院):

宜昌市第二人民医院 

单位级别:

三甲 

Institution
hospital:

Yichang Second People's Hospital  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

视觉模拟量表(VAS)评分

指标类型:

主要指标 

Outcome:

visual analog scale (VAS) scores

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医症候评分

指标类型:

次要指标 

Outcome:

the TCM syndrome score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

COX 痛经症状量表(CMSS)

指标类型:

次要指标 

Outcome:

Cox Menstrual Symptom Scale (CMSS)

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抑郁自评量表(SDS)

指标类型:

次要指标 

Outcome:

Self-rating Depression Scale

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

SAS焦虑自评量表

指标类型:

次要指标 

Outcome:

Self-rating Anxiety Scale

Type:

Secondary 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:

粪便

组织:

Sample Name:

faeces

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 16 years
最大 Max age 30 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):

由本课题组成员罗亚男采用SPSS统计软件包(版本22.0)生成随机序列

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

Luo Yanan, a member of our research group, will use SPSS statistical software package (version 22.0) to generate random sequences.

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):

是否共享原始数据:

IPD sharing

是Yes

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):

试验完成6个月内在本平台公开原始数据

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

The original data will be disclosed on this platform within 6 months after the completion of the test

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:

采用病例记录表方式采集数据和管理数据

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

The data will be collected and managed in the form of CRF

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-06-24
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