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妇科特色外治法治疗原发性痛经寒凝血瘀证的临床疗效评价研究
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注册号:

Registration number:

ChiCTR-IIR-17012977 

最近更新日期:

Date of Last Refreshed on:

2017-10-14 

注册时间:

Date of Registration:

2017-10-14 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

妇科特色外治法治疗原发性痛经寒凝血瘀证的临床疗效评价研究 

Public title:

Evaluation of clinical curative effect of primary dysmenorrhea with cold coagulation and blood stasis syndrome treated with external characteristics of gynecological characteristics 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

妇科特色外治法治疗原发性痛经寒凝血瘀证的临床疗效评价研究 

Scientific title:

Evaluation of clinical curative effect of primary dysmenorrhea with cold coagulation and blood stasis syndrome treated with external characteristics of gynecological characteristics 

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:

佘雪立 

研究负责人:

李玲 

Applicant:

She Xueli 

Study leader:

Li Ling 

申请注册联系人电话:

Applicant telephone:

+86 18384164200 

研究负责人电话:

Study leader's telephone:

+8613408000663 

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:

1542380635@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

1050401188@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:

四川省成都市金牛区十二桥路37号 

研究负责人通讯地址:

四川省成都市金牛区十二桥路37号 

Applicant address:

37 Shi'erqiao Road, Jinniu District, Chengdu, Sichuan, China 

Study leader's address:

37 Shi'erqiao Road, Jinniu District, Chengdu, Sichuan, 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:

成都中医药大学 

Applicant's institution:

Chengdu University of TCM 

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:

2017KL-070 

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:

成都中医药大学附属医院医学伦理会 

Name of the ethic committee:

Medical Ethics Association of Chengdu University of Traditional Chinese Medicine Affiliated Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

 

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:

成都中医药大学附属医院 

Primary sponsor:

Chengdu University of Traditional Chinese Medicine Affiliated Hospital 

研究实施负责(组长)单位地址:

四川省成都市金牛区十二桥路37号 

Primary sponsor's address:

37 Shi'erqiao Road, Jinniu District, Chengdu, Sichuan, 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):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

成都中医药大学附属医院

具体地址:

四川省成都市金牛区十二桥路37号

Institution
hospital:

Chengdu University of Traditional Chinese Medicine Affiliated Hospital

Address:

37 Shi'erqiao Road, Jinniu District, Chengdu, Sichuan, China

经费或物资来源:

成都中医药大学附属医院科技发展基金 

Source(s) of funding:

Science and Technology Development Fund of Chengdu University of Traditional Chinese Medicine Affiliated Hospital 

研究疾病:

原发性痛经寒凝血瘀证 

Target disease:

Primary dysmenorrhea with cold coagulation, blood stasis syndrome 

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:

III期临床试验 

Study phase:

研究目的:

本课题拟通过随机、平行、对照临床试验,客观评价经前艾灸联合经期熨烫的特色外治法治疗原发性痛经(寒凝血瘀证)的临床有效性及安全性,以期为中医中药治疗本病提供新的治疗手段,为痛经的中医外治法和痛经的先防理论提供科学依据,我们希望通过对先期使用中医特色外治法治疗痛经的研究,不仅能阻止疼痛发生及缓解疼痛,且通过整体调节,标本同治,最终达到根治痛经的目的。 

Objectives of Study:

Aim to evaluate the clinical efficacy and safety of the characteristic external therapy of premenstrual moxibustion combined with menstrual ironing in the treatment of primary dysmenorrhea (cold coagulation and blood stasis syndrome),in order to provide a new treatment for the disease of traditional Chinese Medicine and provide scientific basis for the external treatment of dysmenorrhea and the prevention theory of dysmenorrhea.We hope that through the preliminary study of the use of Chinese characteristics of external treatment of dysmenorrhea treatment, not only can prevent pain and relieve pain, and through the overall adjustment, the specimen Tongzhi, and ultimately achieve the purpose of radical dysmenorrhea. 

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:

符合原发性痛经诊断标准;中医辨证属寒凝血瘀证型;年龄18~30岁;1分≤VAS评分≤6分者;既往6个月内有连续3个月的原发性痛经史,月经周期在28天±7天范围;对本研究知情,并签订知情同意书者。 

Inclusion criteria

Consistent with the diagnostic criteria for primary dysmenorrhea;The syndrome differentiation of Chinese medicine belongs to the syndrome of cold congealing blood stasis;Between the ages of 18~30 years; VAS score 1 to 6; For the past 6 months, there was a history of primary dysmenorrhea for 3 consecutive months, with a menstrual cycle ranging from 21 to 35 days;Informed of the study and signed informed consent. 

排除标准:

过敏体质;合并盆腔感染、子宫内膜异位症、子宫腺肌病、子宫肌瘤或生殖系统肿瘤等相关疾病者;合并心、肝、肾等重要脏器功能不全、消化及造血系统等严重疾病、既往精神病史者,法律规定的残疾患者(盲,聋,哑,智力障碍,精神障碍,肢体残疾);6个月内计划妊娠、妊娠期或哺乳期妇女、使用药物宫内节育器者;6个月内使用了注射或皮下植入长效避孕药的患者;服用口服避孕药未满8周洗脱期的患者;正在参加其他药物临床试验的患者。将不适宜参与本研究。 

Exclusion criteria:

Allergic constitution; associated with pelvic infection, endometriosis, adenomyosis, myoma of uterus or tumor of reproductive system; Combined with heart, liver, kidney and other important organ dysfunction, digestive and hematopoietic system and other serious diseases, past psychiatric history,disabled persons (blind, deaf, dumb, mental retardation, mental disorder, physical disability) prescribed by law;Planning women for pregnancy, pregnancy or lactation within 6 months, Using a drug intrauterine device; Patients who had been injected or subcutaneously implanted with long-acting contraceptives within 6 months; Patients who take oral contraceptives for less than 8 weeks; Patients who are participating in other clinical trials of drugs. Will not be appropriate to participate in this study. 

研究实施时间:

Study execute time:

From2016-10-01To 2018-09-30 

征募观察对象时间:

Recruiting time:

From2017-10-15To 2018-03-31 

干预措施:

Interventions:

组别:

试验组

样本量:

75

Group:

experimental group

Sample size:

干预措施:

艾灸,熨烫+基础治疗

干预措施代码:

Intervention:

moxibustion, ironing + routine treatment

Intervention code:

组别:

对照组

样本量:

75

Group:

Control group

Sample size:

干预措施:

常规治疗

干预措施代码:

Intervention:

Routine treatment

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

成都中医药大学附属医院 

单位级别:

3级甲等医院 

Institution
hospital:

Chengdu University of Traditional Chinese Medicine Affiliated Hospital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

经行腹痛程度(VAS评分)

指标类型:

主要指标 

Outcome:

Degree of dysmenorrhea

Type:

Primary indicator 

测量时间点:

测量方法:

VAS score

Measure time point of outcome:

Measure method:

VAS score

指标中文名:

腹痛持续时间

指标类型:

主要指标 

Outcome:

Duration of abdominal pain

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CMSS量表

指标类型:

主要指标 

Outcome:

Gauge

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医证候疗效

指标类型:

主要指标 

Outcome:

Curative effect of TCM Syndrome

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:

组织:

Sample Name:

Nothing

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 18 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):

将符合纳排标准的受试者按就诊顺序,按《中医药统计学与软件应用》随机排列表,进行随机分组并作登记。

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

The subjects who met the inclusion criteria were randomly arranged and registered according to the order of visits according to the random list of traditional Chinese medicine statistics and software applications.

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):

中国临床试验注册中心

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

Chinese clinical trial registry

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:

一为病例记录表,二为电子采集和管理系统

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

Case Record Form and Electronic Data Capture

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2017-10-14
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