针刺对子宫腺肌病痛经止痛作用的临床研究—多中心、随机对照试验

注册号:

Registration number:

AMCTR-IPR-20000324 

注册号获得时间:

Date of releasing the registration number:

2020/1/20 15:54:35 

注册号状态:

补注册  

Registration Status:

1008002 Retrospective registration  

注册题目:

针刺对子宫腺肌病痛经止痛作用的临床研究—多中心、随机对照试验 

Public title:

Clinical Study on the Analgesic Effect of Acupuncture on secondary dysmenorrhea of Adenomyosis:a Multicenter, Randomized Controlled Trial 

研究课题的正式科学名称:

针刺对子宫腺肌病痛经止痛作用的临床研究—多中心、随机对照试验 

Scientific title:

Clinical Study on the Analgesic Effect of Acupuncture on secondary dysmenorrhea of Adenomyosis:a Multicenter, Randomized Controlled Trial 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

侯学思 

研究负责人:

赵吉平 

Applicant:

Xuesi Hou 

Study leader:

Jiping Zhao 

申请注册联系人电话:

Applicant telephone:

15652609134 

研究负责人电话:

Study leader's telephone:

13621382136 

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:

houxuesi@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zjp7883@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:

北京市东城区美术馆后街23号首都医科大学附属北京中医医院针灸中心 

研究负责人通讯地址:

北京市东城区海运仓5号北京中医药大学东直门医院针灸科 

Applicant address:

Acupuncture Centre,Beijing Hospital of Traditional Chinese Medicine, Capital Medical University,No. 23 Back Street, Dongcheng District Art Museum, Beijing 

Study leader's address:

Department of Acupuncture, Dongzhimen Hospital, Beijing University of Chinese Medicine, No. 5 Haiyang Warehouse, Dongcheng District, Beijing 

申请注册联系人邮政编码:

Applicant postcode:

100010 

研究负责人邮政编码:

Study leader's postcode:

100700 

申请人所在单位:

首都医科大学附属北京中医医院 

Applicant's institution:

Beijing Hospital of Traditional Chinese Medicine,Capital Medical 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:

DZMEC-KY-2019-65 

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:

北京中医药大学东直门医院医学伦理委员会 

Name of the ethic committee:

Ethics Committee of Dongzhimen Hospitalaffliated to Beijing University of Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-03-29 

研究实施负责(组长)单位:

北京中医药大学东直门医院 

Primary sponsor:

Dongzhimen Hospital, Beijing University of Chinese Medicine, 

研究实施负责(组长)单位地址:

北京市东城区海运仓5号北京中医药大学东直门医院针灸科 

Primary sponsor's address:

Department of Acupuncture, Dongzhimen Hospital, Beijing University of Chinese Medicine, No. 5 Haiyang Warehouse, Dongcheng District, Beijing 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

北京市

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

北京市东城区海运仓5号北京中医药大学东直门医院

具体地址:

北京市东城区海运仓5号北京中医药大学东直门医院

Institution
hospital:

Dongzhimen Hospital, Beijing University of Chinese Medicine,

Address:

Dongzhimen Hospital, Beijing University of Chinese Medicine, No. 5 Haiyang Warehouse, Dongcheng District, Beijing

经费或物资来源:

国家中医药管理局国家中医临床研究基地 

Source(s) of funding:

National TCM Clinical Research Base of the State Administration of Traditional Chinese Medicine 

研究疾病:

子宫腺肌病 

Target disease:

adenomyosis 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional 

研究所处阶段:

I期临床试验 

Study phase:

Phase I 

研究目的:

通过随机对照研究,观察针刺治疗对子宫腺肌病继发性痛经的止痛作用,以及对患者生存质量的影响,探索针刺治疗该病的有效方案。 

Objectives of Study:

Through a randomized controlled study, to observe the analgesic effect and the effect on the quality of life of acupuncture for secondary dysmenorrhea of adenomyosis. So as to explore effective plans for acupuncture treatment of the disease. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

(1)符合子宫腺肌病西医(影像学)诊断标准; (2)年龄30-40岁,处于生育年龄者; (3)继发性痛经,进行性加剧,病程≥1年; (4)在痛经急性发作期,腹部疼痛的视觉模拟评分(VAS值)≥40分; (5)未接受任何针对子宫腺肌病的治疗至少1个月; (6)受试者知情,自愿签署知情同意书。 以上6条同时符合方可纳入。 

Inclusion criteria

(1) Meet the diagnostic criteria of western medicine (imaging) for adenomyosis; (2) Those aged 30-40 years, who are of childbearing age; (3) secondary dysmenorrhea, progressively worsen, duration of disease ≥1 year; (4) During the acute onset of dysmenorrhea, the visual analogue score (VAS value) of abdominal pain is ≥40 points; (5) Have not received any treatment for adenomyosis for at least 1 month; (6) Subjects were informed and voluntarily signed informed consent. The above 6 items can be included if they meet the requirements. 

排除标准:

(1)合并盆腔急性炎症、子宫肌瘤、子宫腺肌瘤或盆腔恶性肿瘤者; (2)不能接受经阴道超声检查者; (3)闭经或参加研究时月经超过60天未至者; (4)有子宫腺肌病或子宫内膜异位症相关手术病史; (5)正在进行人工周期调节或1年内有生育要求者; (6)妊娠期及哺乳期妇女; (7)合并有心脑血管、肝、肾和造血系统等严重危及生命的原发性疾病以及精神病患者; (8)存在任何针灸的禁忌症,施针部位有伤痕或感染,或研究人员认为因施针部位出现不适合采取措施的全身疾病者; (9)参与其他课题研究者。 存在以上任何一条者均予排除。 

Exclusion criteria:

1) Patients with acute pelvic inflammation, uterine fibroids, adenomyomas or pelvic malignancies; (2) Cannot accept transvaginal ultrasound; (3) Those who have not had menstruation for more than 60 days at the time of amenorrhea or participation in the study; (4) Have a history of adenomyosis or endometriosis related surgery; (5) Those who are undergoing manual cycle adjustment or have fertility requirements within one year; (6) Women during pregnancy and lactation; (7) Patients with cardio-cerebral vascular, liver, kidney and hematopoietic system severely life-threatening primary diseases and patients with mental illness; (8) Any contraindications to acupuncture, wounds or infections at the site of the needle application, or researchers who believe that a systemic disease at the site of the needle application is inappropriate for taking measures; (9) Researchers participating in other topics. ?? Any one of the above is excluded. 

研究实施时间:

Study execute time:

From2016-01-01To 2018-12-31 

干预措施:

Interventions:

组别:

试验组

样本量:

77

Group:

Study group

Sample size:

干预措施:

针灸

干预措施代码:

Intervention:

acupuncture

Intervention code:

组别:

对照组

样本量:

77

Group:

control group

Sample size:

干预措施:

口服布洛芬

干预措施代码:

Intervention:

ibuprofen

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

北京市东城区海运仓5号北京中医药大学东直门医院 

单位级别:

三级甲等 

Institution
hospital:

Dongzhimen Hospital, Beijing University of Chinese Medicine,  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

黑龙江 

市(区县):

哈尔滨 

Country:

China 

Province:

Hei Longjiang 

City:

Ha Erbin 

单位(医院):

黑龙江中医药大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

he First Affiliated Hospital of Heilongjiang University of Chinese Medicine  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

安徽 

市(区县):

合肥 

Country:

China 

Province:

Anhui 

City:

Hefei 

单位(医院):

安徽中医药大学第三附属医院 

单位级别:

三级甲等 

Institution
hospital:

The Third Affiliated Hospital of Anhui University of Traditional Chinese Medicine  

Level of the institution:

Tertiary 

测量指标:

Outcomes:

指标中文名:

经期最痛VAS评分

指标类型:

主要指标 

Outcome:

VAS scores of the most painful point in menstrual phase

Type:

Primary indicator 

指标中文名:

痛经症状评价(COX痛经症状量表,CMSS)

指标类型:

次要指标 

Outcome:

Symptoms of dysmenorrhea (Cox Menstrual Symptom Scale,CMSS)

Type:

Secondary indicator 

指标中文名:

生存质量(子宫内膜异位症患者生存质量量表简化量表,EHP-5)

指标类型:

次要指标 

Outcome:

The Endometriosis Heart Profile-5 questionaire(EHP-5)

Type:

Secondary indicator 

指标中文名:

月经量

指标类型:

次要指标 

Outcome:

Menstrual amount

Type:

Secondary indicator 

指标中文名:

满意度

指标类型:

次要指标 

Outcome:

Patient satisfaction

Type:

Secondary indicator 

指标中文名:

接受度

指标类型:

附加指标 

Outcome:

Acceptance evaluation

Type:

Additional indicator 

指标中文名:

满意度

指标类型:

附加指标 

Outcome:

Patient satisfaction

Type:

Additional indicator 

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 30 years
最大 Max age 40 years

随机方法(请说明由何人用什么方法产生随机序列):

随机化方案以及产生该方案过程中设定的各个参数统称为盲底,由随机方案产生人员密封签名,并由评价中心不参与本项目的课题组管理人员负责保管。中央随机系统由本课题依托基地承担。中央随机系统设定了严格的人员权限,除最高级别的系统管理员外,其他人没有权限查看中央随机系统中的随机方案,能保证做到完全随机分配,排除人为干扰。

性别:

女性

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

The randomized scheme and the parameters set in the process of generating the scheme are collectively referred to as blind bottoms, and are sealed and signed by the personnel who generate the random scheme, and are kept by the project team manager who is not involved in the project by the evaluation center. The central stochastic system is borne by the base of this project. The central random system has set strict personnel permissions. Except for the system administrator at the highest level, n

Gender:

Female

盲法:

实行评价者、针刺操作者及统计人员三分离。因针刺和口服布洛芬胶囊的治疗形态差别太大,无法对受试者施盲。仅对疗效评价者及统计分析人员施盲。

Blinding:

The evaluator, acupuncture operator and statistician are separated. Acupuncture and oral ibuprofen capsules were too different in treatment modality to blind the subjects. Only blinders of curative effects and statistical analysts.

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

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):

2019年7月,ResMan临床试验公共管理平台,数据上传并使用该网站的数据库进行后期分析

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

July,2019. ResMan Clinical Trial Management Public Platform,upload and post analysis using the website's database

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

原始记录(痛经日记卡)、病例报告表等由第三方保管,采用临床试验公共平台管理

The repository and management of the data(Please specify what repository will be used for management of the metadata):

Original records (dysmenorrhea diary card), case report forms, etc. are kept by a third party and managed by a public platform for clinical trials.

创建人:

Creater Name:

 2020-01-05
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