穴位贴敷治疗乳腺增生的前瞻性、随机、双盲、平行、安慰剂对照、多中心临床研究

注册号:

Registration number:

ITMCTR2200005622

最近更新日期:

Date of Last Refreshed on:

2022-02-08

注册时间:

Date of Registration:

2022-02-08

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

穴位贴敷治疗乳腺增生的前瞻性、随机、双盲、平行、安慰剂对照、多中心临床研究

Public title:

A prospective, randomized, double-blind, parallel, placebo-controlled, multicenter clinical study of acupoint application in the treatment of hyperplasia of mammary glands

注册题目简写:

English Acronym:

研究课题的正式科学名称:

穴位贴敷适宜病证的临床研究

Scientific title:

Clinical study on appropriate acupoint application for diseases and syndromes

研究课题的正式科学名称简写:

Scientific title acronym:

研究课题代号(代码):

Study subject ID:

H20210908-01-02

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:

ChiCTR2200056568 ; ChiMCTR2200005622

申请注册联系人:

刘晓菲

研究负责人:

刘晓菲

Applicant:

Liu Xiaofei

Study leader:

Liu Xiaofei

申请注册联系人电话:

Applicant telephone:

15615611377

研究负责人电话:

Study leader's telephone:

15615611377

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:

drliuxf@126.com

研究负责人电子邮件:

Study leader's E-mail:

drliuxf@126.com

申请单位网址(自愿提供):

Study leader's 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:

山东省济南市历下区经十路16369号山东中医药大学附属医院

研究负责人通讯地址:

山东省济南市历下区经十路16369号山东中医药大学附属医院

Applicant address:

Affiliated Hospital of Shandong University of Traditional Chinese Medicine, No. 16369 Jingshi Road, Lixia district, Jinan City, Shandong Province

Study leader's address:

Affiliated Hospital of Shandong University of Traditional Chinese Medicine, No. 16369 Jingshi Road, Lixia district, Jinan City, Shandong Province

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:

山东中医药大学附属医院

Applicant's institution:

Affiliated Hospital of Shandong University of Traditional Chinese medicine

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

(2022)伦审第(004)号-KY

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

山东中医药大学附属医院伦理委员会

Name of the ethic committee:

Ethics Committee of Affiliated Hospital of Shandong University of Traditional Chinese medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2022/1/20 0:00:00

伦理委员会联系人:

张鑫

Contact Name of the ethic committee:

Zhang Xin

伦理委员会联系地址:

山东省济南市历下区经十路16369号山东中医药大学附属医院

Contact Address of the ethic committee:

Affiliated Hospital of Shandong University of Traditional Chinese Medicine, No. 16369 Jingshi Road, Lixia district, Jinan City, Shandong Province

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:

山东中医药大学附属医院

Primary sponsor:

Affiliated Hospital of Shandong University of Traditional Chinese medicine

研究实施负责(组长)单位地址:

山东省济南市历下区经十路16369号山东中医药大学附属医院

Primary sponsor's address:

Affiliated Hospital of Shandong University of Traditional Chinese Medicine, No. 16369 Jingshi Road, Lixia district, Jinan City, Shandong Province

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

山东

市(区县):

济南

Country:

China

Province:

Shandong

City:

Jinan

单位(医院):

山东中医药大学附属医院

具体地址:

山东省济南市历下区经十路16369号山东中医药大学附属医院

Institution
hospital:

Affiliated Hospital of Shandong University of Traditional Chinese medicine

Address:

Affiliated Hospital of Shandong University of Traditional Chinese Medicine, No. 16369 Jingshi Road, Lixia district, Jinan City, Shandong Province

经费或物资来源:

亚宝药业集团股份有限公司

Source(s) of funding:

Yabao Pharmaceutical Group Co. , Ltd.

研究疾病:

乳腺增生

研究疾病代码:

Target disease:

Mammary gland hyperplasia

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

其它

Others

研究目的:

本研究拟采用临床试验方法,开展中药贴剂穴位贴敷治疗乳腺增生的前瞻性、多中心、随机、双盲、安慰剂平行对照,为临床治疗乳腺增生提供客观、有效的循证证据。

Objectives of Study:

This study is a prospective, multicenter, randomized, double-blind, placebo-controlled clinical trial of acupoint application of Chinese herbal patches in the treatment of breast hyperplasia, to provide objective and effective evidence-based evidence for clinical treatment of Breast Hyperplasia.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

1.年龄在18~45周岁的女性; 2.符合上述中医诊断标准及西医诊断标准; 3.自愿参与本研究者,治疗期间不加服其他治疗乳腺增生的相关药物; 4.知情同意并签署知情同意书者。

Inclusion criteria

1. Women aged between 18 and 45; 2. Meet the above diagnostic criteria of traditional Chinese Medicine and Western Medicine; 3. Participants who volunteered for the study did not take any other drug related to breast hyperplasia during treatment. 4. Informed Consent and signed informed consent.

排除标准:

1.严重月经周期紊乱的患者; 2.乳腺炎症、乳房恶性肿瘤者; 3.3个月内有妊娠计划的人; 4.并有严重的心脑血管及肝肾及造血系统等严重原发性疾病; 5.3个月内口服治疗乳腺疾病相关者; 6.合并其他疾病需要常规用药治疗者; 7.贴敷部位有皮肤创伤、溃疡、皮肤感染或瘢痕体质者及对贴剂过敏者。 注:以上各项满足任何1项或多项均应排除,不能入选。

Exclusion criteria:

1. Patients with Severe Menstrual Cycle Disorder; 2. Breast Inflammation, breast cancer; 3.3 months with a pregnancy plan; 4. And has the serious primary disease and so on serious heart brain blood vessel and liver kidney and hematopoiesis system; 5.3 months Oral Treatment Breast Disease Related Person; 6. Patients with other diseases requiring conventional treatment; 7. Pastes the place to have the skin wound, the ulcer, the skin infection or the scar constitution person and to the pastes allergic person. Note: The above items meet any 1 or more items should be excluded, can not be selected.

研究实施时间:

Study execute time:

From 2021-12-01

To      2023-05-31

征募观察对象时间:

Recruiting time:

From 2022-02-08

To      2023-05-31

干预措施:

Interventions:

组别:

对照组

样本量:

74

Group:

Control Group

Sample size:

干预措施:

安慰剂贴剂+中药粉安慰剂穴位贴敷

干预措施代码:

Intervention:

Placebo patch Chinese medicine powder placebo acupoint application

Intervention code:

组别:

试验组

样本量:

74

Group:

Test Group

Sample size:

干预措施:

消肿止痛贴+中药粉穴位贴敷

干预措施代码:

Intervention:

Detumescence analgesic paste Chinese medicine powder acupoint paste

Intervention code:

样本总量 Total sample size : 148

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

山东

市(区县):

泰安

Country:

China

Province:

Shandong

City:

Taian

单位(医院):

山东第一医科大学第二附属医院

单位级别:

三级甲等

Institution/hospital:

The Second Affiliated Hospital of Shandong First Medical University

Level of the institution:

Class three, first class

国家:

中国

省(直辖市):

山东

市(区县):

Country:

China

Province:

Shandong

City:

单位(医院):

潍坊市中医院

单位级别:

三级甲等

Institution/hospital:

Weifang Chinese Medicine Hospital

Level of the institution:

Class three, first class

国家:

中国

省(直辖市):

山东

市(区县):

济南

Country:

China

Province:

Shandong

City:

Jinan

单位(医院):

山东第一医科大学第一附属医院

单位级别:

三级甲等

Institution/hospital:

The First Affiliated Hospital of Shandong First Medical University

Level of the institution:

Class three, first class

国家:

中国

省(直辖市):

山东

市(区县):

济南

Country:

China

Province:

Shandong

City:

Jinan

单位(医院):

山东中医药大学附属医院

单位级别:

三级甲等

Institution/hospital:

Affiliated Hospital of Shandong University of Traditional Chinese medicine

Level of the institution:

Class three, first class

国家:

中国

省(直辖市):

山东

市(区县):

Country:

China

Province:

Shandong

City:

单位(医院):

淄博市中心医院

单位级别:

三级甲等

Institution/hospital:

Zibo Central Hospital

Level of the institution:

Class three, first class

测量指标:

Outcomes:

指标中文名:

肝肾功

指标类型:

次要指标

Outcome:

Liver and kidney function

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

心电图

指标类型:

次要指标

Outcome:

Ekg

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

乳房疼痛(VAS 评分)

指标类型:

主要指标

Outcome:

Breast Pain (Vas Score)

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清性激素水平检测

指标类型:

主要指标

Outcome:

Detection of serum sex hormone level

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

乳头溢液程度

指标类型:

主要指标

Outcome:

Degree of nipple discharge

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血常规

指标类型:

次要指标

Outcome:

CBC

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

乳房肿块大小、硬度及分布范围

指标类型:

主要指标

Outcome:

Size, hardness and distribution of breast masses

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

临床疗效

指标类型:

主要指标

Outcome:

Clinical efficacy

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医证候积分

指标类型:

主要指标

Outcome:

Integral of TCM Syndrome

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量量表积分:SF-36量表

指标类型:

主要指标

Outcome:

Integration of quality of life scale: SF-36 scale

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良事件严重程度、发生率

指标类型:

次要指标

Outcome:

Severity and incidence of adverse events

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

乳腺彩超

指标类型:

主要指标

Outcome:

Color doppler ultrasound of mammary gland

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生命体征T\P\R\BP

指标类型:

次要指标

Outcome:

Vital signs T\P\R\BP

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

尿常规

指标类型:

次要指标

Outcome:

Urine routine

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

大便常规

指标类型:

次要指标

Outcome:

Stool routine

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:

大便

组织:

Sample Name:

Shit

Tissue:

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note:

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:

标本中文名:

尿液

组织:

Sample Name:

Urine

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:

尚未开始

Not yet recruiting

年龄范围:

最小 18
Min age years
最大 45
Max age years

Recruiting status:

Participant age:

性别:

Gender:

女性

Female

随机方法(请说明由何人用什么方法产生随机序列):

将筛选病例作为受试对象,由第三方运用SPSS统计软件,按各参加单位的病例分配数及随机比例生成随机数字分组表进行随机化,以保证组间均衡性。采用信封法施行随机方案的隐藏:将随机数字按设计要求分组后,在每个不透光的信封内装入一个随机数字和分组类别,发放给各参加单位,信封封面只显示入组的流水序号。受试者入选后,由研究者打开信封查看分组结果,分入相应组别,按照受试者进入研究的先后顺序,发放相应编号药品,各单位不得随意更改分配顺序。

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

The selected cases were randomly divided into groups according to the number of cases allocated and the random proportion by the third party using SPSS statistical software, in order to ensure the balance between groups. Using the envelope method to implement the hiding of RANDOM SCHEME: after grouping the&

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

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):

2023-12-31

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

2023-12-31

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:

1.病例记录表(CRF);2.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:

1. Case record form(CRF); 2. Electronic acquisition and management system

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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