A randomized, double-blind, placebo-controlled clinical study on the effectiveness and safety of Wan's Yanghe Jiening ointment in the treatment of hyperplasia of mammary glands

注册号:

Registration number:

ITMCTR2000004016

最近更新日期:

Date of Last Refreshed on:

2020-08-27

注册时间:

Date of Registration:

2020-08-27

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

万氏阳和解凝膏治疗乳腺增生病有效性及安全性的随机、双盲、安慰剂平行对照的临床研究

Public title:

A randomized, double-blind, placebo-controlled clinical study on the effectiveness and safety of Wan's Yanghe Jiening ointment 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:

万氏阳和解凝膏治疗乳腺增生病有效性及安全性的随机、双盲、安慰剂平行对照的临床研究

Scientific title:

A randomized, double-blind, placebo-controlled clinical study on the effectiveness and safety of Wan's Yanghe Jiening ointment in the treatment of hyperplasia of mammary glands

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:

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:

ChiCTR2000037296 ; ChiMCTR2000004016

申请注册联系人:

高晴倩

研究负责人:

高晴倩

Applicant:

Gao Qingqian

Study leader:

Gao Qingqian

申请注册联系人电话:

Applicant telephone:

+86 13361925025

研究负责人电话:

Study leader's telephone:

+86 13361925025

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:

gaoqq88@163.com

研究负责人电子邮件:

Study leader's E-mail:

gaoqq88@163.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:

上海市普安路185号住院部九楼乳腺科医生办公室

研究负责人通讯地址:

上海市普安路185号住院部九楼乳腺科医生办公室

Applicant address:

Mammologist's Office, 9th Floor, Inpatient Department,185 Pu'an Road, Shanghai

Study leader's address:

Mammologist's Office, 9th Floor, Inpatient Department, 185 Pu'an Road, Shanghai

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:

上海中医药大学附属曙光医院

Applicant's institution:

Shuguang Hospital Affiliated to Shanghai 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:

2020-sgys-007

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:

上海中医药大学附属曙光医院伦理委员会

Name of the ethic committee:

Ethics Committee of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2013/8/26 0:00:00

伦理委员会联系人:

马俊坚

Contact Name of the ethic committee:

Ma Junjian

伦理委员会联系地址:

上海市张衡路528号

Contact Address of the ethic committee:

528 Zhangheng Road, Pudong New Area, Shanghai

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:

上海中医药大学附属曙光医院

Primary sponsor:

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

上海市张衡路528号

Primary sponsor's address:

528 Zhangheng Road, Pudong New Area, Shanghai

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海申康医院发展中心

具体地址:

静安区康定路2号

Institution
hospital:

Shanghai Shenkang Hospital Development Center

Address:

2 Kangding Road, Jing'an District

经费或物资来源:

上海申康医学发展中心

Source(s) of funding:

Shanghai Shenkang Hospital Development Center

研究疾病:

乳腺增生病

研究疾病代码:

Target disease:

Breast 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:

探索性研究/预试验

Pilot clinical trial

研究目的:

围绕临床常见病乳腺增生病,开展前瞻性、双盲、随机对照的试验,验证万氏阳和解凝膏对乳腺增生病的疗效和安全性,为万氏阳和解凝膏的进一步推广应用提供依据。

Objectives of Study:

Carry out prospective, double-blind, randomized controlled trials focusing on common clinical diseases of mammary gland hyperplasia to verify the efficacy and safety of Wan's Yanghe Jiening ointment on hyperplasia of mammary glands, and provide basis for the further promotion and application of Wanshiyanghe Jiening ointment.

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)符合乳腺增生病诊断,病程>3 个月; (2)年龄18-50岁,女性,有基本规则的月经周期(21-35 天)与经期(3-7 天); (3)乳腺彩超 BI-RADS 分级为 2-3 级; (4)导入期疼痛累及天内的 VAS 平均分≥4 分且触诊仍有靶肿块存在; (5)疼痛天数≥3天(以治疗前一月内累计疼痛天数为准); (6)受试者知情同意,自愿受试并签署知情同意书者。

Inclusion criteria

(1) In line with the diagnosis of hyperplasia of mammary glands, the course of the disease is> 3 months; (2) 18-50 years old, female, with basic regular menstrual cycle (21-35 days) and menstrual period (3-7 days); (3) Breast color Doppler ultrasound BI-RADS is graded 2-3; (4) The average score of VAS within the pain-involved days during the lead-in period is >= 4 points and there is still a target mass on palpation; (5) Pain days >= 3 days (in the first month of treatment) Accumulated pain days within); (6) Subjects with informed consent, voluntarily taking the test and signing informed consent.

排除标准:

(1)合并乳腺炎症、乳腺肿瘤及其他有手术指征的乳腺疾病患者; (2)合并有严重原发性心、脑、肝、肾、血等疾病与合并影响其生存的严重疾病者; (3)Cr>正常值上限;ALT、AST、BUN>20%正常值上限; (4)乳腺局部皮肤有破损者; (5)妊娠或哺乳期妇女、近半年有妊娠计划者; (6)过敏性体质,或皮肤易对橡胶膏等外用制剂过敏者,或已知对本药成分过敏者; (7)酗酒和/或精神活性物质,药物滥用者和依赖者; (8)正在参加其他临床试验者; (9)本次治疗前1个月内使用治疗乳腺增生病的中西药物者(包含外敷药、针灸等)且半年内未使用激素类药物; (10)根据研究者的判断,有降低入组可能性或使入组复杂化的其他病变或情况,如工作环境经常变动等易造成失访的情况,以及由于精神和行为障碍不能给予充分知情同意者。

Exclusion criteria:

(1) Patients with breast inflammation, breast tumors, and other breast diseases with surgical indications; (2) Patients with severe primary heart, brain, liver, kidney, blood and other diseases combined with severe diseases that affect their survival; (3) Cr> upper limit of normal value; ALT, AST, BUN> 20% upper limit of normal value; (4) Those with local breast skin damage; (5) Pregnant or breast-feeding women, those with pregnancy plans in the past six months; (6) People with allergic physique, or skin allergic to external preparations such as rubber paste, or known to Those who are allergic to the ingredients of the medicine; (7) Alcohol and/or psychoactive substances, drug abusers and dependents; (8) Those who are participating in other clinical trials; (9) Those who are used to treat breast hyperplasia within 1 month before this treatment Chinese and Western medicines (including topical medicine, acupuncture, etc.) and have not used hormone drugs within six months; (10) According to the judgment of the investigator, there are other diseases or conditions that reduce the possibility of enrollment or complicate enrollment, such as working environment Frequent changes and other situations that are likely to cause loss to follow-up, and those who cannot give full informed consent due to mental and behavioral disorders.

研究实施时间:

Study execute time:

From 2020-09-01

To      2023-08-31

征募观察对象时间:

Recruiting time:

From 2021-01-01

To      2022-12-31

干预措施:

Interventions:

组别:

试验组

样本量:

78

Group:

experimental group

Sample size:

干预措施:

万氏阳和解凝膏

干预措施代码:

Intervention:

Wan's Yanghe Jiening ointment

Intervention code:

样本总量 Total sample size : 156

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海中医药大学附属曙光医院

单位级别:

三级甲等

Institution/hospital:

Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

乳腺靶肿块范围和最大径

指标类型:

次要指标

Outcome:

Breast target mass range and maximum diameter

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疼痛分级指数评定

指标类型:

主要指标

Outcome:

Pain grading index assessment

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

最痛一日疼痛强度评定

指标类型:

主要指标

Outcome:

Pain intensity assessment on the most painful day

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

乳腺彩超检查靶肿块

指标类型:

次要指标

Outcome:

Breast color ultrasound examination target mass

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疼痛持续时间

指标类型:

主要指标

Outcome:

Duration of 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:

中医证候积分

指标类型:

次要指标

Outcome:

TCM Syndrome Points

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

视觉模拟评分法

指标类型:

主要指标

Outcome:

Visual analog scale

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:

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:

正在进行

Recruiting

年龄范围:

最小 18
Min age years
最大
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):

借助 SAS 统计软件,产生 156 例(试验组78例、对照组 78例)受试者所接受处理的随机安排,即列出流水号为 001~156 所对应的治疗分配。

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

With the help of SAS statistical software, a random arrangement for the treatment of 156 subjects (78 in the experimental group and 78 in the control group) was generated, that is, the treatment allocation corresponding to the serial number 001~156 is listed.

盲法:

双盲

Blinding:

Double blind

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):

电子excel表

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

Electronic excel sheet

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(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC)

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

One is the case record form (Case Record Form, CRF), and the other is the electronic data capture and management system (Electronic Data Capture, EDC)

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):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above