耳穴刺络结合耳穴贴压治疗寻常型痤疮的作用机制研究

注册号:

Registration number:

AMCTR-ICR-19000310 

注册号获得时间:

Date of releasing the registration number:

2019/12/19 16:22:10 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

耳穴刺络结合耳穴贴压治疗寻常型痤疮的作用机制研究 

Public title:

Study on the mechanism of auricular point pricking and auricular point sticking in the treatment of acne vulgaris 

研究课题的正式科学名称:

耳穴刺络结合耳穴贴压治疗寻常型痤疮的作用机制研究 

Scientific title:

Study on the mechanism of auricular point pricking and auricular point sticking in the treatment of acne vulgaris 

研究课题代号(代码):

Study subject ID:

KTZ2019013 

在其它机构的注册号:

Secondary ID:

 

申请注册联系人:

张曼 

研究负责人:

佘延芬 

Applicant:

Man Zhang 

Study leader:

Yanfen She 

申请注册联系人电话:

Applicant telephone:

18231171823 

研究负责人电话:

Study leader's telephone:

15833955088 

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:

1144090065@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

sheyanfen@163.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:

河北省石家庄市桥西区新石南路326号河北中医学院橘泉校区 

研究负责人通讯地址:

河北省石家庄市鹿泉区杏苑路3号河北中医学院杏苑校区 

Applicant address:

326 Xinshi South Road, Qiaoxi District, Shijiazhuang City, Hebei Province 

Study leader's address:

3 Xingyuan Road, Luquan District, Shijiazhuang City, Hebei 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:

河北中医学院 

Applicant's institution:

Hebei University of Chinese Medicine 

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:

YXLL2019035 

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:

河北中医学院伦理委员会 

Name of the ethic committee:

Ethics Committee of Hebei University of Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-09-12 

研究实施负责(组长)单位:

河北中医学院 

Primary sponsor:

Hebei University of Chinese Medicine 

研究实施负责(组长)单位地址:

河北省石家庄市桥西区新石南路326号河北中医学院橘泉校区 

Primary sponsor's address:

326 Xinshi South Road, Qiaoxi District, Shijiazhuang City, Hebei 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):

河北省

市(区县):

Country:

China

Province:

Hebei Province

City:

单位(医院):

河北中医学院

具体地址:

河北省石家庄市桥西区新石南路326号河北中医学院橘泉校区

Institution
hospital:

Hebei University of Chinese Medicine

Address:

326 Xinshi South Road, Qiaoxi District, Shijiazhuang City, Hebei Province

经费或物资来源:

河北中医学院科技能力提升项目基金 

Source(s) of funding:

Hebei University of Chinese Medicine science and technology capacity improvement project fund 

研究疾病:

寻常型痤疮 

Target disease:

acne vulgaris 

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:

临床预试验 

Study phase:

Clinical pre-test 

研究目的:

本课题通过对血清睾酮、胰岛素样生长因子1(IGF-1)、IgG、IgM、sIL-2R、乙酰胆碱(Ach)等指标的检测,从神经、激素、免疫多角度对耳穴刺络结合耳穴贴压治疗痤疮的作用机制进行初步探讨,为临床应用提供理论依据。 

Objectives of Study:

Through the detection of serum testosterone, insulin-like growth factor-1 (IGF-1), IgG, IgM, sIL-2R, acetylcholine (ACh) and other indicators, the mechanism of auricular point pricking and auricular point sticking in the treatment of acne was preliminarily discussed from the perspectives of nerve, hormone and immunity, so as to provide theoretical basis for clinical application. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

①符合寻常型痤疮的诊断标准; ②年龄符合18-35岁,痤疮GAGS评分1-30分(分级为轻中度); ③治疗前30日内未用过与本病相关的内服药,7天内未用过与本病相关的外用药; ④自愿参加并签署知情同意书者。 

Inclusion criteria

① the diagnosis criteria of acne vulgaris were met; ② the age was 18-35 years old, and the acne gags score was 1-30 (light to moderate); ③ no internal medicine related to the disease was used within 30 days before treatment, and no external medicine related to the disease was used within 7 days; ④ those who voluntarily participate in and sign the informed consent. 

排除标准:

①患有其他会影响痤疮严重性的疾病的患者,如多囊卵巢综合征、甲状腺疾病、非典型先天性肾上腺增生患者;或使用其他治疗全身性疾病的药物; ②在接受本临床研究观察期间不可避免直接的曝晒或者较大强度的紫外线的病人; ③对本临床研究所使用的耳穴贴压有抗拒、过敏体质或者瘢痕体质者; ④患有严重的心、肝、肾脏、造血系统疾病、全身营养状况不良的患者; ⑤妊娠或哺乳期妇女。 

Exclusion criteria:

① patients with other diseases that will affect the severity of acne, such as polycystic ovary syndrome, thyroid disease, atypical congenital adrenal hyperplasia, or use other drugs to treat systemic diseases; ② patients who are inevitably exposed to direct sunlight or strong ultraviolet during the observation period of this clinical study; ③those who have resistance, allergic constitution or scar constitution to the auricular point sticking used in this clinical research; ④ patients with serious heart, liver, kidney, hematopoietic system diseases and general malnutrition; ⑤ pregnant or lactating women. 

研究实施时间:

Study execute time:

From2020-01-01To 2020-12-31 

干预措施:

Interventions:

组别:

对照组

样本量:

35

Group:

control group

Sample size:

干预措施:

耳穴刺络结合耳穴贴压

干预措施代码:

Intervention:

Auricular point pricking and auricular point sticking

Intervention code:

组别:

试验组A

样本量:

35

Group:

Test group A

Sample size:

干预措施:

耳穴刺络结合耳穴贴压

干预措施代码:

Intervention:

Auricular point pricking and auricular point sticking

Intervention code:

组别:

试验组B

样本量:

35

Group:

Test group B

Sample size:

干预措施:

耳穴刺络结合耳穴贴压

干预措施代码:

Intervention:

Auricular point pricking and auricular point sticking

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

河北省 

市(区县):

 

Country:

China 

Province:

Hebei Province 

City:

 

单位(医院):

河北中医学院 

单位级别:

高等中医药院校 

Institution
hospital:

Hebei University of Chinese Medicine  

Level of the institution:

College of traditional Chinese Medicine 

测量指标:

Outcomes:

指标中文名:

血清睾酮

指标类型:

主要指标 

Outcome:

serum testosterone

Type:

Primary indicator 

指标中文名:

胰岛素样生长因子1

指标类型:

主要指标 

Outcome:

IGF-1

Type:

Primary indicator 

指标中文名:

免疫球蛋白G

指标类型:

主要指标 

Outcome:

IgG

Type:

Primary indicator 

指标中文名:

免疫球蛋白M

指标类型:

主要指标 

Outcome:

IgM

Type:

Primary indicator 

指标中文名:

可溶性白介素2受体

指标类型:

主要指标 

Outcome:

sIL-2R

Type:

Primary indicator 

指标中文名:

乙酰胆碱

指标类型:

主要指标 

Outcome:

Ach

Type:

Primary indicator 

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:

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 35 years

随机方法(请说明由何人用什么方法产生随机序列):

采用密闭信封法,由第三方(不参与本课题研究的统计学人员)设计好随机分组信封,纳入顺序号贴在信封表面,将随机数及组别密封于不透光的信封内进行随机分配隐藏。

性别:

男女均可

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

Using the sealed envelope method, the third party (the statisticians who do not participate in the research) designed the random grouping envelope, put the sequence number on the envelope surface, and sealed the random number and group in the opaque envelope for random distribution and hiding.

Gender:

Both

盲法:

Blinding:

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):

论文支持材料

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

Paper supporting materials

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):

实验记录本

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

Experimental record book

创建人:

Creater Name:

 2019-11-19
返回列表