针刺改善中重度寻常型痤疮患者生活质量的疗效--随机对照试验

注册号:

Registration number:

AMCTR-IOR-19000247 

注册号获得时间:

Date of releasing the registration number:

2019/1/28 19:02:39 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

针刺改善中重度寻常型痤疮患者生活质量的疗效--随机对照试验 

Public title:

Effect of Acupuncture on quality of Life in patients with moderate or severe Acne Vulgaris: a Randomized controlled trial 

研究课题的正式科学名称:

针刺改善中重度寻常型痤疮患者生活质量的疗效--随机对照试验 

Scientific title:

Effect of Acupuncture on quality of Life in patients with moderate or severe Acne Vulgaris: a 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:

焦睿珉 

研究负责人:

焦睿珉 

Applicant:

RUIMINJIAO 

Study leader:

RUIMINJIAO 

申请注册联系人电话:

Applicant telephone:

18801247843 

研究负责人电话:

Study leader's telephone:

18801247843 

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:

18801247843@163.com 

研究负责人电子邮件:

Study leader's E-mail:

18801247843@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:

北京市西城区北线阁5号 

研究负责人通讯地址:

北京市西城区北线阁5号 

Applicant address:

No. 5, north line, Xicheng district, Beijing 

Study leader's address:

No. 5, north line, Xicheng district, Beijing 

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:

中国中医科学院广安门医院 

Applicant's institution:

Guang’anmen Hospital, China Academy of Chinese Medical Sciences 

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:

2018-137-KY-01 

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:

中国中医科学院广安门医院伦理委员会 

Name of the ethic committee:

Ethics Committee of Guanganmen Hospital, Chinese Academy of traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-12-20 

研究实施负责(组长)单位:

中国中医科学院广安门医院 

Primary sponsor:

Guang’anmen Hospital, China Academy of Chinese Medical Sciences 

研究实施负责(组长)单位地址:

中国中医科学院广安门医院 

Primary sponsor's address:

Guang’anmen Hospital, China Academy of Chinese Medical Sciences 

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):

中国中医科学院广安门医院

具体地址:

北京市西城区北线阁5号

Institution
hospital:

Guang’anmen Hospital, China Academy of Chinese Medical Sciences

Address:

No. 5, north line, Xicheng district, Beijing

经费或物资来源:

中国中医科学院广安门医院针灸科自拟课题 

Source(s) of funding:

Self-designed subject of Department of Acupuncture and moxibustion in Guanganmen Hospital, Chinese Academy of traditional Chinese Medicine 

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:

其它 

Study phase:

Other 

研究目的:

评价针刺改善中重度寻常痤疮患者生活质量的疗效和安全性。 

Objectives of Study:

To evaluate the efficacy and safety of acupuncture in improving the quality of life of patients with moderate or severe acne vulgaris. 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

① 符合寻常痤疮的诊断标准; ② GAGS评分为19-38分; ③ 年龄符合16-48岁。 

Inclusion criteria

① According to the diagnostic criteria for acne vulgaris, ② The score of GAGS was from 19 to 38; ③ The age of participant is from 18 to 48 years old. 

排除标准:

① 其他类型痤疮:聚合性痤疮、爆发性痤疮、药物性痤疮、月经前痤疮、化妆品痤疮、职业性痤疮患者; ② 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; ③ 在过去1个月内曾使用抗生素进行局部或系统治疗的患者;或在过去1个月内曾使用过避孕药或抗炎药物;或在过去1个月内曾使用维甲酸类药物或类固醇类药物进行系统治疗的患者; ④ 目前正合并患有其他会干扰痤疮评价的皮肤病,如玫瑰痤疮、毛囊炎等; ⑤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; ⑥妊娠或哺乳期妇女,7个月内计划妊娠。 

Exclusion criteria:

① Other types of acne: acne polymerization, explosive acne, drug acne, premenstrual acne, cosmetic acne, occupational acne patients; ② Patients with other diseases that affect the severity of acne, such as polycystic ovary syndrome, thyroid disease, and atypical congenital adrenal hyperplasia; ③ Patients who have been treated locally or systematically with antibiotics in the past month; or who have used contraceptive or anti-inflammatory drugs in the past month; Or patients who have been treated systematically with retinoic acid or steroid drugs in the past month; ④ Patients who currently associated with other skin diseases that interfere with acne evaluation, such as roseacne, folliculitis, and so on; ⑤ Patients with severe heart, liver, kidney, hematopoietic diseases and systemic malnutrition; ⑥ Pregnant or lactating women who plan to become pregnant within 7 months. 

研究实施时间:

Study execute time:

From2019-01-01To 2020-01-01 

干预措施:

Interventions:

组别:

针刺组

样本量:

35

Group:

Acupuncture

Sample size:

干预措施:

针刺

干预措施代码:

Intervention:

Acupuncture

Intervention code:

组别:

浅针刺组

样本量:

35

Group:

Sham Acupuncture

Sample size:

干预措施:

浅针刺

干预措施代码:

Intervention:

Sham Acupuncture

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

China 

市(区县):

北京 

Country:

Beijing 

Province:

 

City:

 

单位(医院):

中国中医科学院广安门医院 

单位级别:

Guang’anmen Hospital, China Academy of Chinese Medical Sciences 

Institution
hospital:

三甲医院  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

第4周结束治疗后Skindex-16生活质量指数总分较基线的变化值

指标类型:

主要指标 

Outcome:

change in the Skindex-16 quality of Life Index total score from baseline to the 4th week

Type:

Primary indicator 

指标中文名:

过去一周的Skindex-16生活质量指数总分较基线变化值的比较

指标类型:

次要指标 

Outcome:

Comparison of the total score of Skindex-16 quality of life index over baseline in the past week

Type:

Secondary indicator 

指标中文名:

过去一周的Skindex-16生活质量指数各维度评分较基线变化值的比较

指标类型:

次要指标 

Outcome:

Comparison of Skindex-16 quality of life index dimension scores over baseline changes over the past week

Type:

Secondary indicator 

指标中文名:

过去一周的皮肤病生活质量指数总分较基线变化值的比较

指标类型:

次要指标 

Outcome:

Comparison of the total score of the skin disease quality of life index over the baseline in the past week

Type:

Secondary indicator 

指标中文名:

过去24h的面部皮损瘙痒VAS视觉模拟评分

指标类型:

次要指标 

Outcome:

VAS visual analogue score of facial pruritus in the past 24 hours

Type:

Secondary indicator 

指标中文名:

过去24h的面部皮损疼痛VAS视觉模拟评分

指标类型:

次要指标 

Outcome:

VAS visual analogue score for facial lesions pain over the past 24 years

Type:

Secondary indicator 

指标中文名:

寻常痤疮药物使用

指标类型:

次要指标 

Outcome:

Acne vulgaris drug use

Type:

Secondary indicator 

指标中文名:

方案的针刺盲法成功率分析

指标类型:

次要指标 

Outcome:

Analysis of the success rate of Acupuncture Blind method based on Acupuncture

Type:

Secondary indicator 

指标中文名:

面部总皮损计数

指标类型:

次要指标 

Outcome:

Total facial lesions count

Type:

Secondary indicator 

指标中文名:

面部炎性皮损计数

指标类型:

次要指标 

Outcome:

Facial inflammatory lesions count

Type:

Secondary indicator 

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

不涉及

组织:

Sample Name:

NA

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

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 48 years

随机方法(请说明由何人用什么方法产生随机序列):

随机方案由广安门医院国家临床药物试验机构办公室编制。采用密闭信封法,进行区组随机。使用SAS软件PROC PLAN过程语句进行区组随机分组,按照试验患者入组顺序将研究对象编为1-70号,

性别:

男女均可

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

Randomization?approach uses closed envelope method to use block random,it prepared by?the National Clinical Drug testing Institute?in Guanganmen Hospital.According to SAS Software generate random groups at a ratio of 1:1,and according to the sequence of patient entry,the unmbers of 1-70 were edited for particpants of this trial.

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):

试验完成后6个月内公开;与研究负责人联系

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

Open to the public within 6 months of completion of the trial; contact with research director of this trial

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):

受试者的个人隐私将在法律允许的范围内得到严格保密。伦理委员会和管理当局应被准予在不违反适用法律和法规所准许的范围内,在不侵犯受试者的隐私的情况下,直接查阅受试者的原始医疗记录。

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

All the information related to participants in this study was kept confidentially. Only clinical research institutes, and ethics committees may have access to the medical records.

创建人:

Creater Name:

 2019-01-02
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