火针联合黑布药膏治疗瘢痕疙瘩的临床随机对照研究

注册号:

Registration number:

ITMCTR2024000046

最近更新日期:

Date of Last Refreshed on:

2024-04-18

注册时间:

Date of Registration:

2024-04-18

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

火针联合黑布药膏治疗瘢痕疙瘩的临床随机对照研究

Public title:

Clinical Randomized Controlled Trial of Fire Needle Combined with Black Cloth Ointment in the Treatment of Keloid

注册题目简写:

English Acronym:

研究课题的正式科学名称:

中医皮肤病学

Scientific title:

Traditional Chinese medicine dermatology

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:

申请注册联系人:

李林昌

研究负责人:

陈维文

Applicant:

Linchang Li

Study leader:

Weiwen Chen

申请注册联系人电话:

Applicant telephone:

+8615613519620

研究负责人电话:

Study leader's telephone:

18519866309

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:

aristc@mail.ccmu.edu.cn

研究负责人电子邮件:

Study leader's E-mail:

chenweiwen@bjzhongyi.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:

北京市东城区美术馆后街23号

研究负责人通讯地址:

北京市东城区美术馆后街23号

Applicant address:

23 Art Museum back street, Dongcheng District, Beijing

Study leader's address:

23 Art Museum back street, Dongcheng 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:

首都医科大学附属北京中医医院

Applicant's institution:

Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University

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:

2024BL02-020-02

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:

首都医科大学附属北京中医医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of Beijing Hospital of Traditional Chinese Medicine, Capital Medical University

伦理委员会批准日期:

Date of approved by ethic committee:

2024/3/8 0:00:00

伦理委员会联系人:

刘声

Contact Name of the ethic committee:

Liu Sheng

伦理委员会联系地址:

北京市东城区美术馆后街23号

Contact Address of the ethic committee:

23 Art Museum back street, Dongcheng District, Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

010-87906734

伦理委员会联系人邮箱:

Contact email of the ethic committee:

liusheng@bjzhongyi.com

研究实施负责(组长)单位:

首都医科大学附属北京中医医院

Primary sponsor:

Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University

研究实施负责(组长)单位地址:

北京市东城区美术馆后街23号

Primary sponsor's address:

23 Art Museum back street, 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(区县):

Country:

中国

Province:

北京

City:

单位(医院):

首都医科大学附属北京中医医院

具体地址:

北京市东城区美术馆后街23号

Institution
hospital:

Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University

Address:

23 Art Museum back street, Dongcheng District, Beijing

经费或物资来源:

自筹

Source(s) of funding:

self-raised

研究疾病:

瘢痕疙瘩

研究疾病代码:

Target disease:

keloid

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:

证实火针联合黑布药膏相对于黑布药膏单独治疗瘢痕疙瘩临床疗效更优; 火针联合黑布药膏治疗瘢痕疙瘩与单纯黑布药膏治理瘢痕疙瘩组织细胞学变化与炎症因子改变

Objectives of Study:

It is confirmed that fire needle combined with black cloth ointment has better clinical efficacy than black cloth ointment alone in the treatment of keloids; Changes in Histocytology and Inflammatory Factors of Keloid Treated with Fire Needle Combined with Black Cloth Ointment and Simple Black Cloth 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)符合瘢痕疙瘩诊断标准; (2)瘢痕皮损1cm≤长度≤15cm且0.5cm≤宽度≤8cm且厚度≤8mm; (3)瘢痕形成时间>1年; (4)瘢痕数量≤5个; (5)非手足且非黏膜附近瘢痕; (6)年龄在18~65岁之间,性别不限; (7)无严重不能控制的系统性疾病; (8)签署知情同意书。 同时符合以上所有标准准予纳入。

Inclusion criteria

(1) meet the diagnostic criteria of keloid; (2) Scar skin lesions 1 cm ≤ length ≤ 15 cm and 0.5 cm ≤ width ≤ 8 cm and thickness ≤ 8 mm; (3) Scar formation time > 1 year; (4) The number of scars ≤ 5; (5) Non-hand and foot and non-scar near mucosa; (6) Age between 18 and 65 years old, regardless of gender; (7) No serious uncontrollable systemic diseases; (8) Signing informed consent. At the same time meet all the above criteria to be included.

排除标准:

(1)瘢痕周围皮肤存在明显的原发或继发感染者; (2)对治疗药物过敏者; (3)备孕、妊娠期的女性; (4)正在参加其他临床试验的患者; (5)对利多卡因过敏者; (6)纳入前一月内对瘢痕疙瘩采取过治疗者。 符合以上任何一项者不能入选。

Exclusion criteria:

(1) There are obvious primary or secondary infections in the skin around the scar; (2) Allergic to therapeutic drugs; (3) Women preparing for pregnancy and pregnancy; (4) Patients who are participating in other clinical trials; (5) Allergy to lidocaine; (6) Those who had been treated for keloids within one month before inclusion. Those who meet any of the above items cannot be selected.

研究实施时间:

Study execute time:

From 2023-07-30

To      2025-12-31

征募观察对象时间:

Recruiting time:

From 2024-04-22

To      2025-12-31

干预措施:

Interventions:

组别:

联合治疗组

样本量:

15

Group:

Combination therapy group

Sample size:

干预措施:

火针治疗+黑布药膏外用

干预措施代码:

1

Intervention:

Fire needle treatment + black cloth ointment for external use

Intervention code:

组别:

黑布药膏治疗组

样本量:

15

Group:

Black cloth ointment treatment group

Sample size:

干预措施:

黑布药膏外用

干预措施代码:

2

Intervention:

black cloth ointment for external use

Intervention code:

样本总量 Total sample size : 30

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):

北京

Country:

china

Province:

beijing

City:

beijing

单位(医院):

首都医科大学附属北京中医医院

单位级别:

三级甲等中医医院

Institution/hospital:

Beijing Traditional Chinese Medicine Hospital Affiliated to Capital Medical University

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

瘢痕疙瘩体积

指标类型:

次要指标

Outcome:

volume of keloid

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

医生满意度

指标类型:

次要指标

Outcome:

Doctor satisfaction

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

温哥华瘢痕量表

指标类型:

主要指标

Outcome:

The Vancouver Scar 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:

患者满意度

指标类型:

次要指标

Outcome:

Patient satisfaction

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

瘢痕处体表超声

指标类型:

次要指标

Outcome:

Ultrasound of the body surface at the keloid

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

瘢痕疼痛评分

指标类型:

次要指标

Outcome:

keloid pain VAS

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

瘢痕瘙痒评分

指标类型:

次要指标

Outcome:

keloid itching VAS

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:

瘢痕组织

组织:

Sample Name:

keloid tissue

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:

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 65
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

随机数法

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

Random number method

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

No

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):

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

none

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:

病例记录表

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

CRF

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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