ChiCTR2400079974 版本V1.0 版本创建时间2024/01/17 15:46:14 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2400079974 

最近更新日期：

Date of Last Refreshed on：

 2024-01-17 15:45:52 

注册时间：

Date of Registration：

 2024-01-17 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于转录组学探讨散结祛瘢方调控TGF-β1相关通路抑制成纤维细胞异常增殖治疗瘢痕疙瘩的作用机制

Public title：

Transcriptomics-based investigation of the mechanism of action of Dispersing Knot and Dispelling Keloid Formula in inhibiting the abnormal proliferation of fibroblasts by regulating the TGF-β1-related pathway for the treatment of keloid scars

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于转录组学探讨散结祛瘢方调控TGF-β1相关通路抑制成纤维细胞异常增殖治疗瘢痕疙瘩的作用机制

Scientific title：

Transcriptomics-based investigation of the mechanism of action of Dispersing Knot and Dispelling Keloid Formula in inhibiting the abnormal proliferation of fibroblasts by regulating the TGF-β1-related pathway for the treatment of keloid scars

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：

王之涵 

研究负责人：

刘青武 

Applicant：

Wang Zhihan 

Study leader：

Liu Qingwu 

申请注册联系人电话：

Applicant telephone：

 +86 182 6349 0369

研究负责人电话：

Study leader's
telephone：

+86 188 1101 6462

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：

 1765805760@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 454293138@qq.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：

北京市朝阳区北三环东路11号

研究负责人通讯地址：

北京市朝阳区樱花园东街2号

Applicant address：

No. 11, Beisanhuan East Road, Chaoyang District, Beijing, China

Study leader's address：

No.2, Cherry Blossom Garden East Street, Chaoyang District, Beijing, China

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：

北京中医药大学

Applicant's institution：

Beijing University of Chinese Medicine

研究负责人所在单位：

中日友好医院

Affiliation of the Leader：

China-Japan Friendship Hospital

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：

 2023-KY-301

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：

中日友好医院临床研究伦理委员会

Name of the ethic committee：

Clinical Research Ethics Committee, China-Japan Friendship Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-11-06 00:00:00

伦理委员会联系人：

闫旭

Contact Name of the ethic committee：

Yan Xu

伦理委员会联系地址：

北京市朝阳区樱花园东街2号中日友好医院行政楼科研处

Contact Address of the ethic committee：

Research Department, Administration Building, China-Japan Friendship Hospital, No.2, Cherry Blossom Garden East Street, Chaoyang District, Beijing, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 10 8420 6250

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：

中日友好医院

Primary sponsor：

China-Japan Friendship Hospital

研究实施负责（组长）单位地址：

北京市朝阳区樱花园东街2号

Primary sponsor's address：

No.2, Cherry Blossom Garden East Street, Chaoyang District, Beijing, China

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)：

朝阳区

Country：

China

Province：

Beijing

City：

Chaoyang District

单位(医院)：

中日友好医院

具体地址：

北京市朝阳区樱花园东街2号

Institution
hospital：

China-Japan Friendship Hospital

Address：

No.2, Cherry Blossom Garden East Street, Chaoyang District, Beijing, China

经费或物资来源：

中日友好医院“菁英计划”人才培育工程

Source(s) of funding：

China-Japan Friendship Hospital "Elite Program" Talent Cultivation Project

研究疾病：

瘢痕疙瘩  

Target disease：

keloid

研究疾病代码：

EE60.0

Target disease code：

EE60.0

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

1.验证散结祛瘢方是否通过抑制瘢痕疙瘩成纤维细胞的异常增殖，从而抑制瘢痕疙瘩的持续性增殖。 2.通过转录组学获取散结祛瘢方治疗瘢痕疙瘩的机制靶点  

Objectives of Study：

1. To verify whether Sanjie Quban Formula inhibits the persistent proliferation of keloids by suppressing the abnormal proliferation of keloid fibroblasts. 2. Obtain the mechanistic targets of Sanjie Quban Formula for keloid treatment through transcriptomics

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: 瘢痕疙瘩诊断标准：病例收集以中日友好医院皮肤科门诊患者为主，纳入病例须满足瘢痕疙瘩临床诊断标准。诊断标准参照蔡景龙等提出的标准：肿块隆起于皮肤表面，坚硬，表面光滑发亮，界限欠规则，1年内无退缩征象；病变超过原始损伤边缘，向周围正常组织发生浸润，呈蟹足状生长；具有持续性生长、发红、疼痒等临床症状，无自愈倾向，不能自行消退； 2: 瘢痕疙瘩中医辨证标准：以皮损辨证与整体辨证相结合，瘢痕色暗红，局部刺痛、拒按，痛重于痒。伴有健忘、胁痛、胁胀，女性可伴有痛经，舌有瘀点、瘀斑，脉沉细涩，证属气滞血瘀证； 3: 符合瘢痕疙瘩的诊断标准，且皮损辨证属于气滞血瘀证； 4: 瘢痕处无伤口或伤口愈合良好、完全上皮化一个月后； 5: 受试者自愿加入研究，并签署知情同意书。

Inclusion criteria

1: Keloid diagnostic criteria: cases were collected mainly from outpatients of the Department of Dermatology of China-Japan Friendship Hospital, and the included cases had to meet the clinical diagnostic criteria of keloid. Diagnostic criteria refer to the criteria proposed by Cai Jinglong et al: the mass is elevated on the skin surface, hard, smooth and shiny surface, irregular boundaries, no signs of regression within 1 year, the lesion exceeds the edge of the original injury, infiltrates into the surrounding normal tissues, and grows in the shape of a crab's foot with persistent growth, redness, pain and itching, and no tendency to self-healing, and it cannot subside by itself 2: Keloid Chinese medicine identification criteria: the combination of skin lesion identification and overall identification, scar color dark red, local tingling, refusing to press, pain is heavier than itching. Accompanied by forgetfulness, coercive pain, coercive distension, women may be accompanied by dysmenorrhea, the tongue has petechiae, ecchymosis, the pulse is thin and astringent, the evidence belongs to qi stagnation and blood stasis 3: The diagnostic criteria for keloids were met, and the skin lesions were identified as belonging to the Qi stagnation and blood stasis syndrome 4: One month after the scar is free of wounds or wounds are well healed and fully epithelialized 5: Subjects voluntarily enrolled in the study and signed an informed consent form

排除标准：

1: 不符合气滞血瘀证辨证的瘢痕疙瘩； 2: 有其他严重肝、肾、心脏及造血系统疾病； 3: 有明显精神症状不能配合试验； 4: 孕妇或其他研究者认为不适合参加试验的情况。

Exclusion criteria：

1: Keloids that do not meet the diagnosis of Qi stagnation and blood stasis 2: Have other serious liver, kidney, heart and hematopoietic system diseases 3: Have significant psychiatric symptoms that prevent them from cooperating with the test 4: Pregnant women or other conditions deemed by the investigator to be unsuitable for participation in the trial

研究实施时间：

Study execute time：

从 From 2023-09-30 00:00:00至 To 2026-08-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-01-31 00:00:00 至 To 2024-10-30 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 20

Group：

comparison group

Sample size：

干预措施：

不干预

干预措施代码：

Intervention：

non-intervention

Intervention code：

组别：

试验组

样本量：

 20

Group：

test group

Sample size：

干预措施：

散结祛瘢汤:早、晚各口服散结祛瘢汤1袋/次（30毫升/袋），疗程1月。

干预措施代码：

Intervention：

Sanjie Quban Formula:Take 1 sachet/dose (30 ml/sachet) of Dispersing Knot Dispelling Scarring Soup orally in the morning and evening for 1 month.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京市 

市(区县)：

 朝阳区 

Country：

CHina

Province：

Beijing

City：

Chaoyang district

单位(医院)：

 中日友好医院 

单位级别：

 三甲 

Institution
hospital：

China-Japan Friendship Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

有效率

指标类型：

主要指标

Outcome：

efficient

Type：

Primary indicator

测量时间点：

手术1月后

测量方法：

有效率测量方法：①痊愈：瘢痕基本正常，患者满意，皮损mVSS评分下降≥90%；②显效：瘢痕外观接近正常，质地变软，瘙痒、疼痛症状消失，患者比较满意，皮损mVSS评分下降60%～89%；③有效：瘢痕有改善，症状有减轻，患者可接受，皮损mVSS评分下降20%～59%；④无效：瘢痕无改善，患者不满意，mVSS评分下降≤19%

Measure time point of outcome：

After one month of surgery

Measure method：

Effectiveness measures: ① cured: scar is basically normal, patient satisfaction, skin lesion mVSS score decreased by ≥ 90%; ② effective: scar appearance is close to normal, the texture becomes softer, itching, pain symptoms disappeared, the patient is more satisfied, the skin lesion mVSS score decreased by 60% to 89%; ③ effective: scar has improved, the symptom has been alleviated, the patient can be accepted, the skin lesion mVSS score decreased by 20% to 59%; ④ ineffective: no improvement in t

指标中文名：

瘢痕增生指数

指标类型：

次要指标

Outcome：

hypertrophic index, HI

Type：

Secondary indicator

测量时间点：

手术后1月

测量方法：

HI=SH/DH，SH(scar height)为瘢痕厚度，DH(dermis height)指瘢痕周边正常皮肤表皮加真皮的厚度，SH值与DH值均来自超声测量，多点测量者HI取均值

Measure time point of outcome：

After one month of surgery

Measure method：

HI=SH/DH, SH (scar height) is the thickness of the scar, DH (dermis height) refers to the thickness of the epidermis plus the dermis of the normal skin surrounding the scar, SH and DH values are from ultrasound measurements, and the HI of the multipoint measurements is taken as the mean value.

指标中文名：

患者满意度评价

指标类型：

次要指标

Outcome：

Patient satisfaction ratings

Type：

Secondary indicator

测量时间点：

手术后1月

测量方法：

使两组患者对治疗效果进行满意度的总体评价，结果分为非常满意（4分）、满意（3分）、一般（2分）、不满意（1分），其中非常满意+满意定义为对治疗满意，满意率=满意例数/病例总数×100%

Measure time point of outcome：

After one month of surgery

Measure method：

To make the overall evaluation of the two groups of patients' satisfaction with the treatment effect, the results were categorized as very satisfied (4 points), satisfied (3 points), average (2 points), and dissatisfied (1 point), in which very satisfied+satisfied was defined as being satisfied with the treatment, and the rate of satisfaction = the number of cases of satisfaction/total number of cases x 100%

指标中文名：

转录组学分析结果

指标类型：

次要指标

Outcome：

Transcriptomics analysis results

Type：

Secondary indicator

测量时间点：

手术时收集组织，试验开始后每3月统一送检

测量方法：

收取组织后，于-80℃冰箱冻存，进行转录组测序，并对调控靶点进行相互作用和功能富集分析。

Measure time point of outcome：

Tissue was collected at the time of surgery and uniformly sent every 3 months after the start of the trial

Measure method：

After harvesting the tissues, they were frozen at -80°C in a freezer for transcriptome sequencing and interaction and functional enrichment analysis of regulatory targets.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

瘢痕组织

组织：

瘢痕组织

Sample Name：

keloid tissue

Tissue：

keloid tissue

人体标本去向

 使用后销毁  

说明

所收集的瘢痕组织将于研究结束后3个月统一销毁。

Fate of sample：

Destruction after use  

Note：

The collected scar tissue will be uniformly destroyed 3 months after the end of the study.

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 1 岁 years
最大 Max age 80 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

无

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

无

Blinding：

None

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

是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）：

需发送邮件申请，仅针对该领域学者共享

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

Email request required, shared only for scholars in the field

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.数据采集：CRF表填写； 2.数据管理：上传到临床试验公共管理平台 Clinical Trial Management Public Platform

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

1. Data collection: fill in CRF form; 2. Data Management: Upload to Clinical Trial Management Public Platform.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2024-01-17 15:45:52