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评价注射用重组Ⅲ型人源化胶原蛋白溶液锐针点状注射和钝针线性注射用于改善面部皮肤状态的有效性与安全性的临床试验
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注册号：

Registration number：

 ChiCTR2400082129 

最近更新日期：

Date of Last Refreshed on：

 2024-07-22 17:59:52 

注册时间：

Date of Registration：

 2024-03-21 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

评价注射用重组Ⅲ型人源化胶原蛋白溶液锐针点状注射和钝针线性注射用于改善面部皮肤状态的有效性与安全性的临床试验

Public title：

To evaluate the efficacy and safety of sharp needle point injection and blunt needle linear injection of recombinant type III humanized collagen solution for injection in dermis to improve the skin condition of forehead and cheek

注册题目简写：

English Acronym：

研究课题的正式科学名称：

评价注射用重组Ⅲ型人源化胶原蛋白溶液锐针点状注射和钝针线性注射用于改善面部皮肤状态的有效性与安全性的临床试验

Scientific title：

To evaluate the efficacy and safety of sharp needle point injection and blunt needle linear injection of recombinant type III humanized collagen solution for injection in dermis to improve the skin condition of forehead and cheek

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：

俞楠泽\王晓军 

研究负责人：

俞楠泽\王晓军 

Applicant：

Nanze Yu\Xiaojun Wang 

Study leader：

Nanze Yu\Xiaojun Wang 

申请注册联系人电话：

Applicant telephone：

 +86 10 6915 1188

研究负责人电话：

Study leader's
telephone：

+86 10 6915 1188

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：

 yunanze@163.com

研究负责人电子邮件：

Study leader's E-mail：

 yunanze@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：

北京东城区帅府园1号

研究负责人通讯地址：

北京东城区帅府园1号

Applicant address：

No.1 Shuaifuyuan, Dongcheng District, Beijing

Study leader's address：

No.1 Shuaifuyuan, 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：

中国医学科学院北京协和医院

Applicant's institution：

Peking Union Hospital, Chinese Academy of Medical Sciences

研究负责人所在单位：

中国医学科学院北京协和医院

Affiliation of the Leader：

Peking Union Hospital, Chinese Academy of 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：

 I-24PJ0129

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：

中国医学科学院北京协和医院伦理审查委员会

Name of the ethic committee：

Ethics Review Committee of Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-01-18 00:00:00

伦理委员会联系人：

李佳月

Contact Name of the ethic committee：

Jiayue Li

伦理委员会联系地址：

北京东城区帅府园1号

Contact Address of the ethic committee：

No.1 Shuaifuyuan, Dongcheng District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 10 6915 6874

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：

中国医学科学院北京协和医院

Primary sponsor：

Peking Union Hospital, Chinese Academy of Medical Sciences

研究实施负责（组长）单位地址：

北京东城区帅府园1号

Primary sponsor's address：

No.1 Shuaifuyuan, 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)：

北京

Country：

China

Province：

Beijing

City：

Beijing

单位(医院)：

中国医学科学院北京协和医院

具体地址：

北京东城区帅府园1号

Institution
hospital：

Peking Union Hospital, Chinese Academy of Medical Sciences

Address：

No.1 Shuaifuyuan, Dongcheng District, Beijing

经费或物资来源：

校级/院级-AI及三维图像技术处理在体表软组织整形美容临床诊疗中的应用；AI及三维图像技术处理在体表软组织整形美容临床诊疗中的应用（OL6169）；

Source(s) of funding：

School Class/College Class - Application of AI and 3D image technology processing in the clin(OL6169)

研究疾病：

皮肤松弛  

Target disease：

Cutis Laxa

研究疾病代码：

ME66.2

Target disease code：

ME66.2

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：

随机平行对照 

Study design：

Parallel 

研究目的：

评价注射用重组Ⅲ型人源化胶原蛋白溶液在真皮层进行锐针点状注射和钝针线性注射改善额部、颊部皮肤状态的有效性与安全性  

Objectives of Study：

To evaluate the efficacy and safety of sharp needle point injection and blunt needle linear injection of recombinant type III humanized collagen solution for injection in dermis to improve the skin condition of forehead and cheek

药物成份或治疗方案详述：

注射用重组Ⅲ型人源化胶原蛋白溶液为无色或类白色液体，由重组Ⅲ型人源化胶原蛋白（A型）和0.9%的生理盐水组成，胶原蛋白浓度2mg/ml。产品预装于无菌预灌封注射器中，产品经过滤除菌及无菌过程生产，一次性使用。货架有效期2年。 注射方案：受试者试验侧接受钝针线状注射；受试者对照侧接受锐针点状注射。共接受3次注射治疗。 注射剂量：额部+颊部共注射最大剂量不超过12ml产品（产品规格：2.0ml/支）。左侧额部注射剂量不超过2ml（1支），右侧额部注射剂量不超过2ml（1支）；左侧颊部注射剂量不超过4ml（2支）；右侧颊部注射剂量不超过4ml（2支）。 具体操作如下： 试验侧注射方式：用钝针以线状的方式（边退针边注射）在额部和颊部进行注射。将受试者的试验侧额部平均分为3部分。在每个部分的中间处平行于皮肤插入钝针，进入真皮深层后，边退针边注射，将1支注射产品均匀分布于待注射部位。试验侧颊部使用同样的注射方法。 对照侧注射方式：用锐针以点状的方式在额部和颊部进行注射。以对照侧额部为例：斜插皮肤，打到真皮深层后，推药至皮肤可见浅白色小鼓包。注射位点需均匀分布于待注射部位。对照侧颊部使用同样的注射方法。  

Description for medicine or protocol of treatment in detail：

Recombinant type III humanized collagen solution for injection is colorless or white liquid, composed of recombinant type III humanized collagen (type A) and 0.9% normal saline, with a collagen concentration of 2mg/ml. The product is pre-packed in sterile pre-potting syringes, and the product is produced through filtration, sterilization and aseptic process, one-time use. Shelf life is 2 years. Injection plan: the subject will receive blunt needle injection of Linear injection on the experimental face side, and sharp needle of punctate injection on the control face side. Subject will receive total 3 injection treatment. Injection dose requiremet: The maximum injection dose both of forehead and cheek shall not exceed 12ml(product specification: 2.0ml/one). The injection dose of the left frontal part shall not exceed 2ml (1 product), and the injection dose of the right frontal part shall not exceed 2ml (1 product); The injection dose of the left cheek was not more than 4ml (2 products ); The injection dose of the right cheek should not exceed 4ml (2 products). The specific operations are as follows: Experimental side injection method: blunt needle is used to inject in the forehead and cheek in a linear injection waywithdrawing the needle while injection). The subjects' frontal parts on the experimental side will be divided into 3 parts. Insert a blunt needle parallel to the skin in the middle of each part, enter the deep dermis, withdraw the needle while injecting, and evenly distribute 1 injection product at the site to be injected. The same injection method will samely used on the experimental side of the cheek. Control side injection method: The injection was carried out in the forehead and cheek with sharp needle in a punctate injection way. Taking the frontal part of the control as an example, the skin should be inserted diagonally into the deep dermis, and push the product till a small white bulge was visible on the skin. Injection points should be evenly distributed at injection site. The same injection method will samely used on used on the control side of the cheek. 

纳入标准：

Inclusion criteria

排除标准：

1)受试者面部有瘢痕或皮肤疾病可能影响治疗效果的判断，处于过敏发作期，或者存在活动性感染（如炎症性痤疮、单纯疱疹等），和/或未愈合的伤口，处于进展期的皮肤病如：白癜风、银屑病等； 2)筛选前接受过或在研究期间内计划进行以下影响本试验的手术或治疗： a.筛选前或在研究期间计划在全面部进行：硅胶、自体脂肪移植、面部提升手术、埋线提升术、永久性真皮填充剂（如聚甲基丙烯酸甲酯等）治疗等改善面部皱纹手术治疗； b.筛选前18个月或在研究期间计划在全面部进行：半永久性真皮填充剂（如聚左旋乳酸类、羟基磷灰石类、聚己内酯类等）治疗； c.筛选前12个月或在研究期间计划在全面部进行：可降解皮肤填充剂（如透明质酸钠凝胶或胶原蛋白等）治疗； d.筛选前6个月或在研究期间计划在全面部进行：肉毒毒素、美塑疗法、除光调节疗法和强脉冲光之外能量类设备（如激光、射频、超声等）、皮肤磨削术、中等深度或更大深度的化学剥脱术或其他剥脱性治疗（如三氯乙酸、石碳酸、10%及以上浓度果酸或2%及以上浓度水杨酸等）； e.筛选前3个月或在研究期间计划在全面部进行：光调节疗法、强脉冲光、浅层剥脱术或其他剥脱性治疗（如10%以下浓度果酸或2%以下浓度水杨酸等）； 3)身体任何部位多次严重过敏史、遗传性过敏史，在研究期间计划进行脱敏治疗者，或对试验治疗方法使用药物或器械的成分过敏的受试者（透明质酸、链球菌蛋白、利多卡因或其他酰胺类麻醉剂等）； 4)受试者有凝血功能异常病史，或在筛选前14天内使用过或计划使用抗凝血、抗血小板或溶栓治疗（如华法林、阿司匹林等）； 5) 妊娠或哺乳、试验期间计划怀孕、或在筛选期内妊娠试验结果呈现阳性； 6)受试者患有重要脏器严重疾病史或存在活动性自身免疫性疾病史； 7)有增生性瘢痕或瘢痕体质者； 8)筛选期前30天内参加过其它临床试验的受试者； 9)经研究者判断受试者具有不适宜参与本试验的其它系统疾病； 10)无法交流或不遵循研究者指导的受试者； 11)研究者认为不宜参加本试验的其他情况。 注：以上各项均为“否”者方可入选

Exclusion criteria：

(1) The subject has facial scars or skin diseases that may affect the judgment of the treatment effect, is in the allergy attack stage, or has active infection (such as inflammatory acne, herpes simplex, etc.), and/or unhealed wounds, and is in the advanced stage of skin diseases such as vitiligo, psoriasis, etc.; (2) Received or planned to have the following surgeries or treatments affecting this trial prior to screening or planned during the study period: a) Before screening or during the study period, it is planned to be carried out in the whole department: silicone, autologous fat grafting, face lift surgery, thread lift, permanent dermal filler (such as polymethyl methacrylate, etc.) treatment and other surgical treatments to improve facial wrinkles; b) 18 months prior to screening or planned in the comprehensive department during the study period: semi-permanent dermal filler treatment (such as poly-L-lactic acid, hydroxyapatite, polycaprolactone, etc.); c) 12 months prior to screening or planned in the full part during the study period: degradable dermal filler (such as sodium hyaluronate gel or collagen, etc.) treatment; d) 6 months before screening or planned to be performed in the whole department during the study period: botulinum toxin, mesotherapy, energy devices (such as laser, radio frequency, ultrasound, etc.) other than photomodulation therapy and intense pulsed light, dermabrasion, chemical peels of medium or greater depth or other ablative treatments (such as trichloroacetic acid, carbolic acid, 10% and above concentration of fruit acid or 2% or more concentration of salicylic acid, etc.); e) 3 months before screening or planned to be carried out in the comprehensive part during the study period: photomodulation therapy, intense pulsed light, superficial decortication or other ablative treatments (such as less than 10% concentration of AHA or less than 2% concentration of salicylic acid, etc.); (3) Multiple history of severe allergies to any part of the body, history of hereditary allergies, those who plan to undergo desensitization treatment during the study period, or subjects who are allergic to the components of drugs or devices used in the trial treatment method (hyaluronic acid, streptococcal protein, lidocaine or other amide anesthetics, etc.); (4) Subject has a history of coagulation dysfunction, or has used or plans to use anticoagulant, antiplatelet or thrombolytic therapy (such as warfarin, aspirin, etc.) within 14 days prior to screening; (5) Pregnant or breastfeeding, planning to become pregnant during the trial, or having a positive pregnancy test result during the screening period; (6) Subject has a history of serious disease of important organs or active autoimmune disease; (7) Those with hypertrophic scars or scar constitution; (8) Subjects who have participated in other clinical trials within 30 days prior to the screening period; (9) The subject is judged by the investigator to have other systemic diseases that are not suitable for participating in this trial; (10) Subjects who are unable to communicate or do not follow the investigator's instructions; (11) Other conditions that the investigator considers inappropriate to participate in this trial. Note: All the above criteria are "no" to be enrolled

研究实施时间：

Study execute time：

从 From 2024-01-18 00:00:00至 To 2025-10-13 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-05-15 00:00:00 至 To 2024-08-31 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 50

Group：

experimental group

Sample size：

干预措施：

钝针线性注射

干预措施代码：

Intervention：

blunt needle linear injection

Intervention code：

组别：

对照组

样本量：

 50

Group：

control group

Sample size：

干预措施：

锐针点状注射

干预措施代码：

Intervention：

sharp needle punctate injection

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(区县)：

 北京 

Country：

China

Province：

Beijing

City：

Beijing

单位(医院)：

 中国医学科学院北京协和医院 

单位级别：

 三级，三甲 

Institution
hospital：

Peking Union Hospital, Chinese Academy of Medical Sciences

Level of the institution：

Tertiary, Tertiary A

测量指标：

Outcomes：

指标中文名：

末次治疗后第3月盲态评估研究者评估的Lemperle皱纹分级的改善率

指标类型：

主要指标

Outcome：

The rate of improvement in Lemperle's wrinkle grade as assessed by the blinded investigator

Type：

Primary indicator

测量时间点：

末次治疗后3个月

测量方法：

Lemperle皱纹分级评估 研究者将根据受试者情况进行评分，改善的判定标准为治疗后较基线减轻至少1级。 Lemperle皱纹分级： 0级 没有皱纹 1级 隐约可见的皱纹 2级 浅浅的皱纹 3级 中等深浅的皱纹 4级 较深的皱纹，边缘清晰 5级 很深的皱纹，有多余皮肤

Measure time point of outcome：

3 months after the last treatment

Measure method：

Grade the severity of Lemperle The Lemperle Wrinkle Grading Assessment will be scored according to the subject's condition, and improvement will be determined by a reduction of at least 1 grade from baseline after treatment. Lemperle Wrinkle Grading: Grade 0: no wrinkles Grade 1: faintly visible wrinkles Grade 2: shallow wrinkles Grade 3: medium dark wrinkles Grade 4: deep wrinkles with clear edges Grade 5 deep wrinkles with excess skin

指标中文名：

盲态评估研究者评估的Lemperle皱纹分级改善率

指标类型：

次要指标

Outcome：

The rate of improvement in Lemperle's wrinkle grade as assessed by the blinded investigator

Type：

Secondary indicator

测量时间点：

首次治疗后第1、2月（第二次和第三次治疗前）和末次治疗后第1、2、6月

测量方法：

Lemperle皱纹分级评估 研究者将根据受试者情况进行评分，改善的判定标准为治疗后较基线减轻至少1级。 Lemperle皱纹分级： 0级 没有皱纹 1级 隐约可见的皱纹 2级 浅浅的皱纹 3级 中等深浅的皱纹 4级 较深的皱纹，边缘清晰 5级 很深的皱纹，有多余皮肤

Measure time point of outcome：

1, 2 months after the first treatment and 1, 2, 6 months after the last treatment

Measure method：

Grade the severity of Lemperle The Lemperle Wrinkle Grading Assessment will be scored according to the subject's condition, and improvement will be determined by a reduction of at least 1 grade from baseline after treatment. Lemperle Wrinkle Grading: Grade 0: no wrinkles Grade 1: faintly visible wrinkles Grade 2: shallow wrinkles Grade 3: medium dark wrinkles Grade 4: deep wrinkles with clear edges Grade 5 deep wrinkles with excess skin

指标中文名：

盲态评估研究者评估的全局美容效果分级改善率

指标类型：

次要指标

Outcome：

The assessment of graded improvement rate of GAIS as assessed by the blinded investigator

Type：

Secondary indicator

测量时间点：

首次治疗后第1、2月（第二次和第三次治疗前）和末次治疗后第1、2、3、6月

测量方法：

全局美容效果分级 GAIS 评分参考： 1 改善非常明显 2 改善明显 3 有一定程度改善 4 没有变化 5 比以前更糟 “改善”定义：GAIS评分为3~1分，即有一定程度改善至改善非常明显；“改善率”定义：改善例数/受试者例数×100%。

Measure time point of outcome：

1 , 2 months after first treatment, and1, 2, 3, 6 months after last treatment

Measure method：

GAIS: Global Aesthetic Improvement Scale GAIS score reference: 1 very significant improvement 2 significant improvement 3 improved to some extent 4 no change 5 worse than before "improvement" definition GAIS score of 1 to 3, means a certain degree of improvement to a very significant improvement; Definition of "improvement rate" : number of improvement cases/number of subjects ×100%.

指标中文名：

受试者现场评估的全局美容效果分级改善率

指标类型：

次要指标

Outcome：

The assessment of graded improvement rate of GAIS as assessed by the subject

Type：

Secondary indicator

测量时间点：

首次治疗后第1、2月（第二次和第三次治疗前）和末次治疗后第1、2、3、6月

测量方法：

全局美容效果分级 GAIS 评分参考： 1 改善非常明显 2 改善明显 3 有一定程度改善 4 没有变化 5 比以前更糟 “改善”定义：GAIS评分为3~1分，即有一定程度改善至改善非常明显；“改善率”定义：改善例数/受试者例数×100%。

Measure time point of outcome：

1 , 2 months after first treatment, and1, 2, 3, 6 months after last treatment

Measure method：

GAIS: Global Aesthetic Improvement Scale GAIS score reference: 1 very significant improvement 2 significant improvement 3 improved to some extent 4 no change 5 worse than before "improvement" definition GAIS score of 1 to 3, means a certain degree of improvement to a very significant improvement; Definition of "improvement rate" : number of improvement cases/number of subjects ×100%.

指标中文名：

皮肤状态满意度评分和结果满意度评分

指标类型：

次要指标

Outcome：

FACE-Q Satisfaction with Skin & FACE-Q Satisfaction with Outcome

Type：

Secondary indicator

测量时间点：

首次治疗后第1、2月（第二次和第三次治疗前）和末次治疗后第1、2、3、6月

测量方法：

FACE-Q皮肤满意度评估量表，左右脸分开评估，共有11个问题，问题为受试者对于自己面部皮肤（肤色）的满意程度，共有4个等级，1为非常不满意，2为有些不满意，3为有些满意，4为非常满意。受试者完成评估后，计算分值总和，分数越高，结果越好。 FACE-Q结果满意度评估量表，左右脸分开评估，共有6个问题，问题为受试者对于治疗的满意程度，共有4个等级，1为非常不满意，2为有些不满意，3为有些满意，4为非常满意。受试者完成评估后，计算分值总和，分数越高，结果越好。

Measure time point of outcome：

1 , 2 months after first treatment, and1, 2, 3, 6 months after last treatment

Measure method：

FACE-Q Satisfaction with Skin Assessment Scale, left and right FACE separately assessed, a total of 11 questions, the question is the subject's satisfaction with their facial skin (skin tone), a total of 4 score, sum of the score values was calculated, and the higher score, means the better the result. FACE-Q Satisfaction with Outcome Assessment Scale, left and right FACE separately assessed, a total of 6 questions, the question is the subject's satisfaction with the treatment, a total of 4 scor

指标中文名：

VISIA面部影像采集数据与基线数据的差值

指标类型：

次要指标

Outcome：

Difference between VISIA face image acquisition data and baseline data

Type：

Secondary indicator

测量时间点：

首次治疗后第1、2月（第二次和第三次治疗前）和末次治疗后第1、2、3、6月

测量方法：

VISIA面部影像采集以下信息：斑点，毛孔，皱纹，纹理（皮肤粗糙及平滑度），皮肤真皮层的紫斑，皮肤真皮层的褐色斑，红区及卟啉

Measure time point of outcome：

1 , 2 months after first treatment, and1, 2, 3, 6 months after last treatment

Measure method：

VISIA facial images capture the following information: spots, pores, wrinkles, texture (roughness and smoothness of the skin), purple spots in the dermis, brown spots in the dermis, red areas and porphyrins

指标中文名：

皮肤含水量、油脂量、皮肤弹性测量数据与基线数据的差值

指标类型：

次要指标

Outcome：

Differences in skin water content, oil content, skin elasticity measurements from baseline data

Type：

Secondary indicator

测量时间点：

首次治疗后第1、2月（第二次和第三次治疗前）和末次治疗后第1、2、3、6月

测量方法：

Cutometer MPA580仪器采集皮肤含水量、油脂量、皮肤弹性

Measure time point of outcome：

1 , 2 months after first treatment, and1, 2, 3, 6 months after last treatment

Measure method：

Water content, oil content and elasticity of skin were collected by Cutometer MPA580

指标中文名：

生命体征

指标类型：

次要指标

Outcome：

vital signs

Type：

Secondary indicator

测量时间点：

每次访视时

测量方法：

每次访视时的生命体征：包括呼吸、心率、血压、体温

Measure time point of outcome：

Each visit

Measure method：

Vital signs at each visit: respiration, heart rate, blood pressure, temperature

指标中文名：

视觉模拟评分法（VAS评分）

指标类型：

次要指标

Outcome：

VAS Assessment

Type：

Secondary indicator

测量时间点：

每次治疗后

测量方法：

在纸上面划一条10cm的横线，横线的一端为0，表示无痛；另一端为10，表示剧痛；中间部分表示不同程度的疼痛。受试者在注射研究器械5min内在代表自身疼痛强度的点上做标记。标记处即为该受试者的VAS评分。

Measure time point of outcome：

After each treatment

Measure method：

Draw a 10cm horizontal line on the paper, one end of the horizontal line is 0, indicating no pain; The other end is 10, indicating severe pain; The middle part indicates different levels of pain. Participants marked points representing their own pain intensity within 5 minutes of injecting the study device. Marked is the subject's VAS score.

指标中文名：

不良事件

指标类型：

次要指标

Outcome：

Adverse event

Type：

Secondary indicator

测量时间点：

每次访视

测量方法：

究者收集受试者在试验过程中出现的不良事件

Measure time point of outcome：

Each visit

Measure method：

The investigators collect the adverse events that occurred during the study

指标中文名：

器械故障

指标类型：

次要指标

Outcome：

Device deficiency

Type：

Secondary indicator

测量时间点：

每次治疗后

测量方法：

研究者收集受试者在治疗过程中出现的器械故障事件

Measure time point of outcome：

After each treatment

Measure method：

The investigators collect the Device deficiency event that occurred during treatment

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

不适用

组织：

Sample Name：

NA

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

暂停或中断

Suspending

年龄范围：

Participant age：
最小 Min age 30 岁 years
最大 Max age 55 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

本试验采用区组随机方法，随机表由独立的随机统计师采用SAS软件在计算机上产生，须保障随机的可重现性。随机化工作人员将负责产生随机表和随机信封。

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

a block randomization method was used, and the randomization table was generated on a computer by an independent randomized statistician using SAS software, and the reproducibility of the randomization must be ensured. The randomization staff will be responsible for generating the randomization table and the randomization envelope.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

本研究无法对负责治疗的研究医生和受试者进行设盲。但是试验将对负责疗效评价的研究医生进行设盲，以在最大程度上控制临床试验中因“知晓分组信息”而产生的评价偏倚。

Blinding：

The study could not blind the study physicians and subjects in charge of treatment. However, the trial will blind the study physician responsible for the evaluation of efficacy to minimize the evaluation bias caused by "knowing the group information" in the clinical trial.

是否共享原始数据：

IPD sharing

否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）：

原始数据不共享

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

IPD not sharing

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：

EDC

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

EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2024-03-21 11:45:51
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