维吾尔医联合糖皮质激素治疗进展期白癜风整群随机对照临床试验

注册号:

Registration number:

ITMCTR2023000029

最近更新日期:

Date of Last Refreshed on:

2023-08-15

注册时间:

Date of Registration:

2023-08-15

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

维吾尔医联合糖皮质激素治疗进展期白癜风整群随机对照临床试验

Public title:

A cluster randomized controlled trial of Uyghur medicine combined with glucocorticoid in the treatment of advanced Vitiligo

注册题目简写:

English Acronym:

研究课题的正式科学名称:

维医涩味黏液质白癜风复杂干预优化及整群随机对照试验

Scientific title:

Optimization of complex interventions and a cluster randomizad controlled trial for Vitiligo patients with astringent myxoid syndrome in Uyghur medicine

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:

2022YFC3501004

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:

吐尔逊他依·买买提依明

研究负责人:

吐尔逊·乌甫尔

Applicant:

Tursontai Maimaiti Yiming

Study leader:

Turson Upur

申请注册联系人电话:

Applicant telephone:

15699200061

研究负责人电话:

Study leader's telephone:

13999998814

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:

786670450@qq.com

研究负责人电子邮件:

Study leader's E-mail:

tursun126@126.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:

乌鲁木齐市天山区延安路776号

研究负责人通讯地址:

乌鲁木齐市天山区延安路776号

Applicant address:

No. 776, Yan'an Road, Tianshan District, Ürümqi

Study leader's address:

No. 776, Yan'an Road, Tianshan District, Ürümqi

申请注册联系人邮政编码:

Applicant postcode:

830054

研究负责人邮政编码:

Study leader's postcode:

830054

申请人所在单位:

新疆维吾尔自治区维吾尔医医院

Applicant's institution:

Hospital of Xinjiang Traditional Uyghur Medicine

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:

2022B0312-2

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:

新疆维吾尔自治区维吾尔医医院药物临床试验伦理委员会

Name of the ethic committee:

Xinjiang Traditional Uyghur Medicine Hospital Ethics Committee for Clinical Trials of Drugs

伦理委员会批准日期:

Date of approved by ethic committee:

2023/7/4 0:00:00

伦理委员会联系人:

阿丽耶

Contact Name of the ethic committee:

Aliye

伦理委员会联系地址:

乌鲁木齐市天山区延安路776号

Contact Address of the ethic committee:

No. 776, Yan'an Road, Tianshan District, Ürümqi

伦理委员会联系人电话:

Contact phone of the ethic committee:

13999134672

伦理委员会联系人邮箱:

Contact email of the ethic committee:

40200756@qq.com

研究实施负责(组长)单位:

新疆维吾尔自治区维吾尔医医院

Primary sponsor:

Hospital of Xinjiang Traditional Uyghur Medicine

研究实施负责(组长)单位地址:

乌鲁木齐市天山区延安路776号

Primary sponsor's address:

No. 776, Yan'an Road, Tianshan District, Ürümqi

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

新疆

市(区县):

乌鲁木齐市

Country:

China

Province:

Xinjang

City:

Ürümqi

单位(医院):

自治区维吾尔医医院

具体地址:

乌鲁木齐市天山区延安路776号

Institution
hospital:

Hospital of Xinjiang Traditional Uyghur Medicine

Address:

No. 776, Yan'an Road, Tianshan District, Ürümqi

经费或物资来源:

国家重点研发计划/自治区重点研发计划项目

Source(s) of funding:

National Key R&D Plan Project

研究疾病:

白癜风

研究疾病代码:

Target disease:

Vitiligo

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

整群随机分组

Cluster randomization

研究所处阶段:

Study phase:

其它

Others

研究目的:

针对现有临床治疗方法在进展期白癜风的病情控制、病程缩减及患者生活质量改善等方面存在的问题短板,结合中西医各自的治疗优势,在医联体单位开展整群随机对照试验,评价中西医结合方案治疗白癜风的有效性、安全性,为中医药防治白癜风的方案优化及指南修订提供高质量证据。

Objectives of Study:

In view of the limitations of existing therapeutic methods on disease control, course reduction and improvement of patients' quality of life of in advanced Vitiligo, we combine the Uyghur medicine with Western medicine to take full advantages of their effects. A cluster randomized controlled trial will also be conducted to evaluate the effectiveness and safety of this complex regimens, providing high-quality evidence for the optimization of Uyghur medicine in the prevention and treatment of vitiligo and the revision of clinical guidelines.

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)符合进展期白癜风诊断,VIDA积分>1分。 2)白癜风严重程度评级为1级(为轻度,特殊部位无限制,其他部位白斑面积≥0.09%(3个指节))的白癜风患者;2级(为中度,白斑面积1%-5%体表面积);3级(为中重度,白斑面积6%-50%);4级(为重度,白斑面积>50%)的患者。 3)符合非节段型(寻常型)白癜风诊断,包括散发型、泛发型,混合型。 4)维吾尔医辨证为涩味黏液质型的白癜风患者。 5)年龄18-65岁。 6)知情同意,自愿受试。

Inclusion criteria

1) Patients diagnosed as vitiligo in advanced stage, and with VIDA score>1 point. 2) Patients whose severity rating is Grade 1 (mild, unlimited in special parts, and ≥ 0.09% in other parts (3 knuckles)); Level 2 (moderate, with a white spot area of 1% -5% of the body surface area); Level 3 (moderate to severe, with a white spot area of 6% -50%); Patients with grade 4 (severe, with a white spot area greater than 50%). 3) Vitiligo patients diagnosed as non-segmental (ordinary) Vitiligo, including sporadic, generalized and mixed vitiligo. 4) Vitiligo patients with astringent myxoid syndrome in Uyghur medicine. 5) aged 18-65 6) with imformed consent.

排除标准:

1)特殊部位的外生殖器、肛门、黏膜白癜风患者。 2) 某些皮疹消退后遗留之色素脱失,贫血痣,白化病,以及其他综合征引起白斑,老年性白斑,无色素性痣,日光性白斑等。 3) 活动期结核、恶性肿瘤进展期患者或肿瘤病史5年以内者。 4) 合并严重的心功能不全,肝、肾系统等严重原发性疾病。(注:ALT、AST超过正常值范围上限2倍,Cr超出正常值上限范围。) 5) 近2周内服过类固醇药物,以及服过任何一种治疗白癜风的药物;和/或1周内服过维甲酸类药物或外用过类固醇制剂及任何治疗白癜风外用药物。 6) 计划妊娠、妊娠期或哺乳期妇女。 7) 怀疑或确有酒精、药物滥用病史。 8) 过敏体质(对2种以上其他药物),或对本诊疗方案中药物成分过敏者。 9) 有降低入组可能性或使入组复杂化的其他情况,如工作环境经常变动、精神障碍、沟通困难等研究者认为不适宜参加本次临床试验者。 10) 近1个月内参加过其他药物临床研究或正在参加其他临床试验者。

Exclusion criteria:

1) Patients with Vitiligo of external genitalia, anus and mucous membrane in special parts. 2) Some skin rashes have left behind Depigmentation, anemic nevus, albinism, and other syndromes that cause leukoplakia, senile leukoplakia, amelanotic nevus, and solar leukoplakia. 3) Patients with active tuberculosis, malignant tumor progression, or a history of tumor within 5 years. 4) Combined with severe cardiac insufficiency, severe primary diseases such as liver and kidney systems. (Note: ALT and AST exceed the upper limit of the normal range by 2 times, while Cr exceeds the upper limit of the normal range.) 5) I have taken steroids and any kind of medicine for Vitiligo in recent 2 weeks; And/or took retinoic acid drugs or steroid preparations for external use and any Topical medication for the treatment of Vitiligo within one week. 6) Plan for pregnant, pregnant, or lactating women. 7) Suspected or confirmed history of alcohol or drug abuse. 8) Allergic constitution (to 2 or more other drugs), or allergic to the drug components in this diagnosis and treatment plan. 9) Other situations that reduce the likelihood of enrollment or complicate enrollment, such as frequent changes in the work environment, mental disorders, communication difficulties, etc., are deemed unsuitable by researchers to participate in this clinical trial. 10) participated in clinical trials of other drugs or are currently participating in other clinical trials within the past month.

研究实施时间:

Study execute time:

From 2023-08-31

To      2025-12-31

征募观察对象时间:

Recruiting time:

From 2023-08-31

To      2025-12-31

干预措施:

Interventions:

组别:

维吾尔医治疗组

样本量:

195

Group:

Uyghur medicine group

Sample size:

干预措施:

维吾尔医综合干预

干预措施代码:

Intervention:

Uyghur medicine

Intervention code:

组别:

维西医联合治疗组

样本量:

195

Group:

Combined treatment group

Sample size:

干预措施:

维吾尔医综合干预+激素

干预措施代码:

Intervention:

Uyghur medicine and glucocorticoid

Intervention code:

样本总量 Total sample size : 390

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

新疆

市(区县):

乌什县

Country:

China

Province:

xinjiang

City:

Uqturpan County

单位(医院):

乌什县维吾尔医医院

单位级别:

二甲医院(国营事业单位)

Institution/hospital:

Uqturpan County Uygur Medical Hospital

Level of the institution:

government-sponsored institution Third Class Hospital

国家:

中国

省(直辖市):

新疆

市(区县):

和田地区

Country:

China

Province:

xinjiang

City:

Hotan Prefecture

单位(医院):

和田地区维吾尔医医院

单位级别:

三甲医院(国营事业单位)

Institution/hospital:

Hotan Prefecture Uygur Medical Hospital

Level of the institution:

government-sponsored institution Third Class Hospital

国家:

中国

省(直辖市):

新疆

市(区县):

吐鲁番市

Country:

China

Province:

xinjiang

City:

Turpan

单位(医院):

吐鲁番市维吾尔医医院

单位级别:

二甲医院(国营事业单位)

Institution/hospital:

Turpan Uygur Medical Hospital

Level of the institution:

government-sponsored institution second Class Hospital

国家:

中国

省(直辖市):

新疆

市(区县):

墨玉县

Country:

China

Province:

xinjiang

City:

Karakax County

单位(医院):

墨玉县维吾尔医医院

单位级别:

二甲医院(国营事业单位)

Institution/hospital:

Karakax County Uygur Medical Hospital

Level of the institution:

government-sponsored institution second Class Hospital

国家:

中国

省(直辖市):

新疆

市(区县):

伊宁市

Country:

China

Province:

xinjiang

City:

Yi Ning

单位(医院):

伊宁市维吾尔医医院

单位级别:

二甲医院(国营事业单位)

Institution/hospital:

Yi Ning Uygur Medical Hospital

Level of the institution:

government-sponsored institution second Class Hospital

国家:

中国

省(直辖市):

新疆

市(区县):

乌鲁木齐市

Country:

China

Province:

xinjiang

City:

Kuqa

单位(医院):

库车市维吾尔医医院

单位级别:

二甲医院(国营事业单位)

Institution/hospital:

Kuqa Uyghur Medical Hospital

Level of the institution:

government-sponsored institution second Class Hospital

国家:

中国

省(直辖市):

新疆

市(区县):

乌鲁木齐市

Country:

China

Province:

xinjiang

City:

urumqi

单位(医院):

新疆维吾尔自治区维吾尔医医院

单位级别:

三甲医院(国营事业单位)

Institution/hospital:

hospital of xinjiang traditional Uyghur medicine

Level of the institution:

government-sponsored institution Third Class Hospital

国家:

中国

省(直辖市):

新疆

市(区县):

疏附县

Country:

China

Province:

xinjiang

City:

Shufu County

单位(医院):

疏附县维吾尔医医院

单位级别:

二甲医院(国营事业单位)

Institution/hospital:

Shufu County Uygur Medical Hospital

Level of the institution:

government-sponsored institution second Class Hospital

国家:

中国

省(直辖市):

新疆

市(区县):

阿克苏地区

Country:

China

Province:

xinjiang

City:

Aksu

单位(医院):

阿克苏地区维吾尔医医院

单位级别:

三甲医院(国营事业单位)

Institution/hospital:

Aksu Prefecture Uygur Medical Hospital

Level of the institution:

government-sponsored institution Third Class Hospital

国家:

中国

省(直辖市):

新疆

市(区县):

喀什地区

Country:

China

Province:

xinjiang

City:

Kashgar Prefecture

单位(医院):

喀什地区维吾尔医医院

单位级别:

三甲医院(国营事业单位)

Institution/hospital:

Kashgar Prefecture Uygur Medical Hospital

Level of the institution:

government-sponsored institution Third Class Hospital

测量指标:

Outcomes:

指标中文名:

维吾尔医证候评分

指标类型:

次要指标

Outcome:

Uyghur Medical Syndrome Score

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

24周的后效应

指标类型:

次要指标

Outcome:

Post effect of 24 weeks

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

白癜风面积评分指数(VASI)评分下降指数

指标类型:

主要指标

Outcome:

Vitiligo area score index (VASI) score decline index

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

第12周的病情稳定情况

指标类型:

次要指标

Outcome:

Stable condition in week 12

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

皮肤病生活质量指数

指标类型:

次要指标

Outcome:

Dermatology Life Quality Index, DLQI

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:

白斑处皮肤组织

组织:

Sample Name:

Skin tissue at the white spot

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:

血液标本

组织:

Sample Name:

Blood samples

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:

尿液样本

组织:

Sample Name:

Urine sample

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:

尚未开始

Not yet 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):

以医院为单位的整群随机。随机分配操作由广东省中医院中医循证医学与临床研究服务团队应用SAS软件进行。

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

A hospital-based cluster randomization procedure will be independently performed and managed by the evidence-based medicine and clinical research service team of Guangdong Provincial Hospital of Traditional Chinese Medicine.

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):

-

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:

电子采集和管理系统

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

Electronic Data Capture, EDC

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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