ChiCTR2300076200 版本V1.1 版本创建时间2024/02/27 22:19:30 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：

ChiCTR2300076200 

最近更新日期：

Date of Last Refreshed on：

2023-09-27 11:38:52 

注册时间：

Date of Registration：

2023-09-27 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

当归饮子膏方联合穴位埋线治疗血虚风燥型慢性荨麻疹的临床研究及其对IgE、补体C3、C4的影响

Public title：

Clinical study on Danggui Yinzi ointment combined with acupoint catgut embedding in the treatment of chronic urticaria with blood deficiency and wind dryness and its influence on IgE, complement C3 and C4.

注册题目简写：

English Acronym：

研究课题的正式科学名称：

当归饮子膏方联合穴位埋线治疗血虚风燥型慢性荨麻疹的临床研究及其对IgE、补体C3、C4的影响

Scientific title：

Clinical study on Danggui Yinzi ointment combined with acupoint catgut embedding in the treatment of chronic urticaria with blood deficiency and wind dryness and its influence on IgE, complement C3 and C4.

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：

唐磊 

研究负责人：

唐磊 

Applicant：

Lei Tang 

Study leader：

Lei Tang 

申请注册联系人电话：

Applicant telephone：

+86 183 7575 7901

研究负责人电话：

Study leader's telephone：

+86 183 7575 7901

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：

1119472513@qq.com

研究负责人电子邮件：

Study leader's E-mail：

1119472513@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：

重庆市江北区盘溪7支路6号

研究负责人通讯地址：

重庆市江北区盘溪7支路6号

Applicant address：

No.6 Panxi 7 Branch Road, Jiangbei District, Chongqing

Study leader's address：

No.6 Panxi 7 Branch Road, Jiangbei District, Chongqing

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：

重庆市中医院

Applicant's institution：

chongqing hospital of traditional chinese medicine

研究负责人所在单位：

重庆市中医院

Affiliation of the Leader：

chongqing hospital of traditional chinese medicine

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2023-ky-54

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：

重庆市中医院伦理委员会

Name of the ethic committee：

Ethics Committee of chongqing hospital of traditional chinese medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2023-09-13 00:00:00

伦理委员会联系人：

杨洋

Contact Name of the ethic committee：

yang yang

伦理委员会联系地址：

重庆市江北区盘溪7支路6号

Contact Address of the ethic committee：

No.6 Panxi 7 Branch Road, Jiangbei District, Chongqing

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 23 6763 0637

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：

重庆市中医院

Primary sponsor：

chongqing hospital of traditional chinese medicine

研究实施负责（组长）单位地址：

重庆市江北区盘溪7支路6号

Primary sponsor's address：

No.6 Panxi 7 Branch Road, Jiangbei District, Chongqing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

重庆

市(区县)：

Country：

China

Province：

ChongQing

City：

单位(医院)：

皮肤美容科

具体地址：

重庆市江北区盘溪7支路6号

Institution
hospital：

Skin department

Address：

No.6 Panxi 7 Branch Road, Jiangbei District, Chongqing

经费或物资来源：

2023年度江北区科卫联合医学科研项目

Source(s) of funding：

2023 Jiangbei District Science and Health Joint Medical Research Project

Target disease：

Chronic urticaria

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 治疗新技术临床试验 

Study phase：

New Treatment Measure Clinical Study

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

课题组前期预试验表明当归饮子膏方联合穴位埋线治疗血虚风燥型慢性荨麻疹在中医证候评分、临床有效率、荨麻疹活动性评分、皮肤病生活质量量表、血清补体C3、C4、血清IgE水平等指标方面均得到了改善，且无明显不良反应。课题组拟进一步通过高质量的随机对照研究以验证预实验结果，同时通过进一步研究为临床治疗血虚风燥型慢性荨麻疹开发新方法，也为后期进一步申请院内制剂及产业化，探索中医中药治疗血虚风燥型慢性荨麻疹的分子机制提供临床数据支持。  

Objectives of Study：

The preliminary experiment of our research group showed that Danggui Yinzi ointment combined with acupoint catgut embedding treatment for chronic urticaria with blood deficiency and wind dryness had improved in TCM syndrome score, clinical effective rate, urticaria activity score, dermatology quality of life scale, serum complement C3 and C4, serum IgE level and other indicators, and there was no obvious adverse reaction. The research group intends to further verify the pre-experimental results through high-quality randomized controlled research, and at the same time, develop new methods for clinical treatment of chronic urticaria with blood deficiency and wind dryness through further research, and also provide clinical data support for further application and industrialization of hospital preparations and exploration of the molecular mechanism of traditional Chinese medicine in treating chronic urticaria with blood deficiency and wind dryness.

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) 符合慢性荨麻疹诊断标准;参照《中国荨麻疹诊疗指南( 2022版) 》制定西医诊断标准，即自发性风团和/或血管性水肿，每天或间歇性发作，持续时间超过 6 周者。参照《中医临床诊疗术语·证候部分》关于“血虚风燥证”的辨证分型诊断，即“皮毛、筋脉失养，以皮肤粗糙、干燥脱屑、瘙痒，或枯皱皲裂，毛发失荣脱落，肌肤麻木，手足拘急，面白无华，爪甲淡白，头晕眼花，舌淡脉细等”。 ( 2) 年龄18～75岁; ( 3) 治疗前 10 d，停用其他疗法; ( 4) 可按疗程完成治疗; ( 5) 签署知情同意书。

Inclusion criteria

(1) Meet the diagnostic criteria of chronic urticaria; According to the China Urticaria Diagnosis and Treatment Guidelines (2022 Edition), the diagnostic criteria of western medicine were established, that is, spontaneous wheal and/or vascular edema, which occurred every day or intermittently for more than 6 weeks. Refer to the syndrome differentiation diagnosis of "blood deficiency and wind dryness syndrome" in Clinical Diagnosis and Treatment of Traditional Chinese Medicine, that is, "fur and tendons are dystrophy, with rough skin, dry desquamation, itching, chapped or withered skin, disgraced hair loss, numbness of skin, anxious hands and feet, pale face, pale fingernails, dizziness, pale tongue and thready pulse, etc." (2) the age is 18 ~ 75 years old; (3) Ten days before treatment, other therapies were stopped; (4) The treatment can be completed according to the course of treatment; (5) Sign the informed consent form.

排除标准：

(1) 妊娠期、哺乳期或备孕期患者; ( 2) 患有精神疾患，或依从性低而不能配合完成治疗者; ( 3) 患有严重心肺疾患、肝肾功能衰竭者; ( 4)患有严重感染，或其他严重免疫疾病者; ( 5) 不能配合穴位埋线或膏方治疗者。

Exclusion criteria：

(1) Pregnancy, lactation, or preparation period patients; (2) Those who suffer from mental illness or have low compliance and are unable to cooperate in completing treatment; (3) Patients with severe heart and lung diseases or liver and kidney failure; (4) Those who suffer from severe infections or other serious immune diseases; (5) Those who cannot cooperate with acupoint catgut embedding or cream therapy.

研究实施时间：

Study execute time：

从 From 2023-09-14 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2023-10-01 00:00:00 至 To 2025-03-01 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

30

Group：

Test group

Sample size：

干预措施：

采用当归饮子膏方（重订严氏济生方》，方剂组成为生地黄15 g，白芍15 g，当归15 g，川芎15 g，何首乌20 g，荆芥 15 g，防风15 g，白蒺藜 15 g，黄芪20 g，生甘草 10 g，水煎后叫入蜂蜜制成清膏；本膏方由重庆市中医药药剂科膏方制剂室统一制备及质量控制，用法：20mL/次，2 次/日，早饭前、晚饭后半小时）联合穴位埋线（双侧血海、膈腧、风门、三阴交）治疗，埋线每2周/次，共治疗6次。治疗结束后随访12周；

干预措施代码：

 01

Intervention：

Danggui Yinzi Gao Fang (revised Yanshi Jisheng Fang) was adopted, which consisted of Radix Rehmanniae 15 g, Radix Paeoniae Alba 15 g, Radix Angelicae Sinensis 15 g, Rhizoma Chuanxiong 15 g, Polygoni Multiflori Radix 20 g, Herba Schizonepetae 15 g, Radix Saposhnikoviae 15 g, Fructus Tribuli 15 g, Radix Astragali 20 g, and Radix Glycyrrhizae 10 g. After decoction, honey was added to make fluid extract. This ointment was prepared by the ointment preparation room of Chongqing Traditional Chinese Medicine Pharmacy Department and its quality was controlled. Usage: 20mL/ time, twice a day, half an hour before breakfast and after dinner) combined with acupoint catgut embedding (bilateral blood sea, diaphragm, air door and Sanyinjiao) for 6 times, and catgut embedding every 2 weeks. Follow-up for 12 weeks after treatment;

Intervention code：

组别：

对照组

样本量：

30

Group：

Control group

Sample size：

干预措施：

口服依巴斯汀片，INDUSTRIASFARMACEUTICASALMIRA LL,S.A.批准文号：H20140855。药物服法与疗程：每次一片，每日2次，若服用1周无效，可改为每日2次，每次2片。共治疗12周，治疗结束后随访12周。

干预措施代码：

 02

Intervention：

Oral ebastine tablets, INDUSTRIASFARMACEUTICASALMIRA Ll, s.a. approval number: H20140855. Medication and course of treatment: take one tablet each time, twice a day. If taking it for one week is ineffective, it can be changed to twice a day, two tablets each time. The patients were treated for 12 weeks and followed up for 12 weeks after treatment.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 重庆 

市(区县)：

  

Country：

CHINA 

Province：

Chongqing 

City：

 

单位(医院)：

重庆市中医院 

单位级别：

三甲 

Institution
hospital：

chongqing hospital of traditional chinese medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

临床有效率

指标类型：

主要指标

Outcome：

Clinical effective rate

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

中医症状评分

指标类型：

主要指标

Outcome：

Traditional Chinese medicine symptom score

Type：

Primary indicator

测量时间点：

测量方法：

评分

Measure time point of outcome：

Measure method：

give a mark

指标中文名：

荨麻疹活动性评分

指标类型：

次要指标

Outcome：

USA score

Type：

Secondary indicator

测量时间点：

测量方法：

评分

Measure time point of outcome：

Measure method：

give a mark

指标中文名：

皮肤病生活质量量表

指标类型：

次要指标

Outcome：

DLQI score

Type：

Secondary indicator

测量时间点：

测量方法：

评分

Measure time point of outcome：

Measure method：

give a mark

指标中文名：

生化指标（IgE/C3/C4）

指标类型：

主要指标

Outcome：

Biochemical index (IgE/C3/C4)

Type：

Primary indicator

测量时间点：

测量方法：

抽血

Measure time point of outcome：

Measure method：

blood test

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

静脉血

Sample Name：

Blood

Tissue：

Venous blood

人体标本去向

 使用后销毁  

说明

Destruction after use

Fate of sample：

Destruction after use  

Note：

1 week

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 18 岁 years
最大 Max age 75 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）：

试验开始前由负责统计分析的研究人员利用excel软件生成60个数值在0-1之内的不重复随机数。每个随机数分别对应1-60入组序号，号码对应后将这60个数字按照数值大小进行升序排列，规定数值由小到大的前30数所对应的患者入组序号对应试验组，后30个数入组序号对应对照组。将患者随机分为试验组（当归饮子膏方联合穴位埋线组）30例和对照组（西药组）30例。

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

Before the experiment, researchers in charge of statistical analysis used excel software to generate 60 non-repetitive random numbers with values ranging from 0 to 1. Each random number corresponds to 1-60 enrollment serial numbers respectively, and after the numbers correspond, these 60 numbers are arranged in ascending order according to the numerical size, and the patient enrollment serial numbers corresponding to the first 30 numbers with specified numerical values from small to large correspond to the experimental group, and the last 30 numbers correspond to the control group. Patients were randomly divided into experimental group (Danggui Yinzi ointment combined with acupoint catgut embedding group) and control group (western medicine group) with 30 cases.

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：

单盲（对结局指标评定者设盲）

Blinding：

Single blindness (setting blindness for the evaluator of outcome indicators)

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

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）：

通过发表的论文公开原始数据或通过临床试验注册中心要求的网站

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

Open the original data through published papers or through the website required by the clinical trial registration center

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：

用CRF表

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

Using Case Record Form, CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2023-09-27 11:38:28