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研究中医外治法督脉灸联合西药依巴斯汀治疗慢性荨麻疹的临床评价方式

注册号：

Registration number：

ITMCTR2024000752

最近更新日期：

Date of Last Refreshed on：

2024-11-28

注册时间：

Date of Registration：

2024-11-28

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

研究中医外治法督脉灸联合西药依巴斯汀治疗慢性荨麻疹的临床评价方式

Public title：

Translation: "A clinical evaluation study on the combination of traditional Chinese medicine external treatment method, Du Mai moxibustion, and western drug ebastine in treating chronic urticaria."

注册题目简写：

督脉灸联合依巴斯汀治疗慢性荨麻疹

English Acronym：

CTDEMx-EB

研究课题的正式科学名称：

研究中医外治法督脉灸联合西药依巴斯汀治疗慢性荨麻疹的临床评价方式

Scientific title：

Translation: "A clinical evaluation study on the combination of traditional Chinese medicine external treatment method, Du Mai moxibustion, and western drug ebastine in treating chronic urticaria."

研究课题的正式科学名称简写：

督脉灸联合依巴斯汀治疗荨麻疹

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：

佘蒙迪

研究负责人：

佘蒙迪

Applicant：

megndi She

Study leader：

mengdi she

申请注册联系人电话：

Applicant telephone：

13511248946

研究负责人电话：

Study leader's telephone：

13511248946

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：

631303466@qq.com

研究负责人电子邮件：

Study leader's E-mail：

631303466@qq.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：

浙江省湖州市风雅苹洲10-904室

研究负责人通讯地址：

浙江省湖州市风雅苹洲10-904室

Applicant address：

Room 10-904, Fengya Pingzhou, Huzhou City, Zhejiang Province

Study leader's address：

Room 10-904, Fengya Pingzhou, Huzhou City, Zhejiang Province

申请注册联系人邮政编码：

Applicant postcode：

313000

研究负责人邮政编码：

Study leader's postcode：

313000

申请人所在单位：

长兴县人民医院

Applicant's institution：

Changxing County People's Hospital

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：

2024-EC-006

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：

长兴县人民医院医学伦理研究委员会

Name of the ethic committee：

Changxing County People's Hospital Medical Ethics Research Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2024/11/14 0:00:00

伦理委员会联系人：

林彬

Contact Name of the ethic committee：

Bin Lin

伦理委员会联系地址：

浙江湖州长兴县太湖中路66号

Contact Address of the ethic committee：

No. 66, Taihu Middle Road, Changxing County, Huzhou, Zhejiang Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

0572-6268472

伦理委员会联系人邮箱：

Contact email of the ethic committee：

lb_lb_wzmc@126.com

研究实施负责（组长）单位：

长兴县人民医院

Primary sponsor：

Changxing County People's Hospital

研究实施负责（组长）单位地址：

中国浙江省湖州市长兴县雉城镇太湖中路66号

Primary sponsor's address：

No. 66, Taihu Middle Road, Zhi Town, Changxing County, Huzhou City, Zhejiang Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

浙江

市(区县)：

湖州

Country：

China

Province：

Zhejiang Province

City：

Huzhou City

单位(医院)：

长兴县人民医院

具体地址：

中国浙江省湖州市长兴县雉城镇太湖中路66号

Institution
hospital：

Changxing County People's Hospital

Address：

No. 66, Taihu Middle Road, Zhi Town, Changxing County, Huzhou City, Zhejiang Province

经费或物资来源：

单位

Source(s) of funding：

unit

研究疾病：

荨麻疹

研究疾病代码：

Target disease：

Changxing County People's Hospital

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：

随着我国经济高速发展的到来，CU治疗需要新的策略和方法。临床上也急需一种有效、廉价、实施简便、易被患者接受以及能提高CU患者的生活质量、缓解减少CU带来的严重并发症、提高CU患者治愈率与降低复发率一体化的CU治疗方案。基于督脉灸外治法应用广泛，相比药物治疗次数少，费用低廉，尽显治疗优势。近年来，中医理疗发展迅速，且治疗方法形式多样。本研究根据CU的发病机制和影响因素，经过前期的临床研究发现依巴斯汀联合督脉灸有利于CU的治疗和恢复，具有安全性高、临床效果明显、操作简便、无创伤性、价格低廉等优点，得到了患者的肯定。

Objectives of Study：

With the arrival of China's rapid economic development, new strategies and methods are needed for the treatment of CU (chronic ulcer). There is an urgent clinical need for an effective, affordable, easy-to-implement, patient-accepted treatment approach that can improve the quality of life for CU patients, alleviate and reduce severe complications caused by CU, and enhance cure rates while lowering recurrence rates. Based on the extensive application of Du Mai moxibustion therapy, which has fewer treatment sessions and lower costs compared to drug therapies, it demonstrates significant therapeutic advantages. In recent years, the development of traditional Chinese medicine physiotherapy has been rapid, with various forms of treatment methods. This study, according to the pathogenesis and influencing factors of CU, found through previous clinical research that epinastine combined with Du Mai moxibustion is beneficial for the treatment and recovery of CU, offering high safety, noticeable clinical effects, simplicity of operation, non-traumatic nature, and low cost, which has been affirmed by patients.

药物成份或治疗方案详述：

随着我国经济高速发展的到来，CU治疗需要新的策略和方法。 临床上也急需一种有效、廉价、实施简便、易被患者接受以及能提 高CU患者的生活质量、缓解减少 CU带来的严重并发症、提高CU患者治愈率与降低复发率一体化的CU治疗方案。基于督脉灸外治法应用广泛，相比药物治疗次数少，费用低廉，尽显治疗优势。近年来， 中医理疗发展迅速，且治疗方法形式多样。本研究根据CU的发病机 制和影响因素，经过前期的临床研究发现依巴斯汀联合督脉灸有利 于CU的治疗和恢复，具有安全性高、临床效果明显、操作简便、无 创伤性、价格低廉等优点，得到了患者的肯定。通过对 CU 患者 1 个 月的临床观察，拟采用“定性指标数值化、初始数据归一化、量纲 指标相对比、分散指标加权化”的数据转换模式，将症状症候积分、 现代检测指标、生活质量分别转成“证候指数、现代检测指标及生 活质量指数”，构筑三维空间坐标系，进行三维作图建立模型，验 证督脉灸加依巴斯汀对CU的治疗效果不劣于药物治疗，为CU的治 疗提供可靠的临床依据，具有重要的临床价值。

Description for medicine or protocol of treatment in detail：

With the arrival of high-speed economic development in China new strategies and methods are needed for CU treatment. There is also an urgent clinical need for an effective affordable easy-to-implement acceptable to patients and integrated CU treatment plan that can improve the quality of life for CU patients alleviate and reduce severe complications caused by CUs and increase the cure rate and lower the recurrence rate of CU patients. Based on the extensive application of Du Mai moxibustion as an external treatment method it has fewer treatment sessions and lower costs compared to drug therapy highlighting its therapeutic advantages. In recent years the development of TCM physiotherapy has been rapid with various forms of treatment methods. This study according to the pathogenesis and influencing factors of CUs found through previous clinical research that epinastine combined with Du Mai moxibustion is beneficial for the treatment and recovery of CUs offering advantages such as high safety significant clinical effects simplicity of operation non-traumatic nature and low cost which have been affirmed by patients. Through a one-month clinical observation of CU patients we intend to adopt a data transformation model of qualitative index numericalization initial data normalization dimensional indicator relative comparison and scattered indicator weighting to convert symptom scores modern detection indicators and quality of life into symptom index modern detection indicators and quality of life index respectively. We will then construct a three-dimensional spatial coordinate system for three-dimensional graphing and modeling to verify that Du Mai moxibustion combined with epinastine is not inferior to drug therapy in treating CUs providing reliable clinical evidence for the treatment of CUs and having significant clinical value.

纳入标准：

纳入标准： ①符合中医、西医慢性荨麻疹诊断标准，且患者均经临床检查确诊； ②病程超过6周，每周发作超过3次或每2d发作1次，持续时间<24h； ③年龄大于18岁，小于60岁，近4周未服用免疫抑制剂、糖皮质激素及其他影响T淋巴细胞亚群及凝血功能的药物； ④均无中医督脉灸、伊巴斯汀药物过敏史、禁忌症，且患者均可耐受。

Inclusion criteria

Inclusion criteria: ① Patients met the diagnostic criteria for chronic urticaria in traditional Chinese medicine and Western medicine and all patients were clinically diagnosed; ② The course of disease exceeded 6 weeks with more than three episodes per week or one episode every two days and the duration was less than 24 hours; ③ Ages greater than 18 and less than 60. no immunosuppressants glucocorticoids or other drugs affecting T lymphocyte subsets and coagulation function had been taken in the past 4 weeks; ④ None of them had a history of allergy or contraindications to moxibustion on the Governor Vessel in traditional Chinese medicine or ebastine and all patients could tolerate it.

排除标准：

排除标准： ①精神异常、认知功能异常或血液系统疾病者； ②严重肝肾功能异常、造血系统原发病或自身免疫性疾病者； ③妊娠期、哺乳期或治疗依从性差者； ④精神异常、合并皮肤感染或伴有其他类型荨麻疹者； ⑤严重胃肠道症状、器质性疾病或伴有其他变态反应性疾病者。 终止试验标准： ①依从性差，不能按时接受治疗者或同时接受其他治疗者； ②失访或因资料不全等原因影响治疗效果评定者； ③出现严重药物副作用、不良反应患者（如皮肤过敏等）； ④试验过程中发生临床不良事件患者； ⑤试验中途发生其他并发症或病情加重不能按照此方案继续保守治疗的患者； ⑥中途退出试验患者； ⑦病情加重不能按照此方案继续保守治疗的患者； ⑧中途改变治疗方式而无法判定疗效的患者。

Exclusion criteria：

Exclusion Criteria: ① Individuals with psychiatric disorders, cognitive dysfunction, or blood system diseases; ② Those with severe liver or kidney dysfunction, primary hematopoietic disorders, or autoimmune diseases; ③ Pregnant women, nursing mothers, or individuals with poor adherence to treatment; ④ Individuals with psychiatric disorders, concurrent skin infections, or other types of urticaria; ⑤ Patients with severe gastrointestinal symptoms, organic diseases, or other allergic diseases. Termination of the Trial Criteria: ① Patients who do not adhere to the treatment regimen or cannot receive treatment on time, or those receiving additional treatments; ② Patients lost to follow-up or whose data are incomplete, affecting the assessment of treatment efficacy; ③ Patients experiencing severe drug side effects or adverse reactions (e.g., skin allergies); ④ Patients who experience clinical adverse events during the trial; ⑤ Patients who develop other complications or whose condition worsens and cannot continue conservative treatment according to this protocol; ⑥ Patients who withdraw from the trial in the middle; ⑦ Patients whose condition worsens and cannot continue conservative treatment according to this protocol; ⑧ Patients who change their treatment method in the middle, making it impossible to determine efficacy.

研究实施时间：

Study execute time：

从From 2024-11-30

至To      2025-12-31

征募观察对象时间：

Recruiting time：

从From 2024-11-30

至To      2025-12-31

干预措施：

Interventions：

组别：

对照组

样本量：

30

Group：

Control group

Sample size：

干预措施：

服用依巴斯汀药物

干预措施代码：

1

Intervention：

Take the drug Ebastine.

Intervention code：

组别：

治疗组1

样本量：

30

Group：

Treatment Group 1

Sample size：

干预措施：

督脉灸治疗

干预措施代码：

2

Intervention：

Taking Ebastine and Du Mai moxibustion treatment

Intervention code：

组别：

治疗组2

样本量：

30

Group：

Treatment Group 2

Sample size：

干预措施：

依巴斯汀联合督脉灸治疗组

干预措施代码：

3

Intervention：

The combination of ebastine and Du Meridian moxibustion treatment group

Intervention code：

样本总量 Total sample size ： 90

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

浙江

市(区县)：

湖州长兴

Country：

china

Province：

zhejiang

City：

Huzhou Changxing

单位(医院)：

长兴县人民医院

单位级别：

三乙

Institution/hospital：

Changxing County People's Hospital

Level of the institution：

San Yi

测量指标：

Outcomes：

指标中文名：

症候积分

指标类型：

主要指标

Outcome：

Symptom Score

Type：

Primary indicator

测量时间点：

服用前，2周后，4周后

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

炎性因子

指标类型：

主要指标

Outcome：

Inflammatory factors

Type：

Primary indicator

测量时间点：

服用前，2周后，4周后

测量方法：

采用全自动生化分析仪

Measure time point of outcome：

Measure method：

指标中文名：

血流变学、

指标类型：

主要指标

Outcome：

Hemorheology

Type：

Primary indicator

测量时间点：

服用前，2周后，4周后

测量方法：

采用全自动生化分析仪

Measure time point of outcome：

Measure method：

指标中文名：

生活质量评估表（SF-36）

指标类型：

主要指标

Outcome：

Quality of Life Assessment Form (SF-36)

Type：

Primary indicator

测量时间点：

服用前，2周后，4周后

测量方法：

Measure time point of outcome：

Before taking, 2 weeks later, 4 weeks later

Measure method：

Activated partial thromboplastin time (APTT) is the most commonly used sensitive screening test in clinical practice to reflect the coagulation activity of the endogenous coagulation system.

采集人体标本：

Collecting sample(s)
from participants：

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 岁
Min age years
最大 60 岁
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）：

采用随机开放标签试验（open label trial，RCT）方式，按第四版《中医药统计学与软件应用》随机数字表将病例数按照1:1:1的比例分为治疗组1、治疗组2和对照组三组。本研究在医院伦理委员会批准下进行，且患者治疗前均签署同意书。

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

The study employed a randomized open-label trial (RCT) approach, using the random number table from the fourth edition of Chinese Medicine Statistics and Software Applications to divide the patient cohort into three groups at a ratio of 1:1:1, consisting of treatment group 1, treatment group 2, and a control group. The research was conducted with the approval of the hospital's ethics committee, and all patients provided informed consent before treatment.

盲法：

Blinding：

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）：

631303466@qq.com

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

Not shared

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：

单位东软his系统

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

.DongRuan HIS System

数据管理委员会：

Data Managemen Committee：

暂未确定

Not yet

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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