头部循经刮痧治疗慢性紧张性头痛随机对照临床研究

注册号:

Registration number:

ITMCTR2200005742

最近更新日期:

Date of Last Refreshed on:

2021-07-12

注册时间:

Date of Registration:

2021-07-12

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

头部循经刮痧治疗慢性紧张性头痛随机对照临床研究

Public title:

A randomized controlled clinical study of scalp scraping along meridians in the treatment of chronic tension headache

注册题目简写:

English Acronym:

研究课题的正式科学名称:

头部循经刮痧治疗慢性紧张性头痛随机对照临床研究

Scientific title:

A randomized controlled clinical study of scalp scraping along meridians in the treatment of chronic tension headache

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:

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:

ChiCTR2100048642 ; ChiMCTR2200005742

申请注册联系人:

申莉铎

研究负责人:

张慧

Applicant:

Shen Liduo

Study leader:

Zhang Hui

申请注册联系人电话:

Applicant telephone:

+86 13992625033

研究负责人电话:

Study leader's telephone:

+86 13991057086

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:

29000957@qq.com

研究负责人电子邮件:

Study leader's E-mail:

455840798@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:

陕西省咸阳市秦都区渭阳西路副2号

研究负责人通讯地址:

陕西省咸阳市秦都区渭阳西路副2号

Applicant address:

-2 Weiyang Road West, Qindu District, Xianyang, Shaanxi

Study leader's address:

-2 Weiyang Road West, Qindu District, Xianyang, Shaanxi

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:

陕西中医药大学附属医院

Applicant's institution:

The Affiliated Hospital of Shaanxi University of Chinese 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:

SZFYIEC-PJ-2021年第[34]号

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:

陕西中医药大学附属医院伦理委员会

Name of the ethic committee:

Ethics Committee of the Affiliated Hospital of Shaanxi University of Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2021/6/22 0:00:00

伦理委员会联系人:

吉娜

Contact Name of the ethic committee:

Ji Na

伦理委员会联系地址:

陕西省咸阳市秦都区渭阳西路副2号

Contact Address of the ethic committee:

-2 Weiyang Road West, Qindu District, Xianyang, Shaanxi

伦理委员会联系人电话:

Contact phone of the ethic committee:

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:

陕西中医药大学附属医院

Primary sponsor:

The Affiliated Hospital of Shaanxi University of Chinese Medicine

研究实施负责(组长)单位地址:

陕西省咸阳市秦都区渭阳西路副2号

Primary sponsor's address:

-2 Weiyang Road West, Qindu District, Xianyang, Shaanxi

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

陕西

市(区县):

咸阳

Country:

China

Province:

Shaanxi

City:

Xianyang

单位(医院):

陕西中医药大学附属医院

具体地址:

秦都区渭阳西路副2号

Institution
hospital:

The Affiliated Hospital of Shaanxi University of Chinese Medicine

Address:

-2 Weiyang Road West, Qindu District

经费或物资来源:

陕西中医药大学附属医院

Source(s) of funding:

The Affiliated Hospital of Shaanxi University of Chinese medicine

研究疾病:

慢性紧张性头痛

研究疾病代码:

Target disease:

chronic tension headache

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:

治疗新技术临床试验

New Treatment Measure Clinical Study

研究目的:

观察在中医经络循行指导下刮痧治疗慢性紧张性头痛的临床疗效和安全性,同时观察不同频率对疗效的影响。

Objectives of Study:

To observe the clinical efficacy and safety of Gua Sha for the treatment of chronic tension headache under the guidance of TCM meridian circulation, and also to observe the effect of different frequencies on the efficacy.

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.符合西医诊断慢性紧张性头痛的患者; 2.符合中医诊断为头痛的患者; 3.18 岁≤年龄≤65 岁,性别不限; 4.患有紧张性头痛一年以上; 5.在过去三个月中,每月紧张性头痛发作至少 15 天; 6.能够完成头痛日记; 7.同意参加本研究并签署书面知情同意。

Inclusion criteria

1. Patients with chronic tension headache in line with Western medicine diagnosis; 2. Patients who meet the TCM diagnosis of headache; 3. Aged 18 to 65 years, gender is not limited; 4. Suffering from tension headache for more than one year; 5. Tension headache attacks on at least 15 days per month in the past three months; 6. Able to complete a headache diary; 7. Agree to participate in this study and sign written informed consent.

排除标准:

1.头痛是由其他医学疾病(例如蛛网膜下腔出血,脑出血,脑栓塞,脑血 栓形成,血管畸形,关节炎,高血压或动脉硬化); 2.在过去 3 个月内曾服用预防头痛发作药物(必要时止痛药除外); 3.患有神经系统疾病,精神疾病,免疫缺陷,出血性疾病或过敏; 4.心脏,肝脏,肾脏或其他器官有严重疾病; 5.妊娠及哺乳期妇女; 6.被刮痧部位体表有疖肿、破溃、疮痈、斑疹和不明原因包块者; 7.有接触性传染性皮肤病者; 8.近 3 个月内参加过其他临床研究的患者。

Exclusion criteria:

1. The headache is caused by other medical diseases (such as subarachnoid hemorrhage, cerebral hemorrhage, cerebral embolism, cerebral thrombosis, vascular malformation, arthritis, hypertension or arteriosclerosis); 2. Have taken medication to prevent headache attacks in the past 3 months (except for pain medication if necessary); 3. Suffering from neurological diseases, mental diseases, immunodeficiency, bleeding disorders or allergies; 4. Serious diseases of the heart, liver, kidneys or other organs; 5. Pregnant and lactating women; 6. Furuncle, ulceration, sore carbuncle, rash and unexplained mass on the body surface of the scraped part; 7. Persons with contagious skin diseases; 8. Patients who have participated in other clinical studies within the past 3 months.

研究实施时间:

Study execute time:

From 2021-07-01

To      2022-12-31

征募观察对象时间:

Recruiting time:

From 2021-07-01

To      2022-10-31

干预措施:

Interventions:

组别:

治疗组

样本量:

144

Group:

Treatment group

Sample size:

干预措施:

头部循经刮痧

干预措施代码:

Intervention:

scalp scraping along meridians

Intervention code:

组别:

对照组

样本量:

72

Group:

Control group

Sample size:

干预措施:

心理行为干预

干预措施代码:

Intervention:

Psycho-behavioral interventions

Intervention code:

样本总量 Total sample size : 216

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

陕西

市(区县):

咸阳

Country:

China

Province:

Shaanxi

City:

Xianyang

单位(医院):

陕西中医药大学附属医院

单位级别:

三级甲等

Institution/hospital:

The Affiliated Hospital of Shaanxi University of Chinese Medicine

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

尿素

指标类型:

主要指标

Outcome:

Urea

Type:

Primary indicator

测量时间点:

入组,治疗期

测量方法:

实验室检查

Measure time point of outcome:

Join the group,Treatment period

Measure method:

Laboratory examination

指标中文名:

血红蛋白

指标类型:

主要指标

Outcome:

Hemoglobin

Type:

Primary indicator

测量时间点:

入组,治疗期

测量方法:

实验室检查

Measure time point of outcome:

Join the group,Treatment period

Measure method:

Laboratory examination

指标中文名:

红细胞压积

指标类型:

主要指标

Outcome:

hematocrit

Type:

Primary indicator

测量时间点:

入组,治疗期

测量方法:

实验室检查

Measure time point of outcome:

Join the group,Treatment period

Measure method:

Laboratory examination

指标中文名:

红细胞计数

指标类型:

主要指标

Outcome:

Red blood cell count

Type:

Primary indicator

测量时间点:

入组,治疗期

测量方法:

实验室检查

Measure time point of outcome:

Join the group,Treatment period

Measure method:

Laboratory examination

指标中文名:

尿酸

指标类型:

主要指标

Outcome:

Uric acid

Type:

Primary indicator

测量时间点:

入组,治疗期

测量方法:

实验室检查

Measure time point of outcome:

Join the group,Treatment period

Measure method:

Laboratory examination

指标中文名:

谷草转氨酶

指标类型:

主要指标

Outcome:

Glutathione transaminase

Type:

Primary indicator

测量时间点:

入组,治疗期

测量方法:

实验室检查

Measure time point of outcome:

Join the group,Treatment period

Measure method:

Laboratory examination

指标中文名:

白细胞计数

指标类型:

主要指标

Outcome:

Leukocyte count

Type:

Primary indicator

测量时间点:

入组,治疗期

测量方法:

实验室检查

Measure time point of outcome:

Join the group,Treatment period

Measure method:

Laboratory examination

指标中文名:

慢性紧张性头痛基于患者报告的结局评价量表

指标类型:

主要指标

Outcome:

Patient-Reported Outcome Evaluation Scale for Chronic Tension Headache

Type:

Primary indicator

测量时间点:

入组,治疗期,随访期

测量方法:

慢性紧张性头痛基于患者报告的结局评价量表评分

Measure time point of outcome:

Join the group, Treatment period,Follow-up period

Measure method:

Chronic Tension Headache Patient-Reported Outcome Based Rating Scale Scores

指标中文名:

血小板计数

指标类型:

主要指标

Outcome:

Platelet count

Type:

Primary indicator

测量时间点:

入组,治疗期

测量方法:

实验室检查

Measure time point of outcome:

Join the group,Treatment period

Measure method:

Laboratory examination

指标中文名:

心电图

指标类型:

主要指标

Outcome:

Electrocardiogram

Type:

Primary indicator

测量时间点:

入组,治疗期

测量方法:

心电图

Measure time point of outcome:

Join the group, Treatment period

Measure method:

Electrocardiogram

指标中文名:

肌酐

指标类型:

主要指标

Outcome:

Creatinine

Type:

Primary indicator

测量时间点:

入组,治疗期

测量方法:

实验室检查

Measure time point of outcome:

Join the group,Treatment period

Measure method:

Laboratory examination

指标中文名:

中医头痛信息观察表

指标类型:

主要指标

Outcome:

Chinese Medicine Headache Information Observation Form

Type:

Primary indicator

测量时间点:

入组,治疗期

测量方法:

中医头痛信息观察表评分

Measure time point of outcome:

Join the group, Treatment period

Measure method:

Chinese Medicine Headache Information Observation Form Score

指标中文名:

谷丙转氨酶

指标类型:

主要指标

Outcome:

Glutathione aminotransferase

Type:

Primary indicator

测量时间点:

入组,治疗期

测量方法:

实验室检查

Measure time point of outcome:

Join the group,Treatment period

Measure method:

Laboratory examination

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:

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):

由临床研究助理运用专业统计软件分别产生 2 列共 216 例受试者所接 受处理(治疗组及对照组)的随机安排,即流水号为 001~216 所对应的治疗分配表。

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

The clinical research assistants used professional statistical software to generate the randomization arrangements for the 216 subjects in each of the 2 columns (treatment and control groups), i.e., the treatment assignment tables corresponding to the running numbers 001 to 216.

盲法:

Not stated

Blinding:

Not stated

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):

邮箱,2022.10.1

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

Email, 2021.10.1

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:

病例记录表

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

Case Record Form

数据管理委员会:

Data Managemen Committee:

No

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):

国际传统医学临床试验注册平台 京ICP备07032215号-5 提示:推荐使用IE8.0以上版本 宽屏显示分辨率下使用系统