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Clinical Observation on the Application of Guasha Synthetics in Primary Dysmenorrhea

注册号：

Registration number：

ITMCTR2100004407

最近更新日期：

Date of Last Refreshed on：

2021-02-08

注册时间：

Date of Registration：

2021-02-08

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

吸痧综合疗法应用于原发性痛经的临床疗效观察

Public title：

Clinical Observation on the Application of Guasha Synthetics in Primary Dysmenorrhea

注册题目简写：

English Acronym：

研究课题的正式科学名称：

吸痧综合疗法应用于原发性痛经的临床疗效观察

Scientific title：

Clinical Observation on the Application of Guasha Synthetics in Primary Dysmenorrhea

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：

ChiCTR2100043192 ; ChiMCTR2100004407

申请注册联系人：

宋嘉婷

研究负责人：

黄绮华

Applicant：

Song Jiating

Study leader：

Huang Qihua

申请注册联系人电话：

Applicant telephone：

+86 15103778343

研究负责人电话：

Study leader's telephone：

+86 13710680174

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：

3214753098@qq.com

研究负责人电子邮件：

Study leader's E-mail：

13710680174@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：

广东省广州市白云区机场路16号

研究负责人通讯地址：

广东省广州市越秀区大德路111号

Applicant address：

16 Airport Road, Baiyun District, Guangzhou, Guangdong, China

Study leader's address：

111 Dade Road, Yuexiu District, Guangzhou, Guangdong, China

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：

广州中医药大学

Applicant's institution：

Guangzhou University of Traditional 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：

ZF2020-316

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

广东省中医院伦理委员会

Name of the ethic committee：

Li Xiaoyan

伦理委员会批准日期：

Date of approved by ethic committee：

2021/1/22 0:00:00

伦理委员会联系人：

刘军

Contact Name of the ethic committee：

Liu Jun

伦理委员会联系地址：

广东省广州市越秀区大德路111号广东省中医院研修楼19楼

Contact Address of the ethic committee：

19th Floor, Research building of Guangdong Hospital of traditional Chinese Medicine, 111 Dade Road, Yuexiu District, Guangzhou, Guangdong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 20-81887233

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：

广东省中医院

Primary sponsor：

Guangdong Provincial Hospital of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

广东省广州市越秀区大德路111号广东省中医院

Primary sponsor's address：

111 Dade Road, Yuexiu District, Guangzhou, Guangdong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东

市(区县)：

广州

Country：

China

Province：

Guangdong

City：

Guangzhou

单位(医院)：

广东省中医院

具体地址：

越秀区大德路11号

Institution
hospital：

Guangdong Provincial Hospital of Traditional Chinese Medicine

Address：

111 Dade Road, Yuexiu District

经费或物资来源：

自筹

Source(s) of funding：

Self-financing

研究疾病：

原发性痛经

研究疾病代码：

Target disease：

Primary dysmenorrhea

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：

探究吸痧综合疗法应用于原发性痛经的临床疗效。

Objectives of Study：

To explore the clinical effect of Guasha comprehensive therapy on primary dysmenorrhea.

药物成份或治疗方案详述：

（1）对照组： ①药物服用方法:口服布洛芬缓释胶囊，用法:每次1片，每日2次。从痛经发作当日开始服用，经期不停药，连服3天，若3天内止痛即可停用。每个月经周期治疗 3 天，连续3个月为一个疗程，停止治疗后随访2个月； ②健康教育与随访:建立微信群，给予常规护理指导和健康教育。 （2）治疗组：在对照组治疗基础上给予吸痧综合疗法治疗，自月经后第一周开始，每周两次，1个月为一个治疗周期，每个周期治疗6次，共治疗3个周期。 ①用物准备:一人一个负压吸痧罐，治疗盘，艾油。 ②操作体位:患者取卧位，暴露腹部和背部，操作者站于患者对面，清洁皮肤。 ③操作部位：八髎穴、督脉、带脉、关元、气海。 ④操作方法：抹适量艾油，采用推法和揉法操作分段按摩局部皮肤发热后进行循经走罐吸痧治疗，手法用平补平泻法（力度适中，速度适中，约45-60次/分钟）；患者取仰卧位于关元、气海涂擦艾油，采用推法和揉法按摩至局部皮肤发热，进行循经走罐治疗，而后患者俯卧位于八髎穴、督脉、带脉涂擦艾油，采用推法和揉法操作按摩局部皮肤发热后进行循经走罐治疗，遵循从上到下、逐步由内向外扩展的顺序，至皮肤潮红或出痧大约为3至5分钟左右；操作结束后，用清洁的卫生纸或毛巾按压所刮之处，将油渍擦拭干净。 ⑤健康指导:刮痧前后给予病人正确的护理健康指导，如刮痧时注意保暖，刮痧后适当饮用热水，刮痧6 h后再进行沐浴等。

Description for medicine or protocol of treatment in detail：

1. Control group (1) Medication: oral ibuprofen sustained release capsules, usage: 1 tablet each time, twice a day. Take it from the day of dysmenorrhea attack, and take it continuously for 3 days during the menstrual period. If the pain is relieved within 3 days, it can be stopped. Each menstrual cycle was treated for 3 days for 3 consecutive months as a course of treatment. The patients were followed up for 2 months after stopping treatment; (2) Health education and follow-up: wechat group was established to provide routine nursing guidance and health education. 2. Treatment group: on the basis of the control group, the treatment group was given the comprehensive therapy of sucking Sha, twice a week since the first week after menstruation, one month as a treatment cycle, 6 times per cycle, a total of 3 cycles. (1) Material preparation: one vacuum suction jar for one person, treatment plate, moxa oil. (2) Operating position: the patient is in the supine position, exposing the abdomen and back, and the operator stands opposite the patient to clean the skin. (3) Operating parts: Baliao point, governor vessel, daimai, Guanyuan, Qihai. (4) Operation method: apply proper amount of moxa oil, massage the local skin in sections by pushing and kneading, and then carry out cupping and scraping therapy along the meridians after fever. The method is flat reinforcing and reducing (moderate strength, moderate speed, about 45-60 times / min); The patients were supine at Guanyuan and Qihai and smeared with moxa oil. They were massaged by pushing and kneading until the local skin was hot. Then the patients were prone at Baliao point, Dumai and daimai and smeared with moxa oil. They were massaged by pushing and kneading. After the local skin was hot, they were treated by canning along the meridians, It takes about 3 to 5 minutes for skin flushing or scraping; After the operation, press the scraped area with clean toilet paper or towel to wipe the oil stains clean. (5) Health guidance: give patients correct nursing health guidance before and after scraping, such as keeping warm when scraping, drinking hot water properly after scraping, bathing after 6 hours of scraping, etc.

纳入标准：

（1）中医诊断符合血瘀型痛经的诊断标准； （2）西医诊断符合原发性痛经的诊断标准； （3）年龄在18-45岁； （4）既往月经尚规律，周期 21-35 天, 经期 5-7天； （5）依从性好，研究期间配合随访的患者； （6）连续痛经＞6个月，VAS评分≥4分； （7）自愿参加本研究。

Inclusion criteria

1. Subjects who meet the diagnostic criteria of dysmenorrhea of blood stasis type diagnosed by traditional Chinese medicine; 2. Subjects who were diagnosed as primary dysmenorrhea by western medicine; 3. Subjects aged 18-45 years; 4. Subjects with regular menstruation in the past, with a cycle of 21-35 days; the menstrual period is 5-7 days; 5. Patients with good compliance and cooperation with follow-up during the study period; 6. For the subjects with dysmenorrhea for more than 6 months, the VAS score was more than or equal to 4; 7. Volunteers.

排除标准：

（1）属于子宫肌瘤、子宫腺肌症、盆腔炎症性疾病、盆腔瘀血综合征、子宫内膜异位症等可能引起继发性痛经的患者； （2）属药物过敏体质者及对艾油过敏者； （3）肝肾功能存在异常的患者； （4）一个月内参加过其他试验者； （5）哺乳期、准备妊娠，或已妊娠女性； （6）凝血功能异常者； （7）有皮肤病或局部皮肤异常者。

Exclusion criteria：

1. Patients with uterine fibroids, adenomyosis, pelvic inflammatory diseases, pelvic blood stasis syndrome, endometriosis, etc. may cause secondary dysmenorrhea; 2. Patients with drug allergy constitution and allergic to moxa oil; 3. Patients with abnormal liver and kidney function; 4. Subjects who participated in other trials within one month; 5. Lactation, preparation for pregnancy, or pregnant women; 6. Subjects with abnormal coagulation function; 7. Subjects with skin diseases or local skin abnormalities.

研究实施时间：

Study execute time：

从From 2020-01-01

至To      2023-01-01

征募观察对象时间：

Recruiting time：

从From 2021-02-01

至To      2022-12-31

干预措施：

Interventions：

组别：

对照组

样本量：

33

Group：

matched group

Sample size：

干预措施：

常规护理及用药

干预措施代码：

Intervention：

usual care

Intervention code：

组别：

观察组

样本量：

33

Group：

observation group

Sample size：

干预措施：

吸痧综合疗法

干预措施代码：

Intervention：

Combined therapy for sucking Guasha

Intervention code：

样本总量 Total sample size ： 66

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

广东

市(区县)：

广州

Country：

China

Province：

Guangdong

City：

Guangzhou

单位(医院)：

广东省中医院

单位级别：

三级甲等

Institution/hospital：

Guangdong Provincial Hospital of Traditional Chinese Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

痛经症状评分

指标类型：

主要指标

Outcome：

COX

Type：

Primary indicator

测量时间点：

月经后第2天

测量方法：

自评

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

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 45 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

女性

Female

随机方法（请说明由何人用什么方法产生随机序列）：

采用简单随机使用SPSS23.0统计软件包，将样本量及分组数输入计算机，产生随机种子数及分组数，制备随机卡，装信封后备用。

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

A simple random SPSS23.0 statistical software package is used to input the sample size and grouping number into the computer to produce the random seed number and grouping number, to prepare the random card, and to set aside after the envelope is installed.

盲法：

无法实施

Blinding：

Impracticability

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）：

2023.6.1 请阅读网页注册指南中关于 原始数据共享 的内容。

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

June 1st, 2023

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

数据管理委员会：

Data Managemen Committee：

有

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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