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Observation and research program on therapeutic effect of acupuncture and acupuncture combined with Yijinjing on climacteric syndrome

注册号：

Registration number：

ITMCTR2200005555

最近更新日期：

Date of Last Refreshed on：

2021-06-08

注册时间：

Date of Registration：

2021-06-08

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

针刺治疗与针刺联合易筋经治疗更年期综合征疗效观察研究方案

Public title：

Observation and research program on therapeutic effect of acupuncture and acupuncture combined with Yijinjing on climacteric syndrome

注册题目简写：

English Acronym：

研究课题的正式科学名称：

针刺治疗与针刺联合易筋经治疗更年期综合征疗效观察

Scientific title：

Observation and research program on therapeutic effect of acupuncture and acupuncture combined with Yijinjing on climacteric syndrome

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：

ChiCTR2100047126 ; ChiMCTR2200005555

申请注册联系人：

肖敏

研究负责人：

梁凤霞

Applicant：

Xiao Min

Study leader：

Liang Fengxia

申请注册联系人电话：

Applicant telephone：

+86 18271455866

研究负责人电话：

Study leader's telephone：

+86 18971371818

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：

971855129@qq.com

研究负责人电子邮件：

Study leader's E-mail：

315938821@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：

湖北省武汉市洪山区黄家湖西路16号

研究负责人通讯地址：

湖北省武汉市武昌区昙华林188号

Applicant address：

16 Huangjiahu Road West, Hongshan District, Wuhan, Hubei

Study leader's address：

188 Tanhualin, Wuchang District, Wuhan, Hubei

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：

湖北中医药大学

Applicant's institution：

Hubei 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：

ChiECRCT20210151

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

中国注册临床试验伦理审查委员会

Name of the ethic committee：

Chinese Ethics Review Committee of Registering Clinical Trials

伦理委员会批准日期：

Date of approved by ethic committee：

2021/5/18 0:00:00

伦理委员会联系人：

吴莼

Contact Name of the ethic committee：

Wu Chun

伦理委员会联系地址：

中国香港特别行政区九龙浸会大学道中国临床试验注册中心香港中心

Contact Address of the ethic committee：

Chinese Clinical Trial Registry Hong Kong Centre, Baptist University Road, Kowloon Tong, Hong Kong SAR, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 18980604562

伦理委员会联系人邮箱：

Contact email of the ethic committee：

chictr001@chictr.org.cn

研究实施负责（组长）单位：

湖北中医药大学针灸骨伤学院

Primary sponsor：

College of Acupuncture and Orthopedics, Hubei University of Chinese Medicine

研究实施负责（组长）单位地址：

湖北省武汉市武昌区昙华林188号

Primary sponsor's address：

188 Tanhualin, Wuchang District, Wuhan, Hubei

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

湖北

市(区县)：

武汉

Country：

China

Province：

Hubei

City：

wuhan

单位(医院)：

湖北中医药大学针灸骨伤学院

具体地址：

武昌区昙华林188号

Institution
hospital：

College of Acupuncture and Orthopedics, Hubei University of Chinese Medicine

Address：

188 Tanhualin, Wuchang District

经费或物资来源：

国家中医药管理局中医药传承与创新“百千万”人才工程（岐黄工程）

Source(s) of funding：

National Administration of Traditional Chinese Medicine Inheritance and Innovation

研究疾病：

更年期综合征

研究疾病代码：

Target disease：

Climacteric syndrome

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：

本研究基于目前针刺治疗更年期综合征的研究成果，以及传统功法易筋经自身特点和其丰富临床疗效研究，结合更年期综合征的中医病因病机、常见辨证分型，参考历年循证医学研究中关于针刺治疗更年期综合征使用频次最多的有效穴组，制定研究针刺治疗与针刺联合易筋经治疗更年期综合征的不同临床疗效研究方案，以期丰富和优化临床治疗该病证的手段和提高其临床疗效。同时，作为传统中医导引养生保健手段的易筋经功法，涵盖了人体经络学说，符合中医学“治未病”理论思想，该传统功法的临床疗效亟待大力挖掘。此研究有助于弘扬传统功法易筋经并促进其良性发展，对全民健身有积极作用。

Objectives of Study：

This study is based on the current research results of acupuncture treatment of climacteric syndrome, as well as the characteristics of traditional Chinese medicine Yijinjing and its rich clinical efficacy, combined with TCM etiology, pathogenesis and common syndrome differentiation of climacteric syndrome, referring to the most frequently used effective acupoint group of acupuncture treatment of climacteric syndrome in evidence-based medicine research over the years, in order to enrich and optimize the clinical treatment of climacteric syndrome and improve its clinical efficacy, different clinical efficacy research schemes of acupuncture and acupuncture combined with Yijinjing were formulated. At the same time, Yijinjing, as a traditional Chinese medicine health care method, covers the theory of human meridians, which is in line with the theory of "preventive treatment of disease" in traditional Chinese medicine. The clinical efficacy of the traditional method urgently needs to be explored. This research is helpful to carry forward the traditional Yijinjing and promote its healthy development, and has a positive effect on the national fitness.

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.符合更年期综合征诊断标准； 2.在过去的12个月里，月经周期不规则，经期提前或错后>=7天（绝经过渡期早期）；在过去的12个月里，至少脱落过2个月经周期，或者闭经超过60天，但<=11月（绝经过渡期晚期）；停经在12个月至36个月之间，含12个月和36个月（绝经3年以内）； 3.年龄 45 ~ 55 岁； 4.无激素疗法强制性适应症，如手术后绝经、活动性骨质疏松症； 5.自愿参加本项研究，并签署知情同意书。 注：同时符合以上6项的患者，方可纳入本研究。

Inclusion criteria

1.Meet the diagnostic criteria for climacteric syndrome; 2.In the past 12 months, the menstrual cycle was irregular, and the menstrual period was earlier or later than 7 days (early menopausal transition); In the past 12 months, at least 2 menstrual cycles were lost, or amenorrhea was more than 60 days, but <=November (late menopausal transition period); Menopause between 12 months and 36 months, including 12 months and 36 months (within 3 years of menopause); 3.Aged 45 to 55 years; 4.There are no mandatory indications for hormone therapy, such as post-operative menopause and active osteoporosis; 5.Volunteer to participate in this study and sign the informed consent. Note: Patients who meet the above 6 criteria at the same time can be included in this study.

排除标准：

1.有运动禁忌证，依从性差，不能配合治疗者； 2.试验前3个月内月经周期规则； 3.近4周长时间应用激素； 4.卵巢囊肿、直径大于4cm的子宫肌瘤、卵巢或子宫切除术后； 5.原因不明的阴道出血； 6.严重肝肾功能不全； 7.尚未控制的高血压、糖尿病或甲状腺疾病； 8.患有糖尿病神经病变、恶性肿瘤及精神疾病（包括抑郁症）者； 9.有妊娠意愿或正处于妊娠或哺乳期者； 10.定期使用镇静药或抗焦虑药者； 11.长期吸烟、酗酒； 12.安装心脏起搏器或人工关节者； 13.有系统锻炼史，有规律运动习惯。

Exclusion criteria：

1.Patients have sports contraindications, poor compliance and can not cooperate with treatment; 2.The menstrual cycle was regular in the first 3 months; 3.Hormone was used for 4 weeks; 4.Ovarian cysts, uterine fibroids larger than 4 cm in diameter, ovariectomy or hysterectomy; 5.Unexplained vaginal bleeding; 6.Severe hepatic and renal insufficiency; 7.Uncontrolled hypertension, diabetes or thyroid disease; 8.Patients with diabetic neuropathy, malignant tumor and mental disease (including depression); 9.Patients intend to be pregnant or are pregnant or breast-feeding; 10.Regular use of sedatives or anti anxiety drugs; 11.Smoking and drinking for a long time; 12.Patients with pacemaker or artificial joint; 13.Have a history of systematic exercise and regular exercise habits.

研究实施时间：

Study execute time：

从From 2021-06-06

至To      2022-06-06

征募观察对象时间：

Recruiting time：

从From 2021-06-06

至To      2022-06-06

干预措施：

Interventions：

组别：

对照组

样本量：

36

Group：

control group

Sample size：

干预措施：

不进行易筋经锻炼及其他系统性健身锻炼，针刺治疗方法同研究组

干预措施代码：

Intervention：

do not carry out Yijinjing exercise and other systematic fitness exercise, acupuncture treatment method is the same as the research group

Intervention code：

组别：

试验组

样本量：

36

Group：

experimental group

Sample size：

干预措施：

采用针刺治疗联合易筋经功法锻炼治疗

干预措施代码：

Intervention：

using acupuncture treatment combined with Yijinjing exercise treatment

Intervention code：

样本总量 Total sample size ： 72

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

湖北

市(区县)：

武汉

Country：

China

Province：

Hubei

City：

Wuhan

单位(医院)：

湖北中医药大学国医堂

单位级别：

三级甲等

Institution/hospital：

National Medical Hall, Hubei University of Chinese Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

疗效指数

指标类型：

主要指标

Outcome：

Efficiency 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：

匹茨堡睡眠质量指数量表

指标类型：

主要指标

Outcome：

The Pittsburgh Sleep Quality Index

Type：

Primary indicator

测量时间点：

测量方法：

Buysse编制的睡眠质量自评量表

Measure time point of outcome：

Measure method：

Buysse's Self-rated Sleep Quality Scale

指标中文名：

围绝经期综合征生存质量表评分

指标类型：

主要指标

Outcome：

Perimenopausal syndrome quality of life scale score

Type：

Primary indicator

测量时间点：

测量方法：

李克特7点量表

Measure time point of outcome：

Measure method：

Likert 7-point scale

指标中文名：

Kupperman量表评分

指标类型：

主要指标

Outcome：

Kupperman scale score

Type：

Primary indicator

测量时间点：

测量方法：

改良更年期综合征Kupperman评分标准

Measure time point of outcome：

Measure method：

Modified Kupperman scoring criteria for menopause syndrome

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

其它

说明

Fate of sample 

Others

Note：

征募研究对象情况：

正在进行

Recruiting

年龄范围：

最小 45 岁
Min age years
最大 55 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）：

本研究采用课题以外人员随机数字表法将合格的受试者以 1：1 的比例随机分为试验组和对照组。具体操作步骤是：首先将受试者根据入组的先后编号为 1-72；然后在随机数字表中随机确定某行某列的数字沿某方向以确定每个受试者的随机数字；接着将获得的每个随机数字除以 2，余数为 1 为试验组，余数为 0 则为对照组，若分组不均，则在随机数字表中续抄随机数字，将随机数字除以 2，按照余数继续分组，可不断重复此过程，直到两组的例数相同。将所有受试者的编号、随机数字和分组情况写在纸上并装入按顺序编号、密封且不透光的信封中，在受试者入组时开启。各受试者的分组情况不得人为修改。

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

In this study, qualified subjects were randomly divided into experimental group and control group in a ratio of 1:1 by random number table method of non-subject.

盲法：

未说明

Blinding：

Not stated

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）：

本项目采用Remote Data Capture（RDC）系统进行数据录入。无纸板CRF，所有CRF由研究护士直接录入进RDC系统，所有电子CRF经过研究者审核并电子签名批准后生效。所有的CRF和CRF修订痕迹均保留在Oracle数据库中。

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

This project uses remote data capture (RDC) system for data entry. Paperless CRF. All electronic CRFs have been reviewed by the investigator and approved by electronic signature.

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：

1.项目研究结束后进行资料总结，CRF表及所有相关原始资料交针灸治未病湖北省协同创新中心保存归档； 2.录入电子病历报告表：及时将各研究中心收集的CRF表的数据收集汇总，病历报告表中所记录的数据必须采用数据管理软件建立完整准确的数据库，数据管理人员应在盲态下核查数据。数据存在疑问时，应书面质询研究者，答复记录应有研究者签名，对疑问数据的所有书面质询和答复应与相应的病历报告表一起存放备查。临床试验的病历报告表的数据应来自原始病历及各种其他原始检验结果，并以电子CRF表的形式录入，应使用双份输入方式，即由两个输入员独立地、分别将病历报告表输入数据库中，再用软件包将两份独立的数据文件进行逐项对比，如果发现不一致，就由输入员对照原始的病历报告表，找出原因并修改。电子记录应具有原始、实时、准确、完整、可靠和可溯源性。所有电子记录的修改必须留有痕迹，确保起始记录和试验进程中的记录都是可以复原的；记录的日期和时间应准确到年、月、日、小时和分钟。电子签名须研究单位授权由专人执行； 3.报告电子CRF数据：数据录入应认真核查，分类整理，并通过设置一定的程序保存管理好CRF数据，根据需要随时将试验中心的数据录入，进行修改、维护、存档、查看，并按程序递交至数据管理中心，以便完成数据管理和统计。试验数据电子采集、储存、转换和传输等过程中应充分考虑到网络安全性。数据处理系统应有登录授权，记录轨迹。电子数据应定期，异地备份。试验数据最终必须形成电子数据库，数据库及文档应保存用于核查试验结果。将电子CRF数据报告给数据管理中心。

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

1.After the completion of the project, the data were summarized, and the CRF form and all relevant original data were submitted to Hubei Collaborative Innovation Center for acupuncture and moxibustion prevention and treatment of diseases for archiving; 2.Enter the electronic medical record report form: collect and summarize the CRF data collected by each research center in time. The data recorded in the medical record report form must use the data management software to establish a complete and accurate database, and the data management personnel should check the data blindly. When the data is in doubt, the researcher should be questioned in writing, and the reply record should be signed by the researcher. All written questions and replies to the data in question should be stored together with the corresponding medical record report form for future reference. The data of the medical record report form of clinical trial should come from the original medical record and various other original test results, and should be entered in the form of electronic CRF form. Double input mode should be used, that is, two inputers independently input the medical record report form into the database, and then the software package will compare the two independent data files item by item, The inputer will check the original medical record report form, find out the reason and modify it. Electronic records should be original, real-time, accurate, complete, reliable and traceable. All electronic records must be modified with traces to ensure that the initial records and the records in the test process can be recovered; The date and time recorded shall be accurate to year, month, day, hour and minute. The electronic signature must be authorized by the research unit and executed by a specially assigned person. 3.Report electronic CRF data: data entry should be carefully checked and sorted out, and CRF data should be saved and managed by setting certain procedures. Data of the test center should be entered, modified, maintained, archived and viewed at any time according to the needs, and submitted to the data management center according to the procedures, so as to complete data management and statistics. Network security should be fully considered in the process of electronic acquisition, storage, conversion and transmission of test data. The data processing system should be authorized to log in and record the track. Electronic data should be backed up regularly and in other places. Finally, the test data must form an electronic database, and the database and documents shall be kept for verification of test results. Report electronic CRF data to data management center.

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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