The effectiveness and safety bamboo medicine moxibustion therapy of Ma's in the treatment of chronic fatigue syndrome

注册号:

Registration number:

ITMCTR2000004213

最近更新日期:

Date of Last Refreshed on:

2020-10-07

注册时间:

Date of Registration:

2020-10-07

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

马氏竹技药灸法治疗慢性疲劳综合征的有效性与安全性评价研究

Public title:

The effectiveness and safety bamboo medicine moxibustion therapy of Ma's in the treatment of chronic fatigue syndrome

注册题目简写:

English Acronym:

研究课题的正式科学名称:

马氏竹技药灸法治疗慢性疲劳综合征的有效性与安全性评价研究

Scientific title:

The effectiveness and safety bamboo medicine moxibustion therapy of Ma's in the treatment of chronic fatigue 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:

ChiCTR2000038860 ; ChiMCTR2000004213

申请注册联系人:

薛凯阳

研究负责人:

崔瑾

Applicant:

Xue Kaiyang

Study leader:

Cui Jin

申请注册联系人电话:

Applicant telephone:

+86 15167707825

研究负责人电话:

Study leader's telephone:

+86 13985026278

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:

2317649912@qq.com

研究负责人电子邮件:

Study leader's E-mail:

516260179@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:

贵州省贵阳市市东路50号

研究负责人通讯地址:

贵州省贵阳市市东路50号

Applicant address:

50 Shidong Road, Guiyang, Guizhou, China

Study leader's address:

50 Shidong Road, Guiyang, Guizhou, China

申请注册联系人邮政编码:

Applicant postcode:

550002

研究负责人邮政编码:

Study leader's postcode:

550002

申请人所在单位:

贵州中医药大学

Applicant's institution:

Guizhou 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:

K2020-038

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:

贵州中医药大学第一附属医院伦理委员会

Name of the ethic committee:

Ethics Committee of the First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2020/9/26 0:00:00

伦理委员会联系人:

李红日

Contact Name of the ethic committee:

Li Hongri

伦理委员会联系地址:

贵州省贵阳市云岩区宝山北路71号

Contact Address of the ethic committee:

71 Baoshan North Road, Yunyan District, Guiyang , Guizhou

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 15167707825

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:

贵州中医药大学

Primary sponsor:

Guizhou University of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

贵州省贵阳市市东路50号贵州中医药大学

Primary sponsor's address:

50 Shidong Road,Guiyang,Guizhou,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):

贵州

市(区县):

贵阳

Country:

China

Province:

Guizhou

City:

Guiyang

单位(医院):

贵州中医药大学第一附属医院

具体地址:

云岩区宝山北路71号

Institution
hospital:

The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

Address:

71 Baoshan Road North, Yunyan District

经费或物资来源:

2019年贵州省科技厅国家重点专项后补助项目 马氏竹技药灸与吴氏侗医烧烫伤外治法技术疗效验证及安全性评价研究

Source(s) of funding:

Guizhou Provincial Department of Science and Technology In 2019 national Key special post-subsidy Project

研究疾病:

慢性疲劳综合征

研究疾病代码:

Target disease:

Chronic fatigue 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:

采用平行、随机对照的方法,在以往研究的基础上,对民间中医特色诊疗技术马氏竹技药灸法治疗慢性疲劳综合征的有效性与安全性提供高质量的、符合国际报告规范的临床证据。

Objectives of Study:

Based on previous studies, the parallel and randomized controlled methods were used to provide high-quality clinical evidence in line with international reporting standards for the efficacy and safety of the folk traditional Chinese medicine characteristic diagnosis and treatment techniques of Martensitic bamboo and moxibustion in the treatment of chronic fatigue syndrome.

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 符合上述诊断标准的患者; ② 年龄范围为18-55岁,男女均可; ③ 受试前两周内未接受任何有于本病相关的治疗; ④ 依从性好,愿意配合研究,签署知情同意书者; 注:同时符合以上4条的患者,方可纳入本研究。

Inclusion criteria

1. Patients who meet the above diagnostic criteria; 2. The age range is 18-55 years old, male or female; 3. Subjects did not receive any treatment related to this disease within two weeks; 4. Good compliance, willing to cooperate with the research, signed informed consent; Note: Only patients who meet the above four criteria can be included in this study.

排除标准:

① 妊娠或者准备妊娠的妇女、哺乳期妇女; ② 可以用原发病解释的疲劳:合并有脑、心、肾、甲状腺、肝脏及造血系统等原发性疾病及精神病的患者; ③ 疗效判定困难者; ④ 施灸部位皮肤有病变,不适合药灸者; 注:受试对象但凡符合以上条中任意一条,不得纳入。

Exclusion criteria:

1. A woman who is pregnant or preparing for pregnancy, or a woman who is breastfeeding; 2. Fatigue that can be explained by the primary disease: patients with brain, heart, kidney, thyroid, liver, hematopoietic system and other primary diseases and psychosis; 3. Difficult to judge the curative effect; 4. The moxibustion site has skin lesions, not suitable for medicinal moxibustion; Note: Subjects who conform to any of the above items shall not be included.

研究实施时间:

Study execute time:

From 2019-10-01

To      2023-06-30

征募观察对象时间:

Recruiting time:

From 2020-11-01

To      2022-10-06

干预措施:

Interventions:

组别:

试验组

样本量:

30

Group:

The experimental group

Sample size:

干预措施:

马氏竹技药灸

干预措施代码:

Intervention:

bamboo medicine moxibustion therapy of Ma‘s

Intervention code:

组别:

对照组

样本量:

30

Group:

The control group

Sample size:

干预措施:

针刺

干预措施代码:

Intervention:

needling

Intervention code:

样本总量 Total sample size : 60

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

贵州

市(区县):

贵阳

Country:

China

Province:

Guizhou

City:

Guiyang

单位(医院):

贵州中医药大学第一附属医院

单位级别:

三甲

Institution/hospital:

The first affiliated hospital of Guizhou University of Traditional Chinese Medicine

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

疲劳评定量表

指标类型:

主要指标

Outcome:

Fatigue Assessment Instrument

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

T淋巴细胞亚群含量

指标类型:

主要指标

Outcome:

T lymphocyte subsets

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

慢性疲劳综合征症状评定量表

指标类型:

主要指标

Outcome:

chronic fatigue syndrome symptom rating scale

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疲劳量表-14

指标类型:

主要指标

Outcome:

Fatigue Scale-14

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

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
Min age years
最大 60
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excel随机数字表法生成60个随机数字,平均分成2组,并确定每个序列号的分组;每组个30名受试者; 将代表不同治疗方案的代码(①、②)分别放入相应的编有序列号的不透明信封,受试者入组顺序抽取信封,由研究者打开信封,按代码代表的治疗方案进行治疗。

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

The excel random number table method was used to generate 60 random numbers, which were evenly divided into 2 groups, and the grouping of each serial number was determined. 30 subjects in each group; The codes representing different treatment regimens will be put into the corresponding opaque envelope.

盲法:

未说明

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):

公开原始数据日期:试验完成后6个月内公开;公开内容:原始记录的数据和研究计划书;方式;采用临床试验公共管理平台向公众开放查询。

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

Date of publication of original data: within 6 months after completion of the trial; Disclosure: Original recorded data and research proposal; Way; The public management platform for clinical trials w

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:

由专业的数据采集者采集数据,课题组将完整地保留。

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

Data will be collected by professional data collectors, and the research team will keep the data intact.

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):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above