医疗针刺联合雷火灸治疗慢性疲劳综合征的疗效观察

注册号:

Registration number:

AMCTR-IOR-18000222 

注册号获得时间:

Date of releasing the registration number:

2018/11/12 21:57:09 

注册号状态:

预注册  

Registration Status:

1008001 Prospective registration  

注册题目:

医疗针刺联合雷火灸治疗慢性疲劳综合征的疗效观察 

Public title:

Observation on therapeutic effect of acupuncture combined with leihuo moxibustionn for chronic fatigue syndrome 

研究课题的正式科学名称:

医疗针刺联合雷火灸治疗慢性疲劳综合征的疗效观察 

Scientific title:

Observation on therapeutic effect of acupuncture combined with leihuo moxibustionn for chronic fatigue syndrome 

研究课题代号(代码):

Study subject ID:

 

在其它机构的注册号:

Secondary ID:

ChiCTR1800019444 

申请注册联系人:

王小俊 

研究负责人:

王小俊 

Applicant:

Wang Xiaojun 

Study leader:

Wang Xiaojun 

申请注册联系人电话:

Applicant telephone:

+86 13424488076 

研究负责人电话:

Study leader's telephone:

+86 13424488076 

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:

13424488076@126.com 

研究负责人电子邮件:

Study leader's E-mail:

13424488076@126.com 

申请单位网址(自愿提供):

Applicant 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:

广州市白云区机场路16号广州中医药大学第一附属医院康复护理中心 

研究负责人通讯地址:

广州市白云区机场路16号广州中医药大学第一附属医院康复护理中心 

Applicant address:

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

Study leader's address:

16 Airport Road, Baiyun District, Guangzhou, Guangzhou, 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:

广州中医药大学第一附属医院 

Applicant's institution:

Rehabilitation nursing center, The First Affiliated Hospital of Guangzhou University of Chinese Medicine 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

ZYYECK[2018]025 

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 Guangzhou University of Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-06-04 

研究实施负责(组长)单位:

广州中医药大学第一附属医院 

Primary sponsor:

Rehabilitation nursing center, The First Affiliated Hospital of Guangzhou University of Chinese Medicine 

研究实施负责(组长)单位地址:

广州市白云区机场路16号广州中医药大学第一附属医院康复护理中心 

Primary sponsor's address:

16 Airport Road, Baiyun District, Guangzhou, Guangzhou, 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):

广州中医药大学第一附属医院

具体地址:

广州市白云区机场路16号广州中医药大学第一附属医院康复护理中心

Institution
hospital:

Rehabilitation nursing center, The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Address:

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

经费或物资来源:

广州中医药大学第一附属医院“创新强院”工程 

Source(s) of funding:

The First Affiliated Hospital of Guangzhou University of Chinese Medicine 

研究疾病:

慢性疲劳综合征 

Target disease:

Chronic fatigue syndrome 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional 

研究所处阶段:

其它 

Study phase:

Other 

研究目的:

以针刺为对照,评价医疗针刺联合雷火灸治疗慢性疲劳综合征的临床疗效 

Objectives of Study:

Evaluate the efficacy of acupuncture combined with leihuo moxibustion in the treatment of chronic fatigue syndrome comparing with acupuncture 

研究设计:

随机平行对照 

Study design:

Randomized parallel control 

纳入标准:

1.年龄在18至60岁之间; 2.符合美国疾病控制中心的慢性疲劳综合征诊断标准: 1)持续6个月以上的持续或反复发作的极度疲劳倦怠感; 2)鉴别诊断方面,必须未见明显器质性疾病之外,尚须满足以下症状中的8项: ①低热或畏寒; ②咽喉疼痛; ③颈部或者腋下淋巴结肿大; ④原因不明的虚脱感;⑤肌痛或者不适; ⑥只是轻微活动其后便出现持续24小时以上的全身倦怠感; ⑦头痛[或是首次出现,或在原有症状(程度或者频率)上恶化]; ⑧关节痛; ⑨神经精神症状 (怕光、一过性视力模糊、遗忘、易激怒、精神错乱、注意力和 思考能力减退、抑郁等); ⑩睡眠障碍(失眠或者嗜唾); ?急剧发病(主要症状于几天甚至数小时内短时间出现)。 

Inclusion criteria

1. Aged 18-60 years old; 2. People with chronic fatigue syndrome (meet the CDC diagnose standard). 

排除标准:

1.妊娠或哺乳期妇女; 2.可用原发病解释的慢性疲劳; 3.合并有其他重大疾病或精神病患者。 

Exclusion criteria:

1. pregnant or lactating women; 2. chronic fatigue can be explained by primary diseases; 3. patients with other major diseases or mental patients. 

研究实施时间:

Study execute time:

From2017-12-01To 2019-12-31 

干预措施:

Interventions:

组别:

对照组

样本量:

40

Group:

Group 1

Sample size:

干预措施:

针刺

干预措施代码:

Intervention:

acupuncture

Intervention code:

组别:

试验组

样本量:

40

Group:

Group 2

Sample size:

干预措施:

针刺联合雷火灸

干预措施代码:

Intervention:

acupuncture combined with leihuo moxibustion

Intervention code:

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):

广州中医药大学第一附属医院 

单位级别:

三级甲等 

Institution
hospital:

The First Affiliated Hospital of Guangzhou University of Chinese Medicine  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

疲劳量表-14

指标类型:

主要指标 

Outcome:

FS-14

Type:

Primary indicator 

指标中文名:

抑郁状态问卷

指标类型:

主要指标 

Outcome:

DSI

Type:

Primary indicator 

指标中文名:

焦虑自评量表

指标类型:

主要指标 

Outcome:

SAS

Type:

Primary indicator 

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 0 years
最大 Max age 0 years

随机方法(请说明由何人用什么方法产生随机序列):

选择符合条件的80例受试者后,采用信封法,制作随机卡片,放入不透明信封中。临床实施时将受试者按照就诊顺序对应信封序号依次拆开信封,按内装随机卡片提示分为试验组、对照组

性别:

男女均可

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

After selecting 80 eligible subjects, random cards were made by envelope method and put into opaque envelopes. In clinical practice, the subjects were divided into experimental group or control group according to the random card prompt.

Gender:

Both

盲法:

Blinding:

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

2020年,以论文发表方式

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

By2020 by means of scientific reports

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

病例记录表

The repository and management of the data(Please specify what repository will be used for management of the metadata):

Case Record Form, CRF

创建人:

Creater Name:

 2018-11-12
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