ChiCTR1800018276 版本V1.0 版本创建时间2018/9/7 22:05:21 中国临床试验注册中心

审核状态:

Project audit state:

通过审核

Successful

注册号:

Registration number:

ChiCTR1800018276 

最近更新时间:

Date of Last Refreshed on:

2018/9/7 22:04:51 

注册号状态:

预注册  

Registration Status:

Prospective registration  

填写语言:

中文和英文  

Language:

Chinese And English  

注册题目:

基于子午流注理论择时艾灸对强直性脊柱炎的干预研究 

Public title:

Moxibustion intervention based on Midnight-Midday Ebb Flow theory for Ankylosing Spondylitis patients 

注册题目简写:

 

Public title acronym:

 

研究课题的正式科学名称:

基于子午流注理论择时艾灸对强直性脊柱炎的干预研究 

Scientific title:

Moxibustion intervention based on Midnight-Midday Ebb Flow theory for Ankylosing Spondylitis patients 

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:

ZD201713 

在其它机构的注册号:

Secondary ID:

AMCTR-IPR-18000206 

申请注册联系人:

徐骁 

研究负责人:

孙志琴 

Applicant:

Xu Xiao 

Study leader:

Sun Zhi-Qin 

申请注册联系人电话:

Applicant telephone:

+86 13861016329 

研究负责人电话:

Study leader's telephone:

+86 13861285688 

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:

xuxiao@cczu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

1257509030@qq.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:

中国江苏常州市兴隆巷29号 

研究负责人通讯地址:

中国江苏常州市兴隆巷29号 

Applicant address:

29 Xinglong Lane, Changzhou, Jiangsu, China 

Study leader's address:

29 Xinglong Lane, Changzhou, Jiangsu, China 

申请注册联系人邮政编码:

Applicant postcode:

213000 

研究负责人邮政编码:

Study leader's postcode:

213000 

申请人所在单位:

南京医科大学附属常州第二人民医院 

Applicant's institution:

The Affiliated Changzhou 2nd People's Hospital of Nanjing Medical University 

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:

[2018] YK006-01 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

南京医科大学附属常州第二人民医院伦理委员会 

Name of the ethic committee:

Institutional Review Board (IRB) of The Affiliated Changzhou 2nd People's Hospital of Nanjing Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-03-29 

国家FDA批准文号:

Approved No. of SFDA:

国家FDA批准附件:

Approved file of SFDA:

国家FDA批准日期:

Date of approved by SFDA:

研究实施负责(组长)单位:

南京医科大学附属常州第二人民医院 

Primary sponsor:

The Affiliated Changzhou 2nd People's Hospital of Nanjing Medical University 

研究实施负责(组长)单位地址:

常州市兴隆巷29号 

Primary sponsor's address:

29 Xinglong Lane, Changzhou, Jiangsu, 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):

江苏

市(区县):

常州市

Country:

China

Province:

Jiangsu

City:

Changzhou

单位(医院):

南京医科大学附属常州第二人民医院

具体地址:

常州市兴隆巷29号

Institution
hospital:

The Affiliated Changzhou 2nd People's Hospital of Nanjing Medical University

Address:

29 Xinglong Lane, Changzhou, Jiangsu, China

经费或物资来源:

2017年常州市卫生计生委重大科技项目(ZD201713) 

Source(s) of funding:

This study was supported by a grant from the Key Project of Changzhou Municipal Health Planning Commission (ZD201713) 

研究疾病:

强直性脊柱炎 

Target disease:

Ankylosing Spondylitis 

研究疾病代码:

M45.X91 

Target disease code:

M45.X91 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

基于子午流注理论,探讨艾灸治疗强直性脊柱炎的疗效 

Objectives of Study:

The aim of this study was to assess the effect of Midnight-Midday Ebb Flow theory to guide moxibustion intervention on patients with ankylosing spondylitis 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

年龄18到65岁 满足1984年 modified New York criteria (mNY) 的强直性脊柱炎标准 疾病持续6个月 非甾体类抗炎药持续使用4周 抗风湿类药物 (甲氨蝶呤,柳氮磺砒啶) 或者生物制剂 (英夫利昔单抗, 依那西普, 阿达木单抗) 维持计量使用3个月 能够熟练阅读,使用中文。 签署之情同意书 

Inclusion criteria

1. Aged between 18 and 65 years; 2. Fulfilling the 1984 modified New York criteria (mNY) for AS; 3. Disease lasting for at least 6 months; 4. Nonsteroidal anti-inflammatory drugs (NSAID) will be on stable doses for at least 4 weeks; 5. The disease-modifying anti-rheumatic drugs (methotrexate, sulfasalazine) or anti-tumor necrosis factor (TNF) agents (infliximab, etanercept, adalimumab,etc.) will be on stable dosages for at least 3 months; 6. Able to speak and read Chinese; 7. Sign the informed consent form. 

排除标准:

其它的风湿免疫性疾病 (类风湿关节炎, 干燥综合征, 系统性红斑狼疮, 纤维肌痛综合征.) 心力衰竭病史, 肿瘤病史, 无法控制的高血压, 慢性阻塞性肺疾病, 糖尿病, 淋巴瘤, 神经和胃肠道疾病, 出血性疾病 感染性疾病包括结核 精神疾患 怀孕妊娠妇女 前期依从性较差的患者 酒精药物成瘾 不适合艾灸情况: 中医证型分类为热证, 晕灸, 不乐意接受艾灸治疗. 

Exclusion criteria:

1. Other rheumatic diseases (rheumatoid arthritis, Sjogren syndrome, systemic lupus erythematosus, fibromyalgia,etc.) 2. History of heart failure, malignancies, uncontrolled hypertension, chronic obstructive pulmonary disease, diabetes mellitus requiring insulin injection, lymphoma, life-threatening neurological and gastrointestinal disorders, haemorrhagic disorders; 3. An active infectious disease, including tuberculosis; 4. A diagnosis of mental disorder; 5. Pregnant and lactating women; 6. Previous poor compliance; 7. Alcohol or drug addiction; Not suitable for moxibustion: TCM pattern differentiation of Heat Bi, moxibustion syncope, unwilling to be treated with moxibustion, etc. 

研究实施时间:

Study execute time:

From2018-09-15To 2019-12-31 

干预措施:

Interventions:

组别:

干预组1

样本量:

50

Group:

Group 1

Sample size:

干预措施:

艾灸干预+常规干预措施(时间从17:00到19:00)

干预措施代码:

Intervention:

moxibustion intervenion+conventional intervenion (From 17:00 to 19:00)

Intervention code:

组别:

对照组

样本量:

50

Group:

Group 2

Sample size:

干预措施:

常规干预(非甾体类抗炎药,抗风湿药物,生物制剂)

干预措施代码:

Intervention:

Conventional intervention (NSAIDs, DMARDs, Biological Agents)

Intervention code:

组别:

干预组 2

样本量:

50

Group:

Group 3

Sample size:

干预措施:

艾灸干预+常规干预措施(时间非17:00到19:00)

干预措施代码:

Intervention:

moxibustion intervenion+conventional intervenion (Not from 17:00 to 19:00)

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

江苏 

市(区县):

常州市 

Country:

China 

Province:

Jiangsu 

City:

Changzhou 

单位(医院):

南京医科大学附属常州第二人民医院 

单位级别:

三级甲等 

Institution
hospital:

The Affiliated Changzhou No.2 People's Hospital of Nanjing Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

患者疾病活动性指数

指标类型:

主要指标 

Outcome:

BASDAI

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

功能性指数

指标类型:

主要指标 

Outcome:

BASFI

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

测量性指数

指标类型:

主要指标 

Outcome:

BASMI

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

强直性脊柱炎生活质量量表

指标类型:

主要指标 

Outcome:

ASQoL

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血沉/C反应蛋白

指标类型:

次要指标 

Outcome:

ESR/CRP

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

ASAS20/40标准

指标类型:

次要指标 

Outcome:

ASAS20/40

Type:

Secondary 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 Sample

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:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 65 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

南京医科大学附属常州第二人民医院临床试验中心负责对合格的参加者进行登记,随机分配序列的产生,并将参与者随机分派给不同的干预组。随机数列表由SPSS产生。一个独立的不参与这项研究的统计学家具体实施负责。

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

The Clinical Trial Center at The Affiliated Changzhou No.2 People's Hospital of Nanjing Medical University will be responsible for enrollment of eligible participants, the random allocation sequence generation, and randomly assignment of participants to different intervention groups. Random numbers list will be generated w

UTN(全球唯一识别码):

盲法:

评价者和数据管理统计者盲。

Blinding:

The outcome assessors and the data statistical analysts will be blinded to treatment allocation throughout the study

试验完成后的统计结果:

Calculated Results ater
the Study Completed:

研究负责(组长)单位:

Organizer institution (leader institution):

资料收集汇总单位:

6M

Data collection Institution:

资料管理单位:

本平台公开

Data management Institution:

Shared on this platform

资料分析单位:

在招募之前,研究小组成员将参加一个关于数据管理和测量标准化的培训会议。完成这项临床试验后,评估人员和研究助理必须将与临床试验相关的记录和数据交给数据管理员。数据管理员必须确保在CRF中没有遗漏记录,并且不允许更改数据。原始材料中的任何修改都应在附录中注明并注明日期。然后,根据一个标准的数据录入计划,数据将由两位不参与此次临床试验的数据管理员双录入,如遇到不一致的地方将与原始CRF表进行比较。对分组分配实施盲法的独立的统计学家将进行统计分析。为了保护数据隐私性,我们将依据数据保护法案1998。书面数据将被保存在一个锁定的文件柜中,访问权限限制在研究团队成员的范围内。电子数据将存储在受密码保护的计算机中。所有研究档案从南京医科大学附属常州第二人民医院临床试验完成日起保存至少3年。

Data analysis Institution:

Before recruitment, the research team members will participate in a training meeting about the data management and measurement standardization. After completing this clinical trial, assessors and research assistants must hand over the records and data related to the clinical trial to the data administrator. The data administrator must ensure that no records will be missed or omitted in the CRFs, and the primary input of the data will not be permitted to be changed. Any corrections in the original materials should be explained in the appended notes signed and dated by the researches. Then, according to a standard protocol for data entry, data will be double-entered by data administrators blinded to the group allocation and the source of any inconsistencies will be explored to compare with the original CRFs. An independent statistician who is blind to the treatment group will comprise the medical statistical analysis. To protect confidentiality, all research data will be saved according to the Data Protection Act 1998. Written data will be kept in a locked filing cabinet with access restricted to the research team members. Electronic data will be stored in a password protected computer. All research archives will be preserved for at least 3 years from the completion date of clinical trial in the Affiliated Changzhou No.2 People's Hospital of Nanjing Medical University.

注册人:

Name on Registration:

 2018-08-18