Acupuncture and mesalazine for patients with active mild-to-moderate ulcerative colitis: a randomised controlled multi-centre trial

注册号:

Registration number:

ITMCTR2025000061

最近更新日期:

Date of Last Refreshed on:

2025-01-10

注册时间:

Date of Registration:

2025-01-10

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

针刺联合美沙拉秦治疗活动期轻中度溃疡性结肠炎多中心、单盲、随机对照临床试验

Public title:

Acupuncture and mesalazine for patients with active mild-to-moderate ulcerative colitis: a randomised controlled multi-centre trial

注册题目简写:

English Acronym:

研究课题的正式科学名称:

针刺联合美沙拉秦治疗活动期轻中度溃疡性结肠炎多中心、单盲、随机对照临床试验

Scientific title:

Acupuncture and mesalazine for patients with active mild-to-moderate ulcerative colitis: a randomised controlled multi-centre trial

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:

申请注册联系人:

王照钦

研究负责人:

吴璐一

Applicant:

Zhao-Qin Wang

Study leader:

Lu-Yi Wu

申请注册联系人电话:

Applicant telephone:

18621153795

研究负责人电话:

Study leader's telephone:

13917680799

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:

wangzhaoqin@fudan.edu.cn

研究负责人电子邮件:

Study leader's E-mail:

luyitcm@163.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:

上海市徐汇区宛平南路650号

研究负责人通讯地址:

上海市虹口区甘河路110号

Applicant address:

650 South Wanping Road Xuhui District Shanghai China

Study leader's address:

110 Ganhe Road Honghou District Shanghai

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:

上海中医药大学附属岳阳中西医结合医院

Applicant's institution:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai 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:

2024-235

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:

上海中医药大学附属岳阳中西医结合医院伦理委员会

Name of the ethic committee:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of Traditional Chineses Medicine Ethics committee

伦理委员会批准日期:

Date of approved by ethic committee:

2024/11/28 0:00:00

伦理委员会联系人:

殷从全

Contact Name of the ethic committee:

Cong-Quan Yin

伦理委员会联系地址:

上海市虹口区甘河路110号

Contact Address of the ethic committee:

110 Ganhe Road Hongkou District Shanghai China

伦理委员会联系人电话:

Contact phone of the ethic committee:

021-65161782-8122

伦理委员会联系人邮箱:

Contact email of the ethic committee:

yyyyllwyh@163.com

研究实施负责(组长)单位:

上海中医药大学附属岳阳中西医结合医院

Primary sponsor:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

上海市虹口区甘河路110号

Primary sponsor's address:

110 Ganhe Road Honghou District Shanghai

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

上海

市(区县):

虹口区

Country:

China

Province:

Shanghai

City:

Hongkou District

单位(医院):

上海中医药大学附属岳阳中西医结合医院

具体地址:

上海市虹口区甘河路110号

Institution
hospital:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of Traditional Chinese Medicine

Address:

110 Ganhe Road Hongkou District Shanghai China

经费或物资来源:

国家自然基金优秀青年科学基金

Source(s) of funding:

Excellent Young Scientists Fund of the National Natural Science Foundation of China

研究疾病:

溃疡性结肠炎

研究疾病代码:

Target disease:

Ulcerative colitis

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:

其它

Others

研究目的:

本研究旨在前期临床研究基础上,拟通过多中心、单盲、随机对照临床试验,观察针刺联合美沙拉秦治疗活动期轻中度UC患者的临床疗效;进一步明确针刺干预UC的可行性及安全性,优化UC针刺治疗方案,为针刺治疗UC提供高质量的循证医学证据,为其临床应用及实验探索提供有力的依据

Objectives of Study:

On the basis of the previous clinical studies this study aims to observe the clinical efficacy of acupuncture combined with mesalazine in the treatment of patients with mild-to-moderate UC during the active phase through a multicenter single-blind randomized controlled clinical trial; to further clarify the feasibility and safety of acupuncture intervention for UC to optimize the treatment protocol of acupuncture for UC and to provide high-quality evidence-based medical evidence of the treatment of UC by acupuncture so as to provide a strong basis for its clinical applications and experimental explorations

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符合溃疡性结肠炎中西医诊疗专家共识意见(2022)中溃疡性结肠炎的诊断标准; ②疾病严重程度为活动期轻、中度的UC患者(Mayo评分为3~10); ③年龄≥18岁且≤75岁,性别不限; ④自愿参加本研究并签署知情同意书者。

Inclusion criteria

① Meet the diagnostic criteria for ulcerative colitis in the Expert Consensus Opinion (2022) on the diagnosis and treatment of ulcerative colitis in Chinese and Western medicine; ② Patients with UC whose disease severity is mild or moderate in the active stage (Mayo score of 3~10); ③ Age ≥18 and ≤75 years old gender is not limited; ④ Those who voluntarily participated in this study and signed the informed consent.

排除标准:

①合并严重心、脑、肝、肾等疾病及恶性肿瘤的患者; ②既往或目前诊断为精神分裂症、中重度抑郁症等其他精神病性障碍的患者; ③有严重肠瘘、腹腔脓肿、肠腔狭窄和肠梗阻,消化道大出血、肠穿孔等并发症; ④入组前1个月内参加过针刺临床试验或正在参加其他临床试验者; ⑤在本研究所选用的穴位区域存在皮肤病、肢体残缺等状况而无法施针治疗者; ⑥处于备孕、妊娠及哺乳期的患者; ⑦其它可能导致腹痛、腹泻、黏液脓血便疾病的患者,如细菌性痢疾、阿米巴痢疾、肠易激综合征等。

Exclusion criteria:

① Patients with a combination of severe heart brain liver kidney and other diseases and malignant tumors; ② Patients with previous or current diagnosis of schizophrenia moderate to severe depression and other psychotic disorders; ③ Patients with severe intestinal fistula abdominal abscess intestinal stenosis and intestinal obstruction gastrointestinal hemorrhage intestinal perforation and other complications; ④ Those who have participated in acupuncture clinical trials within 1 month before enrollment or are participating in other clinical trials; ⑤ Those who are unable to administer acupuncture treatment due to the presence of skin diseases limb disfigurement and other conditions in the area of acupoints selected for this study; ⑥ Patients who are in the period of preparation for pregnancy pregnancy and breastfeeding; ⑦Patients with other diseases that may cause abdominal pain diarrhea and mucous-pus-blood stools such as bacillary dysentery amoebic dysentery and irritable bowel syndrome.

研究实施时间:

Study execute time:

From 2025-01-01

To      2027-12-27

征募观察对象时间:

Recruiting time:

From 2025-02-28

To      2027-08-31

干预措施:

Interventions:

组别:

试验组

样本量:

73

Group:

Group 1

Sample size:

干预措施:

基础治疗(美沙拉秦)+针刺

干预措施代码:

Intervention:

usual care(mesalazine) + acupuncture

Intervention code:

组别:

对照组

样本量:

73

Group:

Group 2

Sample size:

干预措施:

基础治疗(美沙拉秦)+假针刺

干预措施代码:

Intervention:

usual care(mesalazine) + sham acupuncture

Intervention code:

样本总量 Total sample size : 146

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

浙江

市(区县):

台州

Country:

China

Province:

Zhejiang

City:

Taizhou

单位(医院):

浙江省人民医院(浙东南院区)

单位级别:

三级乙等医院

Institution/hospital:

Zhejiang Provincial People's Hospital ZheDong South Campus

Level of the institution:

Tertiary B Hospital

国家:

中国

省(直辖市):

上海

市(区县):

虹口区

Country:

China

Province:

Shanghai

City:

Hongkou District

单位(医院):

上海中医药大学附属岳阳中西医结合医院

单位级别:

三级甲等医院

Institution/hospital:

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine Shanghai University of Traditional Chinese Medicine

Level of the institution:

Tertiary A Hospital

国家:

中国

省(直辖市):

江苏

市(区县):

徐州

Country:

China

Province:

Jiangsu

City:

Xuzhou

单位(医院):

徐州市中医院

单位级别:

三级甲等医院

Institution/hospital:

XuZhou City Hospital of TCM

Level of the institution:

Tertiary A Hospital

测量指标:

Outcomes:

指标中文名:

白细胞介素-1β

指标类型:

次要指标

Outcome:

IL-1β

Type:

Secondary indicator

测量时间点:

week0,12

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

第12周粘膜愈合率

指标类型:

次要指标

Outcome:

the mucosal healing rate at week 12

Type:

Secondary indicator

测量时间点:

week 12

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医症候疗效评估

指标类型:

次要指标

Outcome:

Assessment of the efficacy of TCM symptoms

Type:

Secondary indicator

测量时间点:

week0,6,12,16,24

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

第12周临床有效率

指标类型:

主要指标

Outcome:

the clinical response rate at week 12

Type:

Primary indicator

测量时间点:

week 12

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

VAS评分

指标类型:

次要指标

Outcome:

visual analogue scale(VAS)

Type:

Secondary indicator

测量时间点:

week0,6,12,16,24

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肝功能检测

指标类型:

次要指标

Outcome:

liver function

Type:

Secondary indicator

测量时间点:

week0,12

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

白细胞介素-10

指标类型:

次要指标

Outcome:

IL-10

Type:

Secondary indicator

测量时间点:

week0,12

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肿瘤坏死因子α

指标类型:

次要指标

Outcome:

TNF-α

Type:

Secondary indicator

测量时间点:

week0,12

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

炎症性肠病问卷

指标类型:

次要指标

Outcome:

Inflammatory Bowel Disease Questionnaire (IBDQ)

Type:

Secondary indicator

测量时间点:

week0,6,12,16,24

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

医院焦虑抑郁量表

指标类型:

次要指标

Outcome:

Hospital Anxiety and Depress Scale(HADS)

Type:

Secondary indicator

测量时间点:

week0,6,12,16,24

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

第12周临床缓解率

指标类型:

次要指标

Outcome:

the clinical remission rate at week 12

Type:

Secondary indicator

测量时间点:

week 12

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

改良Mayo单项评分

指标类型:

次要指标

Outcome:

Improved Mayo Single Score

Type:

Secondary indicator

测量时间点:

week0,12

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

白细胞介素-6

指标类型:

次要指标

Outcome:

IL-6

Type:

Secondary indicator

测量时间点:

week0,12

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:

尚未开始

Not yet recruiting

年龄范围:

最小 18
Min age years
最大 75
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):

随机分组采用基于网络数据系统(Electronic Data Capture System, EDC)随机系统生成的随机数进行中央随机,分中心作为分层因素竞争入组。纳入随机的受试者将被1:1分为试验组和对照组。临床基地研究人员收到随机号后将进一步告知患者对应的处理方案。

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

Randomization groupings were centrally randomized using random numbers generated by a web-based data system randomization system with sub-centers as stratification factors for competitive enrollment.Subjects included in the randomization will be divided 1:1 into trial and control groups. Patients will be further informed of the corresponding treatment plan by the clinical site investigators upon receipt of the randomization number.

盲法:

Blinding:

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):

2028年06月 Excel数据库

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

June 2028 Excel database

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:

病例记录表及电子采集和管理系统

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

Case Record Form(CRF) and Electronic Data Capture(EDC)

数据管理委员会:

Data Managemen Committee:

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):

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