黛附汤治疗溃疡性结肠炎的临床研究和多组学测序研究

注册号:

Registration number:

ITMCTR2024000505

最近更新日期:

Date of Last Refreshed on:

2024-10-01

注册时间:

Date of Registration:

2024-10-01

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

黛附汤治疗溃疡性结肠炎的临床研究和多组学测序研究

Public title:

Clinical study and multi-omics sequencing study of Daifu Decoction in the treatment of ulcerative colitis

注册题目简写:

English Acronym:

研究课题的正式科学名称:

黛附汤治疗溃疡性结肠炎的临床研究和多组学测序研究

Scientific title:

Clinical study and multi-omics sequencing study of Daifu Decoction in the treatment of ulcerative colitis

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:

崔丹阳

研究负责人:

巩阳

Applicant:

Cui Danyang

Study leader:

Gongyang

申请注册联系人电话:

Applicant telephone:

13309883171

研究负责人电话:

Study leader's telephone:

13309888136

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:

13309883171@163.com

研究负责人电子邮件:

Study leader's E-mail:

goongyang126@126.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:

辽宁省沈阳市沈河区文化路83号

研究负责人通讯地址:

辽宁省沈阳市沈河区文化路83号

Applicant address:

83 Wenhua Road Shenhe District Shenyang City Liaoning Province

Study leader's address:

83 Wenhua Road Shenhe District Shenyang City Liaoning Province

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:

中国人民解放军北部战区总医院

Applicant's institution:

General Hospital of Northern Theater Command

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:

Y (2024)185

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

中国人民解放军北部战区总医院医学伦理委员会

Name of the ethic committee:

Medical ethics committee of General Hospital of Northern Theater Command

伦理委员会批准日期:

Date of approved by ethic committee:

2024/8/16 0:00:00

伦理委员会联系人:

刘宝军

Contact Name of the ethic committee:

Liu Baojun

伦理委员会联系地址:

辽宁省沈阳市沈河区文化路83号

Contact Address of the ethic committee:

83 Wenhua Road Shenhe District Shenyang City Liaoning Province

伦理委员会联系人电话:

Contact phone of the ethic committee:

024-28856577

伦理委员会联系人邮箱:

Contact email of the ethic committee:

bbzqzyykeyan@163.com

研究实施负责(组长)单位:

中国人民解放军北部战区总医院

Primary sponsor:

General Hospital of Northern Theater Command

研究实施负责(组长)单位地址:

辽宁省沈阳市沈河区文化路83号

Primary sponsor's address:

83 Wenhua Road Shenhe District Shenyang City Liaoning Province

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

辽宁

市(区县):

Country:

China

Province:

Liaoning

City:

单位(医院):

北部战区总医院

具体地址:

辽宁省沈阳市沈河区文化路83号

Institution
hospital:

General Hospital of Northern Theater Command

Address:

83 Wenhua Road Shenhe District Shenyang City Liaoning Province

经费或物资来源:

辽宁省自然科学基金

Source(s) of funding:

Natural Science Foundation of Liaoning Province

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:

非随机对照试验

Non randomized control

研究所处阶段:

Study phase:

探索性研究/预试验

Pilot clinical trial

研究目的:

对应用黛附汤和美沙拉秦治疗的UC患者进行临床疗效对比分析,并通过多组学测序研究,确定黛附汤干预UC的特异性标志物和药效靶标,为黛附汤的精准诊疗和临床推广提供高质量循证证据和基础数据。

Objectives of Study:

A comparative analysis of the clinical efficacy of the UC patients treated with Daifu decoction and mesalazine was conducted and the specific markers and efficacy targets of Daifu decoction in the intervention of UC were determined through multi-omics sequencing studies so as to provide high-quality evidence-based evidence and basic data for the accurate diagnosis and treatment and clinical promotion of Daifu Decoction.

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、西医诊断;(2)年龄18~60岁,男女不限;(3)至少入组前1个月未经任何治疗;(4)结肠镜检查符合轻、中、重度炎症表现;(5)病理检查符合活动期表现;(6)自愿签署知情同意书。

Inclusion criteria

(1) Consistent with the diagnosis of ulcerative colitis in Chinese and Western medicine; (2) Age 18-60 years old male or female; (3) No treatment for at least 1 month before enrollment; (4) Colonoscopy was consistent with mild moderate and severe inflammatory manifestations; (5) Pathological examination is consistent with the active stage; (6) Voluntary signing of informed consent.

排除标准:

(1)孕期、哺乳期妇女;(2)既往患有恶性肿瘤、自身免疫性疾病或其他遗传性疾病者;(3)曾服用过激素、免疫制剂、生物制剂或长期使用抗生素者;(4)对本研究药物过敏或不耐受者;(5)不能承受肠镜检查者。

Exclusion criteria:

(1) Pregnant and lactating women; (2) Those who have previously suffered from malignant tumors autoimmune diseases or other genetic diseases; (3) People who have taken hormones immune agents biological agents or long-term use of antibiotics; (4) Those who are allergic or intolerant to the drugs in this study; (5) Patients who cannot withstand colonoscopy.

研究实施时间:

Study execute time:

From 2024-10-20

To      2025-10-01

征募观察对象时间:

Recruiting time:

From 2024-10-20

To      2025-10-01

干预措施:

Interventions:

组别:

黛附汤组

样本量:

36

Group:

Daifu Decoction Group

Sample size:

干预措施:

黛附汤

干预措施代码:

Intervention:

Daifu Decoction

Intervention code:

组别:

美沙拉秦组

样本量:

36

Group:

Mesalazine Group

Sample size:

干预措施:

美沙拉秦缓释颗粒

干预措施代码:

Intervention:

Mesalazine sustained release granules

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):

辽宁

市(区县):

Country:

China

Province:

Liaoning

City:

单位(医院):

北部战区总医院

单位级别:

三家甲等

Institution/hospital:

General Hospital of Northern Theater Command

Level of the institution:

Third class first class

测量指标:

Outcomes:

指标中文名:

中医证候评分

指标类型:

次要指标

Outcome:

TCM syndrome score

Type:

Secondary indicator

测量时间点:

治疗前后

测量方法:

评分表

Measure time point of outcome:

pretherapy and post-treatment

Measure method:

mark sheet

指标中文名:

总有效率

指标类型:

次要指标

Outcome:

total effective rate

Type:

Secondary indicator

测量时间点:

治疗前后

测量方法:

评分表

Measure time point of outcome:

pretherapy and post-treatment

Measure method:

mark sheet

指标中文名:

改良的Mayo评分

指标类型:

主要指标

Outcome:

improved Mayo score

Type:

Primary indicator

测量时间点:

治疗前后

测量方法:

评分表

Measure time point of outcome:

pretherapy and post-treatment

Measure method:

mark sheet

指标中文名:

肾功能

指标类型:

副作用指标

Outcome:

renal function

Type:

Adverse events

测量时间点:

治疗前后

测量方法:

血液检测

Measure time point of outcome:

pretherapy and post-treatment

Measure method:

blood detection

指标中文名:

转录组学检测

指标类型:

附加指标

Outcome:

Transcriptomic detection

Type:

Additional indicator

测量时间点:

治疗前后

测量方法:

血液检测

Measure time point of outcome:

pretherapy and post-treatmen

Measure method:

blood detection

指标中文名:

红细胞沉降率

指标类型:

副作用指标

Outcome:

ESR

Type:

Adverse events

测量时间点:

治疗前后

测量方法:

血液检测

Measure time point of outcome:

pretherapy and post-treatment

Measure method:

blood detection

指标中文名:

代谢组学检测

指标类型:

附加指标

Outcome:

Metabolomics detection

Type:

Additional indicator

测量时间点:

治疗前后

测量方法:

血液、尿液检测

Measure time point of outcome:

pretherapy and post-treatmen

Measure method:

blood and urine detection

指标中文名:

单细胞测序

指标类型:

附加指标

Outcome:

single-cell sequencing

Type:

Additional indicator

测量时间点:

治疗前后

测量方法:

单细胞检测

Measure time point of outcome:

pretherapy and post-treatment

Measure method:

Single cell assay

指标中文名:

血常规

指标类型:

副作用指标

Outcome:

CBC

Type:

Adverse events

测量时间点:

治疗前后

测量方法:

血液检测

Measure time point of outcome:

pretherapy and post-treatment

Measure method:

blood detection

指标中文名:

多组学测序

指标类型:

附加指标

Outcome:

Multi-omics sequencing

Type:

Additional indicator

测量时间点:

治疗前后

测量方法:

组学检测

Measure time point of outcome:

pretherapy and post-treatment

Measure method:

Omics detection

指标中文名:

C反应蛋白

指标类型:

副作用指标

Outcome:

CRP

Type:

Adverse events

测量时间点:

治疗前后

测量方法:

血液检测

Measure time point of outcome:

pretherapy and post-treatment

Measure method:

blood detection

指标中文名:

肝功能

指标类型:

副作用指标

Outcome:

liver function

Type:

Adverse events

测量时间点:

治疗前后

测量方法:

血液检测

Measure time point of outcome:

pretherapy and post-treatment

Measure method:

blood detection

指标中文名:

钙卫蛋白

指标类型:

附加指标

Outcome:

calprotectin

Type:

Additional indicator

测量时间点:

治疗前后

测量方法:

粪便检测

Measure time point of outcome:

pretherapy and post-treatmen

Measure method:

Stool acidity test

指标中文名:

蛋白组学检测

指标类型:

附加指标

Outcome:

Proteomic detection

Type:

Additional indicator

测量时间点:

治疗前后

测量方法:

血液检测

Measure time point of outcome:

pretherapy and post-treatmen

Measure method:

blood detection

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

血液

组织:

结肠黏膜

Sample Name:

blood

Tissue:

colonic mucosa

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note:

标本中文名:

粪便

组织:

Sample Name:

faeces

Tissue:

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note:

标本中文名:

尿液

组织:

Sample Name:

urine

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 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):

不适用

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

NA

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

No

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):

不适用

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

NA

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

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

Case Record Form

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):

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