中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2300077230
最近更新日期： Date of Last Refreshed on：	2024-05-15 19:47:09
注册时间： Date of Registration：	2023-11-02 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	多维度评价腧穴敏化特征与机制研究
Public title：	Multi-dimensional evaluation of sensitization characteristics and mechanisms of acupoints research
注册题目简写：
English Acronym：
研究课题的正式科学名称：	多维度评价腧穴敏化特征与机制研究
Scientific title：	Multi-dimensional evaluation of sensitization characteristics and mechanisms of acupoints research
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：	王雪松	研究负责人：	佘延芬
Applicant：	Wang Xuesong	Study leader：	She Yanfen
申请注册联系人电话： Applicant telephone：	+86 183 3215 6793	研究负责人电话： Study leader's telephone：	+86 158 3395 5508
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：	wangxuesong@hebcm.edu.cn	研究负责人电子邮件： Study leader's E-mail：	sheyanfen@163.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：	河北省石家庄市桥西区新石南路326号	研究负责人通讯地址：	河北省石家庄市鹿泉区杏苑路3号
Applicant address：	326 Xinshi Road South, Qiaoxi District, Shijiazhuang, Hebei	Study leader's address：	3 Xingyuan Road, Luquan District, Shijiazhuang, Hebei, 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：	河北中医药大学
Applicant's institution：	Hebei University of Chinese Medicine
研究负责人所在单位：	河北中医药大学
Affiliation of the Leader：	Hebei 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：	YXLL202212031,YXLL202307003	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：	河北中医学院伦理委员会
Name of the ethic committee：	Ethics Committee of Hebei University of Chinese Medicine
伦理委员会批准日期： Date of approved by ethic committee：	2022-11-30 00:00:00
伦理委员会联系人：	高维娟
Contact Name of the ethic committee：	Gao Weijuan
伦理委员会联系地址：	河北省石家庄市鹿泉区杏苑路3号
Contact Address of the ethic committee：	3 Xingyuan Road, Luquan District, Shijiazhuang, Hebei, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 188 0311 6767	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：

河北中医药大学

Primary sponsor：

Hebei University of Chinese Medicine

研究实施负责（组长）单位地址：

河北省石家庄市桥西区新石南路326号

Primary sponsor's address：

326 Xinshi Road South, Qiaoxi District, Shijiazhuang, Hebei

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	河北	市(区县)：
Country：	China	Province：	Hebei	City：
单位(医院)：	河北中医药大学	具体地址：	河北省石家庄市鹿泉区杏苑路3号
Institution hospital：	Hebei University of Chinese Medicine	Address：	3 Xingyuan Road, Luquan District, Shijiazhuang, Hebei, China

国家：	中国	省(直辖市)：	北京	市(区县)：
Country：	China	Province：	Bingjing	City：
单位(医院)：	中国中医科学院广安门医院	具体地址：	北京市西城区北线阁5号
Institution hospital：	Guang'anmen Hospital, China Academy of Chinese Medical Sciences	Address：	5 Beixiange, Xicheng District, Beijing

国家：	中国	省(直辖市)：	江西	市(区县)：
Country：	China	Province：	Jiangxi	City：
单位(医院)：	江西中医药大学附属医院	具体地址：	江西省南昌市八一大道445号
Institution hospital：	Affiliated Hospital of Jiangxi University of Chinese Medicine	Address：	445 Bayi Avenue, Nanchang, Jiangxi, China

国家：	中国	省(直辖市)：	四川	市(区县)：
Country：	China	Province：	Sichuan	City：
单位(医院)：	成都中医药大学附属医院	具体地址：	四川省成都市十二桥路37号
Institution hospital：	Affiliated Hospital of Chengdu University of Traditional Chinese Medicine	Address：	37 Shi'erqiao Road, Chengdu, Sichuan, China

经费或物资来源：

国家重点研发计划资助项目（No. 2022YFC3500601）

Source(s) of funding：

National Key Research and Development Program of China (No. 2022YFC3500601)

研究疾病：

慢性萎缩性胃炎、溃疡性结肠炎、腹泻型肠易激综合征、功能性消化不良、健康人

Target disease：

Chronic atrophic gastritis, ulcerative colitis, diarrhea-type irritable bowel syndrome, functional dyspepsia

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

探索性研究/预试验

Study phase：

0

研究设计：

横断面

Study design：

Cross-sectional

研究目的：

以正常人、功能性消化不良、萎缩性胃炎、肠易激综合征和溃疡性结肠炎患者为研究对象，通过多中心、大样本的横断面研究，结合审、视、切、扪、循、按6种传统揣穴方法，采用多种客观可视化技术，观察温度、血流、痛阈以及结节/条索的变化，归纳胃肠疾病腧穴敏化规律。

Objectives of Study：

Take normal people, functional dyspepsia, atrophic gastritis, irritable bowel syndrome and ulcerative colitis patients as the research subjects, and summarize the sensitization pattern of acupoints for gastrointestinal diseases through a multicenter and large-sample cross-sectional study, combining six traditional acupoint methods of scrutiny, visualization, incision, searching, following and pressing, and observe the changes of temperature, blood flow, pain threshold and nodule/stripe by adopting a variety of objective visualization techniques.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1. Functional dyspepsia
(1) Meet the diagnostic criteria of Rome IV functional dyspepsia: middle and upper abdominal pain; Early satiety discomfort; Fullness and discomfort after meals; Burning sensation in the middle and upper abdomen; 
(2) Aged 20-70 years old, gender is not limited; 
(3) No organic or metabolic disease that can explain the above symptoms was found in routine examination; 
(4) Symptoms appear for at least 6 months and persist for nearly 3 months; 
(5) Patients with warning symptoms should provide gastroscopy reports in the past 2 years;
2. Diarrheal irritable bowel syndrome
(1) Meeting the diagnostic criteria of Rome IV diarrheal irritable bowel syndrome subtype: related to defecation; Accompanied by changes in bowel frequency; Accompanied by changes in fecal traits (appearance) (Bristol fecal traits type 6 or 7 > 1/4, and Bristol fecal traits type 1 or 2 < 1/4); 
(2) Aged 20-70 years old, gender is not limited; 
(3) Accompanied by a change in the frequency of defecation; 
(4) Symptoms appear for at least 6 months and persist for nearly 3 months; 
(5) Patients with alarm symptoms should provide colonoscopy reports within the last 2 years;
3. Chronic atrophic gastritis
(1) Meet the above diagnostic criteria of atrophic gastritis experts: meet the gastroscopy diagnosis: 
1) Under the endoscope, the gastric mucosa showed red and white phases, mainly white phases, and the folds were flattened or even disappeared;
2) Some mucosal blood vessels are exposed, which may be accompanied by mucosal granules or nodules; 
3) Or other descriptions of atrophy (meet one of them); 
Or meet the pathological diagnosis: 
1) Gastric mucosa atrophy or intrinsic gland atrophy; 
2) Gastric mucosa intestinal metaplasia; 
3) Gastric mucosal dysplasia; 
4) Or other descriptions of atrophy (meet one of them); 
(2) Aged 20-70 years old, gender is not limited; 
(3) Provide gastroscopy or pathological examination reports in the past 2 years;
4. Ulcerative colitis
(1) Meet the diagnostic criteria for adult ulcerative colitis: persistent or recurrent diarrhea; Mucous, pus and blood stool with abdominal pain; Posterior hypersomia; The course of the disease is more than 6 weeks; 
(2) Aged 20-70 years old, gender is not limited; 
(3) Colonoscopy, barium enema, CT or MRI showed changes in typical ulcerative colitis;
(4) The colonoscopy report within the last 2 years should be provided;
5. Normal People
(1) Normal people who have passed the physical examination and suffer from diseases of important organs such as heart, liver, lung and kidney; 
(2) Aged 20-70 years old (age and gender matching recruitment with disease group); 
(3) No gastrointestinal diseases were detected.

排除标准：

1.功能性消化不良（1）意识不清、不能表达主观不适症状者及精神病患者；（2）患有可能引起消化不良症状的慢性疾病，如慢性肝病、糖尿病、甲状腺功能异常等；（3）探测穴位局部有瘢痕、皮肤病及周围神经系统疾病者；（4）患有会导致基础体温异常的疾病者，如甲状腺功能异常等代谢性疾病；（5）近一周发热、前一天剧烈运动导致肌肉酸痛者；（6）备孕、妊娠期或哺乳期妇女； 2.腹泻型肠易激综合征（1）便秘型/混合型IBS，炎性肠病、克罗恩病等器质性肠病者；（2）意识不清、不能表达主观不适症状者及精神病患者；（3）患有可能引起消化不良症状的慢性疾病，如慢性肝病、糖尿病、甲状腺功能异常等；（4）探测穴位局部有瘢痕、皮肤病及周围神经系统疾病者；（5）患有会导致基础体温异常的疾病者，如甲状腺功能异常等代谢性疾病；（6）近一周发热、剧烈运动导致肌肉酸痛者；（7）备孕、妊娠期或哺乳期妇女； 3.慢性萎缩性胃炎（1）伴有胃溃疡、十二指肠溃疡、特殊类型胃炎或消化道出血；（2）胃镜或病理活检已示癌变者，影像学检查提示癌转移者；（3）意识不清、不能表达主观不适症状者及精神病患者；（4）患有可能引起消化不良症状的慢性疾病，如慢性肝病、糖尿病、甲状腺功能异常等；（5）探测穴位局部有瘢痕、皮肤病及周围神经系统疾病者；（6）患有会导致基础体温异常的疾病者，如甲状腺功能异常等代谢性疾病；（7）近一周发热、前一天剧烈运动导致肌肉酸痛者；（8）备孕、妊娠期或哺乳期妇女； 4.溃疡性结肠炎（1）病变类型为急性爆发型；（2）感染性肠病、克罗恩病、缺血性肠病、放射性肠炎等患者；（3）合并严重并发症者，如中毒性肠扩张、肠梗阻、肠穿孔、大出血等，合并结肠癌、直肠癌者，及结肠切除术史；（4）意识不清、不能表达主观不适症状者及精神病患者；（5）探测穴位局部有瘢痕、皮肤病及周围神经系统疾病者；（6）患有会导致基础体温异常的疾病者，如甲状腺功能异常等代谢性疾病；（7）近一周发热、前一天剧烈运动导致肌肉酸痛者；（8）备孕、妊娠期或哺乳期妇女； 5.正常人（1）患有会导致基础体温异常的疾病者，如甲状腺功能异常等代谢性疾病；（2）探测穴位局部有瘢痕、皮肤病及周围神经系统疾病者；（3）近一周发热、前一天剧烈运动导致肌肉酸痛者。

Exclusion criteria：

1. Functional dyspepsia (1) Patients with unclear consciousness, unable to express subjective discomfort symptoms and mental patients; (2) Have chronic diseases that may cause indigestion, such as chronic liver disease, diabetes, thyroid dysfunction, etc.; (3) Detection of acupoints with local scar, skin disease and peripheral nervous system diseases; (4) People with diseases that cause abnormal basal body temperature, such as metabolic diseases such as abnormal thyroid function; (5) Those who have fever for nearly a week and muscle soreness caused by strenuous exercise the day before; (6) Pregnant, pregnant or lactating women; 2. Diarrheal irritable bowel syndrome (1) Patients with constipated/mixed IBS, inflammatory bowel disease, Crohn's disease and other organic bowel diseases; (2) Patients with unconsciousness, unable to express subjective discomfort symptoms and mental patients; (3) Have chronic diseases that may cause indigestion symptoms, such as chronic liver disease, diabetes, thyroid dysfunction, etc.; (4) To detect local scar, skin disease and peripheral nervous system disease at acupoints; (5) People with diseases that cause abnormal basal body temperature, such as metabolic diseases such as abnormal thyroid function; (6) People with fever and muscle soreness caused by intense exercise in the past week; (7) Pregnant, pregnant or lactating women; 3. Chronic atrophic gastritis (1) Accompanied by gastric ulcer, duodenal ulcer, special type of gastritis or gastrointestinal bleeding; (2) Gastroscopy or pathological biopsy has shown cancer, imaging examination suggests cancer metastasis; (3) Patients with unconsciousness, unable to express subjective discomfort symptoms and mental patients; (4) Have chronic diseases that may cause indigestion, such as chronic liver disease, diabetes, thyroid dysfunction, etc.; (5) Detection of acupoints with local scars, skin diseases and peripheral nervous system diseases; (6) Suffer from diseases that cause abnormal basal body temperature, such as metabolic diseases such as abnormal thyroid function; (7) Those with fever for nearly a week and muscle soreness caused by intense exercise the day before; Women who are pregnant, pregnant or breastfeeding; 4. Ulcerative colitis (1) The lesion type was acute outbreak type; (2) Patients with infectious enteropathy, Crohn's disease, ischemic enteropathy, radiation enteritis, etc.; (3) Patients with severe complications, such as toxic intestinal dilation, intestinal obstruction, intestinal perforation, massive hemorrhage, colon cancer, rectal cancer, and history of colectomy; (4) Patients with unclear consciousness, unable to express subjective discomfort symptoms and mental patients; (5) Detection of acupoints with local scars, skin diseases and peripheral nervous system diseases; (6) Suffer from diseases that cause abnormal basal body temperature, such as metabolic diseases such as abnormal thyroid function; (7) Those with fever for nearly a week and muscle soreness caused by intense exercise the day before; Women who are pregnant, pregnant or breastfeeding; 5. Normal People (1) Patients with diseases that cause abnormal basal body temperature, such as metabolic diseases such as abnormal thyroid function; (2) Detection of acupoints with local scar, skin disease and peripheral nervous system diseases; (3) Those who have fever for nearly a week and muscle soreness caused by strenuous exercise the day before.

研究实施时间：

Study execute time：

从 From 2023-11-01 00:00:00至 To 2025-06-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2023-11-02 00:00:00 至 To 2025-06-30 00:00:00

干预措施：

Interventions：

组别：	慢性萎缩性胃炎	样本量：	300
Group：	Chronic atrophic gastritis	Sample size：	300
干预措施：	无	干预措施代码：
Intervention：	None	Intervention code：

组别：	溃疡性结肠炎	样本量：	300
Group：	Ulcerative colitis	Sample size：	300
干预措施：	无	干预措施代码：
Intervention：	None	Intervention code：

组别：	腹泻型肠易激综合征	样本量：	300
Group：	Diarrheal irritable bowel syndrome	Sample size：	300
干预措施：	无	干预措施代码：
Intervention：	None	Intervention code：

组别：	功能性消化不良	样本量：	300
Group：	Functional dyspepsia	Sample size：	300
干预措施：	无	干预措施代码：
Intervention：	None	Intervention code：

组别：	正常组	样本量：	300
Group：	Normal control group	Sample size：	300
干预措施：	无	干预措施代码：
Intervention：	None	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	河北	市(区县)：
Country：	China	Province：	Hebei	City：
单位(医院)：	河北中医药大学	单位级别：	大学
Institution hospital：	Hebei University of Chinese Medicine	Level of the institution：	University

国家：	中国	省(直辖市)：	北京	市(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：	中国中医科学院广安门医院	单位级别：	三甲
Institution hospital：	Guang'anmen Hospital, China Academy of Chinese Medical Sciences	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	江西	市(区县)：
Country：	China	Province：	Jiangxi	City：
单位(医院)：	江西中医药大学附属医院	单位级别：	三甲
Institution hospital：	Affiliated Hospital of Jiangxi University of Chinese Medicine	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	四川	市(区县)：
Country：	China	Province：	Sichuan	City：
单位(医院)：	成都中医药大学附属医院	单位级别：	大学
Institution hospital：	Affiliated Hospital of Chengdu University of Traditional Chinese Medicine	Level of the institution：	University

测量指标：

Outcomes：

指标中文名：	穴位体表温度	指标类型：	主要指标
Outcome：	Body Surface Temperature at Acupuncture Points	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	穴区体表平均血流灌注量	指标类型：	主要指标
Outcome：	Mean body surface perfusion in the acupoint area	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	穴区压痛阈值	指标类型：	主要指标
Outcome：	Pressure pain threshold at acupoints	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	穴区深部血流频谱	指标类型：	次要指标
Outcome：	Spectrum of deep blood flow in the acupoint area	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	穴区ROI血流信号比	指标类型：	次要指标
Outcome：	ROI blood flow signal ratio in acupoint area	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：	无	组织：
Sample Name：	None	Tissue：
人体标本去向	其它	说明
Fate of sample：	0thers	Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：

最小 Min age	20	岁 years
最大 Max age	70	岁 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）：

不适用

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

N/A

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：
Blinding：
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing	是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）：	待试验结束后，原始数据请联系研究负责人进行获取。
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Please contact the study leader to obtain the raw data when the experiment is completed.
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：	使用电子采集和管理系统(Electronic Data Capture, EDC)收集和管理数据。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Collection and management of data using Electronic Data Capture (EDC) systems.
数据与安全监察委员会： Data and Safety Monitoring Committee：	有/Yes
注册人： Name of Registration：	2023-11-02 08:50:35