International Traditional Medicine Clinical Trial Registry

注册号： Registration number：	ITMCTR2024000297
最近更新日期： Date of Last Refreshed on：	2024-08-24
注册时间： Date of Registration：	2024-08-24
注册号状态： Registration Status：	预注册 Prospective registration
注册题目：	维持性血液透析患者中医六经证候特点及影响因素
Public title：	Characteristics and influencing factors of traditional Chinese medicine six meridian syndrome in maintenance hemodialysis patients
注册题目简写：
English Acronym：
研究课题的正式科学名称：	维持性血液透析患者中医六经证候特点及影响因素
Scientific title：	Characteristics and influencing factors of traditional Chinese medicine six meridian syndrome in maintenance hemodialysis 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：
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：	陈士耀	研究负责人：	陈士耀
Applicant：	Chen Shiyao	Study leader：	Chen Shiyao
申请注册联系人电话： Applicant telephone：	17856978269	研究负责人电话： Study leader's telephone：	17856978269
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：	tcmdoctorchensy@163.com	研究负责人电子邮件： Study leader's E-mail：	tcmdoctorchensy@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：	安徽省淮南市寿县寿春镇城南新区310省道寿县中医院	研究负责人通讯地址：	安徽省淮南市寿县寿春镇城南新区310省道寿县中医院
Applicant address：	Shouxian Traditional Chinese Medicine Hospital 310 Provincial Road Chengnan New District Shouchun Town Shouxian County Huainan City Anhui Province	Study leader's address：	Shouxian Traditional Chinese Medicine Hospital, 310 Provincial Road, Chengnan New District, Shouchun Town, Shouxian County, Huainan City, Anhui Province
申请注册联系人邮政编码： Applicant postcode：	232200	研究负责人邮政编码： Study leader's postcode：	232200
申请人所在单位：	寿县中医院
Applicant's institution：	Shouxian Traditional Chinese Medicine Hospital

是否获伦理委员会批准： Approved by ethic committee：	是 Yes
伦理委员会批件文号： Approved No. of ethic committee：	EC-20240812-1003、EC-20240812-1004、EC-20240812-1005、EC-20240812-1006、EC-20240812-1007	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：	寿县中医院医学伦理委员会
Name of the ethic committee：	Medical Ethics Committee of Shouxian Traditional Chinese Medicine Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2024/8/12 0:00:00
伦理委员会联系人：	朱长钧
Contact Name of the ethic committee：	ZhuChangjun
伦理委员会联系地址：	安徽省淮南市寿县寿春镇城南新区310省道寿县中医院
Contact Address of the ethic committee：	Shouxian Traditional Chinese Medicine Hospital, 310 Provincial Road, Chengnan New District, Shouchun Town, Shouxian County, Huainan City, Anhui Province
伦理委员会联系人电话： Contact phone of the ethic committee：	13805641376	伦理委员会联系人邮箱： Contact email of the ethic committee：	1643552749@qq.com
国家药监局批准文号： Approved No. of MPA：		国家药监局批准附件： Approved file of MPA：
国家药监局批准日期： Date of approved by MPA：
研究方案： Study protocol：
知情同意书： Informed consent file：

Primary sponsor：

Shouxian Traditional Chinese Medicine Hospital

Primary sponsor's address：

Shouxian Traditional Chinese Medicine Hospital, 310 Provincial Road, Chengnan New District, Shouchun Town, Shouxian County, Huainan City, Anhui Province

Secondary sponsor：

国家：	中国	省(直辖市)：	安徽	市(区县)：	安徽省淮南市
Country：	China	Province：	Anhui	City：	Huainan City, Anhui Province
单位(医院)：	寿县中医院	具体地址：	安徽省淮南市寿县寿春镇城南新区310省道寿县中医院
Institution hospital：	Shouxian Traditional Chinese Medicine Hospital	Address：	Shouxian Traditional Chinese Medicine Hospital, 310 Provincial Road, Chengnan New District, Shouchun Town, Shouxian County, Huainan City, Anhui Province

Source(s) of funding：

raise independently

研究疾病：	维持性血液透析并发症	研究疾病代码：
Target disease：	Complications of maintenance hemodialysis	Target disease code：
研究类型： Study type：	观察性研究 Observational study	研究设计： Study design：	横断面 Cross-sectional
研究所处阶段： Study phase：	其它 Others
研究目的：	探究维持性血液透析患者中医六经证候的特点及影响因素
Objectives of Study：	Exploring the characteristics and influencing factors of traditional Chinese medicine six meridian syndrome in maintenance hemodialysis patients
药物成份或治疗方案详述：
Description for medicine or protocol of treatment in detail：
纳入标准：	纳入标准： ①符合慢性肾脏病5期的临床诊断标准，且患者规律的血液透析治疗时间≥3个月； ②性别不限，年龄≥18 周岁，且意识清楚者； ③患者心力衰竭、呼吸衰竭、电解质紊乱、代谢性酸中毒等严重症状已有明显控制； ④患者能够配合医生的研究，病例资料真实； ⑤诊断为维持性血液透析并发症，如维持性血液透析并发瘙痒症、维持性血液透析并发肠-肾综合征、维持性血液透析并发甲状旁腺亢进症、维持性血液透析并发不宁腿综合征等。同时符合以上五项标准的患者，方可纳入本项研究｡
Inclusion criteria	Inclusion criteria: ① Meets the clinical diagnostic criteria for stage 5 chronic kidney disease and the patient's regular hemodialysis treatment time is ≥ 3 months; ② Gender not limited age ≥ 18 years old and clear consciousness; ③ The patient's severe symptoms such as heart failure respiratory failure electrolyte imbalance and metabolic acidosis have been significantly controlled; ④ The patient is able to cooperate with the doctor's research and the case information is authentic; ⑤ Diagnosed as complications of maintenance hemodialysis such as pruritus enterorenal syndrome hyperparathyroidism restless leg syndrome etc. Only patients who meet the above five criteria can be included in this study
排除标准：	排除标准： ①拒绝加入研究、依从性差，未按要求接受中医诊断者； ②患有严重的精神疾病、认知存在严重障碍或无法进行有效沟通者； ③合病危急重病，需要进行急救处理者（如：机械通气患者）； ④临床资料严重不全，无法进行研究者。凡符合上述任何一条标准的患者，即予以排除。
Exclusion criteria：	Exclusion criteria: ① Refusal to join the study, poor compliance, and failure to receive traditional Chinese medicine diagnosis as required; ② Individuals with severe mental illness, severe cognitive impairment, or inability to communicate effectively; ③ Those who are critically ill and require emergency treatment (such as mechanically ventilated patients); ④ Clinical data is severely incomplete, making it impossible for researchers to conduct research. Patients who meet any of the above criteria will be excluded.
研究实施时间： Study execute time：	从From 2024-08-28 至To 2025-05-31	征募观察对象时间： Recruiting time：	从From 2024-08-28 至To 2024-09-15

Interventions：

组别：	观察组	样本量：	92
Group：	Observation group	Sample size：	92
干预措施：	无干预	干预措施代码：
Intervention：	No	Intervention code：

Total sample size ： 92

Countries of recruitment
and research settings：

国家：	中国	省(直辖市)：	安徽	市(区县)：	安徽省淮南市
Country：	China	Province：	Anhui	City：	Huainan City, Anhui Province
单位(医院)：	寿县迎河镇中心卫生院	单位级别：	二级医院
Institution/hospital：	Shouxian Yinghe Town Central Health Center	Level of the institution：	Secondary Hospital

国家：	中国	省(直辖市)：	安徽	市(区县)：	安徽省淮南市
Country：	China	Province：	Anhui	City：	Huainan City, Anhui Province
单位(医院)：	寿县中医院	单位级别：	三级中医院
Institution/hospital：	Shouxian Traditional Chinese Medicine Hospital	Level of the institution：	Third level Traditional Chinese Medicine Hospital

国家：	中国	省(直辖市)：	安徽	市(区县)：	安徽省淮南市
Country：	China	Province：	Anhui	City：	Huainan City, Anhui Province
单位(医院)：	寿县晟康血液透析中心	单位级别：	二级专科医院
Institution/hospital：	Shouxian Shengkang Hemodialysis Center	Level of the institution：	Secondary specialized hospital

Outcomes：

指标中文名：	性别、年龄、籍贯、透析龄、白细胞、血小板、血红蛋白、β-2微球蛋白、白蛋白、球蛋白、谷草转氨酶、丙氨酸氨基转移酶、血钙、血磷、钙磷乘积、全段甲状旁腺素、铁蛋白、转铁蛋白饱和度等指标	指标类型：	次要指标
Outcome：	Gender, age, place of origin, dialysis age, white blood cells, platelets, hemoglobin, beta-2 microglobulin, albumin, globulin, aspartate aminotransferase, alanine aminotransferase, blood calcium, blood phosphorus, calcium phosphorus product, whole parathyroid hormone, ferritin, transferrin saturation and other indicators	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	中医六经证候	指标类型：	主要指标
Outcome：	Traditional Chinese Medicine Six Classics Syndrome	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

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：

Not yet recruiting

最小	18	岁
Min age	18	years
最大	99	岁
Max age	99	years

Recruiting status：

Participant age：

Gender：

Both

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

We plan to conduct a multicenter, cross-sectional, and investigative study based on patients with maintenance hemodialysis complications at the Blood Purification Center of Shouxian Traditional Chinese Medicine Hospital, the Hemodialysis Room of Shouxian Yinghe Town Central Health Center, and Shouxian Shengkang Hemodialysis Center in Anhui Province.

隐蔽分组方法和过程：
Process of allocation concealment：
盲法：
Blinding：
揭盲或破盲原则和方法：
Rules of uncover or ceasing blinding：
统计方法名称：
Statistical method：
试验完成后的统计结果（上传文件）：
Calculated Results ater the Study Completed：
上传试验完成后的统计结果： Statistical results after completion of the test file upload
是否公开试验完成后的统计结果： Calculated Results after the Study Completed(upload file)：	公开 Public
全球唯一识别码： UTN

是否共享原始数据： IPD sharing：	否 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）：	无
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	No
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：	采集纳入维持性血液透析并发症患者临床上的基本数据、血液透析方案、生化指标、用药史等。记录维持性血液透析患者的一般资料及临床上的检验数据。在完成对纳入的维持性血液透析并发症患者临床基本数据和检查数据的采集后，开始对纳入的维持性血液透析并发症患者行中医诊断，在患者行血液透析治疗前，行中医望、闻、切诊，分别采集其脉象、舌象，因我县维持性血液透析患者居住于乡镇、农村的人员占比较大，行血液透析治疗前，多会考虑血液透析结束后赶车问题，故在其行血液透析治疗之时，由研究者行中医问诊，执行时，应安抚好患者的情绪，对维持性血液透析患者可能出现的即刻并发症及远期并发症做好处理。在完成对纳入的维持性血液透析并发症患者临床基本数据和检查数据的采集及中医诊断后，整理好数据，进入统计学分析阶段。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Collect basic clinical data, hemodialysis regimen, biochemical indicators, medication history, etc. from patients with complications of maintenance hemodialysis. Record general information and clinical test data of maintenance hemodialysis patients. After completing the collection of clinical basic data and examination data for the included patients with complications of maintenance hemodialysis, traditional Chinese medicine diagnosis was carried out for the included patients with complications of maintenance hemodialysis. Before the patients underwent hemodialysis treatment, traditional Chinese medicine observation, hearing, and palpation were performed, and their pulse and tongue images were collected respectively. Due to the large proportion of maintenance hemodialysis patients living in towns and rural areas in our county, the problem of rushing to the bus after hemodialysis treatment is often considered before undergoing hemodialysis treatment. Therefore, during the hemodialysis treatment, the researcher conducted traditional Chinese medicine consultation, and the patient's emotions should be calmed down. Immediate and long-term complications that may occur in maintenance hemodialysis patients should be handled properly. After completing the collection of clinical basic data and examination data, as well as traditional Chinese medicine diagnosis, for the included patients with complications of maintenance hemodialysis, the data is organized and entered into the statistical analysis stage.
数据管理委员会： Data Managemen Committee：	暂未确定 Not yet
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):