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

请与我们联系上传伦理批件癫痫脂质代谢组学和脑组织中差异基因筛选的研究

注册号： Registration number：	ChiCTR2000039968
最近更新日期： Date of Last Refreshed on：	2020-11-15
注册时间： Date of Registration：	2020-11-15
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	请与我们联系上传伦理批件癫痫脂质代谢组学和脑组织中差异基因筛选的研究
Public title：	Study on Lipid Metabolomics of Epilepsy and Screening of Differential Genes in Brain Tissue
注册题目简写：
English Acronym：
研究课题的正式科学名称：	HIF1a-Lox-ERK-Alox5介导的铁死亡新通路在癫痫发作中的作用机制及治疗策略研究
Scientific title：	The mechanism of action and treatment strategy of the new iron death pathway mediated by HIF1a-Lox-ERK-Alox5 in epileptic seizures
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：	毛小元	研究负责人：	毛小元
Applicant：	Xiaoyuan Mao	Study leader：	Xiaoyuan Mao
申请注册联系人电话： Applicant telephone：	18229491192	研究负责人电话： Study leader's telephone：	18229491192
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：	xiaoyuanm@csu.edu.cn	研究负责人电子邮件： Study leader's E-mail：	xiaoyuanm@csu.edu.cn
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：	中南大学湘雅医院临床药理研究所	研究负责人通讯地址：	中南大学湘雅医院临床药理研究所
Applicant address：	Institute of Clinical Pharmacology, Central South University; Human Key Laboratory of Pharmacogenetics, Changsha 410078, P. R. China	Study leader's address：	Institute of Clinical Pharmacology, Central South University; Human Key Laboratory of Pharmacogenetics, Changsha 410078, P. R. 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：	中南大学湘雅医院临床药理研究所
Applicant's institution：	Institute of Clinical Pharmacology, Central South University; Human Key Laboratory of Pharmacogenetics, Changsha 410078, P. R. China

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：	202001025	伦理委员会批件附件： Approved file of Ethical Committee：
批准本研究的伦理委员会名称：	中南大学湘雅医院医学伦理委员会
Name of the ethic committee：	Central South University’s discipline of bioethics
伦理委员会批准日期： Date of approved by ethic committee：	2020-01-23
伦理委员会联系人：	沈璐
Contact Name of the ethic committee：	Lu Shen
伦理委员会联系地址：	湖南省长沙市
Contact Address of the ethic committee：	Changsha P. R. China
伦理委员会联系人电话： Contact phone of the ethic committee：		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：

毛小元

Primary sponsor：

Xiaoyuan Mao

研究实施负责（组长）单位地址：

中南大学湘雅医院临床药理研究所

Primary sponsor's address：

Institute of Clinical Pharmacology, Central South University; Human Key Laboratory of Pharmacogenetics, Changsha 410078, P. R. 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)：	湖南	市(区县)：
Country：	China	Province：	Hunan	City：
单位(医院)：	中南大学临床药理研究所	具体地址：	湖南省长沙市湘雅路110号
Institution hospital：	Institute of Clinical Pharmacology	Address：	110 Xiangya Road, Changsha City, Hunan Province

经费或物资来源：

国家自然科学基金委员会

Source(s) of funding：

National Natural Science Foundation of China

研究疾病：

癫痫

Target disease：

Epilepsy

研究疾病代码：

Target disease code：

研究类型：

基础科学研究

Study type：

Basic Science

研究所处阶段：

I期临床试验

Study phase：

研究目的：

研究目的： 1. 分析癫痫患者和脑外伤患者血液和脑组织中脂质代谢产物的差异情况； 2. 分析癫痫患者和脑外伤患者脑组织中基因表达水平的差异； 3. 研究癫痫患者和脑外伤患者脑组织中差异基因的表达与临床病理特征的关系；

Objectives of Study：

Research purposes: 1. To analyze the differences in lipid metabolites in blood and brain tissue between patients with epilepsy and patients with traumatic brain injury; 2. To analyze the difference in gene expression levels in brain tissues of patients with epilepsy and traumatic brain injury; 3. To study the relationship between the expression of differential genes in the brain tissue of patients with epilepsy and traumatic brain injury and clinicopathological characteristics;

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

研究设计：

病例研究

Study design：

Case study

纳入标准：

1.健康受试者必须符合下列所有标准才能入选： a）健康志愿者，年龄不限； b）体重大于50 kg，受试者体重指数（BMI）在19～24 kg/m2之间，包括边界值，同批体重相差不宜悬殊； c）体格检查无异常发现者； d）无药物过敏史者； e）无烟、酒嗜好； f ) 受试者自愿参加试验并愿意按照本试验规定的程序进行试验； g ) 签署知情同意书。 2.癫痫患者符合下列标准才能入选： a) 患者自述符合癫痫症状； b) 年龄不限、性别不限的中国籍黄种非混血癫痫患者； c) 诊断符合 1981 年国际抗癫痫联盟癫痫发作分类标准及 1989 年癫痫及癫痫综合征国际分类标准, 经头颅CT 或磁共振成像（MRI）、脑电图检查未发现颅内占位性病变、血管畸型后其他进行性病变, 血液、肝肾功能检查无异常,应用抗癫痫药物正规治疗，无漏服，血药浓度达到稳态； d) 患者自愿参加试验并愿意按照本试验规定的程序进行试验； e) 患者或者监护人同意研究方案； f ) 签署知情同意书。 3.脑外伤患者符合下列标准才能入选： a) 患者无癫痫和癫痫并发症； b) 年龄不限、性别不限的中国籍黄种非混血脑外伤患者； c) 患者自愿参加试验并愿意按照本试验规定的程序进行试验； d) 患者或者监护人同意研究方案； e) 签署知情同意书。

Inclusion criteria

1. Healthy subjects must meet all the following criteria to be selected: a) Healthy volunteers, regardless of age; b) If the body weight is greater than 50 kg, the subject's body mass index (BMI) is between 19-24 kg/m2, including the boundary value, and the weight difference of the same batch should not be large; c) Those who have no abnormal findings during physical examination; d) Those who have no history of drug allergy; e) No smoking and alcohol addiction; f) Subjects voluntarily participate in the test and are willing to carry out the test in accordance with the procedures specified in this test; g) Sign informed consent. 2. Epilepsy patients meet the following criteria to be selected: a) The patient's self-report is consistent with epilepsy symptoms; b) Chinese yellow race non-mixed epilepsy patients of any age and gender; c) The diagnosis complies with the 1981 International Anti-Epilepsy League Seizure Classification Standard and the 1989 International Classification Standard for Epilepsy and Epilepsy Syndrome. No intracranial space-occupying lesions were found by CT or magnetic resonance imaging (MRI) and EEG. Other progressive diseases after vascular malformation, blood, liver and kidney function tests are normal, regular anti-epileptic drugs are applied, no missed doses, and blood drug concentration reaches a steady state; d) The patient voluntarily participates in the trial and is willing to conduct the trial in accordance with the procedures specified in this trial; e) The patient or guardian agrees to the research plan; f) Sign informed consent. 3. Patients with traumatic brain injury meet the following criteria to be selected: a) The patient has no epilepsy and epilepsy complications; b) Chinese yellow non-mixed brain trauma patients of any age and gender; c) The patient voluntarily participates in the trial and is willing to carry out the trial in accordance with the procedures specified in this trial; d) The patient or guardian agrees to the research plan; e) Sign the informed consent form.

排除标准：

(1) 符合一条或多条下列标准的健康受试者将被排除： a) 试验前4周内患过具有临床意义的疾病或接受过外科手术者； b) 任何实验室检查结果存在具有临床意义的异常情况者； c) 3个月内用过已知对某脏器有损害的药物或目前正在使用药物者； d) 有药物过敏史和对环境物质高度敏感者；对黄芪及其任何成分或相关药物过敏者； e) 易患低血钾症者； f) 充血性心力衰竭、胃溃疡、慢性胃炎、十二指肠溃疡、葡萄糖-6-磷酸脱氢酶（G6PD）缺乏症、严重肝功能损害、严重肾功能损害者； g) 有其它任何临床严重疾病史或有心血管系统、内分泌系统、神经系统疾病或肺部、血液学、免疫学、精神病学疾病及代谢异常等病史者； h) 近期感冒者； i) 有活动性出血者，糖尿病、青光眼等疾病者； j) HIV检测阳性者； k) 乙型肝炎表面抗原检测阳性或丙型肝炎检测阳性者； l) 正在进行具有任何医疗意义的伴随治疗者； m) 参加本试验前14天内具有伴随用药者； n) 有药物滥用史者； o) 试验前3个月及试验期间服用软毒品（如：大麻）或试验前一年及试验期间服用硬毒品（如：可卡因、苯环己哌啶，等）者； p) 3个月内参加过其他药物试验者； q) 试验前3个月内参与献血者； r) 患有凝血功能障碍或血栓栓塞性疾病者。 (2) 符合一条或多条下列标准的癫痫患者将被排除： a) 月经期女性； b) 不符合纳入标准中任何一项； c) 有药物滥用史者； d) 有严重器质性病变如恶性肿瘤、严重高血压、不稳定性心脏病、血液病、肝肾功能不全； e) 对依从性很差或者不合作的病人停止试验，更换受试者；脱落病人的结果不参加评价分析；由于疗效不满意，病人提前终止服用药物，不更换病例，病人应做疗效分析；因为不良反应终止试验的患者，其结果用于不良反应的评价分； f) 患有进行性器质性脑病或其它中枢神经系统疾病； g) 患有肝肾疾病； h) 孕妇。 (3) 符合一条或多条下列标准的脑外伤患者将被排除： a) 月经期女性； b) 不符合纳入标准中任何一项； c) 有药物滥用史者； d) 有严重器质性病变如恶性肿瘤、严重高血压、不稳定性心脏病、血液病、肝肾功能不全； e) 对依从性很差或者不合作的病人停止试验，更换受试者；脱落病人的结果不参加评价分析；由于疗效不满意，病人提前终止服用药物，不更换病例，病人应做疗效分析；因为不良反应终止试验的患者，其结果用于不良反应的评价分； f) 患有进行性器质性脑病或其它中枢神经系统疾病； g) 患有肝肾疾病； h) 孕妇。

Exclusion criteria：

(1) Healthy subjects who meet one or more of the following criteria will be excluded: a) Those who have had a clinically significant disease or have undergone surgery within 4 weeks before the test; b) Any clinically significant abnormality in laboratory test results; c) Those who have used drugs that are known to damage an organ within 3 months or are currently using drugs; d) Those who have a history of drug allergy and are highly sensitive to environmental substances; those who are allergic to astragalus and any of its components or related drugs; e) Those who are susceptible to hypokalemia; f) Congestive heart failure, gastric ulcer, chronic gastritis, duodenal ulcer, glucose-6-phosphate dehydrogenase (G6PD) deficiency, severe liver damage, severe renal damage; g) Those who have a history of any other serious clinical disease or a history of cardiovascular system, endocrine system, nervous system disease or lung, hematology, immunology, psychiatric disease, and metabolic abnormality; h) Those who have recently caught a cold; i) Those with active bleeding, diabetes, glaucoma and other diseases; j) Those who have tested positive for HIV; k) Those who have a positive hepatitis B surface antigen test or a hepatitis C test positive; l) Those who are undergoing concomitant therapy of any medical significance; m) Those who have had concomitant medication in the 14 days before participating in this trial; n) Those with a history of drug abuse; o) Those who took soft drugs (such as marijuana) 3 months before and during the test or hard drugs (such as cocaine, phencyclidine, etc.) one year before and during the test; p) Those who have participated in other drug trials within 3 months; q) Participated in blood donors within 3 months before the test; r) People with coagulation dysfunction or thromboembolic disease. (2) Patients with epilepsy who meet one or more of the following criteria will be excluded: a) Menstrual women; b) Does not meet any of the inclusion criteria; c) Those with a history of drug abuse; d) Severe organic diseases such as malignant tumors, severe hypertension, unstable heart disease, blood diseases, liver and kidney dysfunction; e) Stop the test for patients with poor compliance or non-cooperation, and replace the subjects; the results of the patients who fall off will not participate in the evaluation analysis; because the curative effect is not satisfactory, the patient stops taking the drug early, and the patient does not change the case, the patient should do the curative effect analysis; For patients whose adverse reactions terminate the trial, the results are used for the evaluation of adverse reactions; f) Suffering from progressive organic encephalopathy or other central nervous system diseases; g) Suffer from liver and kidney disease; h) Pregnant women. (3) Brain trauma patients who meet one or more of the following criteria will be excluded: a) Menstrual women; b) Does not meet any of the inclusion criteria; c) Those with a history of drug abuse; d) Severe organic diseases such as malignant tumors, severe hypertension, unstable heart disease, blood diseases, liver and kidney dysfunction; e) Stop the test for patients with poor compliance or non-cooperation, and replace the subjects; the results of the patients who fall off will not participate in the evaluation analysis; because the curative effect is not satisfactory, the patient stops taking the drug early, and the patient does not change the case, the patient should do the curative effect analysis; For patients whose adverse reactions terminate the trial, the results are used for the evaluation of adverse reactions; f) Suffering from progressive organic encephalopathy or other central nervous system diseases; g) Suffer from liver and kidney disease; h) Pregnant women.

研究实施时间：

Study execute time：

从From2020-01-01至To 2022-12-31

征募观察对象时间：

Recruiting time：

从From2020-01-01至To 2022-12-31

干预措施：

Interventions：

组别：	无	样本量：	0
Group：	none	Sample size：	0
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)：	湖南	市(区县)：
Country：	China	Province：	Hunan	City：
单位(医院)：	湘雅医院	单位级别：	国家级
Institution hospital：	Xiangya hospital	Level of the institution：	National

测量指标：

Outcomes：

指标中文名：	脂质代谢物	指标类型：	主要指标
Outcome：	Lipid metabolites	Type：	Primary 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：	脑组织	组织：
Sample Name：	Brain tissue	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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：

最小 Min age		岁 years
最大 Max age		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）：

收集海马或皮层组织，进行分子生物学或形态学检测

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

Collect hippocampus or cortical tissue for molecular biology or morphological testing

盲法：
Blinding：

原始数据公开时间： The time of sharing IPD：	试验完成后6个月内公开/Within six months after the trial complete
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）：	实验完成6个月后，NCBI GEO https://www.ncbi.nlm.nih.gov/
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	within six months after the trial complete, NCBI GEO https://www.ncbi.nlm.nih.gov/
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：	对组织患者进行命名和编号, 制作病例报告表并保存
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Named and numbered the tissue of patients, Make the case report form and save it
数据管理委员会： Data Managemen Committee：	暂未确定/Not yet
注册人： Name of Registration：	2020-11-15

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