ChiCTR2400086904 版本V1.0 版本创建时间2024/07/15 11:38:41 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2400086904 

最近更新日期：

Date of Last Refreshed on：

2024-07-15 11:38:37 

注册时间：

Date of Registration：

2024-07-15 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

健脾降浊汤治疗无症状高尿酸血症随机对照临床研究

Public title：

A randomized controlled clinical study on the treatment of asymptomatic hyperuricemia with Jianpi Jiangzhuo Tang

注册题目简写：

English Acronym：

研究课题的正式科学名称：

健脾降浊汤治疗无症状高尿酸血症随机对照临床研究

Scientific title：

A randomized controlled clinical study on the treatment of asymptomatic hyperuricemia with Jianpi Jiangzhuo Tang

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：

申斌 

研究负责人：

申斌 

Applicant：

Shen Bin 

Study leader：

Shen Bin 

申请注册联系人电话：

Applicant telephone：

+86 138 1157 8685

研究负责人电话：

Study leader's telephone：

+86 138 1157 8685

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：

13811578685@163.com

研究负责人电子邮件：

Study leader's E-mail：

13811578685@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：

北京市平谷区平翔路6号平谷区中医医院体检治未病科

研究负责人通讯地址：

北京市平谷区平翔路6号平谷区中医医院体检治未病科

Applicant address：

Department of Health Examination and Pre-disease Prevention, Pinggu District Traditional Chinese Medicine Hospital, No. 6 Pingxiang Road, Pinggu District, Beijing

Study leader's address：

Department of Health Examination and Pre-disease Prevention, Pinggu District Traditional Chinese Medicine Hospital, No. 6 Pingxiang Road, Pinggu District, Beijing

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：

北京市平谷区中医医院

Applicant's institution：

Beijing Pinggu District Hospital of Traditional Chinese Medicine

研究负责人所在单位：

北京市平谷区中医医院

Affiliation of the Leader：

Beijing Pinggu District Hospital of Traditional Chinese Medicine

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2024-sfkt-01

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：

北京市平谷区中医医院医学伦理委员会

Name of the ethic committee：

The Medical Ethics Committee of Beijing Pinggu District Hospital of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2024-06-13 00:00:00

伦理委员会联系人：

冯振东

Contact Name of the ethic committee：

Feng Zhendong

伦理委员会联系地址：

北京市平谷区平翔路6号平谷区中医医院科教处

Contact Address of the ethic committee：

Department of Science and Education, Pinggu District Hospital of Traditional Chinese Medicine, No. 6 Pingxiang Road, Pinggu District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 158 1110 5173

伦理委员会联系人邮箱：

Contact email of the ethic committee：

kjc651@bjpg.gov.cn

研究实施负责（组长）单位：

北京市平谷区中医医院

Primary sponsor：

Beijing Pinggu District Hospital of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

北京市平谷区平翔路6号

Primary sponsor's address：

No.6, Pingxiang Road, Pinggu District, Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京

市(区县)：

平谷区

Country：

China

Province：

Beijing

City：

Pinggu District

单位(医院)：

北京市平谷区中医医院

具体地址：

北京市平谷区平翔路6号

Institution
hospital：

Beijing Pinggu District Hospital of Traditional Chinese Medicine

Address：

No.6, Pingxiang Road, Pinggu District, Beijing

经费或物资来源：

首都卫生发展科研专项（首发2024-3-7132）

Source(s) of funding：

Capital’s Funds for Health Improvement and Research (CFH2024-3-7132)

Target disease：

asymptomatic hyperuricemia

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

针对无症状高尿酸血症患者，通过前瞻随机对照研究，观察总结健脾降浊汤治疗无症状高尿酸血症的疗效与优势。  

Objectives of Study：

Through a prospective randomized controlled study, the efficacy and advantages of Jianpi Jiangzhuo Decoction in the treatment of asymptomatic hyperuricemia were observed and summarized.

药物成份或治疗方案详述：

(1)健康信息收集 对无症状高尿酸血症患者的日常用药、职业、受教育程度、种族、性别、年龄等情况调查，若患者为女性，则对其避孕药物使用、生育史、月经等情况进行了解。对患者的家族史、既往疾病史等调查，包括肥胖、血脂异常、高血压、动脉硬化、吸烟饮酒等危险因素。对患者的血压、体重、身高、腰围等检查，计算其体重指数。 (2)干预方案 ①试验组：口服健脾降浊汤颗粒剂 党参10g 白术10g 茯苓12g 炙甘草5g 法半夏6g 陈皮6g 当归6g 麸炒苍术10g 土茯苓30g 绵萆薢15g 威灵仙10g 盐补骨脂6g 颗粒剂由北京康仁堂药业有限公司提供，每日一剂，早晚各服一次，连续服用4周。 ②对照组：口服中药颗粒安慰剂 安慰剂由北京康仁堂药业有限公司提供，以试验组原药药量的5%+95%糊精制成，每日一剂，早晚各一次，连续服用4周。 ③健康管理指导 通过建立微信群，两组患者均给予健康管理指导，每周相关科普宣教不少于3次。以以下内容为主： 1）饮食指导。参考2022中国居民膳食指南及2016年高尿酸血症专家共识进行饮食指导，以减少嘌呤摄入、控制脂肪和热量、增加水分摄入以及保持饮食均衡等为原则。 A.限制高嘌呤食物：高嘌呤食物如动物内脏（肝、肾、脑等）、海鲜（鱼、虾、蟹等）、肉类（牛肉、羊肉、猪肉等）应尽量减少摄入。可以选择嘌呤含量相对较低的食物，如鸡蛋、牛奶、蔬菜、水果等。 B.控制脂肪和热量摄入：减少高脂肪食物的摄入，如肥肉、动物油等，以降低脂肪代谢产生的热量和尿酸。同时，控制总热量摄入，避免肥胖，因为肥胖也是高尿酸血症的一个风险因素。 C.增加水分摄入：多喝水有助于尿酸的排出，建议每日饮水量保持在2000毫升以上。同时，可以适量饮用淡茶水或柠檬水，以增加尿量，促进尿酸排泄。 D.保持饮食均衡：在限制高嘌呤食物的同时，也要保证其他营养素的摄入。适量摄入优质蛋白质，如瘦肉、鱼、豆腐等，以及富含维生素和矿物质的蔬菜、水果等。 E.避免饮酒：酒精会抑制肝脏对尿酸的代谢，导致尿酸升高。因此，高尿酸血症患者应严格限酒、戒酒。 2）运动指导。以有氧运动为主，提高心肺功能，促进新陈代谢为原则，进行运动指导。 A.选择适合的有氧运动：如快走、慢跑、游泳、骑自行车、太极拳、瑜伽等。这些运动能够持续一段时间，使心率逐渐上升，同时不会给身体带来过大的负担。 B.控制运动强度和时间：运动强度应适中，避免剧烈运动导致乳酸堆积和尿酸升高。一般来说，运动后的心率应控制在最大心率的60%～70%（最大心率约等于220减去年龄）。运动时间每次可持续30～60分钟，每周进行3～5次。 C.注意运动中的水分补充：在运动过程中，由于出汗较多，需要及时补充水分，以维持身体的水平衡和尿酸的排泄。建议每隔15～20分钟喝一次水。 D.保护关节：运动过程中应特别注意保护关节。可以选择使用护膝、减震运动鞋等辅助工具，减少关节受力。 E.根据身体状况和运动能力进行每日的运动，可随时咨询课题组医生指导，以确保运动的安全性和有效性。 

Description for medicine or protocol of treatment in detail：

(1) Health Information Collection A comprehensive survey is conducted to gather information on the daily medications, occupation, education level, ethnicity, gender, and age of patients with asymptomatic hyperuricemia. For female patients, specific inquiries are made regarding contraceptive use, reproductive history, and menstrual status. Additionally, the family history and past medical history of patients are investigated, including risk factors such as obesity, dyslipidemia, hypertension, atherosclerosis, smoking, and alcohol consumption. Physical examinations encompass measurements of blood pressure, weight, height, and waist circumference, from which the body mass index (BMI) is calculated. (2) Intervention Protocol Experimental Group: Administration of Jianpi Jiangzhuo Decoction Granules Ingredients: Dangshen (Codonopsis pilosula) 10g Baizhu (Atractylodes macrocephala) 10g Fuling (Poria cocos) 12g Zhigancao (Glycyrrhizae Radix and Rhizoma Preparata) 5g Banxia (Pinellia ternata) 6g Chenpi (Citrus reticulata pericarpium) 6g Danggui (Angelica sinensis) 6g Cangzhu (Atractylodes lancea rhizoma) stir-fried with bran 10g Tufuling (Smilax glabra rhizoma) 30g Mianbixie (Dioscorea hypoglauca rhizoma) 15g Weilingxian (Clematis chinensis radix) 10g Yanbuchizhi (Psoralea corylifolia fructus salted) 6g The granules are provided by Beijing Kangrentang Pharmaceutical Co., Ltd. Patients are instructed to take one dose daily, split into morning and evening administrations, for a total of 4 weeks. Control Group: Administration of Chinese Medicine Granule Placebo The placebo, also provided by Beijing Kangrentang Pharmaceutical Co., Ltd., consists of 5% of the active ingredients from the experimental group's medication mixed with 95% dextrin. Patients in this group follow the same dosing schedule (one dose daily, morning and evening) for 4 weeks. Health Management Guidance: Both groups receive health management guidance through a dedicated WeChat group, with at least three science-based educational sessions per week. The guidance focuses on: Dietary Recommendations: Based on the 2022 Chinese Dietary Guidelines and the 2016 Expert Consensus on Hyperuricemia, patients are advised to reduce purine intake, control fat and calorie consumption, increase water intake, and maintain a balanced diet. A. Limit high-purine foods such as animal viscera, seafood, and red meat, opting for lower-purine alternatives like eggs, milk, vegetables, and fruits. B. Decrease fatty foods and total calorie intake to prevent obesity, a risk factor for hyperuricemia. C. Drink at least 2000ml of water daily to facilitate uric acid excretion, with the option of light tea or lemon water. D. Ensure a balanced diet with adequate intake of high-quality protein, vitamins, and minerals. E. Strictly avoid alcohol consumption, which inhibits uric acid metabolism. Exercise Recommendations: Emphasizing aerobic exercises to improve cardiorespiratory fitness and promote metabolism. A. Choose suitable aerobic activities like walking, jogging, swimming, cycling, tai chi, or yoga. B. Maintain moderate intensity and duration, aiming for a post-exercise heart rate of 60-70% of the maximum (estimated as 220 minus age), for 30-60 minutes per session, 3-5 times weekly. C. Stay hydrated during exercise, drinking water every 15-20 minutes. D. Protect joints with accessories like knee pads and shock-absorbing shoes. E. Consult with the study's medical team for personalized advice to ensure safe and effective exercise routines. 

纳入标准：

西医诊断标准： 参照我国2019年《中国高尿酸血症与痛风诊疗指南》制定：正常饮食状态下，非同日2次检测空腹血尿酸水平>420μmol/L(成年人，不分性别)，且未出现过痛风发作。 中医诊断标准： 参照《中药新药临床研究指导原则》中“脾气虚证”及“痰浊阻遏证”相关内容拟定AHUA中医证型“脾虚浊阻证”： 主要症状：食少纳呆，乏力肢重，食后腹胀，大便异常（溏、烂、先硬后溏、时溏时硬）；形体肥胖，头重如裹，胸闷脘痞，呕恶痰涎。 次要症状：神疲懒言，口淡不渴，腹痛绵绵，心悸，失眠。 舌脉象：舌淡胖，苔薄腻，脉滑。 上述主症3项结合舌脉象，或主症2项加次症2项结合舌脉象即可诊断。 纳入标准：①符合西医及中医诊断标准；②空腹血尿酸水平<540μmol／L；③年龄18～65岁，性别不限；④自愿参加并签署知情同意书，并能接受长期随访。

Inclusion criteria

Western Medicine Diagnostic Criteria: Formulated with reference to the "Chinese Guidelines for the Diagnosis and Treatment of Hyperuricemia and Gout" in 2019: Under normal dietary conditions, two tests conducted on different days show that the fasting blood uric acid level is >420μmol/L (for adults, regardless of gender), and there has been no occurrence of gout attacks. Traditional Chinese Medicine (TCM) Diagnostic Criteria: Based on the relevant content of "Spleen Qi Deficiency Syndrome" and "Turbid Phlegm Obstruction Syndrome" in the "Guiding Principles for Clinical Research on New Chinese Medicines", the TCM syndrome type of "Spleen Deficiency and Turbid Obstruction Syndrome" for AHUA is formulated as follows: Main Symptoms: Poor appetite, fatigue and heaviness in the limbs, postprandial abdominal distension, abnormal bowel movements (loose, mushy, initially hard then loose, alternately loose and hard); obesity, heavy sensation in the head as if wrapped, chest congestion and epigastric distension, nausea with phlegm. Secondary Symptoms: Mental fatigue, reluctance to speak, bland taste without thirst, lingering abdominal pain, palpitations, insomnia. Tongue and Pulse Conditions: Pale and swollen tongue, thin and greasy tongue coating, slippery pulse. The diagnosis can be made based on three main symptoms combined with tongue and pulse conditions, or two main symptoms plus two secondary symptoms combined with tongue and pulse conditions. Inclusion Criteria: ① Meet both Western medicine and TCM diagnostic criteria; ② Fasting blood uric acid level <540μmol/L; ③ Age range of 18 to 65 years, regardless of gender; ④ Voluntarily participate, sign the informed consent form, and are able to accept long-term follow-up.

排除标准：

①继发性HUA患者，如肿瘤、血液病、肾脏疾病、慢性中毒者；②严重心脑血管疾病、恶性高血压、急性感染、血小板减少性出血性疾病者；③近期服用可引起血尿酸增高的药物，如噻嗪类利尿剂、阿司匹林、左旋多巴、乙胺丁醇者；④妊娠或哺乳期妇女；⑤严重肝肾功能不全者。

Exclusion criteria：

①Patients with secondary hyperuricemia (HUA), such as those with tumors, hematological diseases, kidney diseases, or chronic poisoning; ②Individuals with severe cardiovascular and cerebrovascular diseases, malignant hypertension, acute infections, or thrombocytopenic hemorrhagic diseases; ③Those who have recently taken medications that can cause an increase in blood uric acid levels, such as thiazide diuretics, aspirin, levodopa, or ethambutol; ④Pregnant or lactating women; ⑤Patients with severe liver or kidney dysfunction.

研究实施时间：

Study execute time：

从 From 2024-01-01 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-08-01 00:00:00 至 To 2026-12-31 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

62

Group：

Experimental Group

Sample size：

干预措施：

口服健脾降浊汤颗粒剂

干预措施代码：

Intervention：

Administration of Jianpi Jiangzhuo Decoction Granules

Intervention code：

组别：

对照组

样本量：

62

Group：

Control Group

Sample size：

干预措施：

口服中药颗粒安慰剂

干预措施代码：

Intervention：

Administration of Chinese Medicine Granule Placebo

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

 平谷区 

Country：

China 

Province：

Beijing 

City：

Pinggu District 

单位(医院)：

北京市平谷区中医医院 

单位级别：

三甲 

Institution
hospital：

Beijing Pinggu District Hospital of Traditional Chinese Medicine

Level of the institution：

ertiary A

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

 平谷区 

Country：

China 

Province：

Beijing 

City：

Pinggu District 

单位(医院)：

北京市平谷区黄松峪乡社区卫生服务中心 

单位级别：

社区卫生服务中心 

Institution
hospital：

Huangsongyu Community Health Service Center, Pinggu District, Beijing

Level of the institution：

Community Health Service Center

测量指标：

Outcomes：

指标中文名：

血尿酸水平

指标类型：

主要指标

Outcome：

Blood uric acid level

Type：

Primary indicator

测量时间点：

治疗前、治疗4周后、治疗完成后6个月

测量方法：

采血化验

Measure time point of outcome：

Before treatment, after 4 weeks of treatment, and 6 months after completion of treatment

Measure method：

Blood sampling test

指标中文名：

体重指数

指标类型：

次要指标

Outcome：

Body Mass Index

Type：

Secondary indicator

测量时间点：

治疗前、治疗4周后、治疗完成后6个月

测量方法：

测量身高体重

Measure time point of outcome：

Before treatment, after 4 weeks of treatment, and 6 months after completion of treatment

Measure method：

Measuring height and weight

指标中文名：

中医证候症状评分

指标类型：

次要指标

Outcome：

Scoring of symptoms and syndromes in Traditional Chinese Medicine

Type：

Secondary indicator

测量时间点：

治疗前、治疗4周后、治疗完成后6个月

测量方法：

“脾虚浊阻证”症状分级量化表评分

Measure time point of outcome：

Before treatment, after 4 weeks of treatment, and 6 months after completion of treatment

Measure method：

Scoring of the Graded Quantification Table for Symptoms of Spleen Deficiency and Turbid Obstruction Syndrome

指标中文名：

肌酐

指标类型：

副作用指标

Outcome：

Creatinine

Type：

Adverse events

测量时间点：

治疗前、治疗4周后、治疗完成后6个月

测量方法：

采血化验

Measure time point of outcome：

Before treatment, after 4 weeks of treatment, and 6 months after completion of treatment

Measure method：

Blood sampling test

指标中文名：

尿素氮

指标类型：

副作用指标

Outcome：

Blood urea nitrogen

Type：

Adverse events

测量时间点：

治疗前、治疗4周后、治疗完成后6个月

测量方法：

采血化验

Measure time point of outcome：

Before treatment, after 4 weeks of treatment, and 6 months after completion of treatment

Measure method：

Blood sampling test

指标中文名：

谷丙转氨酶

指标类型：

副作用指标

Outcome：

Alanine Aminotransferase

Type：

Adverse events

测量时间点：

治疗前、治疗4周后、治疗完成后6个月

测量方法：

采血化验

Measure time point of outcome：

Before treatment, after 4 weeks of treatment, and 6 months after completion of treatment

Measure method：

Blood sampling test

指标中文名：

谷草转氨酶

指标类型：

副作用指标

Outcome：

Aspartate Aminotransferase

Type：

Adverse events

测量时间点：

治疗前、治疗4周后、治疗完成后6个月

测量方法：

采血化验

Measure time point of outcome：

Before treatment, after 4 weeks of treatment, and 6 months after completion of treatment

Measure method：

Blood sampling test

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：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 65 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）：

使用R软件，以中心为区组，完成中央区组随机化方案，产生随机号与组别。

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

In R software, using centers as blocks, complete a central block randomization scheme to generate random numbers and group assignments.

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：

对参与研究的医师、随访人员、数据录入管理者、统计分析者、入组患者实施盲法。中药颗粒安慰剂以试验组原药药量的5%+95%糊精制成，在外观上与实验组中药颗粒完全一样，因含有少量原药，故在气味、味道方面也基本类似。患者仅知道接受口服颗粒剂治疗，不知晓具体药物成分。临床收集病例入组的医生不知道随机分组方案，只知道入选病例的总顺序号。

Blinding：

Blind methods are implemented for physicians, follow-up personnel, data entry administrators, statistical analysts, and enrolled patients participating in the study. The placebo of traditional Chinese medicine granules is made of 5% of the original drug dosage of the experimental group and 95% of dextrin, which is identical in appearance to the traditional Chinese medicine granules of the experimental group. Due to containing a small amount of the original drug, it is also basically similar in odor and taste. Patients only know that they are receiving oral granule treatment and are unaware of the specific drug composition. The doctors who clinically collect cases for enrollment do not know the random grouping scheme, but only know the overall order number of the selected cases.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

使用ResMan管理临床试验，并共享试验数据,http://www.medresman.org.cn/uc/project/projectlistauthor.aspx，日期：2026年12月

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

Use ResMan to manage clinical trials and share trial data, www.medresman.org.cn, which is expected to be published after December 2026.

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：

数据采集：1）CRF表由专人看管发放， 填写前行严格的培训， 并按照说明进行填写。 2）及时记录的数据能反映受试者即时的病情，避免补记时由于回忆不准确所造成的误差。3）将受试者在试验中的有关资料正确无误地写入病例报告表中。记录者应在病例报告表上签名, 病例报告表是临床试验中临床资料的记录方式, 它是原始资料,不能更改。如果确实填错, 需要更正时,不得改变原始记录,要保持原始记录清晰可见,再采用附加叙述,并说明理由,由作出更改的研究者签名, 注明日期。不允许用刀刮去或用改正液涂去原始记录。数据管理：1）录入前准备：在数据录入前，检查病例是否完整，有无缺失页。检查病例观察表是否填写完整、填写内容项目是否有误、前后逻辑是否一致；2）数据录入：实行双人双录入，确保数据的准确性； 3）数据预处理：对缺失值、逻辑错误数据等进行核查，根据检查结果再次翻阅原始病例。4）完整：临床医师或资料收集者在收集资料或填写观察表时需经过一定的培训，按临床观察表格的要求填写全部数据，完整收集研究数据，并保持人员的相对恒定。5）真实：临床试验中各种数据均应记录在病例报告表中, 如果能将检验结果的原始报告粘贴在病例报告表中则更好。对于显著偏离正常值范围的检验指标应该加以核实, 最好能复查, 最后由研究者作必要的说明。复制病例报告表副本时不能对原始记录作任何改动。使用ResMan管理临床试验，并共享试验数据。

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

data acquisition:1) the training form shall be filled in and kept by a specially assigned person in strict accordance with the instructions of CRF. 2) The timely recorded data can reflect the real-time condition of the subjects and avoid the error caused by inaccurate recall during supplementary recording. 3) Write the relevant data of the subjects in the trial into the case report form correctly. The recorder shall sign on the case report form. The case report form is the recording method of clinical data in clinical trials. It is the original data and cannot be changed. If the filling is wrong and needs to be corrected, the original record shall not be changed. The original record shall be kept clear and visible, and then an additional description shall be adopted with reasons, which shall be signed and dated by the researcher who made the change. It is not allowed to scrape off the original records with a knife or obliterate them with correction fluid. Data management: 1) preparation before data entry: before data entry, check whether the cases are complete and whether there are missing pages. Check whether the case observation form is filled in completely, whether the contents and items are wrong, and whether the logic is consistent; 2) Data entry: double entry is implemented to ensure the accuracy of data; 3) Data preprocessing: check the missing value and logic error data, and read the original case again according to the inspection results. 4) Integrity: clinicians or data collectors need to receive certain training when collecting data or filling in observation forms, fill in all data according to the requirements of clinical observation forms, collect research data completely, and keep the relative stability of personnel. 5) Authenticity: all kinds of data in clinical trials should be recorded in the case report form. It would be better if the original report of test results could be pasted in the case report form. The test indicators that significantly deviate from the normal value range should be verified, preferably rechecked, and finally the researcher should make necessary explanations. When copying the copy of the case report form, no changes shall be made to the original records.Use ResMan to manage clinical trials and share trial data.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2024-07-15 11:38:37