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Clinical study of mixed linear effect model of inorganic nitrate based on oral health and its antihypertensive effect by individualized intervention

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注册号：

Registration number：

ChiCTR2500110366 

最近更新日期：

Date of Last Refreshed on：

2025-10-13 10:52:26 

注册时间：

Date of Registration：

2025-10-13 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于口腔健康的无机硝酸盐混合线性效应模型及硝酸盐个性化干预降压疗效的临床研究

Public title：

Clinical study of mixed linear effect model of inorganic nitrate based on oral health and its antihypertensive effect by individualized intervention

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于口腔健康的无机硝酸盐混合线性效应模型及硝酸盐个性化干预降压疗效的临床研究

Scientific title：

Clinical study of mixed linear effect model of inorganic nitrate based on oral health and its antihypertensive effect by individualized intervention

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：

魏会珊 

研究负责人：

秦力铮 

Applicant：

Wei Huishan 

Study leader：

Qin Lizheng 

申请注册联系人电话：

Applicant telephone：

+86 10 57099157

研究负责人电话：

Study leader's telephone：

+86 10 57099157

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：

weihuishan@mail.ccmu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

qinlizheng@aliyun.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：

北京市丰台区樊家村路9号院

研究负责人通讯地址：

北京市丰台区樊家村路9号院

Applicant address：

No. 9, Fanjiacun Road, Fengtai District, Beijing

Study leader's address：

No. 9, Fanjiacun Road, Fengtai 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：

首都医科大学附属北京口腔医院

Applicant's institution：

Beijing Stomatological Hospital, Capital Medical University

研究负责人所在单位：

首都医科大学附属北京口腔医院

Affiliation of the Leader：

Beijing Stomatological Hospital, Capital Medical University

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：

CMUSH-IRB-KJ-PJ-2025-48

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：

首都医科大学附属北京口腔医院伦理委员会

Name of the ethic committee：

Institutional Review Board of Beijing Stomatological Hospital, Capital Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2025-08-18 00:00:00

伦理委员会联系人：

夏晓钰

Contact Name of the ethic committee：

Xia Xiaoyu

伦理委员会联系地址：

北京市丰台区樊家村路9号院

Contact Address of the ethic committee：

No. 9, Fanjiacun Road, Fengtai District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 10 57099307

伦理委员会联系人邮箱：

Contact email of the ethic committee：

18602615270@163.com

研究实施负责（组长）单位：

首都医科大学附属北京口腔医院

Primary sponsor：

Beijing Stomatological Hospital , Capital Medical University

研究实施负责（组长）单位地址：

北京市丰台区樊家村路9号院

Primary sponsor's address：

No. 9, Fanjiacun Road, Fengtai 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

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

首都医科大学附属北京口腔医院

具体地址：

北京市丰台区樊家村路9号院

Institution
hospital：

Beijing Stomatological Hospital , Capital Medical University

Address：

No. 9, Fanjiacun Road, Fengtai District, Beijing

经费或物资来源：

首都卫生发展科研专项

Source(s) of funding：

Capital's Funds for Health Improvement and Research

Target disease：

Borderline hypertension

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

1.探究口腔健康指标如何影响无机硝酸盐的降压效果。通过测量受试者口腔健康指标及对硝酸盐干预后的降压效果，对唾液腺功能及口腔硝酸盐还原能力在硝酸盐降压效果中的作用进行量化，建立基于口腔健康指标与无机硝酸盐降压作用的混合线性效应模型，为根据口腔健康状况的硝酸盐降压作用的个性化给药奠定基础。 2.在第一部分中得到的混合线性效应模型的基础上，在临界高血压人群中开展随机对照研究，比较基于口腔健康状况的个性化硝酸盐干预的降压效果是否优于传统的硝酸盐干预，制定针对临界高血压人群的个性化硝酸盐干预的应用标准，为临界高血压的饮食干预提供新的方法，促进无机硝酸盐生理功能的临床转化。  

Objectives of Study：

1.To explore how oral health indicators affect the BP lowering effect of inorganic nitrate. To quantify the role of salivary gland function and oral nitrate reducing capacity in the hypotensive effect of nitrate, a mixed linear effect model was established based on oral health indicators and the hypotensive effect of inorganic nitrate, which laid the foundation for personalized medication of nitrate according to oral health status. 2. On the basis of the mixed linear effect model obtained in Part 1, a randomized controlled trial was conducted in borderline hypertension population to compare the antihypertensive effect of personalized nitrate intervention based on oral health status compared with traditional nitrate intervention, and to formulate the application standard of personalized nitrate intervention for borderline hypertension population. To provide a new method for dietary intervention of borderline hypertension and promote the clinical transformation of physiological function of inorganic nitrate.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

实验一： 1.健康人群，否认既往疾病病史； 2.年龄20~65岁，BMI 20~25 kg/m^2，性别不限； 3.静息血压值SBP <140 mmHg且DBP < 90mmHg； 4.无治疗高血压药物服用史； 5.受试者可遵照计划进行随访。 实验二： 1.健康人群，否认既往疾病病史； 2.年龄20~65岁，BMI 20~25 kg/m^2，性别不限； 3.静息血压值SBP：130~139 mmHg且DBP<=89或DBP：85~89 mmHg且SBP<=139； 4.无治疗高血压药物服用史； 5.受试者可遵照计划进行随访。

Inclusion criteria

Experiment One 1.Healthy individuals who deny a history of previous diseases; 2. Age: 20 to 65 years old, BMI: 20 to 25 kg/m^2, gender not limited; 3. Resting blood pressure values: SBP <140 mmHg and DBP < 90mmHg; 4. No history of taking drugs for treating hypertension; 5. The subjects can follow the plan for follow-up. Experiment Two 1.Healthy individuals who deny a history of previous diseases; 2. Age: 20 to 65 years old, BMI: 20 to 25 kg/m^2, gender not limited; 3. Resting blood pressure value SBP: 130-139 mmHg with DBP<=89 or DBP: 85-89 mmHg with SBP<=139; 4. No history of taking drugs for treating hypertension; 5. The subjects can follow the plan for follow-up.

排除标准：

实验一： 1.长期食用富含硝酸盐或亚硝酸盐食物； 2.长期使用抗菌漱口水； 3.妊娠期或哺乳期妇女； 4.长期吸烟或饮酒； 5.正在参加其他临床试验； 6.精神障碍或智力障碍者； 实验二： 1.妊娠期或哺乳期妇女； 2.长期吸烟或饮酒； 3.饮食习惯以高硝酸盐饮食为主； 4.长期使用抗菌漱口水； 5.精神障碍或智力障碍者； 6.正在参加其他临床试验；

Exclusion criteria：

Experiment One 1. Long-term consumption of foods rich in nitrates or nitrites; 2. Long-term use of antibacterial mouthwash; 3. Pregnant or lactating women; 4. Long-term smoking or drinking; 5. Currently participating in other clinical trials; 6. People with mental or intellectual disabilities; Experiment Two 1.Pregnant or lactating women; 2. Long-term smoking or drinking; 3. The dietary habit mainly consists of a high-nitrate diet; 4. Long-term use of antibacterial mouthwash; 5. People with mental or intellectual disabilities; 6. Currently participating in other clinical trials;

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 2025-10-20 00:00:00 至 To 2026-12-31 00:00:00  

干预措施：

Interventions：

组别：

实验一：建模部分

样本量：

150

Group：

Experiment One: Modeling Section

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

组别：

实验一：验证部分

样本量：

50

Group：

Experiment One: Verification Section

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

组别：

实验二：试验组

样本量：

66

Group：

Experiment Two: Experimental Group

Sample size：

干预措施：

0.15 mmol/kg/天硝酸盐摄入

干预措施代码：

Intervention：

Nitrate intake of 0.15 mmol/kg per day

Intervention code：

组别：

实验二：对照组

样本量：

66

Group：

Experiment Two: Control Group

Sample size：

干预措施：

标准化干预

干预措施代码：

Intervention：

Standardized intervention

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 

市(区县)：

  

Country：

China 

Province：

Beijing 

City：

 

单位(医院)：

首都医科大学附属北京口腔医院 

单位级别：

三级甲等 

Institution
hospital：

Beijing Stomatological Hospital , Capital Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

实验一：血氧饱和度

指标类型：

次要指标

Outcome：

Experiment 1: Blood Oxygen Saturation

Type：

Secondary indicator

测量时间点：

在试验进行的第0天上午8点与试验第8天上午8点

测量方法：

血氧饱和度的测定拟采用承担科室现有指夹式脉搏血氧仪，为临床常规使用设备，运行稳定，持有国家二类医疗器械注册证，符合相关国家标准，符合本研究需要。测定前将由研究者向受试者演示指导设备使用方法，请受试者休息5分钟后，将手和测量仪保持在和心脏相同的水平，将测量仪夹在手指。保持不动直到测量仪显示读数，读数保持不变后，记录1分钟内最高的读数。

Measure time point of outcome：

At 8:00 a.m. on Day 0 and 8:00 a.m. on Day 8 of the trial

Measure method：

The determination of blood oxygen saturation is intended to use the existing finger-clip pulse oximeter in the responsible department. This device is a routine clinical equipment that operates stably, holds a national Class II medical device registration certificate, complies with relevant national standards, and meets the needs of this study. Before the determination, the researcher will demonstrate and guide the subjects on how to use the device.

指标中文名：

实验一：静息血压值

指标类型：

主要指标

Outcome：

Experiment 1: Resting Blood Pressure Values

Type：

Primary indicator

测量时间点：

在试验进行的第0天上午8点与试验第8天上午8点

测量方法：

静息血压值的测定拟采用承担科室现有医用全自动电子血压计（院内资产编号：2150112025001651），为临床常规使用设备，定期校准，运行稳定，持有国家二类医疗器械注册证，符合相关国家标准，符合本研究需要。测定前将由研究者向受试者演示指导设备使用方法，请受试者休息15分钟后，每2分钟测定一次静息血压，测定4次，取后3次测定平均值作为静息血压值。

Measure time point of outcome：

At 8:00 a.m. on Day 0 of the trial

Measure method：

The determination of resting blood pressure values is intended to use the existing medical fully automatic electronic sphygmomanometer in the responsible department (in-hospital asset number: 2150112025001651). This sphygmomanometer is a routine clinical equipment, which is calibrated regularly and operates stably. It holds the national Class II medical device registration certificate, complies with relevant national standards, and meets the needs of this study. Before the determination, the res

指标中文名：

实验一：血清硝酸盐水平

指标类型：

主要指标

Outcome：

Experiment 1: Serum Nitrate Level

Type：

Primary indicator

测量时间点：

在试验进行的第0天上午8点与试验第8天上午8点

测量方法：

采集空腹血液样本5ml，于不含抗凝剂的采血管中静置 30 分钟待其自然凝集后，3000 rpm离心15分钟得到血清样本，应用Griess法测定血清硝酸盐水平。

Measure time point of outcome：

At 8:00 a.m. on Day 0 and 8:00 a.m. on Day 8 of the trial

Measure method：

Five milliliters (mL) of fasting blood samples were collected. The samples were placed in blood collection tubes without anticoagulants and allowed to stand for 30 minutes to coagulate naturally. the samples were centrifuged at 3000 revolutions per minute (rpm) for 15 minutes to obtain serum samples. The serum nitrate levels were determined using the Griess method.

指标中文名：

实验一：唾液流率

指标类型：

次要指标

Outcome：

Experiment 1: Salivary Flow Rate

Type：

Secondary indicator

测量时间点：

在试验进行的第0天上午8点与试验第8天上午8点

测量方法：

分别测定静态唾液流率和动态测定流率。①静态唾液流率：使用吐取法，嘱受试者使唾液在口底聚集，然后每隔 60秒将其吐入试管，收集 10分钟，记录收集的唾液总量。②动态唾液流率：取5克医用白蜡，温水泡软后咀嚼 6 分钟，采用吐取法收集分泌的唾液，记录收集的唾液总量。根据静态和动态唾液总流率计算全天的平均唾液流率。

Measure time point of outcome：

At 8:00 a.m. on Day 0 and 8:00 a.m. on Day 8 of the trial

Measure method：

Static and dynamic salivary flow rates were determined separately. ① Static Salivary Flow Rate: The spitting method was used. Subjects were instructed to allow saliva to accumulate at the floor of the mouth, then spit it into a test tube every 60 seconds. Saliva was collected for 10 minutes, and the total volume of collected saliva was recorded. ② Dynamic Salivary Flow Rate: 5 grams of medical white wax was taken, soaked in warm water to soften it, and then chewed for 6 minutes. The secreted sal

指标中文名：

实验二：24小时动态血压

指标类型：

次要指标

Outcome：

Experiment 2: 24-Hour Ambulatory Blood Pressure

Type：

Secondary indicator

测量时间点：

在试验进行的第0天上午8点至试验第1天上午8点与第28天上午8点至试验第29天上午8点

测量方法：

使用设备拟采购家用便携式动态血压监测仪，所购设备需持有国家二类医疗器械注册证，符合相关国家标准，具备自动定时测量、数据存储与导出功能，支持全天候无创监测，符合本研究需要。设备使用前将由厂家技术人员进行校准，使用过程中定期由厂家技术人员进行校准。进行24小时动态血压监测前由研究者向受试者演示指导设备使用方法并讲解监测期间注意事项，由研究者将监测设备安装在受试者非优势臂上，位于肘前窝上方2.5厘米处。

Measure time point of outcome：

From 8:00 a.m. on Day 0 to Day 1 of the trial, and from Day 28 to Day29 of the trial.

Measure method：

The equipment to be used is a household portable ambulatory blood pressure monitor to be purchased. The purchased device must hold a national Class II medical device registration certificate, comply with relevant national standards, and be equipped with functions of automatic timed measurement, data storage and export. It shall support all-day non-invasive monitoring and meet

指标中文名：

实验二：唾液硝酸盐浓度

指标类型：

次要指标

Outcome：

Experiment 2: Salivary Nitrate Concentration

Type：

Secondary indicator

测量时间点：

在试验进行的第0，8，15，29天上午8点

测量方法：

取上述唾液流率测定中收集的唾液样本14000 rpm 离心10分钟后取上清液，经10 kd超滤管 12000 rpm 离心15分钟后获得超滤后的唾液样本，应用Griess法测定唾液硝酸盐水平。

Measure time point of outcome：

At 8:00 a.m. on Day 0，8，15，29 of the trial

Measure method：

From the saliva samples collected in the aforementioned salivary flow rate measurement, the supernatant was obtained after centrifugation at 14,000 rpm for 10 minutes. Subsequently, the supernatant was centrifuged with a 10 kD ultrafiltration tube at 12,000 rpm for 15 minutes to get ultrafiltered saliva samples. The salivary nitrate level was determined using the Griess method.

指标中文名：

实验二：静息血压值

指标类型：

主要指标

Outcome：

Experiment 2: Resting Blood Pressure Values

Type：

Primary indicator

测量时间点：

在试验进行的第0，8，15，29天上午8点

测量方法：

静息血压值的测定拟采用承担科室现有医用全自动电子血压计（院内资产编号：2150112025001651），为临床常规使用设备，定期校准，运行稳定，持有国家二类医疗器械注册证，符合相关国家标准，符合本研究需要。测定前将由研究者向受试者演示指导设备使用方法，请受试者休息15分钟后，每2分钟测定一次静息血压，测定4次，取后3次测定平均值作为静息血压值。

Measure time point of outcome：

At 8:00 a.m. on Day 0，8，15，29 of the trial

Measure method：

The determination of resting blood pressure values is intended to use the existing medical fully automatic electronic sphygmomanometer in the responsible department (in-hospital asset number: 2150112025001651). This sphygmomanometer is a routine clinical equipment, which is calibrated regularly and operates stably. It holds the national Class II medical device registration certificate, complies with relevant national standards, and meets the needs of this study. Before the determination, the res

指标中文名：

实验二：血氧饱和度

指标类型：

次要指标

Outcome：

Experiment 2: Blood Oxygen Saturation

Type：

Secondary indicator

测量时间点：

在试验进行的第0，8，15，29天上午8点

测量方法：

血氧饱和度的测定拟采用承担科室现有指夹式脉搏血氧仪，为临床常规使用设备，运行稳定，持有国家二类医疗器械注册证，符合相关国家标准，符合本研究需要。测定前将由研究者向受试者演示指导设备使用方法，请受试者休息5分钟后，将手和测量仪保持在和心脏相同的水平，将测量仪夹在手指。保持不动直到测量仪显示读数，读数保持不变后，记录1分钟内最高的读数。

Measure time point of outcome：

At 8:00 a.m. on Day 0，8，15，29 of the trial

Measure method：

The determination of blood oxygen saturation is intended to use the existing finger-clip pulse oximeter in the responsible department. This device is a routine clinical equipment that operates stably, holds a national Class II medical device registration certificate, complies with relevant national standards, and meets the needs of this study. Before the determination, the researcher will demonstrate and guide the subjects on how to use the device.

指标中文名：

实验二：口腔硝酸盐还原能力

指标类型：

次要指标

Outcome：

Experiment 2: Oral Nitrate-Reducing Capacity

Type：

Secondary indicator

测量时间点：

在试验进行的第0天上午8点

测量方法：

将0.5 cm*0.5 cm大小的滤纸片共3枚贴于受试者舌根部，3分钟后取出滤纸片，分别在含有固定水平硝酸盐的液相培养基中37℃孵育2小时；收集孵育后的培养基样本，12000 rpm 离心15分钟后取培养基上清，通过Griess法测定硝酸盐水平，经过计算得到三份样本的平均值为最终的口腔硝酸盐还原能力指标。

Measure time point of outcome：

At 8:00 a.m. on Day 0 of the trial

Measure method：

A total of 3 filter papers (each measuring 0.5 cm × 0.5 cm) were attached to the base of the subject’s tongue. After 3 minutes, the filter papers were removed and each was incubated in a liquid medium containing a fixed level of nitrate at 37°C for 2 hours. The incubated medium samples were collected and centrifuged at 12,000 rpm for 15 minutes, after which the supernatant of the medium was obtained. The nitrate level was determined using the Griess method, and the average value of the three sam

指标中文名：

实验二：唾液流率

指标类型：

次要指标

Outcome：

Experiment 2: Salivary Flow Rate

Type：

Secondary indicator

测量时间点：

在试验进行的第0天上午8点

测量方法：

分别测定静态唾液流率和动态测定流率。①静态唾液流率：使用吐取法，嘱受试者使唾液在口底聚集，然后每隔 60秒将其吐入试管，收集 10分钟，记录收集的唾液总量。②动态唾液流率：取5克医用白蜡，温水泡软后咀嚼 6 分钟，采用吐取法收集分泌的唾液，记录收集的唾液总量。根据静态和动态唾液总流率计算全天的平均唾液流率。

Measure time point of outcome：

At 8:00 a.m. on Day 0 of the trial

Measure method：

Static and dynamic salivary flow rates were determined separately. ① Static Salivary Flow Rate: The spitting method was used. Subjects were instructed to allow saliva to accumulate at the floor of the mouth, then spit it into a test tube every 60 seconds. Saliva was collected for 10 minutes, and the total volume of collected saliva was recorded. ② Dynamic Salivary Flow Rate: 5 grams of medical white wax was taken, soaked in warm water to soften it, and then chewed for 6 minutes. The secreted sal

指标中文名：

实验一：口腔硝酸盐还原能力

指标类型：

次要指标

Outcome：

Experiment 1: Oral Nitrate-Reducing Capacity

Type：

Secondary indicator

测量时间点：

在试验进行的第0天上午8点与试验第8天上午8点

测量方法：

将0.5 cm*0.5 cm大小的滤纸片共3枚贴于受试者舌根部，3分钟后取出滤纸片，分别在含有固定水平硝酸盐的液相培养基中37℃孵育2小时；收集孵育后的培养基样本，12000 rpm 离心15分钟后取培养基上清，通过Griess法测定硝酸盐水平，经过计算得到三份样本的平均值为最终的口腔硝酸盐还原能力指标。

Measure time point of outcome：

At 8:00 a.m. on Day 0 and 8:00 a.m. on Day 8 of the trial

Measure method：

A total of 3 filter papers (each measuring 0.5 cm × 0.5 cm) were attached to the base of the subject’s tongue. After 3 minutes, the filter papers were removed and each was incubated in a liquid medium containing a fixed level of nitrate at 37°C for 2 hours. The incubated medium samples were collected and centrifuged at 12,000 rpm for 15 minutes, after which the supernatant of the medium was obtained. The nitrate level was determined using the Griess method, and the average value of the three sam

指标中文名：

实验一：唾液硝酸盐水平

指标类型：

次要指标

Outcome：

Experiment 1: Salivary Nitrate Level

Type：

Secondary indicator

测量时间点：

在试验进行的第0天上午8点与试验第8天上午8点

测量方法：

取上述唾液流率测定中收集的唾液样本14000 rpm 离心10分钟后取上清液，经10 kd超滤管 12000 rpm 离心15分钟后获得超滤后的唾液样本，应用Griess法测定唾液硝酸盐水平。

Measure time point of outcome：

At 8:00 a.m. on Day 0 and 8:00 a.m. on Day 8 of the trial

Measure method：

From the saliva samples collected in the aforementioned salivary flow rate measurement, the supernatant was obtained after centrifugation at 14,000 rpm for 10 minutes. Subsequently, the supernatant was centrifuged with a 10 kD ultrafiltration tube at 12,000 rpm for 15 minutes to get ultrafiltered saliva samples. The salivary nitrate level was determined using the Griess method.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

唾液

组织：

Sample Name：

Saliva

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：

血清

组织：

Sample Name：

Serum

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 20 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）：

使用随机数字表法

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

Use the random number table method

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

双盲，对研究参与者和研究者设盲

Blinding：

Double-blind, blinding both the research participants and the researchers

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）：

无

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

None

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：

CRF

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

CRF

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-10-13 10:52:19
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