ChiCTR2300068634 版本V1.0 版本创建时间2023/02/26 17:48:33 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：

 ChiCTR2300068634 

最近更新日期：

Date of Last Refreshed on：

 2023-02-26 17:48:09 

注册时间：

Date of Registration：

 2023-02-26 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

口服难吸收药物SY-009 治疗2型糖尿病的代谢调控机制研究

Public title：

Study on the metabolic regulation mechanism of SY-009 in the treatment of type 2 diabetes mellitus

注册题目简写：

English Acronym：

研究课题的正式科学名称：

口服难吸收药物SY-009 治疗2型糖尿病的代谢调控机制研究

Scientific title：

Study on the metabolic regulation mechanism of SY-009 in the treatment of type 2 diabetes mellitus

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：

孙润彬 

研究负责人：

李娟 

Applicant：

Sun Runbin 

Study leader：

Li Juan 

申请注册联系人电话：

Applicant telephone：

 15850686260

研究负责人电话：

Study leader's
telephone：

15951989771

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：

 runbinsun@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 juanli2003@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：

江苏省南京市浦口区浦珠中路359号南京鼓楼医院江北国际医院

研究负责人通讯地址：

江苏省南京市浦口区浦珠中路359号南京鼓楼医院江北国际医院

Applicant address：

Jiangbei International Hospital, Nanjing Drum Tower Hospital, 359 Middle Puzhu Road, Pukou District, Nanjing City, Jiangsu Province

Study leader's address：

Jiangbei International Hospital, Nanjing Drum Tower Hospital, 359 Middle Puzhu Road, Pukou District, Nanjing City, Jiangsu Province

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：

南京鼓楼医院Ⅰ期临床试验室

Applicant's institution：

Phase I Clinical Trial Room, Nanjing Drum Tower Hospital

研究负责人所在单位：

南京鼓楼医院

Affiliation of the Leader：

Nanjing Drum Tower Hospital

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：

 2022-187-02

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：

南京大学医学院附属鼓楼医院医学伦理委员会

Name of the ethic committee：

the ethics committee of Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-06-30 00:00:00

伦理委员会联系人：

姜梅玲

Contact Name of the ethic committee：

Jiang meiling

伦理委员会联系地址：

江苏省南京市中山路321号鼓楼医院伦理委员会

Contact Address of the ethic committee：

Department of Medical Ethics Committee, Drum Tower Hospital, 321 Zhongshan Road, Nanjing, Jiangsu

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 25 68182923

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：

南京鼓楼医院

Primary sponsor：

Nanjing Drum Tower Hospital

研究实施负责（组长）单位地址：

江苏省南京市鼓楼区中山路321号

Primary sponsor's address：

No. 321, Zhongshan Road, Gulou District, Nanjing, Jiangsu Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

江苏

市(区县)：

浦口

Country：

China

Province：

Jiangsu

City：

Pukou

单位(医院)：

南京鼓楼医院

具体地址：

江苏省南京市鼓楼区中山路321号

Institution
hospital：

Nanjing Drum Tower Hospital

Address：

321 Zhongshan Road, Gulou District, Nanjing, Jiangsu

经费或物资来源：

南京鼓楼医院临床研究专项资金项目

Source(s) of funding：

fundings for Clinical Trials from the Affiliated Drum Tower Hospital, Medical School of Nanjing University

研究疾病：

2型糖尿病  

Target disease：

Type 2 diabetes

研究疾病代码：

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：

不同剂量对照 

Study design：

Dose comparison 

研究目的：

(1).主要目的：在2型糖尿病患者中评价SY-009对血浆代谢组的影响并探究其代谢调控机制。 (2).次要目的：在2型糖尿病患者中研究SY-009的药代动力学。  

Objectives of Study：

(1). Main Objective: To evaluate the effect of SY-009 on plasma metabolome in patients with type 2 diabetes mellitus and explore its metabolic regulation mechanism. (2). Secondary objective: To study the pharmacokinetics of SY-009 in patients with type 2 diabetes mellitus.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. 试者在首次筛选时年龄≥18周岁，≤65周岁，性别不限;
2. 受试者在首次筛选和基线期时男性体重≥50kg，女性体重≥45kg，且体重指数（BMI)在18.0?35.0 kg/㎡之间（包含临界值）；
3. 受试者在首次筛选时，已根据1999年WHO诊断标准和分类确诊为2型糖尿病至少3个月；
4. 受试者在首次筛选前的3个月内一直接受饮食控制和运动治疗，且在此期间未接受过糖尿病系统性治疗（近3个月内累计使用降糖药物不超过2周且近1个月内未使用过降糖药）；
5. 受试者在首次筛选时，糖化血红蛋白（HbAlc)在7.0%?9.5%之间（包含临界值）；
6. 受试者在基线期时，空腹血糖在7.0~13.3mmol/L之间（包含临界值）；
7. 受试者研究期间及研究结束后60天内无生育或捐献精子/卵子计划且自愿采取有效物理避孕措施；
8. 试验前己经详细了解试验性质、意义、可能的获益，可能带来的不便和潜在的风险与不适，并自愿参加本项临床试验，能与研究者良好沟通，遵从整个研究的要求，且签署了书面知情同意书。

Inclusion criteria

1. The age of the subjects at the time of the first screening is ≥18 years old, ≤65 years old, gender is not limited;
2. At the time of initial screening and baseline, the subjects weighed at least 50kg for males and 45kg for females, with a body mass index (BMI) ranging from 18.0 to 35.0 kg/㎡ (including the cut-off value);
3. At the time of initial screening, subjects had been diagnosed with type 2 diabetes for at least 3 months according to the 1999 WHO diagnostic criteria and classification;
4. The subjects had been receiving diet control and exercise therapy in the 3 months before the first screening, and had not received systematic treatment for diabetes during this period (the cumulative use of hypoglycemic drugs in the last 3 months was no more than 2 weeks and no use of hypoglycemic drugs in the last 1 month);
5. At the time of initial screening, the subjects' HbAlc was between 7.0% and 9.5% (including the cut-off value);
6. The fasting blood glucose of the subjects in the baseline period was between 7.0 and 13.3mmol/L (including the critical value);
7. During the study period and within 60 days after the end of the study, the subject has no plans to have children or donate sperm/egg and voluntarily takes effective physical contraception;
8. Before the trial, I have had a detailed understanding of the nature, significance, possible benefits, possible inconveniences and potential risks and discomfort of the trial, volunteered to participate in this clinical trial, was able to communicate well with the researchers, complied with the requirements of the whole study, and signed a written informed consent.

排除标准：

1. 己知对试验药物（包括本试验药物辅料）或其类似物过敏者，或为过敏体质（如对两种或两种以上药物、食物和花粉过敏者），或既往1年内服用过SGLT1或SGLT2抑制剂；
2. 诊断为1型糖尿病，或妊娠性糖尿病，或其他特殊类型糖尿病；
3. 有足够的证据显示存在活动性糖尿病増殖性视网膜病变；
4. 重度低血糖发作病史（如低血糖引起的意识障碍、昏迷等），或严重的无意识性低血糖病史；
5. 器官移植史，或患有其它获得性、先天性免疫系统疾病，或有临床意义的周围血管疾病；
6. 有显著高血糖症状，比如多尿、烦渴，意外的体重减轻或脱水者；
7. 有习惯性腹泻、肠易激综合征、有临床显著的胃排空异常（如胃出口梗阻）、 严重慢性胃肠道疾病（如6个月内发生过活动性溃疡）、长期服用对胃肠 蠕动有直接影响的药物，或接受过胃肠道手术；
8. 有明显血液系统疾病（如再生障碍性贫血、骨髓増生异常综合征），或任何引起溶血或红细胞不稳定的疾病（如疟疾），或伴有可能影响HbA1c水平测定的血红蛋白病（如镰刀型红血球疾病）；
9. 有明显的自主神经病变，如尿潴留、体位性低血压、糖尿病腹泻或胃瘫；心力衰竭（NYHA 分级和W级，附件2)病史，或筛选前6个月内存在急性心肌梗塞或不稳定型心绞痛病史；或筛选前6个月内有冠脉血管成形术、冠脉支架植入术或冠脉旁路手术史或近期有心脏手术计划；
10. 心力衰竭（NYHA分级和W级，附件2)病史，或筛选前6个月内存在急性心肌梗塞或不稳定型心绞痛病史；或筛选前6个月内有冠脉血管成形术、冠脉支架植入术或冠脉旁路手术史或近期有心脏手术计划；
11. 筛选前1个月内发生过可能影响血糖控制的严重外伤、严重感染或手术；
12. 筛选前2个月内使用过具有控制体重作用的药物或进行了可导致体重不稳定的手术，或目前正处在减肥计划中且不在维持阶段；
13. 筛选前3个月内完成或退出一项干预性临床试验，或现在正在进行干预性临床试验，或参加了其他医学研究活动，经研究者判断不适合参加本研究；
14. 筛选前3个月内经常饮酒（每周酒精摄取量大于21个单位（男性）和14单位/周（女性）（1单位=360ml啤酒；或150ml
葡萄酒；或45ml白酒），或在试验期间不能戒酒者；
15. 筛选前3个月内嗜烟（每日超过10支香烟或等量烟草）或试验期间不能戒烟（停止尼古丁摄入）者；
16. 筛选前3个月内失血/献血超过400mL(女性生理性失血除外）、接受输血或使用血制品者，或计划在试验期间或试验结束后1个月（30天）内献血者；
17. 筛选前6个月内治疗剂量未稳定的甲状腺功能异常者（如硫脲类、甲状腺激素类药物）；伴有控制较差的甲状腺功能减退或有甲状腺功能减退病史；
18. 筛选前6个月内有糖尿病急性代谢并发症病史（糖尿病酮症酸中毒、高渗性非酮症性昏迷、糖尿病乳酸性酸中毒）；
19. 筛选期在未安装心脏起搏器的情况下，12导联心电图出现II 度或III度的房室传导阻滞或QTcB间期延长>500ms者；
20. 筛选期临床实验室检查结果符合以下任何一项标准者：
血红蛋白（HGB)<正常值下限（LLN);
天冬氨酸转氨酶(AST)或丙氨酸转氨酶(ALT)>2 倍正常值上限(ULN);
总胆红素（TBil)>1.5 倍正常值上限（符合下述要求的己知吉尔伯特综合征除外，即部分胆红素表明结合胆红素<35%
总胆红素）；
甘油三脂（TG)≥5.7 mmol/L;
eGFR<60 mL/min/1.73 m2 (MDRD 公式）；
空腹C肽<1.0 ng/mL (333 pmol/L);
乙型肝炎表面抗原、丙型肝炎病毒抗体、梅毒螺旋体抗体或人类免疫缺陷病毒抗体检查初筛呈阳性者；
便潜血阳性者；
21. 血压控制不佳(收缩压(SBP)≥160mmHg 和/或舒张压(DBP)≥100mmHg)者；
22. 有晕针史、晕血史或不能耐受静脉穿刺者；
23. 有药物滥用史或药物滥用筛查呈阳性者；
24. 有明显的精神障碍、癫痫患者及其他无行为能力或认知能力者；
25. 处于妊娠、哺乳期，或有妊娠意向，或妊娠试验（测血或尿HCG)阳性的 女性受试者；以及在试验期间不能采取有效避孕措施（有效避孕措施包括 实行禁欲、绝育、宫内节育器、或当地法律规定的隔膜法）的育龄期女性受试者；
26. 受试者可能因其他原因不能完成研究或研究者认为不应纳入者。

Exclusion criteria：

1. Those who are known to be allergic to the test drug (including the excipients of the test drug) or its analogues, or have an allergic constitution (such as those who are allergic to two or more drugs, food and pollen), or have taken SGLT1 within 1 year in the past or SGLT2 inhibitors;
2. Diagnosed with type 1 diabetes, or gestational diabetes, or other special types of diabetes;
3. There is sufficient evidence to show that there is active diabetic proliferative retinopathy;
4. History of severe hypoglycemia (such as disturbance of consciousness caused by hypoglycemia, coma, etc.), or history of severe unconscious hypoglycemia;
5. History of organ transplantation, or suffering from other acquired or congenital immune system diseases, or clinically significant peripheral vascular diseases;
6. People with significant hyperglycemia symptoms, such as polyuria, polydipsia, unexpected weight loss or dehydration;
7. Habitual diarrhea, irritable bowel syndrome, clinically significant gastric emptying abnormalities (such as gastric outlet obstruction), severe chronic gastrointestinal diseases (such as active ulcers within 6 months), and long-term administration Drugs that directly affect gastrointestinal motility, or have undergone gastrointestinal surgery;
8. Have obvious blood system diseases (such as aplastic anemia, myelodysplastic syndrome), or any disease that causes hemolysis or red blood cell instability (such as malaria), or accompanied by hemoglobinopathies that may affect the determination of HbA1c levels (such as sickle disease) red blood cell disease);
9. With obvious autonomic neuropathy, such as urinary retention, orthostatic hypotension, diabetic diarrhea or gastroparesis; history of heart failure (NYHA classification and W class, Annex 2), or acute myocardial infarction or acute myocardial infarction within 6 months before screening A history of unstable angina; or a history of coronary angioplasty, coronary stent implantation, or coronary artery bypass surgery within 6 months before screening, or a recent cardiac surgery plan;
10. History of heart failure (NYHA class and W class, Annex 2), or history of acute myocardial infarction or unstable angina within 6 months before screening; or coronary angioplasty, coronary artery disease within 6 months before screening History of stent implantation or coronary artery bypass surgery or recent cardiac surgery plan;
11. Severe trauma, serious infection or surgery that may affect blood sugar control occurred within 1 month before screening;
12. Have used drugs with weight control effect or undergone surgery that can cause weight instability within 2 months before screening, or are currently in a weight loss plan and are not in the maintenance phase;
13. Completed or withdrawn from an interventional clinical trial within 3 months before screening, or is currently undergoing an interventional clinical trial, or participated in other medical research activities, and was judged by the investigator to be inappropriate to participate in this study;
14. Regular drinking within 3 months before screening (weekly alcohol intake greater than 21 units (male) and 14 units/week (female) (1 unit = 360ml beer; or 150ml
Wine; or 45ml liquor), or those who cannot abstain from alcohol during the test;
15. Smokers (more than 10 cigarettes or equivalent amount of tobacco per day) within 3 months before screening or unable to quit smoking (stop nicotine intake) during the test;
16. Those who lost blood/donated more than 400mL within 3 months before screening (except for female physiological blood loss), received blood transfusion or used blood products, or planned to donate blood during the test period or within 1 month (30 days) after the end of the test;
17. Patients with abnormal thyroid function (such as thiourea, thyroid hormone drugs) whose treatment dose was not stable within 6 months before screening; accompanied by poorly controlled hypothyroidism or a history of hypothyroidism;
18. Have a history of acute metabolic complications of diabetes (diabetic ketoacidosis, hyperosmolar nonketotic coma, diabetic lactic acidosis) within 6 months before screening;
19. During the screening period, in the absence of a cardiac pacemaker, 12-lead electrocardiogram showed second-degree or third-degree atrioventricular block or QTcB interval prolongation > 500ms;
20. The results of clinical laboratory tests during the screening period meet any of the following criteria:
Hemoglobin (HGB) < lower limit of normal (LLN);
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 times the upper limit of normal (ULN);
Total bilirubin (TBil) >1.5 times the upper limit of normal (except in known Gilbert syndrome who meet the requirement that fractional bilirubin demonstrates conjugated bilirubin <35% total bilirubin);
Triglyceride (TG) ≥ 5.7 mmol/L;
eGFR<60 mL/min/1.73 m2 (MDRD formula);
Fasting C-peptide<1.0 ng/mL (333 pmol/L);
Hepatitis B surface antigen, hepatitis C virus antibody, Treponema pallidum antibody or human
immunodeficiency virus antibody test positive;
Positive fecal occult blood;
21. Those with poor blood pressure control (systolic blood pressure (SBP) ≥ 160mmHg and/or diastolic blood pressure (DBP) ≥ 100mmHg);
22. Those who have a history of needle fainting, blood fainting or cannot tolerate venipuncture;
23. Those who have a history of drug abuse or who are positive for drug abuse screening;
24. People with obvious mental disorders, epilepsy and other incapacity or cognitive abilities;
25. Female subjects who are pregnant, breast-feeding, or have pregnancy intention, or have a positive pregnancy test (blood or urine HCG); and cannot take effective contraceptive measures during the test (effective contraceptive measures include abstinence, sterilization, uterine Female subjects of childbearing age who have internal contraceptive devices, or the diaphragm law stipulated by local laws);
26. The subjects may not be able to complete the research due to other reasons or the researchers believe that they should not be included.

研究实施时间：

Study execute time：

从 From 2022-09-01 00:00:00至 To 2025-08-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-03-01 00:00:00 至 To 2025-08-31 00:00:00

干预措施：

Interventions：

组别：

1mg日剂量组

样本量：

 10

Group：

1mg daily dose group

Sample size：

干预措施：

日剂量为0.5mgBID,组内纳入10人，按4:1随机分配接受SY-009胶囊或安慰剂,餐前即刻口服。

干预措施代码：

Intervention：

The daily dose was 0.5mg BID, and 10 people were randomly assigned to receive SY-009 capsule or placebo at 4:1, which was taken orally immediately before meals.

Intervention code：

组别：

1mg日剂量组

样本量：

 10

Group：

1mg daily dose group

Sample size：

干预措施：

日剂量为1mgQD,组内纳入10人，按4:1随机分配接受SY-009胶囊或安慰剂,餐前即刻口服。

干预措施代码：

Intervention：

The daily dose was 1mg QD, and 10 people were randomly assigned to receive SY-009 capsule or placebo at 4:1, which was taken orally immediately before meals.

Intervention code：

组别：

2mg日剂量组

样本量：

 10

Group：

2mg daily dose group

Sample size：

干预措施：

日剂量为1mgBID,组内纳入10人，按4:1随机分配接受SY-009胶囊或安慰剂,餐前即刻口服。

干预措施代码：

Intervention：

The daily dose was 1mg BID, and 10 people were randomly assigned to receive SY-009 capsule or placebo at 4:1, which was taken orally immediately before meals.

Intervention code：

组别：

2mg日剂量组

样本量：

 10

Group：

2mg daily dose group

Sample size：

干预措施：

日剂量为2mgQD,组内纳入10人，按4:1随机分配接受SY-009胶囊或安慰剂,餐前即刻口服。

干预措施代码：

Intervention：

The daily dose was 2mg QD, and 10 people were randomly assigned to receive SY-009 capsule or placebo at 4:1, which was taken orally immediately before meals.

Intervention code：

组别：

4mg日剂量组

样本量：

 10

Group：

4mg daily dose group

Sample size：

干预措施：

日剂量为2mgBID,组内纳入10人，按4:1随机分配接受SY-009胶囊或安慰剂,餐前即刻口服。

干预措施代码：

Intervention：

The daily dose was 2mg BID, and 10 people were randomly assigned to receive SY-009 capsule or placebo at 4:1, which was taken orally immediately before meals.

Intervention code：

组别：

3mg日剂量组

样本量：

 10

Group：

3mg daily dose group

Sample size：

干预措施：

日剂量为1.5mgBID,组内纳入10人，按4:1随机分配接受SY-009胶囊或安慰剂,餐前即刻口服。(如在4mg日剂量组试验过程中或完成试验后的安全性评估达到了方案规定的剂量终止标准，则开展3mg日剂量组的研究。）

干预措施代码：

Intervention：

The daily dose was 1.5mg BID, and 10 people were randomly assigned to receive SY-009 capsule or placebo at 4:1, which was taken orally immediately before meals.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 江苏 

市(区县)：

 浦口 

Country：

China

Province：

Jiangsu

City：

Pukou

单位(医院)：

 南京鼓楼医院 

单位级别：

 三甲 

Institution
hospital：

Nanjing Drum Tower Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

最大餐后（早、午、晚餐）血糖较餐前増加值

指标类型：

主要指标

Outcome：

Maximum postprandial (breakfast, lunch, dinner) blood glucose increases compared with preprandial blood glucose

Type：

Primary indicator

测量时间点：

第1天、第7天与第-1 天

测量方法：

Measure time point of outcome：

Day 1, day 7, and day -1

Measure method：

指标中文名：

血糖AUC实测值和差值

指标类型：

主要指标

Outcome：

Measured and differential blood glucose AUC

Type：

Primary indicator

测量时间点：

第7天与第-1天(包括0-4h、4-10h、10-14h、0-24h等）

测量方法：

Measure time point of outcome：

Day 7 and Day 1 (including 0-4h, 4-10h, 10-14h, 0-24h, etc.)

Measure method：

指标中文名：

空腹血糖实测值和差值

指标类型：

主要指标

Outcome：

Measured and differential values of fasting blood glucose

Type：

Primary indicator

测量时间点：

第7天与第-1天

测量方法：

Measure time point of outcome：

Day 7 and day -1

Measure method：

指标中文名：

C肽实测值和变化值

指标类型：

主要指标

Outcome：

Measured and variable values of C peptide

Type：

Primary indicator

测量时间点：

第1天、第7天与第-1天

测量方法：

Measure time point of outcome：

Day 1, day 7, and day -1

Measure method：

指标中文名：

胰岛素实测值和变化值

指标类型：

主要指标

Outcome：

Measured and variable values of insulin

Type：

Primary indicator

测量时间点：

第1天、第7天与第-1天

测量方法：

Measure time point of outcome：

Day 1, day 7, and day -1

Measure method：

指标中文名：

GLP-1实测值和变化值

指标类型：

主要指标

Outcome：

Measured and variable values of GLP-1

Type：

Primary indicator

测量时间点：

第1天、第7天与第-1天

测量方法：

Measure time point of outcome：

Day 1, day 7, and day -1

Measure method：

指标中文名：

GIP实测值和变化值

指标类型：

主要指标

Outcome：

Measured and variable values of GIP

Type：

Primary indicator

测量时间点：

第1天、第7天与第-1天

测量方法：

Measure time point of outcome：

Day 1, day 7, and day -1

Measure method：

指标中文名：

胰岛功能指数

指标类型：

主要指标

Outcome：

Islet function index

Type：

Primary indicator

测量时间点：

第1天、第7天与第-1天

测量方法：

Measure time point of outcome：

Day 1, day 7, and day -1

Measure method：

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

 使用后保存  

说明

Fate of sample：

Preservation 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）：

以SAS软件（9.4或以上版本） 产生随机号以及随机号所对应治疗组别，采用临床试验中央随机系统（DAS for IWRS) 分配随机号。

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

Use SAS software (version 9.4 or above) to generate random numbers and the treatment groups corresponding to the random numbers, and use the Central Random System for Clinical Trials (DAS for IWRS) to assign random numbers.

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）：

Calculated Results after
the Study Completed(upload file)：

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）：

试验完成后6个月内在中国临床试验注册中心公开（www.chictr.org.cn）

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

Opened at the China Clinical Trial Registration Center within 6 months after the completion of the trial (www.chictr.org.cn)

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：

采用R语言(version>=3.6.3)进行数据统计

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

Using R project (version>=3.6.3) for data statistics

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-02-26 17:48:09