ChiCTR2600123651 版本V1.0 版本创建时间2026/04/28 16:04:12 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：

 ChiCTR2600123651 

最近更新日期：

Date of Last Refreshed on：

 2026-04-28 16:03:39 

注册时间：

Date of Registration：

 2026-04-28 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

盐酸精氨酸注射液治疗腰椎间盘退变的随机对照实验

Public title：

A Randomized Controlled Trial of Arginine Hydrochloride Injection in the Treatment of Lumbar Intervertebral Disc Degeneration

注册题目简写：

English Acronym：

研究课题的正式科学名称：

盐酸精氨酸注射液治疗腰椎间盘退变的随机对照实验

Scientific title：

A Randomized Controlled Trial of Arginine Hydrochloride Injection in the Treatment of Lumbar Intervertebral Disc Degeneration

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：

凌泽民 

研究负责人：

魏富鑫 

Applicant：

Zemin Ling 

Study leader：

Fuxin Wei 

申请注册联系人电话：

Applicant telephone：

 +86 135 4447 6775

研究负责人电话：

Study leader's
telephone：

+86 135 6017 0686

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：

 lingzm3@mail.sysu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

 weifuxin@mail.sysu.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：

广东省深圳市圳园路628号

研究负责人通讯地址：

广东省深圳市圳园路628号

Applicant address：

No.628, Zhenyuan Rd, Guangming (New) Dist., Shenzhen, China

Study leader's address：

No.628, Zhenyuan Rd, Guangming (New) Dist., Shenzhen, 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：

中山大学附属第七医院

Applicant's institution：

The Seventh Affiliated Hospital, Sun Yat-sen University

研究负责人所在单位：

中山大学附属第七医院

Affiliation of the Leader：

The Seventh Affiliated Hospital, Sun Yat-sen University

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：

 KY-2026-089-01

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：

中山大学附属第七医院医学伦理委员会

Name of the ethic committee：

Medical ethics committee of The Seventh Affiliated Hospital of Sun Yat-sen University

伦理委员会批准日期：

Date of approved by ethic committee：

 2026-03-06 00:00:00

伦理委员会联系人：

陆葵青

Contact Name of the ethic committee：

Kuiqing Lu

伦理委员会联系地址：

中国深圳市光明区圳园路628号

Contact Address of the ethic committee：

NO.628 Zhenyuan Road, Guangming District, Shenzhen, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 132 8113 0037

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：

中山大学附属第七医院

Primary sponsor：

The Seventh Affiliated Hospital of Sun Yat-sen University

研究实施负责（组长）单位地址：

中国深圳市光明区圳园路628号

Primary sponsor's address：

NO.628 Zhenyuan Road, Guangming District, Shenzhen, 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)：

广东省

市(区县)：

深圳市

Country：

China

Province：

Guangdong Province

City：

Shenzhen

单位(医院)：

中山大学附属第七医院

具体地址：

中国深圳市光明区圳园路628号

Institution
hospital：

The Seventh Affiliated Hospital of Sun Yat-sen University

Address：

NO.628 Zhenyuan Road, Guangming District, Shenzhen, China

经费或物资来源：

无

Source(s) of funding：

no

研究疾病：

腰椎间盘退变  

Target disease：

Lumbar intervertebral disc degeneration

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：

 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：

比较静脉注射精氨酸制剂与安慰剂对慢性椎间盘退变性腰痛的影像学改善情况的差异，研究精氨酸制剂对慢性椎间盘退变的疗效。比较两组干预前后疼痛缓解有效性、腰椎功能与活动度变化（Oswestry功能障碍指数）的差异，描述性分析两组T1ρ与T2 mapping值较基线变化的百分比。记录两组治疗后3个月内的不良反应发生率（如局部疼痛加重、穿刺点感染、神经损伤、出血事件）及实验室指标（血常规、肝肾功能）异常率，比较两组干预的安全性。探索椎间盘退变性腰痛患者的规范精氨酸干预方案。  

Objectives of Study：

To compare the differences in imaging improvements between intravenous arginine preparation and placebo in patients with chronic disc degenerative low back pain, and to investigate the therapeutic effect of arginine preparation on chronic intervertebral disc degeneration. Differences in pain relief efficacy, lumbar function, and range of motion (assessed by the Oswestry Disability Index) will be compared between the two groups before and after intervention. The percentage changes in T1ρ and T2 mapping values relative to baseline will be analyzed descriptively in both groups. The incidence of adverse reactions (such as aggravated local pain, puncture site infection, nerve injury, and bleeding events) and abnormal rates of laboratory parameters (blood routine, liver and renal function) within 3 months after treatment will be recorded in both groups, and the safety of the two interventions will be compared. This study aims to explore a standardized arginine intervention regimen for patients with disc degenerative low back pain.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.2026年4月-2026年12月入院的腰椎间盘退变性腰痛患者，症状持续>=3个月，过去一周疼痛视觉模拟评分(Visual Analogue Scale， VAS)>=2分且签署知情同意书； 2.年龄18至65岁。

Inclusion criteria

1. Patients with disc degenerative low back pain admitted between April 2026 and December 2026, with symptom duration >= 3 months, Visual Analogue Scale (VAS) score >= 2 in the past week, and who have signed the informed consent form. 2.Aged 18 to 65 years.

排除标准：

1.年龄小于18或大于65岁； 2.对研究用精氨酸有医疗禁忌症者； 3.存在严重肝肾功能不全、凝血功能障碍者、无尿患者、高氯性酸中毒患者； 4.近3个月内有消化道溃疡出血、颅内出血病史，或正在服用抗凝药物（如华法林、利伐沙班）； 5.合并精神疾病、恶性肿瘤或其他严重全身性疾病，无法耐受干预或随访； 6.妊娠/哺乳期女性或计划在随访期内妊娠者； 7.经医师评估后考虑用药风险应排除的其他情况。

Exclusion criteria：

1. Age under 18 or over 65 years; 2. Individuals with medical contraindications to research-use arginine; 3. Those with severe liver or kidney dysfunction, coagulation disorders, anuria, or hyperchloremic acidosis; 4. History of gastrointestinal ulcer bleeding or intracranial hemorrhage within the past 3 months, or currently taking anticoagulant medications (such as warfarin or rivaroxaban); 5. Individuals with mental illness, malignant tumors, or other severe systemic diseases who cannot tolerate interventions or follow-up; 6. Pregnant or breastfeeding women, or those planning to become pregnant during the follow-up period; 7. Other situations that, after physician assessment, are considered high-risk for medication and should be excluded.

研究实施时间：

Study execute time：

从 From 2026-04-30 00:00:00至 To 2027-05-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-05-01 00:00:00 至 To 2026-12-31 00:00:00

干预措施：

Interventions：

组别：

试验组（精氨酸组）

样本量：

 50

Group：

Experimental group (Arginine group)

Sample size：

干预措施：

盐酸精氨酸注射液静脉滴注（基线评估后3-7天内开始滴注，每周1次，连续4周，共4次），同时配合基础康复护理。盐酸精氨酸注射液规格为20ml:5g，临用前，用5%葡萄糖注射液1000ml稀释后应用，静脉滴注一次20g于4小时内滴完。

干预措施代码：

Intervention：

Intravenous infusion of arginine hydrochloride injection (initiated within 3–7 days after baseline assessment, once weekly for 4 consecutive weeks, 4 infusions in total), combined with basic rehabilitation care. The specification of arginine hydrochloride injection is 20?mL:5?g. Before use, it shall be diluted in 1000?mL of 5% glucose injection, and 20?g shall be administered intravenously over 4 hours per infusion.

Intervention code：

组别：

对照组（安慰剂组）

样本量：

 50

Group：

Control group (Placebo group)

Sample size：

干预措施：

等量0.9%氯化钠注射液（生理盐水）1000ml静脉滴注（基线评估后3-7天内开始滴注，每周1次，连续4周，共4次），同时配合基础康复护理。输注时间、频次、疗程与试验组完全一致。为保证双盲，试验组与对照组输液袋外观一致，由非盲药师统一配制并以不透明遮光袋包装，研究者与受试者均无法辨别输液内容。

干预措施代码：

Intervention：

An equal volume of 1000?mL 0.9% sodium chloride injection (normal saline) was administered intravenously, initiated within 3–7 days after baseline assessment, once weekly for 4 consecutive weeks (4 infusions in total), combined with basic rehabilitation care. The infusion duration, frequency, and treatment course were identical to those in the experimental group. To ensure double blinding, infusion bags in both the experimental and control groups were identical in appearance. All infusions were prepared uniformly by an unblinded pharmacist and packaged in opaque light?proof bags, such that neither investigators nor participants could identify the infusion contents.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

  

Country：

China

Province：

Guangdong Province

City：

单位(医院)：

 中山大学附属第七医院 

单位级别：

 三甲 

Institution
hospital：

The Seventh Affiliated Hospital of Sun Yat-sen University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

预启动后90天内椎间盘影像改善患者比例的组间差异

指标类型：

主要指标

Outcome：

The difference between groups in the proportion of patients showing improvement in disc imaging within 90 days of pre-treatment

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：

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：

正在进行

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）：

采用SAS 9.4软件生成随机分配序列。随机化类型为区组随机化（Block Randomization），区组大小设为4和6（随机交替），以确保在入组过程中两组样本量始终保持大致均衡。按1:1比例将受试者随机分配至试验组（精氨酸组）和对照组（安慰剂组）。随机序列由独立的非盲统计师在研究启动前一次性生成，并密封保存。

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

Random allocation sequences were generated using SAS 9.4 software. Block randomization was adopted with block sizes of 4 and 6 (randomly alternating) to ensure approximately balanced sample sizes between the two groups throughout enrollment. Participants were randomly assigned in a 1:1 ratio to the experimental group (arginine group) and the control group (placebo group). The random sequence was generated in one batch before study initiation by an independent unblinded statistician and stored in sealed envelopes.

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：

双盲（对受试者和研究者均隐藏分组）

Blinding：

Double-blinding (group allocation concealed from both participants and investigators)

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）：

不共享原始数据

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

Do not share raw data

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：

1. 数据采集和录入：临床指标评估采用调查问卷形式采集，影像学数据利用专用的测量软件进行测量，每个研究中心均安排固定的研究人员进行随访并数据采集，项目启动前对数据采集人员进行统一培训，定期使用Excel表格进行数据汇总。 2. 源文件和源数据的管理：源文件是临床试验数据记录的第一手资料，试验中的任何观察、检查结果均及时、准确、完整、规范、真实地记录于源文件；源文件和源数据的修改必须有充分的证据，否则以首次判断（记录）为准；源文件按照保密程度设置访问权限。

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

1. Data collection and input: Clinical indicator evaluation is collected in the form of a survey questionnaire, and imaging data is measured using specialized measurement software. Each research center arranges fixed researchers for follow-up and data collection. Before the project starts, unified training is provided for data collection personnel, and Excel spreadsheets are regularly used for data summary. 2. Management of source files and data: Source files are the first-hand information for recording clinical trial data, and any observations and examination results during the trial are timely, accurate, complete, standardized, and truthfully recorded in the source files; The modification of source files and data must have sufficient evidence, otherwise the first judgment (record) shall prevail; Set access permissions for source files based on their level of confidentiality.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2026-04-28 16:03:39