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A clinical trial of Wei Bi Formula for treating "Wei Zheng Syndrome" cervical spondylotic myelopathy.

注册号：

Registration number：

ITMCTR2025000334

最近更新日期：

Date of Last Refreshed on：

2025-02-18

注册时间：

Date of Registration：

2025-02-18

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

痿痹方治疗“痿证型”脊髓型颈椎病临床试验

Public title：

A clinical trial of Wei Bi Formula for treating "Wei Zheng Syndrome" cervical spondylotic myelopathy.

注册题目简写：

English Acronym：

研究课题的正式科学名称：

痿痹方治疗“痿证型”脊髓型颈椎病临床试验

Scientific title：

A clinical trial of Wei Bi Fang for treating "Wei Zheng type" cervical spondylotic myelopathy.

研究课题的正式科学名称简写：

Scientific title acronym：

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：

林浩文

研究负责人：

崔学军

Applicant：

Haowen Lin

Study leader：

Xuejun Cui

申请注册联系人电话：

Applicant telephone：

+86 199 2125 3193

研究负责人电话：

Study leader's telephone：

+86 189 1776 3017

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：

lhwsy1210@163.com

研究负责人电子邮件：

Study leader's E-mail：

13917715524@139.com

申请单位网址(自愿提供)：

Study leader's 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：

上海市徐汇区宛平南路725号上海中医药大学附属龙华医院

研究负责人通讯地址：

上海市宛平南路725号

Applicant address：

Shanghai University of Traditional Chinese Medicine Affiliated Longhua HospitalNo.725

Study leader's address：

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine 725 Wanping South Road Xuhui Shanghai China.

申请注册联系人邮政编码：

Applicant postcode：

200032

研究负责人邮政编码：

Study leader's postcode：

200032

申请人所在单位：

上海中医药大学附属龙华医院

Applicant's institution：

Longhua Hospital Shanghai University of Traditional Chinese Medicine

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

2022ZZ01009

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

上海中医药大学附属龙华医院医学伦理委员会

Name of the ethic committee：

Medical Ethics CommitteeLonghua Hospital Shanghai University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2023/12/28 0:00:00

伦理委员会联系人：

肖臻

Contact Name of the ethic committee：

Zhen Xiao

伦理委员会联系地址：

上海市徐汇区宛平南路725号特诊部311室

Contact Address of the ethic committee：

Room 311 Special Clinic No. 725 Wanping South Road Xuhui District Shanghai China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 21 5466 6653

伦理委员会联系人邮箱：

Contact email of the ethic committee：

lhtcmirb@sina.cn

研究实施负责（组长）单位：

上海中医药大学附属龙华医院

Primary sponsor：

Longhua Hospital Shanghai University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

上海市宛平南路725号

Primary sponsor's address：

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine 725 Wanping South Road Xuhui Shanghai 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)：

上海

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海中医药大学附属龙华医院

具体地址：

上海市宛平南路725号

Institution
hospital：

Longhua Hospital Shanghai University of Traditional Chinese Medicine

Address：

Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine 725 Wanping South Road Xuhui Shanghai China.

经费或物资来源：

上海市“重中之重”临床医学中心

Source(s) of funding：

Shanghai "Top priority"Clinical Medical Center

研究疾病：

脊髓型颈椎病

研究疾病代码：

Target disease：

cervical spondylotic myelopathy

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段：

Study phase：

探索性研究/预试验

Pilot clinical trial

研究目的：

以安慰剂为对照，评价痿痹方治疗“痿证型”脊髓型颈椎病的有效性和安全性，为进一步推广应用提供依据。

Objectives of Study：

To evaluate the efficacy and safety of Wibi Formula in treating "Wibi Syndrome" cervical spondylosis with placebo as control and to provide evidence for further promotion and application.

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.符合西医诊断标准者； 2.轻度和中度患者（mJOA评分≥12分）者； 3.中医辨证属于“痿证型”者； 4.自愿接受中药治疗者； 5.年龄≥18岁，≤75岁者； 6.筛选前2周内没有采用其他治疗者； 7.同意参与试验并签署知情同意书者。

Inclusion criteria

1. those who met the diagnostic criteria of western medicine; 2. Mild and moderate patients (mJOA score ≥12); 3. Those who are recognized as "Wibi Syndrome" in Chinese medicine; 4. Voluntary acceptance of Chinese medicine treatment; 5. Age ≥18 years ≤75 years; 6. Those who have not used other treatments within 2 weeks before the screening; 7. Those who agreed to participate in the trial and signed the informed consent form.

排除标准：

1.有明显兼夹证或合并症者（如服降压药后高血压收缩压≥160mmHg，舒张压≥100mmHg、服降糖药后糖尿病空腹血糖≥7.0mmol/L的患者）； 2.哺乳期、妊娠期或正准备妊娠的妇女； 3.伴有其他类型颈椎病，如神经根型颈椎病、椎动脉型颈椎病者； 4.椎管矢状径小于11mm以及Pavlvo比小于0.75（颈椎管中矢径与颈椎体中矢径的比值），或见椎体不稳（椎体向前或向后滑移距离大于或等于3. 5mm 或椎体间成角大于或等于11°）者； 5.MRI检查见T2加权高信号，提示脊髓变性，或者MRI检查见椎管狭窄达到1/2，或者脊髓受压达三个节段者； 6.体格检查见动态霍夫曼征阳性，或手部肌肉萎缩，或痉挛，难以独立行走，或排尿功能障碍者； 7.伴有颈椎骨折、颈椎先天畸形、颈椎管骨性狭窄症、后纵韧带骨化症、多发性硬化； 8.脊髓型颈椎病术后患者； 9.过敏体质及对多种药物过敏者； 10.合并肝、肾、造血系统、内分泌系统等严重原发性疾病、肿瘤及精神病患者； 11.入选前3个月参加或正在参加其它药物临床试验者； 存在其他研究者认为不宜入选本试验的原因者。

Exclusion criteria：

1. Those with obvious concurrent evidence or comorbidities (e.g. patients with hypertension systolic blood pressure ≥160mmHg and diastolic blood pressure ≥100mmHg after taking antihypertensive drugs and diabetes mellitus fasting blood glucose ≥7.0mmol/L after taking hypoglycemic drugs); 2. Women who are breastfeeding pregnant or preparing for pregnancy; 3. Those with other types of cervical spondylosis such as nerve root type cervical spondylosis and vertebral artery type cervical spondylosis; 4. The sagittal diameter of the spinal canal is less than 11mm and the Pavlvo ratio is less than 0.75 (the ratio of the mid-sagittal diameter of the cervical spinal canal to the mid-sagittal diameter of the cervical vertebral body) or vertebral instability (the vertebral body sliding forward or backward by a distance of more than or equal to 3.5mm or the vertebral body angle of more than or equal to 11°) is seen; 5. MRI with T2-weighted high signal suggestive of spinal degeneration or MRI with spinal stenosis up to 1/2 or spinal cord compression up to three segments; 6. those who see positive dynamic Hoffman's sign on physical examination or atrophy of hand muscles or spasticity difficulty in walking independently or dysfunction of urination; 7. with cervical spine fracture congenital malformation of cervical vertebrae cervical spinal canal bony stenosis ossification of posterior longitudinal ligament multiple sclerosis; 8. Postoperative patients with spinal cord cervical spondylosis; 9. Allergic body and people who are allergic to many kinds of drugs; 10. patients with combined liver kidney hematopoietic system endocrine system and other serious primary diseases tumors and mental illness; 11. Those who have participated or are participating in other drug clinical trials 3 months before enrollment; The existence of other reasons that the investigator believes that it is inappropriate to enroll in this trial.

研究实施时间：

Study execute time：

从From 2023-12-01

至To      2025-09-09

征募观察对象时间：

Recruiting time：

从From 2024-02-01

至To      2025-05-01

干预措施：

Interventions：

组别：

对照组（安慰剂组）

样本量：

40

Group：

comparison group

Sample size：

干预措施：

安慰剂治疗 4袋/次，2次/日，早中晚餐后口服，治疗期8周。

干预措施代码：

Intervention：

Placebo treatment 4 sachets/dose, 2 times/day, taken orally after breakfast, lunch and dinner for 8 weeks.

Intervention code：

组别：

治疗组（痿痹方组）

样本量：

40

Group：

treatment group

Sample size：

干预措施：

痿痹方 4袋/次，2次/日，早中晚餐后口服，治疗期8周。

干预措施代码：

Intervention：

Wibi Formula 4 sachets/times 2 times/day taken orally after breakfast lunch and dinner for a treatment period of 8 weeks.

Intervention code：

样本总量 Total sample size ： 80

研究实施地点：

Countries of recruitment
and research settings：

国家：

中华人民共和国

省(直辖市)：

上海

市(区县)：

Country：

The People's Republic of China

Province：

Shanghai

City：

单位(医院)：

上海市中医医院

单位级别：

三甲

Institution/hospital：

Shanghai Municipal Hospital of Traditional Chinese Medicine

Level of the institution：

Grade A tertiary hospital

国家：

中华人民共和国

省(直辖市)：

上海

市(区县)：

Country：

The People's Republic of China

Province：

Shanghai

City：

单位(医院)：

上海中医药大学附属龙华医院

单位级别：

三甲

Institution/hospital：

Longhua Hospital Shanghai University of Traditional Chinese Medicine

Level of the institution：

Grade A tertiary hospital

国家：

中华人民共和国

省(直辖市)：

上海

市(区县)：

Country：

The People's Republic of China

Province：

Shanghai

City：

单位(医院)：

复旦大学附属华东医院

单位级别：

三甲

Institution/hospital：

Huadong Hospital Affillated to Fudan University

Level of the institution：

Grade A tertiary hospital

国家：

中华人民共和国

省(直辖市)：

上海

市(区县)：

Country：

The People's Republic of China

Province：

Shanghai

City：

单位(医院)：

苏州市中医医院

单位级别：

三甲

Institution/hospital：

Suzhou Hospital of Traditional Chinese Medicine

Level of the institution：

Grade A tertiary hospital

测量指标：

Outcomes：

指标中文名：

脊髓型颈椎病临床症状、体征积分变化

指标类型：

次要指标

Outcome：

Changes in clinical symptoms signs and points of spinal cervical spondylosis

Type：

Secondary indicator

测量时间点：

基线、2周、4周、8周、12周

测量方法：

Measure time point of outcome：

Baseline.2 week.4 week.8week.12 week

Measure method：

指标中文名：

中医病症疗效

指标类型：

次要指标

Outcome：

Chinese Medicine Disease Treatment

Type：

Secondary indicator

测量时间点：

基线、2周、4周、8周、12周

测量方法：

Measure time point of outcome：

Baseline.2 week.4 week.8week.12 week

Measure method：

指标中文名：

生活质量（采用SF-36量表）评分

指标类型：

次要指标

Outcome：

Quality of life (using SF-36 scale) scores

Type：

Secondary indicator

测量时间点：

基线、2周、4周、8周、12周

测量方法：

Measure time point of outcome：

Baseline.2 week.4 week.8week.12 week

Measure method：

指标中文名：

修订版日本骨科学会评分

指标类型：

主要指标

Outcome：

mJOA score

Type：

Primary indicator

测量时间点：

基线、2周、4周、8周、12周

测量方法：

Measure time point of outcome：

Baseline.2 week.4 week.8week.12 week

Measure method：

指标中文名：

Nurick评分

指标类型：

次要指标

Outcome：

Nurick score

Type：

Secondary indicator

测量时间点：

基线、2周、4周、8周、12周

测量方法：

Measure time point of outcome：

Baseline.2 week.4 week.8week.12 week

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

none

Tissue：

人体标本去向

其它

说明

Fate of sample 

Others

Note：

征募研究对象情况：

正在进行

Recruiting

年龄范围：

最小 18 岁
Min age years
最大 75 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男女均可

Both

随机方法（请说明由何人用什么方法产生随机序列）：

随机分配编码采用随机数字表方法，每个病例列出流水号为01～80所对应的药物治疗方式，配备相应的治疗药盒。

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

Random assignment codes were coded using the random number table method with each case listing the medication modality corresponding to the running numbers 01 to 80 with the corresponding treatment kit.

盲法：

采用随机、双盲、多中心、安慰剂平行对照试验，设置试验组与对照组，按1:1比例分配病例，每组40例，共计80例。所有病例配备相应流水号的药物治疗方式。随机分配编码采用随机数字表方法，每个病例列出流水号为01～80所对应的药物治疗方式，配备相应的治疗药盒。采用两级盲法设计，第1级为各病例号所对应的组别(如A组、B组和C组)，第2级为各组所对应的处理（试验1组、试验2组和对照组）。盲底由专人统一保管。

Blinding：

A randomized double-blind multicenter placebo-parallel controlled trial was used to set up a test group and a control group and cases were assigned in a 1:1 ratio with 40 cases in each group and 80 cases in total. All cases were equipped with corresponding running numbers of drug treatment modalities. Random assignment coding was done by random number table method and each case listed the drug treatment modality corresponding to the running numbers 01 to 80 equipped with the corresponding therapeutic pill box. A two-level blinded design was used with level 1 being the group corresponding to each case number (e.g. group A group B and group C) and level 2 being the treatment corresponding to each group (test 1 test 2 and control groups). Blind bottoms were kept in a single place.

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）：

2025.09.09 网络平台 http://www.medresman.org.cn/

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

2025.09.09 web-based public database http://www.medresman.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：

（一）研究病历 鉴于我国医院门诊病历多由患者自带的情况，为完整保存临床试验第一手数据资料，设计本试验专用的“研究病历”。 研究病历是临床试验受试者的源文件（source document），应保存于医院。研究病历是门诊受试者的病历资料，与住院病历共同组成住院受试者的病历资料。 （二）数据记录 1.研究病历记录要求：①研究者必须在诊治受试者同时书写研究病历，保证数据记录及时、完整、准确、真实。②研究病历做任何有证据的更正时只能划线，旁注改后的数据，由研究者签名并注明日期，不得擦涂、覆盖原始记录。③门诊受试者的原始化验单粘贴在研究病历上，住院受试者的原始化验单粘贴在住院病历上。门诊与住院受试者的化验结果均需填写至研究病历的“理化检查结果报告表”。 2.研究病历的审核：每一受试者观察疗程结束后，研究者应在3个工作日内将“研究病历”、“知情同意书”、“患者服药记录卡”交本单位主要研究者审核。 （三）数据安全监察计划 由专人会对数据进行每周一次的数据监察，如果出现数据错漏遗失等情况，则召开讨论会议讨论是否进一步进行研究或方案的优化，并将进展报告向伦理委员会进行申报。 （四）电子采集 原始数据将在审查后上传至ResMan系统

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

(1) Research Medical Records Considering that outpatient medical records in Chinese hospitals are often brought in by patients we have designed a dedicated "Research Medical Record" to comprehensively preserve first-hand data from clinical trials. The Research Medical Record serves as the source document for trial participants and should be retained in the hospital. It comprises the medical records of outpatient participants in conjunction with the inpatient medical records of hospitalized participants. (2) Data Recording Requirements for Research Medical Record Keeping: i. The researcher must document the Research Medical Record concurrently with the diagnosis and treatment of the participant ensuring timely complete accurate and truthful data recording. ii. Any corrections made to the Research Medical Record must be evidenced by a line drawn through the original entry with the revised data noted in the margin accompanied by the researchers signature and date. Erasure or covering of original records is prohibited. iii. Original laboratory test reports for outpatient participants should be affixed to the Research Medical Record while those for inpatient participants should be attached to the inpatient medical records. The laboratory results for both outpatient and inpatient participants must also be recorded in the "Physical Examination Results Report" section of the Research Medical Record. Review of Research Medical Records: After each participant's observation period the researcher must submit the "Research Medical Record" "Informed Consent Form" and "Patient Medication Record Card" to the principal investigator of the institution for review within three working days. (3) Data Safety Monitoring Plan A designated individual will conduct weekly data monitoring. In cases of data errors omissions or losses a discussion meeting will be convened to assess whether to continue the research or optimize the protocol. Progress reports will be submitted to the ethics committee. (4) Electronic Data Capture Original data will be uploaded to the ResMan system following review.

数据管理委员会：

Data Managemen Committee：

暂未确定

Not yet

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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