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Exploring the Impact of Acupuncture on the Regulation of Intestinal Flora in Patients with Chronic Disorders of Consciousness After Brain Injury Based on the "Brain-Gut Axis" Theory

注册号：

Registration number：

ITMCTR2025001167

最近更新日期：

Date of Last Refreshed on：

2025-06-12

注册时间：

Date of Registration：

2025-06-12

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

基于“脑肠轴”理论探究针刺对脑损伤后慢性意识障碍患者肠道菌群调节的影响

Public title：

Exploring the Impact of Acupuncture on the Regulation of Intestinal Flora in Patients with Chronic Disorders of Consciousness After Brain Injury Based on the "Brain-Gut Axis" Theory

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于“脑肠轴”理论探究针刺对脑损伤后慢性意识障碍患者肠道菌群调节的影响

Scientific title：

Exploring the Impact of Acupuncture on the Regulation of Intestinal Flora in Patients with Chronic Disorders of Consciousness After Brain Injury Based on the "Brain-Gut Axis" Theory

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：

王凌燕

研究负责人：

王凌燕

Applicant：

Lingyan Wang

Study leader：

Lingyan Wang

申请注册联系人电话：

Applicant telephone：

18257092270

研究负责人电话：

Study leader's telephone：

18257092270

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：

lynna0312@126.com

研究负责人电子邮件：

Study leader's E-mail：

lynna0312@126.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：

浙江省金华市婺城区双溪西路439号

研究负责人通讯地址：

浙江省金华市婺城区双溪西路439号

Applicant address：

No. 439 Shuangxi West Road Wucheng District Jinhua City Zhejiang Province.China

Study leader's address：

No. 439 Shuangxi West Road Wucheng District Jinhua City Zhejiang Province.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：

浙江中医药大学附属金华中医院

Applicant's institution：

Jinhua Hospital of TCM Afliated to Zhejiang 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：

WLY-2023070403-02

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：

金华市中医医院伦理委员会

Name of the ethic committee：

Ethics Committee of Jinhua Hospital of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2025/2/8 0:00:00

伦理委员会联系人：

冷燕奎

Contact Name of the ethic committee：

Yankui Leng

伦理委员会联系地址：

浙江省金华市婺城区双溪西路439号

Contact Address of the ethic committee：

No. 439 Shuangxi West Road Wucheng District Jinhua City Zhejiang Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 137 5799 7858

伦理委员会联系人邮箱：

Contact email of the ethic committee：

kjc82136871@163.com

研究实施负责（组长）单位：

浙江中医药大学附属金华中医院

Primary sponsor：

Jinhua Hospital of TCM Afliated to Zhejiang University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

浙江省金华市婺城区双溪西路439号

Primary sponsor's address：

No. 439 Shuangxi West Road Wucheng District Jinhua City Zhejiang 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)：

浙江省

市(区县)：

金华市

Country：

China

Province：

zhejiang

City：

JInhua

单位(医院)：

浙江中医药大学附属金华中医院

具体地址：

浙江省金华市婺城区双溪西路439号

Institution
hospital：

Jinhua Hospital of TCM Afliated to?Zhejiang University of?Traditional Chinese Medicine

Address：

No. 439 Shuangxi West Road Wucheng District Jinhua City Zhejiang Province

经费或物资来源：

金华市卫生健康委员会、浙江中医药大学附属金华中医院

Source(s) of funding：

Health Commission of Jinhua City; Jinhua Hospital of Traditional Chinese Medicine

研究疾病：

脑损伤后意识障碍

研究疾病代码：

Target disease：

Disturbance of consciousness after brain injury

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：

其它

Others

研究目的：

(1)基于“脑肠轴”理论选穴针刺治疗脑损伤后pDOC是否有效，从而扩宽脑损伤后慢性意识障碍的针刺处方思路。(2)基于PCR技术从机制层面初步阐述针刺改善意识状态与肠道菌群的关系，阐述“脑肠轴”理论指导下的针刺选穴的肠道生物学机制。

Objectives of Study：

(1) To investigate the effectiveness of acupuncture treatment for persistent disorders of consciousness (pDOC) after brain injury based on the "brain-gut axis" theory thereby broadening the approach to acupuncture prescriptions for chronic disorders of consciousness following brain injury.(2) To preliminarily elucidate the relationship between acupuncture-induced improvement in consciousness and intestinal flora based on PCR technology and to explain the intestinal biological mechanism of acupuncture point selection guided by the "brain-gut axis" theory.

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符合颅脑损伤（包括脑卒中、脑外伤）的诊断标准：脑卒中符合全国第四届脑血管病学术会议（1995年）修订的脑卒中诊断标准，并且经头颅CT或MRI证实。脑外伤有明确的头颅外伤史，CT或MRI 明确诊断为脑外伤导致的弥漫性轴索损伤、脑干损伤、硬膜下（外）血肿、脑挫裂伤等；②符合慢性意识障碍的诊断标准；根据中国医师协会神经修复专业委员会意识障碍与促醒学组制定的《慢性意识障碍诊断与治疗中国专家共识》：各种严重脑损伤导致的意识丧失的状态，如昏迷、植物状态和微小意识状态，并且意识丧失时间大于28天；③年龄18-70岁；④生命体征平稳；⑤家属或授权委托人同意参加本课题研究并在知情同意书。

Inclusion criteria

(1) Meet the diagnostic criteria for head injury (including stroke and traumatic brain injury): stroke meets the diagnostic criteria for stroke revised by the Fourth National Academic Conference on Cerebrovascular Diseases (1995) and is confirmed by head CT or MRI. Traumatic brain injury has a clear history of head trauma CT or MRI confirmed the diagnosis of diffuse axonal injury brainstem injury subdural (external) hematoma cerebral contusion etc. caused by traumatic brain injury; (2) meet the diagnostic criteria for chronic impairment of consciousness; According to the "Chinese Expert Consensus on the Diagnosis and Treatment of Chronic Consciousness Disorders" formulated by the Consciousness Disorder and Awakening Promotion Group of the Neurorepair Professional Committee of the Chinese Medical Doctor Association the state of loss of consciousness caused by various severe brain injuries such as coma vegetative state and microconscious state and the loss of consciousness for more than 28 days;(3) Age 18-70 years old;(4) Stable vital signs;(5) Family members or authorized representatives agree to participate in the research of this topic and sign the informed consent form.

排除标准：

①存在呼吸、循环等系统的严重并发症，生命体征不平稳者； ②合并有癫痫持续状态者； ③存在颅内感染者； ④年龄大于70岁或年龄小于18岁； ⑤CT或MRI示脑水肿明显； ⑥家属或其监护人不愿或不能配合治疗，拒绝填写《知情同意书》； ⑦病情不稳定和其他患严重心、肺、肝、肾疾病者。

Exclusion criteria：

(1) Those with serious complications of respiratory circulatory and other systems and unstable vital signs; (2) Patients with status epilepticus; (3) Patients with intracranial infection; (4) Age greater than 70 years old or less than 18 years old; (5) CT or MRI showed obvious cerebral edema; (6) Family members or their guardians are unwilling or unable to cooperate with the treatment and refuse to fill in the Informed Consent Form; (7) Those who are unstable and suffer from other serious heart lung liver and kidney diseases.

研究实施时间：

Study execute time：

从From 2025-01-01

至To      2026-12-31

征募观察对象时间：

Recruiting time：

从From 2025-05-23

至To      2026-04-22

干预措施：

Interventions：

组别：

常规促醒组

样本量：

30

Group：

Routine Awakening Group

Sample size：

干预措施：

常规促醒治疗：包括药物治疗：采用醒脑静20ml，用5%的葡萄糖或0.9%的氯化钠注射液250ml稀释后静脉注射，每日一次，治疗1月。康复治疗：根据患者情况可选用高压氧，床边被动肌力训练，电动起立床训练等。

干预措施代码：

Intervention：

Routine Awakening Treatment: This includes pharmacological therapy with Xingnaojing injection (20 ml) diluted in 250 ml of 5% glucose or 0.9% sodium chloride injection and administered intravenously once daily for one month. Rehabilitation therapy may include hyperbaric oxygen therapy passive muscle strength training at the bedside electric standing bed training etc. depending on the patient's condition.

Intervention code：

组别：

针刺促醒组

样本量：

30

Group：

Acupuncture-induced Awakening Group

Sample size：

干预措施：

1.针刺穴位：沟、中脘、天枢（双）、足三里（双）、上巨虚（双） 2.常规促醒治疗：同常规促醒组

干预措施代码：

Intervention：

1. Acupuncture Points: Gou (LI4) Zhongwan (CV12) Tianshu (ST25 bilateral) Zusanli (ST36 bilateral) and Shangjuxu (ST37 bilateral). 2.Routine Awakening Treatment：The same to Routine Awakening Group.

Intervention code：

样本总量 Total sample size ： 60

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

浙江

市(区县)：

金华

Country：

China

Province：

Zhejiang

City：

Jinhua

单位(医院)：

浙江中医药大学附属金华中医院

单位级别：

三级甲等

Institution/hospital：

Jinhua Hospital of TCM Afliated to?Zhejiang University of?Traditional Chinese Medicine

Level of the institution：

Class III Grade A Hospital

测量指标：

Outcomes：

指标中文名：

修订的昏迷恢复量表

指标类型：

主要指标

Outcome：

Coma Recovery Scale-Revised

Type：

Primary indicator

测量时间点：

干预前后一周内

测量方法：

该量表由 6 个子量表构成，涉及听觉、语言、视觉、交流、运动和觉醒水平，包括 23 项分层有序的评分标准。

Measure time point of outcome：

Within one week before and after the intervention

Measure method：

This scale consists of six subscales covering auditory language visual communication motor and arousal levels with a total of 23 items. The total score ranges from 0 to 23 and points are assigned based on clinical assessments.

指标中文名：

粪便菌群检测

指标类型：

主要指标

Outcome：

Fecal Microbiota Testing

Type：

Primary indicator

测量时间点：

干预前后一周内

测量方法：

用十六烷基三甲基溴化铵(CTAB)和十二烷基硫酸钠(SDS)法提取样本的全基因组DNA，利用荧光定量 PCR 检测，通过荧光染料法原理进行测定，对 6 种肠道优势菌群进行定量分析，比较两组受试者肠道菌群的数量差异。

Measure time point of outcome：

Within one week before and after the intervention

Measure method：

Extract the whole genome DNA of the samples using Cetyltrimethyl Ammonium Bromide (CTAB) and Sodium Dodecyl Sulfate (SDS) methods, detect it with fluorescent quantitative PCR, measure it through the principle of fluorescent dye method, quantitatively analyze six dominant intestinal flora, and compare the quantity difference of intestinal flora between the two groups of subjects.

指标中文名：

脑干听觉诱发电位

指标类型：

次要指标

Outcome：

Brainstem Auditory Evoked Potential

Type：

Secondary indicator

测量时间点：

干预前后一周内

测量方法：

在神经电生理室进行采集

Measure time point of outcome：

Within one week before and after the intervention

Measure method：

Collected in the neuroelectrophysiology lab

指标中文名：

事件相关电位

指标类型：

次要指标

Outcome：

Event-related Potential

Type：

Secondary indicator

测量时间点：

干预前后一周内

测量方法：

在神经电生理室进行采集

Measure time point of outcome：

Within one week before and after the intervention

Measure method：

Collected in the neuroelectrophysiology lab

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

粪便

组织：

Sample Name：

feces

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：

正在进行

Recruiting

年龄范围：

最小 18 岁
Min age years
最大 70 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）：

简单随机：由临床干预人员按照纳入对象的先后顺序依次交替随机分配到两组中。

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

The clinical intervention personnel sequentially and alternately assigned the enrolled subjects to two groups in the order they were enrolled using a randomized allocation method.

盲法：

双盲（对受试者和研究者均隐藏分组）

Blinding：

Double-blind (with both subjects and researchers blinded to the group assignments)

是否共享原始数据：

IPD sharing：

是

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）：

ResMan临床试验公共管理平台“http://www.medresman.org.cn/uc/index.aspx”

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

ResMan Clinical Trial Public Management Platform“http://www.medresman.org.cn/uc/index.aspx”

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：

数据采集和记录由CRF完成

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

Data collection and recording are completed by CRF (Case Report Form).

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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