Randomized controlled trial of acupuncture treatment for acute schizophrenia

注册号:

Registration number:

ITMCTR2025000073

最近更新日期:

Date of Last Refreshed on:

2025-01-10

注册时间:

Date of Registration:

2025-01-10

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

针刺治疗急性期精神分裂症的随机对照试验

Public title:

Randomized controlled trial of acupuncture treatment for acute schizophrenia

注册题目简写:

English Acronym:

研究课题的正式科学名称:

针刺治疗急性期精神分裂症的随机对照试验

Scientific title:

Randomized controlled trial of acupuncture treatment for acute schizophrenia

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:

姚高磊

研究负责人:

姚高磊

Applicant:

Gaolei Yao

Study leader:

Gaolei Yao

申请注册联系人电话:

Applicant telephone:

15728255237

研究负责人电话:

Study leader's telephone:

15728255237

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:

yaogaoleitcm@163.com

研究负责人电子邮件:

Study leader's E-mail:

yaogaoleitcm@163.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:

广东省广州市番禺区大学城外环东路232号

研究负责人通讯地址:

广东省广州市番禺区大学城外环东路232号

Applicant address:

No. 232 Outer Ring East Road University City Panyu District Guangzhou City Guangdong Province

Study leader's address:

No. 232 Outer Ring East Road University City Panyu District Guangzhou City Guangdong 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:

中山市第三人民医院

Applicant's institution:

Third People's Hospital of Zhongshan

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:

SSYLL-KY-20240709

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:

中山市第三人民医院

Name of the ethic committee:

Third People's Hospital of Zhongshan

伦理委员会批准日期:

Date of approved by ethic committee:

2024/7/12 0:00:00

伦理委员会联系人:

刘新霞

Contact Name of the ethic committee:

Xinxia Liu

伦理委员会联系地址:

中山市翠亨新区南朗街道田边正街80号

Contact Address of the ethic committee:

No. 80 Tianbianzheng Street Nanlang Street Cuiheng New District Zhongshan City

伦理委员会联系人电话:

Contact phone of the ethic committee:

0760-85528987

伦理委员会联系人邮箱:

Contact email of the ethic committee:

syliuxinxia@163.com

研究实施负责(组长)单位:

中山市第三人民医院

Primary sponsor:

Third People's Hospital of Zhongshan

研究实施负责(组长)单位地址:

中山市翠亨新区南朗街道田边正街80号

Primary sponsor's address:

No. 80 Tianbianzheng Street Nanlang Street Cuiheng New District Zhongshan City

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):

Country:

China

Province:

guangdong province

City:

单位(医院):

广州中医药大学

具体地址:

广东省广州市番禺区大学城外环东路232号

Institution
hospital:

Guangzhou University of Chinese Medicine

Address:

No. 232 Outer Ring East Road University City Panyu District Guangzhou City Guangdong Province

经费或物资来源:

广州中医药大学一流大学和高水平优势学科建设项目(A1-2601-24-414-109Z71, A1-2601-24-415-109Z50和A1-2601-24-415-109Z76)

Source(s) of funding:

the Project of First Class Universities and High-level Dual Discipline for Guangzhou University of Chinese Medicine (A1-2601-24-414-109Z71 A1-2601-24-415-109Z50 and A1-2601-24-415-109Z76)

研究疾病:

精神分裂症

研究疾病代码:

Target disease:

schizophrenia

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:

本研究拟探讨针刺治疗急性期精神分裂症(acute schizophrenia, ASCZ)的临床疗效,并使用血液代谢组学检测方法分析与代谢物变化相关的机制。通过比较干预后针刺组和假针刺组阳性和阴性症状量表(Positive And Negative Symptom Scale, PANSS)评分评估针刺的临床治疗效果,同时,结合SCZ生活质量量表(The Schizophrenia Quality of Life Scale,SQLS)、副反应量表(Treatment Emergent Symptom Scale, TESS)、汉密尔顿抑郁量表(Hamilton Depression Scale,HAMD)、汉密尔顿焦虑量表(Hamilton Anxiety Scale,HAMA)分别评估患者的生活质量、不良反应、抑郁、焦虑情绪。通过血清炎症指标变化分析针刺治疗ASCZ可能的炎症机制。通过血液代谢物检测从代谢物层面分析针刺治疗的可能机制。

Objectives of Study:

This study aims to explore the clinical efficacy of acupuncture treatment for acute schizophrenia (ASCZ) and analyze the mechanisms related to metabolite changes using blood metabolomics detection methods. The clinical treatment effect of acupuncture was evaluated by comparing the positive and negative symptom scale (PANSS) scores between the post intervention acupuncture group and the sham acupuncture group. At the same time the SCZ Quality of Life Scale (SQLS) Treatment Emergent Symptom Scale (TESS) Hamilton Depression Scale (HAMD) and Hamilton Anxiety Scale (HAMA) were used to evaluate the patients' quality of life adverse reactions depression and anxiety respectively. Analyze the possible inflammatory mechanism of acupuncture treatment for ASCZ through changes in serum inflammatory indicators. Analyze the possible mechanism of acupuncture treatment at the metabolite level through blood metabolite detection.

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)符合上述诊断标准且为复发急性期(14天内)患者; (2)年龄为18岁-60岁之间; (3)PANSS评分≤80; (4)研究开展前患者或其家属签署知情同意书并遵守方案的要求。

Inclusion criteria

(1) Patients who meet the above diagnostic criteria and are in the acute phase of recurrence (within 14 days); (2) Age between 18 and 60 years old; (3) PANSS score ≤ 80; (4) Prior to conducting the study patients or their families shall sign an informed consent form and comply with the requirements of the protocol.

排除标准:

(1)针刺部位皮肤存在明显感染、溃疡,影响针刺治疗者; (2)存在严重躯体疾病,生命体征不平稳者,如中风,心血管疾病,恶性肿瘤等; (3)妊娠或哺乳期患者; (4)合并有其他精神性疾病者如物质滥用,急性自杀,癫痫,双向情感障碍等; (5)拒绝接受针刺治疗或针刺不耐受者; (6)首发SCZ患者; (7)正在参与其他临床试验者。

Exclusion criteria:

(1) There are obvious infections and ulcers on the skin at the acupuncture site which affect the effectiveness of acupuncture treatment; (2) Individuals with serious physical illnesses and unstable vital signs such as stroke cardiovascular disease malignant tumors etc; (3) Pregnant or lactating patients; (4) Combine individuals with other mental illnesses such as substance abuse acute suicide epilepsy bipolar disorder etc; (5) Refusing to accept acupuncture treatment or those who are intolerant to acupuncture; (6) First onset SCZ patients; (7) Participants in other clinical trials.

研究实施时间:

Study execute time:

From 2025-02-17

To      2025-07-12

征募观察对象时间:

Recruiting time:

From 2025-02-17

To      2025-07-12

干预措施:

Interventions:

组别:

针刺组

样本量:

46

Group:

Acupuncture group

Sample size:

干预措施:

针刺+基础治疗

干预措施代码:

Intervention:

Acupuncture+basic treatment

Intervention code:

组别:

假针刺组

样本量:

46

Group:

sham acupuncture group

Sample size:

干预措施:

假针刺+基础治疗

干预措施代码:

Intervention:

sham acupuncture+basic treatment

Intervention code:

样本总量 Total sample size : 92

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):

中山市第三人民医院

单位级别:

三级

Institution/hospital:

Third People's Hospital of Zhongshan

Level of the institution:

tertiary hospital

测量指标:

Outcomes:

指标中文名:

阳性和阴性症状量表

指标类型:

主要指标

Outcome:

Positive And Negative Symptom Scale

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

C反应蛋白

指标类型:

次要指标

Outcome:

C-reactive protein

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

白细胞介素6

指标类型:

次要指标

Outcome:

interleukin 6

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

汉密尔顿焦虑量表

指标类型:

次要指标

Outcome:

Hamilton Anxiety Scale

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

副反应量表

指标类型:

次要指标

Outcome:

Treatment Emergent Symptom Scale

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

白细胞介素1β

指标类型:

次要指标

Outcome:

interleukin 1β

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量量表

指标类型:

次要指标

Outcome:

The Schizophrenia Quality of Life Scale

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

汉密尔顿抑郁量表

指标类型:

次要指标

Outcome:

Hamilton Depression Scale

Type:

Secondary 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:

尚未开始

Not yet recruiting

年龄范围:

最小 18
Min age years
最大 60
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):

采用随机分配的方法分组,将纳入患者随机分配为针刺组和假针刺组。随机分配采用中央随机系统区组随机的随机数字产生方法,将纳入患者随机分组。随机分配系统研发及执行由广州中医药大学临床研究与数据中心人员完成。

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

The patients were randomly assigned to the acupuncture group and the sham acupuncture group by random assignment method. The random assignment was randomly generated by the central random system group and the patients were randomly assigned. The development and implementation of the random assignment system were completed by the staff of the Clinical Research and Data Center of Guangzhou University of Traditional Chinese Medicine.

盲法:

Blinding:

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):

原始数据查看请邮箱联系通讯作者。

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

For sharing of raw data, please contact the corresponding author via email.

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:

数据采集和管理使用病例记录表。

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

Data Collection and Management Were Conducted Using Case Record Forms

数据管理委员会:

Data Managemen Committee:

No

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):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above