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Clinical Research on the Treatment of Functional Constipation with Dragon-Tiger Combat Acupuncture and Multimodal Brain Functional Imaging Analysis

注册号：

Registration number：

ITMCTR2025000330

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：

龙虎交战针法治疗功能性便秘临床研究及多模态脑功能影像学分析

Public title：

Clinical Research on the Treatment of Functional Constipation with Dragon-Tiger Combat Acupuncture and Multimodal Brain Functional Imaging Analysis

注册题目简写：

English Acronym：

研究课题的正式科学名称：

龙虎交战针法治疗功能性便秘临床研究及多模态脑功能影像学分析

Scientific title：

Clinical Research on the Treatment of Functional Constipation with Dragon-Tiger Combat Acupuncture and Multimodal Brain Functional Imaging Analysis

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：

李柏

研究负责人：

贾红玲

Applicant：

Li Bai

Study leader：

Jia Hongling

申请注册联系人电话：

Applicant telephone：

18615220017

研究负责人电话：

Study leader's telephone：

18254178199

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：

libaizyy@163.com

研究负责人电子邮件：

Study leader's E-mail：

jiahl1969@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：

山东省济南市市中区经八路1号

研究负责人通讯地址：

山东省济南市市中区经八路1号

Applicant address：

No. 1 Jingba Road Shizhong District Jinan City Shandong Province China

Study leader's address：

No. 1 Jingba Road Shizhong District Jinan City Shandong 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：

山东中医药大学

Applicant's institution：

Shandong 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：

2024伦审-KY-081

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：

山东中医药大学第二附属医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2024/12/16 0:00:00

伦理委员会联系人：

袁媛

Contact Name of the ethic committee：

Yuan Yuan

伦理委员会联系地址：

山东省济南市市中区经八路1号

Contact Address of the ethic committee：

No. 1 Jingba Road Shizhong District Jinan City Shandong Province China

伦理委员会联系人电话：

Contact phone of the ethic committee：

0531-82436062

伦理委员会联系人邮箱：

Contact email of the ethic committee：

zdeyllwyh@163.com

研究实施负责（组长）单位：

山东中医药大学第二附属医院

Primary sponsor：

The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

山东省济南市市中区经八路1号

Primary sponsor's address：

No. 1 Jingba Road Shizhong District Jinan City Shandong Province 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)：

山东

市(区县)：

济南

Country：

China

Province：

Shandong

City：

Jinan

单位(医院)：

山东中医药大学第二附属医院

具体地址：

山东省济南市市中区经八路1号

Institution
hospital：

The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Address：

No. 1 Jingba Road Shizhong District Jinan City Shandong Province China

经费或物资来源：

研究者及患者自费

Source(s) of funding：

The investigator and the patient are self-paying

研究疾病：

功能性便秘

研究疾病代码：

Target disease：

Functional constipation

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：

功能性便秘（Functional Constipation, FC）是临床常见的慢性难治性疾病，患者证型并非单一，常常有虚实夹杂，以虚为本，又可兼见瘀、痰、湿和气滞等实证，临床治疗不仅要兼顾其气血阴阳虚损的内在因素，还要祛瘀、痰、湿等实邪。龙虎交战针法是一种补泻兼施的复式针刺补泻手法，此法采用一补一泻，既补脏腑阴阳之不足，又泻痰瘀热之阻滞。临床根据病症虚实、病势深浅以及病性寒热予以灵活运用。龙虎交战针法用于治疗虚实夹杂的 FC 是一种中医药特色技术，根据 FC 虚实夹杂的证型特点，采用该针法可补虚泻实，调和阴阳。因此，本研究以 FC 为疾病载体，采用随机对照试验，观察龙虎交战针法治疗 FC 的临床效应，这将为 FC 的治疗手段提供新方法和思路。

Objectives of Study：

Functional constipation (FC) is a common chronic and intractable disease in clinical practice. The syndrome types of patients with FC are not single often with a mixture of deficiency and excess with deficiency as the root cause and may also be accompanied by excess conditions such as blood stasis phlegm dampness and qi stagnation. Clinical treatment should not only take into account the internal factors of deficiency of qi blood yin and yang but also eliminate the excess conditions such as blood stasis phlegm and dampness. The Dragon-Tiger Battle acupuncture technique is a compound acupuncture manipulation that combines both tonification and reduction. This technique uses one tonifying and one reducing manipulation which not only replenishes the deficiency of the zang-fu organs and yin-yang but also eliminates the obstruction caused by blood stasis phlegm and heat. It is flexibly applied in clinical practice based on the degree of deficiency and excess the depth of the disease and the nature of the disease as cold or hot. The Dragon-Tiger Battle acupuncture technique is a characteristic traditional Chinese medicine technique for treating FC with mixed deficiency and excess syndrome types. According to the characteristics of the syndrome types of FC this technique can tonify deficiency and reduce excess and harmonize yin and yang. Therefore this study takes FC as the disease carrier and uses a randomized controlled trial to observe the clinical effect of the Dragon-Tiger Battle acupuncture technique in treating FC which will provide new methods and ideas for the treatment of FC.

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）符合上述西医诊断标准，并符合阴虚肠燥证中医辨证标准； （2）年龄在40-70周岁内，性别不限； （3）至少1周内未服用与本病相关的药物或接受其他治疗手段，未参加其他正在进行的临床研究； （4）签署知情同意书，患者自愿受试。

Inclusion criteria

(1) Meets the above-mentioned diagnostic criteria of Western medicine and the diagnostic criteria of Yin deficiency and dry intestines syndrome in traditional Chinese medicine; (2) Age within 40-70 years old gender not limited; (3) At least one week has passed since the last intake of drugs related to this disease or other treatment methods and no other ongoing clinical research has been participated in; (4) Signed the informed consent form and the patient voluntarily participates in the trial.

排除标准：

（1）不符合本研究中阴虚肠燥证FC的中西医诊断标准； （2）经检查证实有直肠、结肠器质性病变（如肿瘤、克隆氏病、结肠息肉、肠结核等）所致肠道狭窄引起者； （3）肠易激综合征及器质性或药物引起的便秘；继发于内分泌、代谢性、神经性或外科术后的便秘； （4）合并有心血管、肝、肾和造血系统、精神病等严重原发性疾病而不能耐受便秘治疗者； （5）妊娠、哺乳期妇女，或备孕者； （6）1周内接受其他治疗或服用与本病相关的药物； （7）不愿参加试验、签订知情同意书或不能遵守试验要求者。

Exclusion criteria：

(1) Not meeting the diagnostic criteria for the syndrome of Yin deficiency and dry intestines in this study as defined by both traditional Chinese and Western medicine; (2) Those with organic lesions in the rectum and colon (such as tumors Crohn's disease colonic polyps intestinal tuberculosis etc.) causing intestinal stenosis confirmed by examination; (3) Irritable bowel syndrome and constipation caused by organic or drug-related factors; secondary constipation due to endocrine metabolic neurological or surgical conditions; (4) Those with severe primary diseases such as cardiovascular liver kidney and hematopoietic system diseases mental disorders etc. that cannot tolerate constipation treatment; (5) Pregnant or lactating women or those planning to conceive; (6) Those who have received other treatments or taken related medications within one week; (7) Those who are unwilling to participate in the trial sign the informed consent form or cannot comply with the trial requirements.

研究实施时间：

Study execute time：

从From 2024-12-20

至To      2025-12-19

征募观察对象时间：

Recruiting time：

从From 2024-12-20

至To      2025-12-19

干预措施：

Interventions：

组别：

试验组

样本量：

42

Group：

Experimental Group

Sample size：

干预措施：

龙虎交战针法治疗

干预措施代码：

Intervention：

Treatment with Dragon Tiger Clash Acupuncture Technique

Intervention code：

组别：

对照组

样本量：

42

Group：

Control Group

Sample size：

干预措施：

常规针刺治疗

干预措施代码：

Intervention：

Conventional acupuncture treatment

Intervention code：

样本总量 Total sample size ： 84

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

山东

市(区县)：

济南

Country：

China

Province：

Shandong

City：

Jinan

单位(医院)：

山东中医药大学第二附属医院

单位级别：

三级甲等

Institution/hospital：

The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine

Level of the institution：

Tertiary Grade A

测量指标：

Outcomes：

指标中文名：

便秘临床评分量表

指标类型：

主要指标

Outcome：

Cleveland Clinic Score

Type：

Primary indicator

测量时间点：

治疗前和治疗结束后及治疗结束后1个月

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

焦虑自评量表

指标类型：

次要指标

Outcome：

Self-rating Anxiety Scale

Type：

Secondary indicator

测量时间点：

治疗前和治疗结束后及治疗结束后1个月

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Bristol粪便性状量表

指标类型：

次要指标

Outcome：

Bristol Stool Form Scale

Type：

Secondary indicator

测量时间点：

治疗前和治疗结束后及治疗结束后1个月

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

抑郁自评量表

指标类型：

次要指标

Outcome：

Self-rating Depression Scale

Type：

Secondary indicator

测量时间点：

治疗前和治疗结束后及治疗结束后1个月

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

便秘患者生活质量量表

指标类型：

次要指标

Outcome：

Patient Assessmentof Constipation Quality of Life questionnaire

Type：

Secondary indicator

测量时间点：

治疗前和治疗结束后及治疗结束后1个月

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

正在进行

Recruiting

年龄范围：

最小 40 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）：

本研究为随机对照研究，采用随机、单盲、平行对照的方法进行。通过 SPSS25.0 统计软件，产生 84 个随机数，按 1:1 比例随机分成对照组和治疗组，将随机数与其组别制作成数字卡片，内容包括随机数字、组别、治疗方法，将信封密封并编号，信封编号与随机顺序相同。让符合病例选取标准的患者按照就诊顺序，抽取信封，按照信封中卡片的信息，进入相应组别，进行对应治疗及评估，同时将分配序列隐藏。

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

This study is a randomized controlled trial using a randomized single-blind parallel control method. A total of 84 random numbers were generated using SPSS 25.0 statistical software and randomly divided into control and treatment groups at a 1:1 ratio. Random numbers group assignments and treatment methods were written on numbered cards sealed in envelopes and numbered in sequence corresponding to the randomization order. Patients meeting the inclusion criteria were enrolled according to their order of consultation selected an envelope and were assigned to the respective group and treatment based on the card's information. The allocation sequence was concealed.

盲法：

Blinding：

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）：

通过邮件向研究负责人索要，项目组根据情况提供。

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

Data can be requested from the research director by email and the project team will provide it according to the situation.

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：

数据采集用CRF表，研究者根据受试者的原始观察记录，将数据及时、完整、正确、清晰的载入病例报告表，录入采用相应的数据库系统双人双机录入，之后对数据库进行两边比对。电子数据文件分类保存，并有多个备份保存于不同磁盘或记录介质上，妥善保存，防止损坏。

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

Data collection was performed using Case Report Forms (CRFs). Researchers transferred data from the subjects original observation records to the CRFs in a timely complete accurate and clear manner. Data entry was conducted using a double-entry method with two individuals and two separate systems. The database entries were then cross-checked for consistency. Electronic data files were categorized and saved with multiple backups stored on different disks or recording media to ensure proper preservation and prevent damage.

数据管理委员会：

Data Managemen Committee：

有

Yes

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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