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基于脾虚湿瘀理论探讨加味参苓白术散干预结直肠腺瘤术后复发及炎腺转化、肠道菌群生物学特征影响

注册号：

Registration number：

ITMCTR2024000039

最近更新日期：

Date of Last Refreshed on：

2024-03-31

注册时间：

Date of Registration：

2024-03-31

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

基于脾虚湿瘀理论探讨加味参苓白术散干预结直肠腺瘤术后复发及炎腺转化、肠道菌群生物学特征影响

Public title：

Discussion on the prevention of recurrence and inflammatory gland transformation after surgery for colorectal adenomas with modified Shenling Baizhu powder based on the theory of spleen deficiency dampness and blood stasis, and the influence on the biological characteristics of intestinal flora.

注册题目简写：

加味参苓白术散干预结直肠腺瘤术后复发研究

English Acronym：

Study on the prevention of recurrence of rectal adenoma after surgery with Weicao Shen Ling Bai Zhu powder

研究课题的正式科学名称：

中医内科学

Scientific title：

Internal Medicine in Traditional Chinese Medicine

研究课题的正式科学名称简写：

中医内科

Scientific title acronym：

Traditional Chinese Medicine Internal Medicine

研究课题代号(代码)：

Study subject ID：

105701

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：

王锦程

研究负责人：

王锦程

Applicant：

Wang Jin cheng

Study leader：

Wang Jin cheng

申请注册联系人电话：

Applicant telephone：

13074973828

研究负责人电话：

Study leader's telephone：

13074973828

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：

1054608254@qq.com

研究负责人电子邮件：

Study leader's E-mail：

1054608254@qq.com

申请单位网址(自愿提供)：

Study leader's website(voluntary supply)：

https://www.zydyfy.cn/additions/ctms/

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：

贵州省贵阳市云岩区宝山北路171号贵州中医药大学第一附属医院

研究负责人通讯地址：

贵州省贵阳市云岩区宝山北路171号贵州中医药大学第一附属医院

Applicant address：

The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, No. 171, Baoshan North Road, Yunyan District, Guiyang City, Guizhou Province

Study leader's address：

The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, No. 171, Baoshan North Road, Yunyan District, Guiyang City, Guizhou Province

申请注册联系人邮政编码：

Applicant postcode：

550001

研究负责人邮政编码：

Study leader's postcode：

550001

申请人所在单位：

贵州中医药大学第一附属医院

Applicant's institution：

The First Affiliated Hospital of Guizhou 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：

KY2023-001A

伦理委员会批件附件：

Approved file of Ethical Committee：

查看附件

批准本研究的伦理委员会名称：

贵州中医药大学第一附属医院伦理委员会

Name of the ethic committee：

Ethics Committee of the First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2024/2/1 0:00:00

伦理委员会联系人：

王宝娟

Contact Name of the ethic committee：

Wang Bao juan

伦理委员会联系地址：

贵州省贵阳市云岩区宝山北路171号贵州中医药大学第一附属医院

Contact Address of the ethic committee：

The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, No. 171, Baoshan North Road, Yunyan District, Guiyang City, Guizhou Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

15208516782

伦理委员会联系人邮箱：

Contact email of the ethic committee：

2173877107@qq.com

研究实施负责（组长）单位：

贵州中医药大学第一附属医院

Primary sponsor：

The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

贵州省贵阳市云岩区宝山北路171号贵州中医药大学第一附属医院

Primary sponsor's address：

The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine, No. 171, Baoshan North Road, Yunyan District, Guiyang City, Guizhou Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中华人民共和国

省(直辖市)：

贵州省

市(区县)：

贵阳市

Country：

People's Republic of China

Province：

Guizhou Province

City：

Guiyang City

单位(医院)：

贵州中医药大学第一附属医院

具体地址：

贵州省贵阳市云岩区宝山北路171号贵州中医药大学第一附属医院

Institution
hospital：

The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

Address：

贵州省贵阳市云岩区宝山北路171号贵州中医药大学第一附属医院

经费或物资来源：

2023 年贵州中医药大学研究生教育创新计划项目

Source(s) of funding：

2023 Guizhou University of Traditional Chinese Medicine Graduate Education Innovation Program

研究疾病：

结直肠腺瘤

研究疾病代码：

Target disease：

Colorectal adenoma

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、探讨中医理论与结直肠腺瘤疾病发展及复发之间的关联性：本研究的首要目的是探讨中医脾虚湿瘀理论在结直肠腺瘤疾病发展过程中的临床诊疗认识，基于“脾虚湿瘀”这一病机，从“健脾祛湿化瘀”治则指导下开展运用加味参苓白术散干预结直肠腺瘤术后患者，验证中医脾虚湿瘀理论在该病的认识是否有效准确。 2、验证分析加味参苓白术散在结直肠腺瘤术后患者中的干预效果：本研究通过应用加味参苓白术散的干预，探究评估其对结直肠腺瘤术后患者复发情况的影响，探究其对结直肠腺瘤从炎腺转化角度的影响，对结直肠腺瘤患者肠道菌群的影响，并构建三者的临床相关性。 3、探讨相关血清学指标在结直肠腺瘤炎腺转化中的特征及影响：白介素IL-6、IL-8，肿瘤坏死因子TNF-α，在结直肠腺瘤及结直肠癌发展中具有水平变化趋势，进一步探讨二者在结直肠腺瘤炎腺转化的特征及影响。 4、研究结直肠腺瘤肠道菌群生物学特征：通过应用16SrRNA高通量测序的方法，对结直肠腺瘤患者的肠道菌群进行特征分析研究，通过观察肠道菌群丰度、多样性等角度，探究该特征影响是否与结直肠腺瘤复发、炎腺转化等相关。

Objectives of Study：

1. Explore the correlation between traditional Chinese medicine theory and the development and recurrence of colorectal adenoma disease: The primary purpose of this study is to investigate the clinical diagnosis and treatment awareness of traditional Chinese medicine theory of spleen deficiency, dampness and blood stasis in the development process of colorectal adenoma disease. Based on the pathogenesis of "spleen deficiency, dampness and blood stasis," the intervention of modified Shen Ling Bai Zhu San is carried out under the guidance of the treatment principle of "invigorating the spleen, eliminating dampness, and resolving stasis" to intervene in postoperative patients with colorectal adenoma, in order to verify whether the understanding of traditional Chinese medicine theory of spleen deficiency, dampness and blood stasis is effective and accurate in this disease. 2. Verify and analyze the intervention effect of modified Shen Ling Bai Zhu San in postoperative patients with colorectal adenoma: This study evaluates the intervention effect of modified Shen Ling Bai Zhu San on the recurrence of postoperative patients with colorectal adenoma, explores its impact on the transformation of colorectal adenoma from inflammatory gland perspective, its impact on the intestinal flora of colorectal adenoma patients, and constructs the clinical relevance among the three. 3. Investigate the characteristics and effects of relevant serological indicators in the transformation of colorectal adenoma to adenocarcinoma: Interleukin IL-6, IL-8, and Tumor Necrosis Factor TNF-α exhibit changes in levels during the development of colorectal adenoma and colorectal cancer. Further exploration is needed to investigate the characteristics and effects of these indicators in the transformation of colorectal adenoma to adenocarcinoma. 4. Study the biological characteristics of the intestinal microbiota in colorectal adenomas: By applying high-throughput sequencing of 16S rRNA, the characteristics of the intestinal microbiota in patients with colorectal adenomas are analyzed. Through observations of the abundance and diversity of the intestinal microbiota, this study aims to investigate whether these characteristics are related to colorectal adenoma recurrence, inflammation transformation, and other factors.

药物成份或治疗方案详述：

予“加味参苓白术散”，处方由贵州省中医院消化内科周素芳专家提供，由贵州省中医院中药房提供，具体药物组成：白扁豆20g、党参15g、麸炒白术20g、茯苓15g、炙甘草6g、山药30g、莲子10g、桔梗10g、薏苡仁30g、砂仁6g、白花蛇舌草20g、半枝莲15g、玄参10g；予水煎服，每天三次，每次约150ml，治疗周期为3个月，术后1年复查肠镜。

Description for medicine or protocol of treatment in detail：

The prescription of "Jiawei Shen Ling Bai Zhu San" was provided by expert Zhou Sufang from the Department of Gastroenterology at Guizhou Provincial Hospital of Traditional Chinese Medicine, and provided by the Chinese medicine pharmacy of Guizhou Provincial Hospital of Traditional Chinese Medicine. The specific composition of the medicine includes 20g of white hyacinth bean, 15g of codonopsis, 20g of fried white atractylodes, 15g of poria, 6g of licorice, 30g of Chinese yam, 10g of lotus seed, 10g of platycodon root, 30g of coix seed, 6g of amomum, 20g of snake tongue grass, 15g of half-stemmed lotus, and 10g of scutellaria. It is to be decocted in water, taken three times a day, approximately 150ml each time, with a treatment period of 3 months, followed by a colonoscopy reexamination 1 year after surgery.

纳入标准：

（1）经肠镜检查发现结直肠息肉并行内镜下息肉切除术，术后符合结直肠腺瘤诊断标准； （2）符合中医脾虚湿瘀证候诊断标准； （3）年龄在18-70岁之间，性别不限； （4）未服用有相关可能预防药物的作用如，阿司匹林、塞来昔布、叶酸片、黄连素等； （5）患者知情同意并签署同意书；

Inclusion criteria

(1) Colorectal polyps found by colonoscopy and endoscopic polypectomy were performed, which met the diagnostic criteria for colorectal adenoma after surgery; (2) Meet the diagnostic criteria for spleen deficiency and dampness stasis syndrome in traditional Chinese medicine; (3) Age between 18-70 years old, gender is not limited; (4) Not taking relevant drugs that may prevent the effects of drugs, such as aspirin, celecoxib, folic acid tablets, berberine, etc.; (5) Patient informed consent and signed consent form;

排除标准：

（1）存在严重并发症，如肠根阻，消化道出血等； （2）经病理证实发生癌变者 （3）合并有其他如锯齿状息肉、幼年型息肉综合征、家族腺瘤样息肉病等； （4）患有精神疾患，无法配合临床诊治者； （5）妊娠期妇女或哺乳期妇女； （6）合并有其他严重原发性疾病者，如肝肾心肺脏器损害者； （7）过敏体质或有多种药物过敏史者

Exclusion criteria：

(1) There are serious complications, such as intestinal root obstruction, gastrointestinal bleeding, etc.; (2) Those who have been pathologically confirmed to have cancer (3) Combined with other such as serrated polyps, juvenile polyposis syndrome, familial adenomatous polyposis, etc.; (4) Those who suffer from mental disorders and are unable to cooperate with clinical diagnosis and treatment; (5) Pregnant women or lactating women; (6) Patients with other serious primary diseases, such as liver, kidney, cardiopulmonary organ damage; (7) Those with allergies or a history of allergies to multiple drugs

研究实施时间：

Study execute time：

从From 2024-01-01

至To      2025-12-31

征募观察对象时间：

Recruiting time：

从From 2024-04-01

至To      2025-12-31

干预措施：

Interventions：

组别：

观察组

样本量：

29

Group：

Observation group

Sample size：

干预措施：

加味参苓白术散

干预措施代码：

Intervention：

modified Shenling Baizhu powder

Intervention code：

组别：

对照组

样本量：

29

Group：

Control group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

none

Intervention code：

样本总量 Total sample size ： 58

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)：

贵州省

市(区县)：

贵阳市

Country：

People's Republic of China

Province：

Guizhou Province

City：

Guiyang City

单位(医院)：

贵州中医药大学第一附属医院

单位级别：

三级甲等中医院

Institution/hospital：

The First Affiliated Hospital of Guizhou University of Traditional Chinese Medicine

Level of the institution：

Tertiary A Traditional Chinese Medicine Hospital

测量指标：

Outcomes：

指标中文名：

心电图

指标类型：

副作用指标

Outcome：

electrocardiogram

Type：

Adverse events

测量时间点：

治疗前后

测量方法：

十二导联法

Measure time point of outcome：

Before and after treatment

Measure method：

Twelve-lead ECG

指标中文名：

中医症状积分评价

指标类型：

主要指标

Outcome：

TCM symptom score evaluation

Type：

Primary indicator

测量时间点：

治疗前后

测量方法：

病史采集

Measure time point of outcome：

Before and after treatment

Measure method：

Medical history collection

指标中文名：

肠道菌群生物学特征

指标类型：

主要指标

Outcome：

Biological characteristics of the gut microbiota

Type：

Primary indicator

测量时间点：

治疗前后

测量方法：

高通量测序法

Measure time point of outcome：

Before and after treatment

Measure method：

High-throughput sequencing method

指标中文名：

血常规

指标类型：

副作用指标

Outcome：

Complete Blood Count

Type：

Adverse events

测量时间点：

治疗前后

测量方法：

化学法

Measure time point of outcome：

Before and after treatment

Measure method：

Chemical method

指标中文名：

病理检查

指标类型：

主要指标

Outcome：

Pathological examination

Type：

Primary indicator

测量时间点：

治疗前后

测量方法：

黏膜组织活检法

Measure time point of outcome：

Before and after treatment

Measure method：

Mucosal tissue biopsy

指标中文名：

肿瘤坏死因子TNF-α

指标类型：

主要指标

Outcome：

Tumor Necrosis Factor alpha (TNF-α)

Type：

Primary indicator

测量时间点：

治疗前后

测量方法：

酶联免疫法

Measure time point of outcome：

Before and after treatment

Measure method：

Enzyme-linked immunosorbent assay

指标中文名：

复发评价

指标类型：

次要指标

Outcome：

Evaluation of recurrence

Type：

Secondary indicator

测量时间点：

治疗后

测量方法：

肠镜检查

Measure time point of outcome：

After treatment

Measure method：

Colonoscopy

指标中文名：

肠镜检查

指标类型：

主要指标

Outcome：

Colonoscopy

Type：

Primary indicator

测量时间点：

治疗前后

测量方法：

电子肠镜检查

Measure time point of outcome：

Before and after treatment

Measure method：

Electronic colonoscopy

指标中文名：

肝肾功能检查

指标类型：

副作用指标

Outcome：

Liver and kidney function tests

Type：

Adverse events

测量时间点：

治疗前后

测量方法：

化学法

Measure time point of outcome：

Before and after treatment

Measure method：

Chemical method

指标中文名：

白介素IL-8

指标类型：

主要指标

Outcome：

Interleukin-8(IL-8)

Type：

Primary indicator

测量时间点：

治疗前后

测量方法：

酶联免疫法

Measure time point of outcome：

Before and after treatment

Measure method：

Enzyme-linked immunosorbent assay

指标中文名：

白介素IL-6

指标类型：

主要指标

Outcome：

Interleukin-6 (IL-6)

Type：

Primary indicator

测量时间点：

治疗前后

测量方法：

酶联免疫法

Measure time point of outcome：

Before and after treatment

Measure method：

Enzyme-linked immunosorbent assay

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

息肉黏膜

组织：

肠息肉

Sample Name：

Polyp mucosa

Tissue：

Colorectal polyps

人体标本去向

使用后保存

说明

6个月

Fate of sample 

Preservation after use

Note：

6months

标本中文名：

粪便

组织：

直肠

Sample Name：

feces

Tissue：

rectum

人体标本去向

使用后销毁

说明

3个月

Fate of sample 

Destruction after use

Note：

3months

标本中文名：

血液

组织：

静脉血

Sample Name：

blood

Tissue：

Fingertips

人体标本去向

使用后销毁

说明

3个月

Fate of sample 

Destruction after use

Note：

3months

征募研究对象情况：

尚未开始

Not yet 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）：

本研究的随机序列是由参与课题的研究员使用Excel软件生成的。该研究人员采用了随机数字生成的方法来产生随机序列。具体步骤如下：符合纳入标准的患者按照就诊先后顺序排列。研究人员使用Excel软件中的随机数函数，如RAND，生成与患者数目相等的随机数字。生成的随机数字与患者的就诊顺序进行匹配，以确定患者的分组归属。观察组和对照组均包含29例患者。通过这种随机化方法，每个患者都有被分配到观察组或对照组的机会，并且可以减少研究结果的偏倚。

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

The random sequences in this study were generated by the researchers involved in the project using Excel software. The researchers employed a random number generation method to generate random sequences. The specific steps are as follows: Patients who meet the inclusion criteria are listed in the order of presentation. The researchers used a random number function in the Excel software, such as RAND, to generate a random number equal to the number of patients. The generated random numbers are matched with the order of the patient's visit to determine the patient's grouping. Twenty-nine patients were included in both the observation and control groups. With this method of randomization, each patient has the opportunity to be assigned to either the observation group or the control group, and the bias of the study results can be reduced.

盲法：

单盲：在单盲设计中，患者不知道自己所接受的治疗是实验组还是对照组，但研究人员知道患者分组信息。这样可以减少主观偏见的发生。

Blinding：

Single-blind: In a single-blind design, patients do not know whether the treatment they are receiving is experimental or control, but the researchers know the patient grouping. This reduces the occurrence of subjective bias.

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）：

word文档

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

Word document

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：

临床病例数据采集通过病例观察表、病例报告、住院HIS系统记录、检验报告等获取，形成专门的文档管理和纸质管理，有专门研究员负责保存。

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

Clinical case data collection is obtained through case observation forms, case reports, inpatient HIS system records, laboratory reports, etc., forming specialized document management and physical management, which is managed by designated researchers.

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）：

暂无

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

no

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