ChiCTR2500107809 版本V1.0 版本创建时间2025/08/19 11:55:37 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2500107809 

最近更新日期：

Date of Last Refreshed on：

2025-08-19 11:55:23 

注册时间：

Date of Registration：

2025-08-19 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

男性骶尾部藏毛窦的中医证型分布及与性激素的相关性研究

Public title：

Study on the Distribution of Traditional Chinese Medicine Syndromes and Their Correlation with Sex Hormones in Male Patients with Sacrococcygeal Pilonidal Sinus

注册题目简写：

English Acronym：

研究课题的正式科学名称：

男性骶尾部藏毛窦的中医证型分布及与性激素的相关性研究

Scientific title：

Study on the Distribution of Traditional Chinese Medicine Syndromes and Their Correlation with Sex Hormones in Male Patients with Sacrococcygeal Pilonidal Sinus

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：

徐星丽 

研究负责人：

吴炯 

Applicant：

Xingli Xu 

Study leader：

Jiong Wu 

申请注册联系人电话：

Applicant telephone：

+86 21 5598 1782

研究负责人电话：

Study leader's telephone：

+86 181 2120 6616

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：

1803255704@qq.com

研究负责人电子邮件：

Study leader's E-mail：

tcmoctober9@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

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：

上海市虹口区甘河路110号

研究负责人通讯地址：

上海市虹口区甘河路110号

Applicant address：

No. 110, Ganhe Road, Hongkou District, Shanghai, China

Study leader's address：

No. 110, Ganhe Road, Hongkou District, Shanghai, China

申请注册联系人邮政编码：

Applicant postcode：

200000

研究负责人邮政编码：

Study leader's postcode：

200000

申请人所在单位：

上海中医药大学附属岳阳中西医结合医院

Applicant's institution：

Shanghai University of Traditional Chinese Medicine Yueyang Hospital of Integrated Traditional Chinese and Western Medicine

研究负责人所在单位：

上海中医药大学附属岳阳中西医结合医院

Affiliation of the Leader：

Shanghai University of Traditional Chinese Medicine Yueyang Hospital of Integrated Traditional Chinese and Western Medicine

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2025-105

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

上海中医药大学附属岳阳中西医结合医院伦理委员会

Name of the ethic committee：

Ethics Committee of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2025-05-06 00:00:00

伦理委员会联系人：

殷从全

Contact Name of the ethic committee：

Congquan Yin

伦理委员会联系地址：

上海市虹口区甘河路110号

Contact Address of the ethic committee：

No. 110, Ganhe Road, Hongkou District, Shanghai, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 21 6516 1782

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

上海中医药大学附属岳阳中西医结合医院

Primary sponsor：

Shanghai University of Traditional Chinese Medicine Yueyang Hospital of Integrated Traditional Chinese and Western Medicine

研究实施负责（组长）单位地址：

上海市虹口区甘河路110号

Primary sponsor's address：

No. 110, Ganhe Road, Hongkou District, 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岳阳中西医结合医院

具体地址：

上海市虹口区甘河路110号

Institution
hospital：

Shanghai University of Traditional Chinese Medicine Yueyang Hospital of Integrated Traditional Chinese and Western Medicine

Address：

No. 110, Ganhe Road, Hongkou District, Shanghai, China

经费或物资来源：

自筹

Source(s) of funding：

Self-funded

Target disease：

sacrococcygeal pilonidal sinus

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

横断面 

Study design：

Cross-sectional 

研究目的：

本研究拟通过收集男性骶尾部藏毛窦患者的相关病例资料，开展横断面研究，分析藏毛窦的中医证型分布，结合中医辨证论治的核心理念，进一步探讨中医证候类型与潜在危险因素的相关性，尝试寻找可量化的诊断指标，以优化现代中医的辨证思路，进一步彰显“治病求本”与“因人制宜”的理论精髓。并通过回归分析探索藏毛窦与性激素的相关性，为藏毛窦的预防提供科学依据，或可降低其发病率。通过本研究，探索男性骶尾部藏毛窦患者的中医证型分布及其与性激素的相关性，将西医辨病与中医辨证相结合，期望弥补现代医学诊断之不足，并为中医药在藏毛窦的诊疗干预中提供新的学术视角和应用路径，推动中医药在这一领域的临床应用与发展。  

Objectives of Study：

This study aims to conduct a cross-sectional analysis by collecting clinical data from male patients with sacrococcygeal pilonidal sinus. It will examine the distribution of Traditional Chinese Medicine (TCM) syndrome patterns, based on the core principles of syndrome differentiation and treatment in TCM, and further explore the correlations between TCM syndromes and potential risk factors. The study seeks to identify quantifiable diagnostic indicators to optimize modern TCM diagnostic approaches and to further embody the theoretical essence of "treating the root cause of disease" and "individualized treatment." In addition, regression analysis will be used to investigate the relationship between pilonidal sinus and sex hormones, providing a scientific basis for prevention strategies that may contribute to reducing the incidence of the disease. By integrating disease diagnosis in Western medicine with syndrome differentiation in TCM, this study aims to explore the distribution of TCM syndromes and their correlation with sex hormones in male patients with sacrococcygeal pilonidal sinus, addressing gaps in current medical diagnostics and offering new academic perspectives and clinical pathways for the application of TCM in the management of pilonidal sinus. This is expected to promote further clinical development of TCM in this field.

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.骶尾部藏毛窦患者 （1）拟于我院肛肠科住院，符合骶尾部藏毛窦中、西医诊断标准的骶尾部藏毛窦患者； （2）性别为男性； （3）年龄>=18且<=40岁； （4）患者及家属对本试验表示知情、自愿参与本课题研究并签署知情同意书； 2.非骶尾部藏毛窦受试者 (1)拟于我院肛肠科住院，且未发现骶尾部藏毛窦的受试者; (2)性别为男性; (3)年龄≥18且<=40岁; (4)患者及家属对本试验表示知情、自愿参与本课题研究并签署知情同意书.

Inclusion criteria

1. Patients with sacrococcygeal pilonidal sinuses (1) Patients with sacrococcygeal pilonidal sinuses who are planned to be hospitalized in the proctology department of our hospital and meet the diagnostic criteria of traditional Chinese and Western medicine for sacrococcygeal pilonidal sinuses; (2) The gender is male; (3) Age >=18 and <=40 years old; (4) Patients and their families expressed their knowledge of this trial, voluntarily participated in this research and signed the informed consent form; 2. Subjects with non-sacrococcygeal pilonidal sinuses (1) Subjects who plan to be hospitalized in the proctology department of our hospital and do not find pilonidal sinuses in the sacrococcygeal region; (2) The gender is male; (3) Age >= 18 and <=40 years old; (4) Patients and their families expressed their knowledge of this trial, voluntarily participated in this research and signed the informed consent form.

排除标准：

1.骶尾部藏毛窦患者 (1)合并其他肛肠疾病（包括肛瘘、混合痔、克罗恩病、溃疡性结肠炎等）; (2)合并化脓性汗腺炎、聚合性痤疮、头皮蜂窝织炎等其他毛囊闭塞征; (3)合并其他与性激素相关的疾病; (4)合并有心血管、脑血管、肝、肾和造血系统等严重原发性疾病; (5)严重精神障碍患者; 2.非骶尾部藏毛窦受试者 (1)患有化脓性汗腺炎、聚合性痤疮、头皮蜂窝织炎等其他毛囊闭塞征; (2)患有其他与性激素相关的疾病; (3)患有心血管、脑血管、肝、肾和造血系统等严重原发性疾病; (4)严重精神障碍患者.

Exclusion criteria：

1. Patients with sacrococcygeal pilonidal sinuses (1) Combined with other anorectal diseases (including anal fistula, mixed hemorrhoids, Crohn's disease, ulcerative colitis, etc.); (2) Combined with hidradenitis suppurativa, aggregated acne, scalp cellulitis and other hair follicle occlusion signs; (3) Combined with other sex hormone-related diseases; (4) Combined with serious primary diseases such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system; (5) Patients with severe mental disorders; 2. Subjects with non-sacrococcygeal pilonidal sinuses (1) Suffering from hidradenitis suppurativa, convergent acne, scalp cellulitis and other hair follicle occlusion signs; (2) Suffering from other sex hormone-related diseases; (3) Suffering from serious primary diseases such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system; (4) Patients with severe mental disorders.

研究实施时间：

Study execute time：

从 From 2025-05-07 00:00:00至 To 2026-05-05 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-05-07 00:00:00 至 To 2026-02-28 00:00:00  

干预措施：

Interventions：

组别：

骶尾部藏毛窦患者组

样本量：

224

Group：

Patients with sacrococcygeal pilonidal sinus

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

组别：

非藏毛窦受试者组

样本量：

35

Group：

Non-pilonidal sinus subject group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

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岳阳中西医结合医院 

单位级别：

三甲 

Institution
hospital：

Shanghai University of Traditional Chinese Medicine Yueyang Hospital of Integrated Traditional Chinese and Western Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

性激素水平：雌激素、孕酮、睾酮、泌乳素、促黄体生成素、促卵泡生成素

指标类型：

主要指标

Outcome：

Sex hormone levels: estradiol, progesterone, testosterone, prolactin, luteinizing hormone (LH), follicle-stimulating hormone (FSH)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

病情情况：临床症状及局部体征，包括疼痛程度性质等主要症状，伴随症状以及骶尾部局部体征，包括骶尾部毛发密度、肿块大小颜色及压痛情况、成脓情况、有无渗出及溢液、窦道长度、小凹个数等

指标类型：

次要指标

Outcome：

Condition: Clinical symptoms and local signs, including main symptoms such as pain intensity and nature, accompanying symptoms, and sacrococcygeal local signs, including hair density in the sacrococcygeal region, size, color, and tenderness of the mass, suppuration status, presence of exudate or discharge, length of the sinus tract, and number of pits

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

个人史：包括吸烟、饮酒史，饮食习惯，每周洗澡次数，久坐行为等

指标类型：

次要指标

Outcome：

Personal history: Including smoking history, alcohol consumption, dietary habits, frequency of bathing per week, sedentary behavior, etc

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

家族史

指标类型：

次要指标

Outcome：

Family history

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

临床检验指标：CRP、白细胞计数

指标类型：

次要指标

Outcome：

Clinical laboratory indicators: C-reactive protein (CRP), white blood cell count

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：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 40 岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

无

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Blinding：

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

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）：

邮件联系研究者

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

Contact the researcher by 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：

本研究采用纸质版病例报告表（Case Record Form，CRF）进行数据采集，内容包括患者基本信息、临床症状体征、中医证型分布、性激素水平等信息。采集后的数据由研究者采用电子表格（Excel）进行整理和管理，确保数据完整性与准确性所有数据分析将使用SPSS软件进行统计处理。

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

which include patient demographic information, clinical symptoms and signs, distribution of Traditional Chinese Medicine (TCM) syndrome patterns, and sex hormone levels. The collected data will be organized and managed by the researchers using electronic spreadsheets (Excel) to ensure data integrity and accuracy. All statistical analyses will be performed using SPSS software.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2025-08-19 11:55:23