青附柴金颗粒治疗气滞血瘀型子宫腺肌病痛经的临床研究及智能化平台构建

注册号:

Registration number:

ITMCTR2024000455

最近更新日期:

Date of Last Refreshed on:

2024-09-19

注册时间:

Date of Registration:

2024-09-19

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

青附柴金颗粒治疗气滞血瘀型子宫腺肌病痛经的临床研究及智能化平台构建

Public title:

Clinical Research and Intelligent Platform Construction of Qingfu Chaijin Granules in Treating Dysmenorrhea of Qi Stagnation and Blood Stasis Type Uterine Adenomyosis

注册题目简写:

English Acronym:

研究课题的正式科学名称:

青附柴金颗粒治疗气滞血瘀型子宫腺肌病痛经的临床研究及智能化平台构建

Scientific title:

Clinical Research and Intelligent Platform Construction of Qingfu Chaijin Granules in Treating Dysmenorrhea of Qi Stagnation and Blood Stasis Type Uterine Adenomyosis

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:

王浩

研究负责人:

王浩

Applicant:

Wang Hao

Study leader:

Wang Hao

申请注册联系人电话:

Applicant telephone:

+86 135 8157 7090

研究负责人电话:

Study leader's telephone:

+86 135 8157 7090

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:

pgwanghao@126.com

研究负责人电子邮件:

Study leader's E-mail:

pgwanghao@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:

北京市朝阳区望京中环南路6号,中国中医科学院望京医院

研究负责人通讯地址:

北京市朝阳区望京中环南路6号,中国中医科学院望京医院

Applicant address:

No. 6 Zhonghuan South Road Wangjing Chaoyang District Beijing Wangjing Hospital Chinese Academy of Traditional Chinese Medicine

Study leader's address:

No. 6 Zhonghuan South Road Wangjing Chaoyang District Beijing Wangjing Hospital Chinese Academy of Traditional Chinese Medicine

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:

中国中医科学院望京医院

Applicant's institution:

Wangjing Hospital China Academy of Chinese Medical Sciences

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:

WJEC-KT-2024-039-P002

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:

中国中医科学院望京医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of Wangjing Hospital China Academy of Chinese Medical Sciences

伦理委员会批准日期:

Date of approved by ethic committee:

2024/7/8 0:00:00

伦理委员会联系人:

王浩

Contact Name of the ethic committee:

Wang Hao

伦理委员会联系地址:

北京市朝阳区花家地街中国中医科学院望京医院

Contact Address of the ethic committee:

Wangjing Hospital China Academy of Chinese Medical Sciences Huajiadi Street Chaoyang District Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 10 8473 9223

伦理委员会联系人邮箱:

Contact email of the ethic committee:

pgwanghao@126.com

研究实施负责(组长)单位:

中国中医科学院望京医院

Primary sponsor:

Wangjing Hospital China Academy of Chinese Medical Sciences

研究实施负责(组长)单位地址:

北京市朝阳区花家地街中国中医科学院望京医院

Primary sponsor's address:

Wangjing Hospital China Academy of Chinese Medical SciencesHuajiadi Street Chaoyang District Beijing 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):

北京市

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国中医科学院望京医院

具体地址:

北京市朝阳区花家地街中国中医科学院望京医院

Institution
hospital:

Wangjing Hospital China Academy of Chinese Medical Sciences

Address:

Wangjing Hospital China Academy of Chinese Medical SciencesHuajiadi Street Chaoyang District Beijing China

经费或物资来源:

首都卫生发展科研专项项目

Source(s) of funding:

Capital's Funds for Health Improvement and Research

研究疾病:

子宫腺肌病

研究疾病代码:

Target disease:

adenomyosis

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:

1.1 AM 痛经是临床的痛点、难点,结合临床实践,选用临床确有疗效、具有自主知识产权的国家级名老中医于增瑞教授经验方青附柴金颗粒开展高质量临床研究:通过120例样本临床试验,评价该方治疗AM 痛经的临床疗效及其安全性;为治疗AM 新药研发奠定基础。 1.2 AM 痛经病因病机复杂,故需长期甚至终身管理,但目前管理手段及管理工具缺乏、患者依从性差。本课题组意在充分发挥中医药优势特色,开展中西医结合管理体系研究,结合移动医疗、智慧医疗技术,开发基于患者的AM 长期管理工具,打造并推广AM 健康管理平台,提高医患用户体验度,为患者提供个体、持续、有效的中医药健康管理服务,帮助患者提高疾病认知、改善临床症状、预防疾病进展

Objectives of Study:

1.1 AM dysmenorrhea is a clinical pain point and difficulty. Based on clinical practice clinical efficacy and Professor Yu Zengrui a nationally renowned traditional Chinese medicine practitioner with independent intellectual property rights conducted high-quality clinical research on the experience formula Qingfu Chaijin Granules. Through 120 sample clinical trials the clinical efficacy and safety of this formula in treating AM dysmenorrhea were evaluated; To lay the foundation for the development of new drugs for the treatment of AM. 1.2 The etiology and pathogenesis of AM dysmenorrhea are complex requiring long-term or even lifelong management. However there is currently a lack of management methods and tools and poor patient compliance. Our research group aims to fully leverage the advantages and characteristics of traditional Chinese medicine conduct research on the integrated management system of traditional Chinese and Western medicine and combine mobile medical and smart medical technologies to develop patient based long-term management tools for AM. We aim to create and promote an AM health management platform improve the user experience of doctors and patients and provide patients with individual continuous and effective traditional Chinese medicine health management services to help them improve disease awareness clinical symptoms and prevent disease progression

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)符合子宫腺肌病西医诊断标准; (2)符合中医气滞血瘀证辨证标准; (3)年龄在 18-50 岁之间,月经周期规律者(月经周期 21-35 天); (4)痛经症状视觉模拟评分(VAS)≥4分; (5)自愿签署知情同意书。

Inclusion criteria

(1) Meets the Western diagnostic criteria for adenomyosis; (2) Meets the traditional Chinese medicine differentiation criteria for qi stagnation and blood stasis syndrome; (3) Individuals aged between 18-50 with regular menstrual cycles (21-35 days); (4) Visual Analog Scale (VAS) score for dysmenorrhea symptoms ≥ 4 points; (5) Voluntarily sign the informed consent form.

排除标准:

(1)未确诊的异常子宫出血或子宫内膜病变,急性盆腔炎、宫腔粘连、盆腔结核患者; (2)近1个月接受过治则相同的中药治疗的患者; (3)子宫平均径线大于10.0cm; (4)血红蛋白浓度<90g/dL; (5)血肌酐超过正常值上限或ALT、AST中任一项超过正常值上限1.5倍; (6)妊娠期或半年内准备妊娠妇女,哺乳期妇女; (7)合并有严重心、脑血管、肝、肾及造血系统、糖尿病、甲状腺疾病等严重原发性疾病、精神病患者; (8)过敏体质,以及对本药相关成份过敏者; (9)近1个月内参与其他临床研究者; (10)由于其他潜在疾病需经常服用止痛药者; (11)怀疑或确认有酒精成瘾、药物滥用病史,或者根据研究者的判断,具有降低入组可能性或使入组复杂化的其他病变或情况,如工作环境经常变动、生活环境不稳定等易造成失随访的情况; (12)研究者认为不适宜参加本临床试验者。

Exclusion criteria:

(1) Patients with undiagnosed abnormal uterine bleeding or endometrial lesions acute pelvic inflammatory disease intrauterine adhesions and pelvic tuberculosis; (2) Patients who have received the same traditional Chinese medicine treatment in the past month; (3) The average diameter of the uterus is greater than 10.0cm; (4) Hemoglobin concentration<90g/dL; (5) Blood creatinine exceeds the upper limit of normal value or any one of ALT and AST exceeds 1.5 times the upper limit of normal value; (6) Pregnant or lactating women who are preparing for pregnancy within six months; (7) Patients with serious primary diseases such as heart cerebrovascular liver kidney and hematopoietic system diabetes thyroid disease and psychosis; (8) Individuals with allergic constitution and those who are allergic to the relevant ingredients of this medicine; (9) Participated in other clinical studies within the past month; (10) Individuals who require frequent use of painkillers due to other underlying illnesses; (11) Suspecting or confirming a history of alcohol addiction or drug abuse or other lesions or conditions that based on the researcher's judgment reduce the likelihood of inclusion or complicate inclusion such as frequent changes in work environment unstable living environment etc. which can easily lead to loss of follow-up; (12) Researchers believe that participants are not suitable for this clinical trial.

研究实施时间:

Study execute time:

From 2024-07-08

To      2026-12-31

征募观察对象时间:

Recruiting time:

From 2024-07-08

To      2026-12-31

干预措施:

Interventions:

组别:

安慰剂组

样本量:

40

Group:

placebo group

Sample size:

干预措施:

青附柴金颗粒模拟剂口服,规格、外观、包装均与青附柴金颗粒相同。早晚饭后半小时开水冲服,每次1袋,每日2次,疗程3个月,经期不停药。

干预措施代码:

Intervention:

Qingfu Chaijin Granules Simulant is orally administered, with the same specifications, appearance, and packaging as Qingfu Chaijin Granules. Take it half an hour after breakfast and dinner with boiling water, 1 bag each time, twice a day, for a course of 3 months, and continue taking the medicine during menstruation.

Intervention code:

组别:

高剂量组

样本量:

40

Group:

High dose group

Sample size:

干预措施:

高剂量青附柴金颗粒剂,早晚饭后半小时开水冲服,每次1袋,每日2次,疗程3个月,经期不停药。

干预措施代码:

Intervention:

High dose Qingfu Chaijin granules taken with boiling water half an hour after meals in the morning and evening 1 bag each time twice a day for a course of 3 months without stopping during menstruation.

Intervention code:

组别:

低剂量组

样本量:

40

Group:

Low dose group

Sample size:

干预措施:

低剂量青附柴金颗粒剂,早晚饭后半小时开水冲服,每次1袋,每日2次,疗程3个月,经期不停药。

干预措施代码:

Intervention:

Low dose Qingfu Chaijin granules, taken with boiling water half an hour after meals in the morning and evening, 1 bag each time, twice a day, for a course of 3 months without stopping during menstruation.

Intervention code:

样本总量 Total sample size : 120

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国中医科学院望京医院

单位级别:

三甲

Institution/hospital:

Wangjing hospital Chinese academy of Chinese medical sciences

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

血红蛋白水平

指标类型:

次要指标

Outcome:

Hemoglobin levels

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

痛经视觉模拟量表

指标类型:

主要指标

Outcome:

Visual analogue 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:

月经量评分

指标类型:

次要指标

Outcome:

Menstrual volume score

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清 CA125水平;血清CA199 水平

指标类型:

次要指标

Outcome:

Serum CA125 levels; Serum CA199 level

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

布洛芬使用情况

指标类型:

次要指标

Outcome:

Usage of Ibuprofen

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生存质量评分

指标类型:

次要指标

Outcome:

Quality of Life Score

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

COX 痛经症状评分

指标类型:

主要指标

Outcome:

the Cox Menstrual 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:

中医证候评分

指标类型:

次要指标

Outcome:

Traditional Chinese Medicine Syndrome Score

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

子宫体积大小及局限性子宫腺肌病的病灶大小

指标类型:

次要指标

Outcome:

Uterine volume size and lesion size of localized adenomyosis

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:

正在进行

Recruiting

年龄范围:

最小 18
Min age years
最大 50
Max age years

Recruiting status:

Participant age:

性别:

Gender:

女性

Female

随机方法(请说明由何人用什么方法产生随机序列):

患者筛选合格后,研究人员登陆IWRS系统申请随机号,将IWRS系统的随机化信息打印或下载保存。

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

After the patient screening is qualified the researchers log in to the IWRS system to apply for a random number print or download the randomization information of the IWRS system and save it.

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):

即时公开

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

Real time access

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:

通过CRF表记录原始数据。

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

Record the raw data through a CRF table.

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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