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温肾化痰方对肾虚痰湿证多囊卵巢综合征不孕患者妊娠率及雄激素代谢的影响

注册号：

Registration number：

ITMCTR2025000410

最近更新日期：

Date of Last Refreshed on：

2025-02-25

注册时间：

Date of Registration：

2025-02-25

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

温肾化痰方对肾虚痰湿证多囊卵巢综合征不孕患者妊娠率及雄激素代谢的影响

Public title：

The effect of Wenshen Huatan Formula on pregnancy rate and androgen metabolism in infertile patients with polycystic ovary syndrome of kidney deficiency and phlegm dampness syndrome

注册题目简写：

English Acronym：

研究课题的正式科学名称：

温肾化痰方对肾虚痰湿证多囊卵巢综合征不孕患者妊娠率及雄激素代谢的影响

Scientific title：

The effect of Wenshen Huatan Formula on pregnancy rate and androgen metabolism in infertile patients with polycystic ovary syndrome of kidney deficiency and phlegm dampness syndrome

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：

黄千千

研究负责人：

辛明蔚

Applicant：

Huang Qianqian

Study leader：

Xin Mingwei

申请注册联系人电话：

Applicant telephone：

17860503224

研究负责人电话：

Study leader's telephone：

13552866767

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：

994518164@qq.com

研究负责人电子邮件：

Study leader's E-mail：

1355286676@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：

北京市东城区北池子大街骑河楼17号

研究负责人通讯地址：

北京市东城区北池子大街骑河楼17号

Applicant address：

No. 17 Qihelou, Beichizi Street, Dongcheng District, Beijing

Study leader's address：

No. 17 Qihelou, Beichizi Street, Dongcheng District, Beijing

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：

首都医科大学附属北京妇产医院

Applicant's institution：

Beijing Obstetrics and Gynecology Hospital Affiliated to Capital Medical University

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：

2023-KY-092-01

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：

首都医科大学附属北京妇产医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Beijing Obstetrics and Gynecology Hospital Affiliated to Capital Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2023/11/13 0:00:00

伦理委员会联系人：

赵娟

Contact Name of the ethic committee：

Zhao Juan

伦理委员会联系地址：

北京市朝阳区姚家园路251号

Contact Address of the ethic committee：

No. 251 Yaojiayuan Road Chaoyang District Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

85968407

伦理委员会联系人邮箱：

Contact email of the ethic committee：

fcyylunli@163.com

研究实施负责（组长）单位：

首都医科大学附属北京妇产医院

Primary sponsor：

Beijing Obstetrics and Gynecology Hospital Affiliated to Capital Medical University

研究实施负责（组长）单位地址：

首都医科大学附属北京妇产医院

Primary sponsor's address：

Beijing Obstetrics and Gynecology Hospital Affiliated to Capital Medical University

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)：

北京市

Country：

China

Province：

Beijing

City：

Beijing

单位(医院)：

首都医科大学附属北京妇产医院

具体地址：

北京市朝阳区姚家园路251号

Institution
hospital：

Beijing Obstetrics and Gynecology Hospital Affiliated to Capital Medical University

Address：

No. 251 Yaojiayuan Road Chaoyang District Beijing

经费或物资来源：

北京市中医药科技发展资金项目

Source(s) of funding：

Beijing Traditional Chinese Medicine Technology Development Fund Project

研究疾病：

多囊卵巢综合征

研究疾病代码：

Target disease：

Polycystic ovary syndrome

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：

治疗新技术临床试验

New Treatment Measure Clinical Study

研究目的：

1、通过分析试验组和对照组治疗后妊娠率、排卵率以及治疗前后中医证候评分、胰岛素抵抗指数的变化，明确温肾化痰方治疗肾虚痰湿证PCOS患者不孕的优效性； 2、通过分析试验组和对照组治疗前后雄激素水平的变化，明确温肾化痰方改善肾虚痰湿证PCOS不孕合并高雄激素血症患者雄激素代谢的有效性； 3、通过进行安全性评价为大范围开展温肾化痰方治疗肾虚痰湿证PCOS不孕患者奠定基础。

Objectives of Study：

1. By analyzing the changes in pregnancy rate, ovulation rate, TCM syndrome score, and insulin resistance index before and after treatment in the experimental and control groups, the superiority of Wenshen Huatan Formula in treating infertility in PCOS patients with kidney deficiency and phlegm dampness syndrome was clarified; 2. By analyzing the changes in androgen levels before and after treatment in the experimental group and control group, the effectiveness of Wenshen Huatan Formula in improving androgen metabolism in PCOS infertility patients with kidney deficiency and phlegm dampness syndrome combined with hyperandrogenism was clarified; 3. By conducting safety evaluations, we lay the foundation for the widespread use of Wenshen Huatan Formula in the treatment of PCOS infertility patients with kidney deficiency and phlegm dampness syndrome.

药物成份或治疗方案详述：

温肾化痰方主要组成为主要组成为肉苁蓉、鹿角、淫羊藿、枸杞子、柴胡、当归、清半夏、橘红、白术、茯苓、香附等。中药材供应为北京同仁堂股份有限公司。 来曲唑组，来曲唑，2.5mg/片。生产企业：大连美仑生物技术有限公司。 所有研究用药均检验合格。

Description for medicine or protocol of treatment in detail：

The main components of Wenshen Huatan Formula include Cistanche deserticola, Antlers antler, Epimedium, Goji berry, Bupleurum chinense, Angelica sinensis, Pinellia ternata, Citrus reticulata, Atractylodes macrocephala, Poria cocos, and Aconitum carmichaelii. The supply of traditional Chinese medicine is provided by Beijing Tongrentang Co., Ltd. Letrozole group, Letrozole, 2.5mg/tablet. Production enterprise: Dalian Meilun Biotechnology Co., Ltd. All research drugs have passed the inspection.

纳入标准：

（1）符合上述中医辨证及西医诊断标准者。 （2）合并高雄激素血症患者（睾酮、游离睾酮、雄烯二酮、硫酸脱氢表雄酮任何一项升高均可纳入）。 （3）年龄在18-40岁之间(包括18岁与40岁)，有生育要求者。 （4）患者愿意接受试验措施和对照措施，并签署知情同意书，可随访者。

Inclusion criteria

(1) Those who meet the above traditional Chinese medicine syndrome differentiation and Western medicine diagnostic criteria. (2) Patients with combined hyperandrogenism (elevated levels of testosterone, free testosterone, androstenedione, and dehydroepiandrosterone sulfate can be included). (3) Individuals between the ages of 18 and 40 (including 18 and 40) who have a desire to have children. (4) Patients who are willing to accept experimental and control measures, sign informed consent forms, and are eligible for follow-up.

排除标准：

（1）既往用来曲唑促排卵无效者。 （2）经检查为生殖器官器质性病变(如子宫肌瘤、子宫腺肌病、垂体肿瘤等)引起的月经不调者。 （3）患有肾上腺皮质增生综合征、甲状腺疾病或肿瘤等；功能性子宫出血；原发性糖尿病和内分泌紊乱性疾病；存在其他原因引起的高雄激素血症。 （4）合并有肝肾、心血管、脑血管和造血系统等原发性疾病及精神病患者。 （5）过敏体质，如对两种或以上药物或食物过敏史者；或已知的本药成分过敏者。 （6）正在参加其他药物临床试验的患者。 （7）不能配合治疗，不能随访者。

Exclusion criteria：

(1) Those who have been ineffective in using trastuzumab to induce ovulation in the past. (2) Menstrual disorders caused by organic lesions of the reproductive organs (such as uterine fibroids, adenomyosis, pituitary tumors, etc.) after examination. (3) Suffering from adrenal hyperplasia syndrome, thyroid disease, or tumors, etc; Functional uterine bleeding; Primary diabetes and endocrine disorders; There are other causes of hyperandrogenism. (4) Patients with primary diseases such as liver and kidney, cardiovascular, cerebrovascular, and hematopoietic systems, as well as psychiatric disorders. (5) Allergic constitution, such as a history of allergies to two or more drugs or foods; Or those who are allergic to known ingredients of this medicine. (6) Patients who are currently participating in clinical trials of other drugs. (7) Those who cannot cooperate with treatment and cannot be followed up.

研究实施时间：

Study execute time：

从From 2023-09-01

至To      2025-08-01

征募观察对象时间：

Recruiting time：

从From 2023-11-14

至To      2025-08-01

干预措施：

Interventions：

组别：

试验组

样本量：

40

Group：

Test group

Sample size：

干预措施：

中西医结合治疗

干预措施代码：

Intervention：

conbined treatment of traditional chinese medicine and western medicine

Intervention code：

组别：

对照组

样本量：

40

Group：

control group

Sample size：

干预措施：

西药治疗

干预措施代码：

Intervention：

Comparison with Western Medicine Treatment

Intervention code：

样本总量 Total sample size ： 80

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)：

北京

Country：

China

Province：

Beijing

City：

Beijing

单位(医院)：

首都医科大学附属北京妇产医院

单位级别：

三级甲等医院

Institution/hospital：

Beijing Obstetrics and Gynecology Hospital Affiliated to Capital Medical University

Level of the institution：

Class A tertiary hospital

测量指标：

Outcomes：

指标中文名：

排卵率

指标类型：

次要指标

Outcome：

ovulation rate

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

雄激素

指标类型：

主要指标

Outcome：

testosterone

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

妊娠率

指标类型：

主要指标

Outcome：

Pregnancy rate

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

胰岛素抵抗指数

指标类型：

次要指标

Outcome：

HOMA-IR

Type：

Secondary 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：

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 岁
Min age years
最大 40 岁
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）：

课题组医生借助SPSS22.0统计软件编辑各组，产生80例受试者所接受处理的随机安排（即随机编码表）。根据随机数字表，将研究用药分为对照组、试验组发给患者。患者将按比率随机入组。

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

The doctors in the research group used SPSS 22.0 statistical software to edit each group and generated a random arrangement (i.e. random coding table) of 80 subjects who received the treatment. According to the random number table, the study medication was divided into a control group and an experimental group and distributed to patients. Patients will be randomly assigned to the group according to the ratio.

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）：

计划于2025年12月于RESMAN临床试验公共管理平台公布,网址http://d.medsci.cn

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

-

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：

研究者根据受试者的原始观察记录，将数据及时、完整、正确、清晰地载入病例报告表。 监查员监查研究的进行是否遵循研究方案。确认所有病例报告表填写正确完整，并与原始资料一致。如有错误和遗漏，及时要求研究者改正。修改时需保持原有记录清晰可见，改正处需经研究者签名并注明日期。 经过监查员检查后的病例报告表，由监查员核查签字后，及时送交临床研究数据管理员。对于完成的病例报告表在研究者、监查员、数据管理员之间的传送应有专门的记录，收到时应有相应的签名，记录需妥善保存。 数据管理员在数据录入前再次核查，发现问题及时通知监查员，要求研究者作出回答。他们间的各种疑问及解答的交换应当采用疑问表形式，疑问表应保存备查。 数据管理员在进行数据录入前，要了解观察表格各项目的内容及编码情况，将编码工作过程记录于编码本保存。数据库命名应规范、易读、易查找。并保证其正确、安全和保密。 数据录入员录入数据采用二次录入Excel表。录入过程发现问题或意外情况，应做好登记并及时报告，以便迅速处理问题，数据录入结束后应抽查部分观察表格，了解录入质量，分析并处理存在的问题。 数据管理员应与主要研究者一起，按病例报告表中各指标数值的范围和相互关系拟定数据范围检查和逻辑检查内容。并编写相应的计算机程序，在输入前控制错误数据输入，找出错误原因加以改正，所有错误内容及修改结果应有记录并妥善保存。 原始病例报告表在按要求完成数据录入和核查后，按编号的顺序归档保存，并填有检索目录等，以备查考。电子数据文件包括数据库、检查程序、分析程序、分析结果、编码本和说明文件等，应分类保存，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。所有原始档案应按我国的有关规定期限保存

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

The researchers timely, completely, correctly, and clearly recorded the data in the case report form based on the original observation records of the subjects. The inspector monitors whether the research is conducted in accordance with the research protocol. Confirm that all case report forms are filled in correctly and completely, and consistent with the original data. If there are any errors or omissions, promptly request the researcher to correct them. When making modifications, the original records must be kept clear and visible, and any corrections must be signed and dated by the researcher. After being inspected by the inspector, the case report form shall be verified and signed by the inspector, and promptly submitted to the clinical research data administrator. There should be dedicated records for the transmission of completed case report forms between researchers, monitors, and data administrators, and corresponding signatures should be provided upon receipt. The records should be properly kept. The data administrator checks again before data entry, promptly notifies the monitor if any problems are found, and requests the researcher to provide answers. The exchange of various questions and answers between them should be in the form of a question sheet, which should be kept for future reference. Before entering data, the data administrator should understand the content and coding situation of each item in the observation table, and record the coding process in the coding book. Database naming should be standardized, easy to read, and searchable. And ensure its correctness, security, and confidentiality. The data entry personnel use a secondary input Excel table to input data. If any problems or unexpected situations are found during the data entry process, they should be registered and reported in a timely manner for quick resolution. After the data entry is completed, some observation forms should be randomly checked to understand the quality of the entry, analyze and handle the existing problems. The data administrator should work with the primary researchers to develop data range and logic checks based on the range and interrelationships of each indicator value in the case report form. And write corresponding computer programs to control erroneous data input before input, identify the cause of the error and correct it. All erroneous content and modification results should be recorded and properly saved. After completing data entry and verification as required, the original case report form is archived and saved in the order of numbering, and a search directory is filled in for future reference. Electronic data files, including databases, inspection programs, analysis programs, analysis results, codebooks, and instruction files, should be classified and saved, with multiple backups stored on different disks or recording media, properly stored to prevent damage. All original archives should be kept for the prescribed period in accordance with relevant regulations in China

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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