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Traditional Chinese medicine formulation combined with promestriene in the treatment of genitourinary syndrome of menopause (GSM) : a randomized, double-blind, controlled clinical trial

注册号：

Registration number：

ITMCTR2000003596

最近更新日期：

Date of Last Refreshed on：

2020-08-21

注册时间：

Date of Registration：

2020-08-21

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

中药配方制剂联合局部雌激素治疗绝经泌尿生殖综合征（GSM）：一项随机、双盲、对照临床试验

Public title：

Traditional Chinese medicine formulation combined with promestriene in the treatment of genitourinary syndrome of menopause (GSM) : a randomized, double-blind, controlled clinical trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

上海市申康医院发展中心促进市级医院临床技能与临床创新三年行动计划：中药配方制剂联合局部雌激素治疗绝经泌尿生殖综合征（GSM）——一项随机、双盲、对照临床试验

Scientific title：

Traditional Chinese medicine formulation combined with promestriene in the treatment of genitourinary syndrome of menopause (GSM) : a randomized, double-blind, controlled clinical trial

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：

ChiCTR2000036007 ; ChiMCTR2000003596

申请注册联系人：

顾倪浩

研究负责人：

许泓

Applicant：

Ni-hao Gu

Study leader：

Hong Xu

申请注册联系人电话：

Applicant telephone：

+86 13817296773

研究负责人电话：

Study leader's telephone：

+86 18017316266

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：

marcogoo@sjtu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

xuhong1168@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：

上海市徐汇区广元路145号

研究负责人通讯地址：

上海市徐汇区衡山路910号

Applicant address：

145 Guangyuan Road, Xuhui District, Shanghai, China

Study leader's address：

NO.910,Hengshan Road,Xuhui District,Shanghai

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：

上海交通大学医学院附属国际和平妇幼保健院

Applicant's institution：

International Peace Maternity & Child Health Hospital affiliated with Shanghai Jiao Tong University School of Medicine, Shanghai 200030, China

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：

国科伦委（GKLW）2020-28

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：

国际和平妇幼保健院科研伦理委员会

Name of the ethic committee：

The research ethics committee of International Peace Maternity & Child Health Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2020/8/15 0:00:00

伦理委员会联系人：

张延菲

Contact Name of the ethic committee：

Yan-fei Zhang

伦理委员会联系地址：

上海市徐汇区衡山路910号

Contact Address of the ethic committee：

NO.910,Hengshan Road,Xuhui District,Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

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：

上海交通大学医学院附属国际和平妇幼保健院

Primary sponsor：

International Peace Maternity & Child Health Hospital affiliated with Shanghai Jiao Tong University School of Medicine, Shanghai 200030, China

研究实施负责（组长）单位地址：

上海市徐汇区衡山路910号

Primary sponsor's address：

NO.910,Hengshan Road,Xuhui District,Shanghai

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)：

上海交通大学医学院附属国际和平妇幼保健院

具体地址：

上海市徐汇区衡山路910号

Institution
hospital：

International Peace Maternity & Child Health Hospital affiliated with Shanghai Jiao Tong University School of Medicine, Shanghai 200030, China

Address：

NO.910,Hengshan Road,Xuhui District,Shanghai

经费或物资来源：

上海市申康医院发展中心

Source(s) of funding：

Shanghai Hospital Development Center

研究疾病：

绝经泌尿生殖综合征

研究疾病代码：

Target disease：

genitourinary syndrome of menopause, GSM

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：

绝经泌尿生殖综合征（genitourinary syndrome of menopause，GSM）是一种雌激素水平低下引起的疾病，以生殖道症状、泌尿道症状和性功能障碍为主要表现，绝经期及绝经后妇女的发病率超过50%。目前，绝经泌尿生殖综合征的诊断主要依靠患者的症状和体征；而治疗GSM的一线用药是局部雌激素治疗，疗效较为肯定，但仍存在适用人群的局限性与激素长期运用带来的不良风险。因此，对GSM人群的精准诊治，以及寻找进一步提高疗效同时可以逐步减少、优化激素使用，显效缓解患者症状、减轻激素相关不良反应的联合治疗方法是GSM诊疗所面临的重要课题。中医药在防治GSM的基础和临床研究上亦取得了不少成果，同时总结出了许多宝贵的用药经验。本项目运用基于前期动物模型研究成果的中药方（缩泉回春方），联合局部普罗雌烯治疗GSM，并设计了一组随机、双盲、对照的临床试验评价其疗效。 本项目以绝经泌尿生殖综合征三大主要表现和中医辨证结合的计分量表，为整个实验方案提供一种准确、可量化的评价标准。对符合纳入标准的人群进行统计，并按照缩泉回春方联合局部普罗雌烯组和安慰剂加局部普罗雌烯组1：1对纳入人群随机分组。在入组时、用药3个月、停药3个月分别填写量表并进行相关辅助检查。以包含症状（生殖道症状、泌尿道症状、性功能障碍症状）及中医辨证（“阴痿”、“阴枯”、“淋证”）的绝经泌尿生殖综合征计分量表为主要指标；以泌尿系统影像学检测、尿动力检测、细胞学检测、阴道pH测定与阴道健康评分、女性性功能指数量表、泌尿道、生殖道、肠道微生物多样性测序、非靶向代谢组学测定为次要指标；收集所有数据后，统计并对比缩泉回春方联合局部普罗雌烯与单用局部普罗雌烯缓解GSM症状的临床疗效，根据泌尿道、生殖道、肠道微生物多样性测序及非靶向代谢组测序结果寻找潜在的治疗靶标。本项目能够为研究人员比较不同方法治疗GSM的临床效果时提供准确、可量化的参考，开发改善GSM临床疗效的中西医结合特征明显的临床治疗方案。

Objectives of Study：

Genitourinary syndrome of menopause (GSM) is a disease caused by low level of estrogen and mainly characterized by symptoms of genital tracturinary tract and sexual dysfunction. The incidence of the disease is more than 50% in menopausal and postmenopausal women. At present, the diagnosis of genitourinary syndrome of menopause mainly depends on the symptoms and signs of patients. The first-line drug for the treatment of GSM is local use of estrogen, the curative effect is relatively certain, but there are still limitations of the applicable population and the adverse risk of long-term use of hormone. Therefore, accurate diagnosis and treatment of GSM, and finding a combination therapy that can further improve the efficacy, and gradually reduce, optimize the use of hormones, relieve symptoms of patients and reduce hormone related adverse reactions is an important issue about GSM. Traditional Chinese medicine has also made a lot of achievements in the basic and clinical research on the prevention and treatment of GSMand has summed up many valuable experiences about drug use. In this project, we used Chinese medicine (Suoquan Huichun prescription) that based on the previous animal model research results to combine with local promestriene in the treatment of GSM, and designed a group of randomized, double-blind, controlled clinical trials to evaluate its efficacy. This project provides an accurate and quantifiable evaluation standard for the whole experimental scheme based on the scoring scale including the three main manifestations of menopausal urogenital syndrome and TCM syndrome differentiation. The people who meet the inclusion criteria were statistically analyzed and randomly divided into Suoquan Huichun decoction combined with local promestriene group and placebo combined with local promestriene group with a ratio of 1:1. At the time of enrollment, 3 months of medication and 3 months of withdrawal, we all asked the patient to fill out the scale and perform relevant auxiliary examinations. In our project, the main indicators were the scoring scale including the three symptoms of genital tract，urinary tract and sexual dysfunction and TCM syndrome differentiation about impotence，yinku and stranguria. The secondary indicators were urinary system imaging, urodynamic, cytology, vaginal pH measurement and vaginal health score, female sexual function index scale, urinary tract, reproductive tract, intestinal microbial diversity sequencing, and non-targeted metabolomics. After all the data were collected, the clinical efficacy of Suoquan Huichun decoction combined with local progesterone and single use of local progesterone to alleviate GSM symptoms was statistically analyzed and compared. Potential therapeutic targets were found according to the results of urinary tract, reproductive tract, intestinal microbial diversity and no targeted metabonomic sequencing results. This project can provide accurate and quantifiable reference for researchers to compare the clinical effects of different methods in the treatment of GSM, and develop a clinical treatment scheme with obvious characteristics of integrated traditional Chinese and Western medicine to improve the clinical efficacy of GSM.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

1.2纳入标准 1.2.1符合GSM诊断标准，年龄＞40周岁绝经女性； 1.2.2至少近3个月内未用激素类药物者； 1.2.3自愿参加本实验，并签署知情同意书者。

Inclusion criteria

1.2 inclusion criteria 1.2.1 the postmenopausal women meeting the GSM diagnostic criteria and age over 40 years old 1.2.2 the people of no use of hormonal drugs at least 3 months 1.2.3 the people volunteered for the experiment, and signed the informed consent

排除标准：

1.3排除标准 1.3.1未婚、离婚、寡居等原因无性伴侣者； 1.3.2 3个月内有 GnRH-a 及甾体类激素使用史者； 1.3.3左炔诺孕酮宫内缓释系统放置者； 1.3.4合并心脑血管、肝、肾、糖尿病、恶性肿瘤等严重疾病患者； 1.3.5精神病患者以及长期饮酒或服药影响认知； 1.3.6凝血功能障碍及既往有血栓性疾病的患者； 1.3.7正在参加其他药物临床实验者。

Exclusion criteria：

1.3 exclusion standard 1.3.1the people without sexual partners because of unmarried, divorced, widowed and other reasons 1.3.2 the people who use GnRH - a or steroid hormone in three months 1.3.3 the people who place levonorgestrel intrauterine sustained release system into uterus 1.3.4 the people who have severe disease about heart and cerebral vessels or liver or kidney or diabetes or malignant tumor or the others. 1.3.5 the people who affect cognition on account of mental disorder or medicine or chronic drinking 1.3.6 the people who have coagulation dysfunction or thrombotic disease 1.3.7 the people who participate in other drug clinical trials

研究实施时间：

Study execute time：

从From 2020-10-01

至To      2022-09-30

征募观察对象时间：

Recruiting time：

从From 2020-10-01

至To      2021-12-31

干预措施：

Interventions：

组别：

对照组

样本量：

150

Group：

Control group

Sample size：

干预措施：

安慰剂颗粒+普罗雌烯

干预措施代码：

Intervention：

The placebo combined with promestriene

Intervention code：

组别：

观察组

样本量：

150

Group：

Observation group

Sample size：

干预措施：

缩泉回春方+普罗雌烯

干预措施代码：

Intervention：

Traditional Chinese medicine formulation combined with promestriene

Intervention code：

样本总量 Total sample size ： 300

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)：

上海交通大学医学院附属国际和平妇幼保健院

单位级别：

三级甲等

Institution/hospital：

International Peace Maternity & Child Health Hospital affiliated with Shanghai Jiao Tong University School of Medicine, Shanghai 200030, China

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

泌尿道、生殖道、肠道微生物多样性测序

指标类型：

次要指标

Outcome：

High-throughput sequencing technoligy for the diversity of urinary tract, reproductive tract& gut microbiota

Type：

Secondary indicator

测量时间点：

在治疗前与口服中药方3月停药时、停药后3个月重复测定

测量方法：

16S rDNA特定区段PCR产物高通量测序

Measure time point of outcome：

The test was repeated before treatment and at the time of discontinuation of oral traditional Chinese medicine for 3 months and 3 months after discontinuation of medicine

Measure method：

High throughput sequencing of 16S rDNA specific segment PCR products

指标中文名：

女性性功能指数量表

指标类型：

次要指标

Outcome：

CVFSFI Score Scale

Type：

Secondary indicator

测量时间点：

治疗前与口服中药方3月（每月1次）、停药后3个月

测量方法：

女性性功能指数量表

Measure time point of outcome：

Before the treatment, take Chinese medicine for 3 months(every mouth) and stop for 3 months

Measure method：

CVFSFI Score Scale

指标中文名：

血清肝肾功能水平监测

指标类型：

副作用指标

Outcome：

Serum liver and kidney function level monitoring

Type：

Adverse events

测量时间点：

在治疗前与口服中药方3月停药时、停药后3个月重复测定

测量方法：

化学发光免疫分析法

Measure time point of outcome：

The test was repeated before treatment and at the time of discontinuation of oral traditional Chinese medicine for 3 months and 3 months after discontinuation of medicine

Measure method：

Chemiluminescence immunoassay

指标中文名：

生存质量测定量表QOL评分表

指标类型：

次要指标

Outcome：

QOL Score Scale

Type：

Secondary indicator

测量时间点：

治疗前与口服中药方3月（每月1次）、停药后3个月

测量方法：

生存质量测定量表QOL评分表

Measure time point of outcome：

Before the treatment, take Chinese medicine for 3 months(every mouth) and stop for 3 months

Measure method：

QOL Score Scale

指标中文名：

血清性激素水平监测

指标类型：

副作用指标

Outcome：

Serum E2&FSH levels delection

Type：

Adverse events

测量时间点：

在治疗前与口服中药方3月停药时、停药后3个月重复测定

测量方法：

化学发光免疫分析法

Measure time point of outcome：

The test was repeated before treatment and at the time of discontinuation of oral traditional Chinese medicine for 3 months and 3 months after discontinuation of medicine

Measure method：

Chemiluminescence immunoassay

指标中文名：

绝经泌尿生殖综合征分期量表

指标类型：

主要指标

Outcome：

GSM Score Scale

Type：

Primary indicator

测量时间点：

治疗前与口服中药方3月（每月1次）、停药后3个月

测量方法：

绝经泌尿生殖综合征分期量表

Measure time point of outcome：

Before the treatment, take Chinese medicine for 3 months(every mouth) and stop for 3 months

Measure method：

GSM Score Scale

指标中文名：

证候量化评分

指标类型：

主要指标

Outcome：

Traditional Chinese Medicine Syndrome Score Scale

Type：

Primary indicator

测量时间点：

治疗前与口服中药方3月（每月1次）、停药后3个月

测量方法：

证候量化评分

Measure time point of outcome：

Before the treatment, take Chinese medicine for 3 months(every mouth) and stop for 3 months

Measure method：

Traditional Chinese Medicine Syndrome Score Scale

指标中文名：

细胞学检测

指标类型：

次要指标

Outcome：

Cytological detection

Type：

Secondary indicator

测量时间点：

治疗前与口服中药方3月（每月1次）、停药后3个月

测量方法：

细胞巴氏染色法

Measure time point of outcome：

Before the treatment, take Chinese medicine for 3 months(every mouth) and stop for 3 months

Measure method：

Cell staining

指标中文名：

尿动力检测

指标类型：

次要指标

Outcome：

Urodynamic test

Type：

Secondary indicator

测量时间点：

在治疗前与口服中药方停药后重复测定1次

测量方法：

重量-时间法（承重法）

Measure time point of outcome：

The measurements were repeated 1 time before treatment and after discontinuation of oral traditional Chinese medicine.

Measure method：

Weight-time method (Load-Bearing method)

指标中文名：

影像学检查

指标类型：

副作用指标

Outcome：

Imageological examination

Type：

Adverse events

测量时间点：

在治疗前与口服中药方3月停药时、停药后3个月重复测定

测量方法：

超声、钼靶

Measure time point of outcome：

The test was repeated before treatment and at the time of discontinuation of oral traditional Chinese medicine for 3 months and 3 months after discontinuation of medicine

Measure method：

B-US&Mammary gland molybdenum target

指标中文名：

泌尿系统影像学检测

指标类型：

次要指标

Outcome：

Imaging examination of urinary system

Type：

Secondary indicator

测量时间点：

治疗前与口服中药方3月（每月1次）、停药后3个月

测量方法：

超声

Measure time point of outcome：

Before the treatment, take Chinese medicine for 3 months(every mouth) and stop for 3 months

Measure method：

B-US

指标中文名：

阴道pH测定与阴道健康评分

指标类型：

次要指标

Outcome：

Vaginal pH measurement and vaginal health score

Type：

Secondary indicator

测量时间点：

治疗前与口服中药方3月（每月1次）、停药后3个月

测量方法：

酸碱指示剂溴酚蓝

Measure time point of outcome：

Before the treatment, take Chinese medicine for 3 months(every mouth) and stop for 3 months

Measure method：

The acid-base indicator bromophenol blue

指标中文名：

非靶向代谢组学测定

指标类型：

次要指标

Outcome：

Untargeted metabonomics method

Type：

Secondary indicator

测量时间点：

在治疗前与口服中药方3月停药时、停药后3个月重复测定

测量方法：

液-质相联用法

Measure time point of outcome：

The test was repeated before treatment and at the time of discontinuation of oral traditional Chinese medicine for 3 months and 3 months after discontinuation of medicine

Measure method：

LC–MS/MS

指标中文名：

更年期相关症状的kupperman评分表

指标类型：

次要指标

Outcome：

Kupperman Score Scale

Type：

Secondary indicator

测量时间点：

治疗前与口服中药方3月（每月1次）、停药后3个月

测量方法：

更年期相关症状的kupperman评分表

Measure time point of outcome：

Before the treatment, take Chinese medicine for 3 months(every mouth) and stop for 3 months

Measure method：

Kupperman Score Scale

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：

标本中文名：

分泌物

组织：

泌尿道、生殖道、肠道

Sample Name：

Secreta

Tissue：

Urinary tract, reproductive tract& intestinal tract

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：

尚未开始

Not yet recruiting

年龄范围：

最小 40 岁
Min age years
最大 99 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）：

随机、双盲：由专人采用计算机编程随机法产生的0或1，0或1分别为观察组（缩泉回春方+普罗雌烯）、对照组（安慰剂+普罗雌烯）。符合入选标准的病人，按就诊顺序，专人依次按计算机随机数字分别计入观察组、对照组。过程中，研究者、观察对象均对分组情况未知。

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

0 or 1 generated randomly by specially-assigned person by computer programming was divided into observation group and control group .

盲法：

双盲

Blinding：

Double blind

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）：

2021年12月，在国际和平妇幼保健院的官网的科研专栏。网址：https://www.ipmch.com.cn/hospital/channels/196.html

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

the research department of the official website of IPMCH in December 2021 .Website:https://www.ipmch.com.cn/hospital/channels/196.html

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：

使用患者信息采集表进行患者的数据采集，利用Excel和SPSS进行数据管理。

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

The patient information collection form was used for patient data collection, and Excel and SPSS were used for data management.

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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