红花逍遥片治疗经前期综合征(肝郁气滞证)的有效性和安全性的随机、开放、阳性药平行对照、多中心临床研究

注册号:

Registration number:

ITMCTR2200005676

最近更新日期:

Date of Last Refreshed on:

2022-03-04

注册时间:

Date of Registration:

2022-03-04

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

红花逍遥片治疗经前期综合征(肝郁气滞证)的有效性和安全性的随机、开放、阳性药平行对照、多中心临床研究

Public title:

Efficacy and safety of safflower Xiaoyao tablets in the treatment of Premenstrual syndrome (liver depression and qi stagnation syndrome): a multicenter, randomized, open, positive drug parallel controlled clinical trial

注册题目简写:

红花逍遥片治疗经前期综合征临床研究

English Acronym:

Clinical trial of safflower Xiaoyao tablets in the treatment of Premenstrual syndrome

研究课题的正式科学名称:

红花逍遥片治疗经前期综合征(肝郁气滞证)的有效性和安全性的随机、开放、阳性药平行对照、多中心临床研究

Scientific title:

Efficacy and safety of safflower Xiaoyao tablets in the treatment of Premenstrual syndrome (liver depression and qi stagnation syndrome): a multicenter, randomized, open, positive drug parallel controlled clinical trial

研究课题的正式科学名称简写:

红花逍遥片治疗经前期综合征临床研究

Scientific title acronym:

Clinical trial of safflower Xiaoyao tablets in the treatment of Premenstrual syndrome

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:

ChiCTR2200057224 ; ChiMCTR2200005676

申请注册联系人:

邵良碧

研究负责人:

李蓉

Applicant:

Liangbi Shao

Study leader:

Rong Li

申请注册联系人电话:

Applicant telephone:

13757026013

研究负责人电话:

Study leader's telephone:

010-82264567

申请注册联系人传真 :

Applicant Fax:

0570-8599868

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:

kangde6666@126.com

研究负责人电子邮件:

Study leader's E-mail:

lirong_0101@163.com

申请单位网址(自愿提供):

Study leader's website(voluntary supply):

http://www.zj-kangde.com.cn

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:

浙江省衢州市经济开发区世纪大道889号

研究负责人通讯地址:

北京市海淀区花园北路49号

Applicant address:

No.889,shiji Road Street Avenue,Economic and Technological Development zone, Quzhou City, Zhejiang Province

Study leader's address:

No.49,Huayuanbei Street,Haidian District,Beijing

申请注册联系人邮政编码:

Applicant postcode:

324000

研究负责人邮政编码:

Study leader's postcode:

申请人所在单位:

浙江康德药业集团股份有限公司

Applicant's institution:

Zhejiang Kangde Pharmaceutical Group Co.,Ltd

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:

(2022)医伦审第(020-02)号

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:

北京大学第三医院医学科学研究伦理委员会

Name of the ethic committee:

Peking University Third Hospital Medical Science Reserech Ethics Committee

伦理委员会批准日期:

Date of approved by ethic committee:

2022/2/16 0:00:00

伦理委员会联系人:

洪老师

Contact Name of the ethic committee:

Miss Hong

伦理委员会联系地址:

北京市海淀区花园北路49号

Contact Address of the ethic committee:

No.49,Huayuanbei Street,Haidian District,Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

010-82266872

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:

北京大学第三医院

Primary sponsor:

Peking University Third Hospital

研究实施负责(组长)单位地址:

北京市海淀区花园北路49号

Primary sponsor's address:

No.49,Huayuanbei Street,Haidian District,Beijing

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

浙江

市(区县):

衢州

Country:

China

Province:

Zhejiang

City:

Quzhou

单位(医院):

浙江康德药业集团股份有限公司

具体地址:

浙江省衢州市经济开发区世纪大道889号

Institution
hospital:

Zhejiang Kangde Pharmaceutical Group Co.,Ltd

Address:

No.889,shiji Road Street Avenue,Economic and Technological Development zone, Quzhou City, Zhejiang Province

经费或物资来源:

浙江康德药业集团股份有限公司

Source(s) of funding:

Zhejiang Kangde Pharmaceutical Group Co.,Ltd

研究疾病:

经前期综合征

研究疾病代码:

Target disease:

PMS

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:

上市后药物

Post-marketing clinical trial

研究目的:

(1)评价红花逍遥片治疗经前期综合征(肝郁气滞证)的有效性; (2)评价红花逍遥片临床应用的安全性。

Objectives of Study:

(1) To evaluate the efficacy of safflower Xiaoyao tablets in the treatment of premenstrual syndrome (liver depression and qi stagnation syndrome); (2)To evaluate the safety of safflower Xiaoyao tablet in clinical application.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

病例纳入标准 对一名合格的受试者,所有入选标准的回答必须为“是”。 (1)符合 PMS 西医诊断标准者; (2)符合中医辨证肝郁气滞证诊断标准者; (3)月经来潮前 5 天(黄体期)的症状严重程度每日记录量表(DRSP)总分> 50 分,DRSP 中至少有 3 个症状评分均>3 分; (4)22 天≤月经周期≤42 天; (5)18 岁≤年龄<45 岁; (6)患者本人知情同意,并签署知情同意书。

Inclusion criteria

Inclusive criteria for a qualified subject, the answer to all inclusion criteria must be "yes". (1) Those who meet the diagnostic criteria of PMS western medicine; (2) Those who meet the diagnostic criteria of liver depression and qi stagnation syndrome in traditional Chinese medicine; (3) The total score of daily record scale (DRSP) of symptom severity 5 days before menstruation (luteal phase) is more than 50, and the scores of at least three symptoms in DRSP are more than 3; (4) 22 days ≤ menstrual cycle ≤ 42 days; (5) 18 years ≤ age < 45 years; (6) The patient gave informed consent and signed the informed consent form.

排除标准:

对一名合格的受试者,所有排除标准的回答必须为“否”: (1)既往诊断乳腺肿瘤、生殖系统恶性肿瘤、多囊卵巢综合征、高泌乳素血 症、卵巢功能减退、卵巢囊肿、早发性卵巢功能不全、卵巢早衰、甲状腺功能亢 进或减退等疾病者; (2)既往被确诊为精神分裂症、焦虑症、抑郁症等精神疾病患者; (3)有睡眠障碍需要药物治疗患者; (4)合并心、脑、肝、肾及造血系统等严重原发性疾病者,其中 ALT、AST >2.0 倍正常值上限,Cr>正常值上限者; (5)合并出血性疾病患者; (6)妊娠或计划妊娠,哺乳期的女性; (7)对已知试验用药中药物成分过敏者; (8)在入组前 1 个月内参加其他相关临床研究; (9)研究者认为不适合入选者。

Exclusion criteria:

For a qualified subject, the answer to all exclusion criteria must be "no": (1) patients with previously diagnosed diseases such as breast tumor, malignant tumor of reproductive system, polycystic ovary syndrome, hyperprolactinemia, ovarian hypofunction, ovarian cyst, early-onset ovarian insufficiency, premature ovarian failure, hyperthyroidism or hypothyroidism; (2) Previously diagnosed with schizophrenia, anxiety disorder, depression and other mental diseases; (3) Patients with sleep disorders requiring medication; (4) Patients with severe primary diseases such as heart, brain, liver, kidney and hematopoietic system, in which ALT and AST > 2.0 times the upper limit of normal value and Cr > the upper limit of normal value; (5) Patients with hemorrhagic diseases; (6) Pregnant or planned pregnancy, lactating women; (7) Those who are allergic to the drug components in the known test drug; (8) Participate in other relevant clinical studies within 1 month before enrollment; (9) The researchers did not consider it suitable for inclusion.

研究实施时间:

Study execute time:

From 2021-12-01

To      2022-12-31

征募观察对象时间:

Recruiting time:

From 2022-02-20

To      2022-06-30

干预措施:

Interventions:

组别:

试验组

样本量:

120

Group:

experimental group

Sample size:

干预措施:

红花逍遥片

干预措施代码:

Intervention:

safflower Xiaoyao tablets

Intervention code:

组别:

对照组

样本量:

120

Group:

comparison group

Sample size:

干预措施:

逍遥丸

干预措施代码:

Intervention:

Xiaoyao Pill

Intervention code:

样本总量 Total sample size : 240

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

山西

市(区县):

阳泉

Country:

China

Province:

Shanxi

City:

Yangquan

单位(医院):

阳泉煤业(集团)有限责任公司总医院

单位级别:

三甲

Institution/hospital:

General Hospital of Yangquan Coal Industry (Group) Co., Ltd

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

甘肃

市(区县):

武威

Country:

China

Province:

Gansu

City:

Wuwei

单位(医院):

武威市人民医院

单位级别:

三甲

Institution/hospital:

Wuwei people's Hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

河南

市(区县):

南阳

Country:

China

Province:

Henan

City:

Nanyang

单位(医院):

南阳市第一人民医院

单位级别:

三甲

Institution/hospital:

Nanyang first people's Hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

山西

市(区县):

晋中

Country:

China

Province:

Shanxi

City:

Jinzhong

单位(医院):

晋中市第一医院

单位级别:

三甲

Institution/hospital:

Jinzhong First Hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

陕西

市(区县):

咸阳

Country:

China

Province:

Shanxi

City:

Xianyang

单位(医院):

陕西省核工业二一五医院

单位级别:

三甲

Institution/hospital:

Shanxi nuclear industry 215 hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

北京

市(区县):

丰台

Country:

China

Province:

Beijing

City:

Fengtai

单位(医院):

北京中医药大学东方医院

单位级别:

三甲

Institution/hospital:

Oriental Hospital of Beijing University of traditional Chinese Medicine

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

陕西

市(区县):

咸阳

Country:

China

Province:

Shanxi

City:

Xianyang

单位(医院):

咸阳市第一人民医院

单位级别:

三甲

Institution/hospital:

Xianyang first people's Hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

甘肃

市(区县):

兰州

Country:

China

Province:

Gansu

City:

Lanzhou

单位(医院):

甘肃中医药大学附属医院

单位级别:

三甲

Institution/hospital:

Affiliated Hospital of Gansu University of traditional Chinese Medicine

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

甘肃

市(区县):

兰州

Country:

China

Province:

Gansu

City:

Lanzhou

单位(医院):

甘肃宝石花医院

单位级别:

三甲

Institution/hospital:

Gansu baoshihua hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

河北

市(区县):

邯郸

Country:

China

Province:

Hebei

City:

Handan

单位(医院):

华北医疗健康集团峰峰总医院

单位级别:

三甲

Institution/hospital:

Fengfeng General Hospital of North China Medical and Health Group

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

四川

市(区县):

眉山

Country:

China

Province:

Sichuan

City:

Meishan

单位(医院):

眉山市中医医院

单位级别:

三甲

Institution/hospital:

Meishan traditional Chinese medicine hospital

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

北京

市(区县):

朝阳

Country:

China

Province:

Beijing

City:

Chaoyang

单位(医院):

北京中医药大学第三附属医院

单位级别:

三甲

Institution/hospital:

The Third Affiliated Hospital of Beijing University of traditional Chinese Medicine

Level of the institution:

Tertiary A hospital

国家:

中国

省(直辖市):

北京

市(区县):

海淀

Country:

China

Province:

Beijing

City:

Haidian

单位(医院):

北京大学第三医院

单位级别:

三甲

Institution/hospital:

Peking University Third Hospital

Level of the institution:

Tertiary A hospital

测量指标:

Outcomes:

指标中文名:

性激素五项(FSH、LH、E2、PRL、T)变化值

指标类型:

次要指标

Outcome:

Changes of five items of sex hormones (FSH, LH, E2, PRL, t)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

单项中医症状疗效

指标类型:

次要指标

Outcome:

Curative effect of single TCM symptom

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

月经失血图PBAC评分变化值

指标类型:

次要指标

Outcome:

PBAC score change value of menstrual blood loss map

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医证候有效率

指标类型:

次要指标

Outcome:

Effective rate of TCM Syndrome

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

DRSP 量表评分

指标类型:

主要指标

Outcome:

DRSP score

Type:

Primary 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:

尿液

组织:

Sample Name:

urine

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:

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:

尚未开始

Not yet recruiting

年龄范围:

最小 18
Min age years
最大 45
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):

采用区组随机方法,运用 SAS9.4 统计软件,试验组、对照组 1:1 的比例 用区组随机化方法产生随机编码。

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

Block random method was adopted ,the experimental group and the control group were randomly coded according to the ratio of 1:1 by using SAS9.4 statistical software.

盲法:

Blinding:

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):

试验完成后公开

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

Within six months after the tril complete

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:

电子采集和管理系统

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

Electronic Data Capture, EDC

数据管理委员会:

Data Managemen Committee:

No

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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