A multicenter, randomized, controlled study of a novel detoxifying, detoxifying, detoxifying, detoxifying, and regulating vaginal microecology in the treatment of persistent cervical human papillomavirus infection at high risk

注册号:

Registration number:

ITMCTR2000004006

最近更新日期:

Date of Last Refreshed on:

2020-08-27

注册时间:

Date of Registration:

2020-08-27

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

新型脱毒清营栓调节阴道微生态治疗宫颈高危人乳头瘤病毒持续感染的多中心、随机、对照研究

Public title:

A multicenter, randomized, controlled study of a novel detoxifying, detoxifying, detoxifying, detoxifying, and regulating vaginal microecology in the treatment of persistent cervical human papillomavirus infection at high risk

注册题目简写:

English Acronym:

研究课题的正式科学名称:

新型脱毒清营栓调节阴道微生态治疗宫颈高危人乳头瘤病毒持续感染的多中心、随机、对照研究

Scientific title:

A multicenter, randomized, controlled study of a novel detoxifying, detoxifying, detoxifying, detoxifying, and regulating vaginal microecology in the treatment of persistent cervical human papillomavirus infection at high risk

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:

ChiCTR2000037212 ; ChiMCTR2000004006

申请注册联系人:

钱麟

研究负责人:

钱麟

Applicant:

Qian lin

Study leader:

Qian lin

申请注册联系人电话:

Applicant telephone:

+86 13816572075

研究负责人电话:

Study leader's telephone:

+86 13816572075

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:

qqqq19740@vip.sina.com

研究负责人电子邮件:

Study leader's E-mail:

qqqq19740@vip.sina.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:

上海市浦东新区张衡路528路曙光医院妇产科

研究负责人通讯地址:

上海市浦东新区张衡路528号

Applicant address:

528 Zhangheng Road, Pudong District, Shanghai, China

Study leader's address:

528 Zhangheng Road, Pudong District, Shanghai, China

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:

上海中医药大学附属曙光医院

Applicant's institution:

Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine

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:

2020-sgys-027

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:

上海中医药大学附属曙光医院伦理委员会

Name of the ethic committee:

Ethics Committee of Shuguang Hospital affiliated to Shanghai University of Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2020/8/24 0:00:00

伦理委员会联系人:

马俊坚

Contact Name of the ethic committee:

Ma Junjian

伦理委员会联系地址:

上海市浦东新区张衡路528号

Contact Address of the ethic committee:

528 Zhangheng Road, Pudong District, Shanghai, China

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:

上海中医药大学附属曙光医院

Primary sponsor:

Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

上海市浦东新区张衡路528号妇产科

Primary sponsor's address:

528 Zhangheng Road, Pudong 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曙光医院

具体地址:

浦东新区张衡路528号

Institution
hospital:

Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine

Address:

528 Zhangheng Road, Pudong District

经费或物资来源:

政府

Source(s) of funding:

The government

研究疾病:

宫颈高危人乳头瘤病毒持续感染

研究疾病代码:

Target disease:

Cervical high risk human papillomavirus (HPV) infection continues

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:

明确新型脱毒清营栓对于高危型宫颈HPV感染人群病毒的有效性及安全性;了解脱毒清营栓对于阴道内微环境及局部免疫功能的影响,探索中药的部分疗效机制,以期形成新的高危型宫颈HPV感染的中医治疗方案,降低宫颈癌的发病率,并为开发新药提供基础。

Objectives of Study:

To clarify the effectiveness and safety of the new detoxification and detoxification suppositories for high-risk cervical HPV infection population; To understand the influence of virus-free qingying suppositoryon vaginal microenvironment and local immune function, and to explore the partial therapeutic mechanism of Traditional Chinese medicine, so as to form a new traditional Chinese medicine treatment plan for high-risk cervical HPV infection, reduce the incidence of cervical cancer, and provide a basis for the development of new drugs.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

⑴ 年龄在18-55岁之间,已婚或有性生活的女性; ⑵ 既往有感染HPV病毒一年以上 ⑶ 经本院取样送检后分型报告存在宫颈HPV感染状态、中医辨证属湿毒下注型患者; ⑷ 签署知情同意书者。

Inclusion criteria

(1) Between the ages of 18 and 55, married or sexually active women; (2) Had been infected with HPV virus for more than one year; (3) After sampling and examination in our hospital, the classification reported the presence of cervical HPV infection status, and the syndrome differentiation of TRADITIONAL Chinese medicine belongs to the wet-toxin type; (4) Those who sign the informed consent.

排除标准:

⑴ 液基薄层细胞学检查(TCT)高度鳞状上皮内病变及浸润癌,或组织病理学检查CINII及以上高级别病变者; ⑵ 入组前一周内有阴道感染者; ⑶ 入组前三个月在使用其他治疗HPV感染的药物或免疫抑制药物者; ⑷ 妊娠期和哺乳期女性; ⑸ 合并有精神疾病,或者伴有机体重要脏器疾病、代谢疾病者; ⑹ 合并有传染性疾病,如肺结核、乙肝、性病者; ⑺ 有不良生活嗜好或近期接触有毒物品,如:毒品、X射线者; ⑻ 正在接受其他临床试验研究者。

Exclusion criteria:

(1) Liquid base thin layer cytological examination (TCT) of highly squamous intraepithelial lesions and infiltrating carcinoma, or histopathological examination of CINII and above high-grade lesions; (2) Vaginal infections during the week prior to enrollment; (3) Those who were using other drugs to treat HPV infection or immunosuppressive drugs in the first three months before inclusion; (4) Women during pregnancy and lactation; (5) people who have mental diseases or diseases of important organs or metabolic diseases of the body; (6) Persons with infectious diseases, such as tuberculosis, hepatitis B, or venereal diseases; (7) For bad life habits or recent exposure to toxic substances, such as drugs, X-rays; (8) Therefore, other clinical trial investigators are being accepted.

研究实施时间:

Study execute time:

From 2020-09-01

To      2021-08-31

征募观察对象时间:

Recruiting time:

From 2020-09-01

To      2021-08-31

干预措施:

Interventions:

组别:

试验组

样本量:

120

Group:

experimental group

Sample size:

干预措施:

新型托毒清营栓(阴道内给药)

干预措施代码:

Intervention:

A new Type of Totoqingying suppository (vaginal administration)

Intervention code:

组别:

对照组

样本量:

120

Group:

control group

Sample size:

干预措施:

重组人干扰素α2b 阴道泡腾胶囊(辛复宁)阴道内给药

干预措施代码:

Intervention:

Intravaginal administration of recombinant human interferon alpha 2b vaginal effervescent capsules (cinfenine)

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):

上海

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海中医药大学附属曙光医院

单位级别:

三级甲等

Institution/hospital:

Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

中医证候积分

指标类型:

次要指标

Outcome:

TCM 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:

HPV复发率

指标类型:

次要指标

Outcome:

HPV recurrence 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:

HPV转阴率

指标类型:

主要指标

Outcome:

HPV negative 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:

阴道微生态环境基因序列测定

指标类型:

次要指标

Outcome:

Gene sequencing of vaginal microecological environment

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:

阴道灌洗液

组织:

Sample Name:

Vaginal lavage fluid

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:

正在进行

Recruiting

年龄范围:

最小
Min age years
最大
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):

采用中央随机化的方法,通过基于交互式网络响应系统(IWRS)实现。

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

The method of central randomization is implemented based on interactive network response system (IWRS).

盲法:

未说明

Blinding:

Not stated

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):

病例登记表

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

Case Record Form, CRF

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:

参与数据管理的人员均需参加数据管理专业培训,具备资质。试验过程随访由研究者采用电子化数据管理系统对数据进行录入、管理及保存。通过建立组织结构确定的质量保障体系,保证临床试验数据的质量。

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

Data management personnel are required to participate in data management professional training, qualified. The researchers used electronic data management system to input, manage and save the data during the follow-up. To ensure the quality of clinical trial data by establishing a quality assurance system determined by organizational structure.

数据管理委员会:

Data Managemen Committee:

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):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above