灵归养元膏治疗少、弱精子症肾虚血瘀证有效性和安全性的 多中心、随机、双盲、双模拟平行对照临床试验

注册号:

Registration number:

ITMCTR2023000009

最近更新日期:

Date of Last Refreshed on:

2023-05-18

注册时间:

Date of Registration:

2023-05-18

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

灵归养元膏治疗少、弱精子症肾虚血瘀证有效性和安全性的 多中心、随机、双盲、双模拟平行对照临床试验

Public title:

Linggui Yangyuan Paste for patients with male infertility: a multicenter, double-blind, double-dummy, randomized controlled trial

注册题目简写:

English Acronym:

研究课题的正式科学名称:

灵归养元膏治疗少、弱精子症肾虚血瘀证有效性和安全性的 多中心、随机、双盲、双模拟平行对照临床试验

Scientific title:

Linggui Yangyuan Paste for patients with male infertility: a multicenter, double-blind, double-dummy, randomized controlled 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:

申请注册联系人:

刘胜京

研究负责人:

郭军

Applicant:

Liu shengjing

Study leader:

Guo jun

申请注册联系人电话:

Applicant telephone:

+86 10 62835134

研究负责人电话:

Study leader's telephone:

+86 10 62835134

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:

shengjing0514@163.com

研究负责人电子邮件:

Study leader's E-mail:

guojun1126@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:

北京市海淀区西苑操场一号中国中医科学院西苑医院

研究负责人通讯地址:

北京市海淀区西苑操场一号中国中医科学院西苑医院

Applicant address:

Xiyuan Hospital of China Academy of Chinese Medical Sciences, No.1 Xiyuan Caochang Road, Haidian District, Beijing, China

Study leader's address:

Xiyuan Hospital of China Academy of Chinese Medical Sciences, No.1 Xiyuan Caochang Road, Haidian District, Beijing, 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:

中国中医科学院西苑医院

Applicant's institution:

Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing, 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:

2021XLA114-5

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:

中国中医科学院西苑医院医学伦理委员会

Name of the ethic committee:

Ethics Committee of Xiyuan Hospital, China Academy of Chinese Medical Sciences

伦理委员会批准日期:

Date of approved by ethic committee:

2022/10/28 0:00:00

伦理委员会联系人:

訾明杰

Contact Name of the ethic committee:

Zi mingjie

伦理委员会联系地址:

中国中医科学院西苑医院

Contact Address of the ethic committee:

Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 10 62835646

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:

中国中医科学院西苑医院

Primary sponsor:

Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing, China

研究实施负责(组长)单位地址:

中国中医科学院西苑医院

Primary sponsor's address:

Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing, China

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

中国中医科学院科技创新工程

Source(s) of funding:

Scientific and Technological Innovation Project of China Academy of Chinese Medical Sciences

研究疾病:

男性不育症(弱精子症及少弱精子症)

研究疾病代码:

Target disease:

male infertility (asthenozoospermia and oligoasthenozoospermia)

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:

其它

Others

研究目的:

评价灵归养元膏治疗弱精子症及少弱精子症(肾虚血瘀证)的有效性及安全性。

Objectives of Study:

To study the efficacy and safety of Linggui Yangyuan Paste in patients with asthenozoospermia and oligoasthenozoospermia (kidney deficiency and blood stasis).

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)符合男性不育症西医诊断标准; (2)符合弱精子症或少弱精子症西医诊断标准; (3)符合肾虚血瘀证中医辨证标准; (4)年龄范围为22~45岁的男性; (5)自愿签署知情同意书。

Inclusion criteria

(1) Study participants met the diagnostic criteria for male infertility (2) Study participants met the diagnostic criteria for asthenozoospermia or oligoasthenozoospermia (3) Study participants met the traditional Chinese medicine diagnosis criteria for kidney deficiency and blood stasis (4) Men aged 22 to 45 years (5) The participants signed informed consent forms

排除标准:

(1)勃起功能障碍、射精异常等性功能障碍,导致无法完成阴道内射精; (2)生殖系统(如睾丸或附睾等)有明确器质性病变; (3)泌尿生殖系统感染,如支原体或者衣原体感染等; (4)中重度精索静脉曲张; (5)性激素检查(促卵泡激素、促黄体生成素、睾酮)异常且有临床意义; (6)合并肝肾功能不全、严重心脑血管疾病、造血系统疾病、精神病等其它合并症; (7)对本研究中使用的任何药物或成分有过敏史; (8)治疗前2周接受针对本病的其它相关治疗。

Exclusion criteria:

(1)infertility is caused by the inability to complete sexual intercourse, including but not limited to erectile dysfunction or ejaculatory disorders (2)with infertility caused by organic lesions of the reproductive system (3)with reproductive system infection, such as chlamydia trachomatis or mycoplasma infection (4)with palpable varicocele (5)with abnormal and clinical significance of sex hormone (follicle stimulating, hormoneluteinizing, testosterone) (6)complicated with liver and kidney dysfunction, severe basic diseases such as diabetes, cardiovascular and cerebrovascular diseases, mental diseases, malignant tumors, or serious organic diseases (7)with a history of allergy to any medicine or ingredients used in this study (8)receive other relevant treatment for the disease 2 weeks before treatment

研究实施时间:

Study execute time:

From 2023-03-01

To      2024-06-01

征募观察对象时间:

Recruiting time:

From 2023-06-01

To      2024-06-01

干预措施:

Interventions:

组别:

试验组

样本量:

81

Group:

treatment group

Sample size:

干预措施:

灵归养元膏+五子衍宗口服液模拟剂

干预措施代码:

Intervention:

Ling-Gui-Yang-Yuan Paste and Wu-Zi-Yan-Zong oral solution mimetics

Intervention code:

组别:

对照组

样本量:

81

Group:

treatment group

Sample size:

干预措施:

五子衍宗口服液+灵归养元膏模拟剂

干预措施代码:

Intervention:

Wu-Zi-Yan-Zong oral solution and Ling-Gui-Yang-Yuan Gel mimetics

Intervention code:

样本总量 Total sample size : 162

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

深圳

市(区县):

Country:

China

Province:

Shenzhen

City:

单位(医院):

深圳市中医院

单位级别:

三甲

Institution/hospital:

Shenzhen Traditional Chinese Medicine Hospital, Shenzhen, China

Level of the institution:

tertiary grade A hospitals

国家:

中国

省(直辖市):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国中医科学院西苑医院

单位级别:

三甲

Institution/hospital:

Xiyuan Hospital of China Academy of Chinese Medical Sciences, Beijing, China

Level of the institution:

tertiary grade A hospitals

国家:

中国

省(直辖市):

成都

市(区县):

Country:

China

Province:

chengdu

City:

单位(医院):

成都市第五人民医院

单位级别:

三甲

Institution/hospital:

Chengdu Fifth People's Hospital, Chengdu, China

Level of the institution:

tertiary grade A hospitals

国家:

中国

省(直辖市):

山东

市(区县):

Country:

China

Province:

Shandong

City:

单位(医院):

山东中医药大学附属医院

单位级别:

三甲

Institution/hospital:

Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Shandong, China

Level of the institution:

tertiary grade A hospitals

国家:

中国

省(直辖市):

天津

市(区县):

Country:

China

Province:

tianjin

City:

单位(医院):

天津中医药大学第一附属医院

单位级别:

三甲

Institution/hospital:

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China

Level of the institution:

ertiary grade A hospitals

测量指标:

Outcomes:

指标中文名:

中医症状评分

指标类型:

次要指标

Outcome:

traditional chinese medicine symptom score

Type:

Secondary indicator

测量时间点:

第4周、8周、12周、24周

测量方法:

量表评价

Measure time point of outcome:

Weeks 4, 8, 12,24

Measure method:

scale evaluation

指标中文名:

精液常规参数(精液量、精子浓度、精子总数、精子前向活力、精子总活力)

指标类型:

次要指标

Outcome:

semen parameters (semen volume、sperm concentration、total sperm count、progressive motility、progressive motility+nonprogressive motility)

Type:

Secondary indicator

测量时间点:

第4周、8周、12周

测量方法:

精液常规

Measure time point of outcome:

Weeks 4, 8, 12

Measure method:

routine semen analysis

指标中文名:

妊娠等待时间

指标类型:

次要指标

Outcome:

time to pregnancy

Type:

Secondary indicator

测量时间点:

第4周、8周、12周、24周

测量方法:

Measure time point of outcome:

Weeks 4, 8, 12, 24

Measure method:

指标中文名:

前向运动精子总数

指标类型:

主要指标

Outcome:

total progressive motile sperm count

Type:

Primary indicator

测量时间点:

第4周、8周、12周

测量方法:

精液常规

Measure time point of outcome:

Weeks 4, 8, 12

Measure method:

routine semen analysis

指标中文名:

妊娠率

指标类型:

次要指标

Outcome:

pregnancy rate

Type:

Secondary indicator

测量时间点:

第4周、8周、12周、24周

测量方法:

Measure time point of outcome:

Weeks 4, 8, 12, 24

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:

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:

精液

组织:

Sample Name:

semen

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 22
Min age years
最大 45
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男性

Male

随机方法(请说明由何人用什么方法产生随机序列):

采用分层区组随机化的方法。签署知情同意书后,研究者需对受试者的入组标准进行筛查。对于筛查合格,确定入组的受试者,按区组随机方式入组。委托中国中医科学院西苑医院临床药理中心利用SAS 9.4统计软件产生随机号及随机号对应的治疗药物编号,并根据此随机号对药物进行编盲。受试者随机号与药物编号将一一对应,每个受试者将得到一个独立的试验随机编号和药品编号,这一号码是受试者的唯一识别号。

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

Adopting a hierarchical block randomization method. After signing the informed consent form, the researcher needs to screen the inclusion criteria of the subjects. For those who pass the screening and are confirmed to be enrolled, they will be randomly enrolled according to the block grouping method. The Clinical Pharmacology Center of Xiyuan Hospital, China Academy of Chinese Medical Sciences was entrusted to use SAS 9.4 statistical software to generate the random number and the corresponding therapeutic drug number, and the drugs were blinded according to the random number. The subject random number and drug number will correspond one by one, and each subject will receive an independent trial random number and drug number, which is the unique identification number of the subject.

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):

研究结束后通过论文形式共享原始数据

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

Share raw data in paper form after research

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:

为了确保结果评估和数据收集的准确性,所有医生、评估员和研究助理将在试验开始前参加培训研讨会。不同中心的所有研究人员必须遵循标准操作程序。所有临床试验信息应准确、完整地记录,并在适当情况下拍照。建立一个包含两名数据研究助理(非研究人员)的数据管理和质量控制团队。试验数据将由两名助手独立输入电子表格。对于每个异常或缺失的数据点,将向研究人员发送查询。

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

To ensure the accuracy of the outcome assessment and data collection, all physicians, assessors, and research assistants will attend training workshops before the start of the trial. A standard operating procedure must be followed by all investigators at different centers. All clinical trial information should be accurately and completely recorded and, if appropriate, photographed. Establish a data management and quality control team containing two data research assistants (non-researchers). The trial data will be entered into a spreadsheet by two assistants independently. For each exception or missing data point, a query will be sent to the researcher. The assistants and statistical analysts will be kept blinded during the trial until statistical analyses are performed. The principal investigator will coordinate and monitor all recruitment, intervention, and follow-up procedures.

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):

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