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Clinical Study of Guangsi Yulin Decoction's Effect on Sperm DNA Fragmentation Index of asthenospermia patients

注册号：

Registration number：

ITMCTR2000004121

最近更新日期：

Date of Last Refreshed on：

2020-12-01

注册时间：

Date of Registration：

2020-12-01

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

广嗣育麟汤对弱精子症患者精子DNA碎片指数影响的临床研究

Public title：

Clinical Study of Guangsi Yulin Decoction's Effect on Sperm DNA Fragmentation Index of asthenospermia patients

注册题目简写：

English Acronym：

研究课题的正式科学名称：

广嗣育麟汤对弱精子症患者精子DNA碎片指数影响的临床研究

Scientific title：

Clinical Study of Guangsi Yulin Decoction's Effect on Sperm DNA Fragmentation Index of asthenospermia patients

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：

ChiCTR2000040516 ; ChiMCTR2000004121

申请注册联系人：

王世桢

研究负责人：

李海松

Applicant：

Shi-Zhen Wang

Study leader：

Hai-Song Li

申请注册联系人电话：

Applicant telephone：

+86 18533617207

研究负责人电话：

Study leader's telephone：

+86 13601221399

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：

407363586@qq.com

研究负责人电子邮件：

Study leader's E-mail：

lihs369@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：

北京市东城区海运仓5号

研究负责人通讯地址：

北京市东城区海运仓5号

Applicant address：

5 Haiyuncang Street, Dongcheng District, Beijing, China

Study leader's address：

5 Haiyuncang Street, Dongcheng District, Beijing, China

申请注册联系人邮政编码：

Applicant postcode：

100700

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

北京中医药大学东直门医院

Applicant's institution：

Dongzhimen Hospital, Beijing University of 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：

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

Name of the ethic committee：

伦理委员会批准日期：

Date of approved by ethic committee：

2013/8/26 0:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

伦理委员会联系地址：

Contact Address of the ethic committee：

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：

北京中医药大学东直门医院

Primary sponsor：

Dongzhimen Hospital, Beijing University of Chinese Medicine

研究实施负责（组长）单位地址：

北京市东城区海运仓5号

Primary sponsor's address：

5 Haiyuncang Street, Dongcheng District, Beijing, 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)：

北京市

市(区县)：

东城区

Country：

China

Province：

Beijing

City：

单位(医院)：

北京中医药大学东直门医院

具体地址：

北京市东城区海运仓5号

Institution
hospital：

Dongzhimen Hospital, Beijing University of Chinese Medicine

Address：

5 Haiyuncang Street, Dongcheng District

经费或物资来源：

首都卫生发展科研专项项目资金

Source(s) of funding：

Capital Health development research special Project fund

研究疾病：

弱精子症

研究疾病代码：

Target disease：

Asthenospermia

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

连续入组

Sequential

研究所处阶段：

Study phase：

I期临床试验

Phase I clinical trial

研究目的：

① 研究广嗣育麟汤是否通过改善DFI来提高弱精子症致男性不育患者的精子活力，明确广嗣育麟汤治疗弱精子症的具体作用机制之一。 ② 明确广嗣育麟汤改善弱精子症致男性不育患者的疗效，为补肾生精中药治疗男性不育症提供临床依据。

Objectives of Study：

To study whether Guangji Yulintang can improve the sperm motility of male infertility patients caused by asthenospermia by improving DFI, and to clarify one of the specific mechanisms of guangji Yulintang in the treatment of asthenospermia. It is clear that Guangsi Yulin Decoction improves the curative effect of male infertility patients caused by asthenospermia, and provides clinical basis for the treatment of male infertility by tonifying kidney and spermatogenic Traditional Chinese medicine.

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)符合西医诊断标准“男性不育”和“弱精子症”，同时具备此两项诊断； (2)中医辨证符合肾虚证； (3)男性，年龄22-45岁之间； (4)已婚，夫妻家庭关系和睦； (5)精子DNA碎片指数（DFI）≥30%； (6)无其他生殖系统器质性病变者； (7)研究前2周内未接受同类药品治疗或其他疗法者； (8)了解研究内容并签署知情同意书。 同时符合上述8项者，纳入研究，否则不予纳入

Inclusion criteria

(1) Meet the western medical diagnostic criteria of "male infertility" and "asthenospermia", and have the two diagnoses at the same time; (2) TCM syndrome differentiation conforms to kidney deficiency syndrome; (3) Male aged 22 to 45 years; (4) Married, husband and wife have a harmonious family relationship; (5) Sperm DNA fragmentation index (DFI) >=30%; (6) No other organic lesions of the reproductive system; (7) Those who did not receive treatment with similar drugs or other therapies within 2 weeks before the study; (8) Understand the content of the study and sign the informed consent. Those who meet the above 8 criteria at the same time will be included in the study; otherwise, they will not be included

排除标准：

(1)依据《人类精液检验与处理实验室手册》第5版，除了精子总活力＜40%，前向运动精子＜32%以外，精液检查存在其他异常； (2)有遗传性疾病家族史的患者； (3)患有精索静脉曲张、前列腺炎等导致精子质量下降的疾病； (4)有活动性感染的患者； (5)合并有心血管、肝、肾和造血系统等严重原发性疾病患者； (6)精神障碍患者； (7)有长期大量嗜烟、饮酒习惯，或接触高温、放射、有毒化学环境，而不能改变或放弃的患者； (8)过敏体质及对多种药物过敏者。 满足以上任意一项即为符合排除标准，需要进行排除。

Exclusion criteria：

(1) According to the Manual of Human Semen Examination and Treatment Laboratory, edition 5, except for total sperm motility < 40% and forward motility < 32%, there are other abnormalities in semen examination; (2) Patients with a family history of genetic diseases; (3) Suffering from varicocele, prostatitis and other diseases that lead to sperm quality decline; (4) Patients with active infection; (5) Patients with severe primary diseases such as cardiovascular, liver, kidney and hematopoietic system; (6) Patients with mental disorders; (7) Patients who have a long-term and large amount of smoking and drinking habits, or are exposed to high temperature, radiation and toxic chemical environment, but cannot change or give up; (8) Allergic constitution and allergic to multiple drugs. Meeting any of the above is considered as meeting the exclusion criteria, and exclusion is required.Those who meet the above 8 criteria at the same time will be included in the study; otherwise, they will not be included

研究实施时间：

Study execute time：

从From 2020-07-01

至To      2023-06-30

征募观察对象时间：

Recruiting time：

从From 2020-12-01

至To      2022-06-30

干预措施：

Interventions：

组别：

符合纳入标准的全部样本

样本量：

100

Group：

Case series

Sample size：

干预措施：

服用广嗣育麟汤

干预措施代码：

Intervention：

Taking Guang Si Yu Lin Tang

Intervention code：

样本总量 Total sample size ： 100

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

北京市

市(区县)：

东城区

Country：

China

Province：

Beijing

City：

单位(医院)：

北京中医药大学东直门医院

单位级别：

三甲医院

Institution/hospital：

Dongzhimen Hospital, Beijing University of Chinese Medicine

Level of the institution：

Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：

精液常规

指标类型：

主要指标

Outcome：

Semen routine

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：

精液

组织：

Sample Name：

seminal fluid

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 岁
Min age years
最大 45 岁
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）：

No

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

No

盲法：

N/A

Blinding：

N/A

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）：

2023年7月

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

In July 2023

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：

采用PDC数据采集方法，依据研究方案设计并制作合理的病例报告表（Case Report Form, CRF表），由经过高级职称的男科医生按照研究方案统一培训的6名临床研究者掌握病例收集方法和评估方法，负责研究资料的收集，以最大限度的减少选择偏移。每位患者均使用CRF表作为临床的原始记录，研究中如实记录受试者的各项指标，中途若有退出和脱落详细记录退出及脱落的原因，并严格控制退出和脱落比例.随访的情况也应详细地记录在CRF表中。采用Epidata3.1软件建数据库，再将表中数据双份录入，录入前由固定项目组成员进行核对，以减少偏倚。

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

Using PDC data collection method, based on the research design and produce a reasonable Case Report Form (Case Report Form, CRF table), by a male doctor senior titles in accordance with the unified research plan training of six cases of clinical researchers to master collection methods and evaluation methods, is responsible for research data collection, in order to minimize offset choice.The CRF table was used as the original clinical record for each patient. In the study, all indicators of the subjects were recorded truthfully. If there were exit and fall off during the study, the reasons for exit and fall off were recorded in detail, and the ratio of exit and fall off was strictly controlled.Follow-up should also be recorded in detail in the CRF table.Epidata3.1 software was used to establish a database, and the data in the table was recorded in double copies, which was checked by the fixed project team members before entry to reduce bias.

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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