ChiCTR-INR-17010790 版本V1.2 版本创建时间2017/11/18 21:03:51 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR-INR-17010790 

最近更新日期：

Date of Last Refreshed on：

 2017-11-18 20:58:15 

注册时间：

Date of Registration：

 2017-02-27 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

中國傳統醫藥五子衍宗丸對不佳精液質素影響的隨機對照研究

Public title：

A randomized placebo controlled trial on effect of modified traditional Chinese medicine formula Wuzi Yanzong Pill on improving semen qualities in men with sub-optimal parameters

注册题目简写：

English Acronym：

研究课题的正式科学名称：

中國傳統醫藥五子衍宗丸對不佳精液質素影響的隨機對照研究

Scientific title：

A randomized placebo controlled trial on effect of modified traditional Chinese medicine formula Wuzi Yanzong Pill on improving semen qualities in men with sub-optimal parameters

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：

CUHK_CCRB00548

申请注册联系人：

Professor Li Tin Chiu 

研究负责人：

Professor Li Tin Chiu 

Applicant：

Professor Li Tin Chiu 

Study leader：

Professor Li Tin Chiu 

申请注册联系人电话：

Applicant telephone：

 +852 2632 3199

研究负责人电话：

Study leader's
telephone：

+852 2632 2800

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：

 tinchiu.li@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 tinchiu.li@cuhk.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 https://www2.ccrb.cuhk.edu.hk/registry/public/437

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 https://www2.ccrb.cuhk.edu.hk/registry/public/437

申请注册联系人通讯地址：

Office 4, 1F, Block EF (special block), Prince of wales hospital, 30-32 Ngan Shing Street, Shatin, N.T.

研究负责人通讯地址：

1E, Block E (special block), Prince of wales hospital, 30-32 Ngan Shing Street, Shatin, N.T.

Applicant address：

Office 4, 1F, Block EF (special block), Prince of wales hospital, 30-32 Ngan Shing Street, Shatin, N.T.

Study leader's address：

1E, Block E (special block), Prince of wales hospital, 30-32 Ngan Shing Street, Shatin, N.T.

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：

Department of Obstetric and Gynaecology, Prince of wales hospital

Applicant's institution：

Department of Obstetric and Gynaecology, Prince of wales hospital

研究负责人所在单位：

Department of Obstetric and Gynaecology, Prince of wales hospital

Affiliation of the Leader：

Department of Obstetric and Gynaecology, Prince of wales hospital

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2016.617-T

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：

Joint CUHK-NTEC Clinical Research Ethics Committee

Name of the ethic committee：

Joint CUHK-NTEC Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2017-02-03 00:00:00

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：

Prince of wales hospital

Primary sponsor：

Prince of wales hospital

研究实施负责（组长）单位地址：

Prince of wales hospital

Primary sponsor's address：

Prince of wales hospital

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

NA

Source(s) of funding：

NA

研究疾病：

sub-optimal semen parameters  

Target disease：

sub-optimal semen parameters

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 治疗新技术临床试验 

Study phase：

New Treatment Measure Clinical Study

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

1. To investigate the therapeutic effect of modified Wuzi Yanzong Pill (五子衍宗丸) on semen quality and sperm functions. 2. To investigate the effect of modified Wuzi Yanzong Pill (五子衍宗丸) on androgens/hormonal and other seminal biomolecules in the semen; 3. To investigate the impact of modified Wuzi Yan  

Objectives of Study：

1. To investigate the therapeutic effect of modified Wuzi Yanzong Pill on semen quality and sperm functions. 2. To investigate the effect of modified Wuzi Yanzong Pill on androgens/hormonal and other seminal biomolecules in the semen; 3. To investigate the impact of modified Wuzi Yan.

药物成份或治疗方案详述：

the individual concentrated herbal medicine granules prepared from standardized decoction methods using state-of-art concentration technologies in GMP standard will be obtained from PuraPharm International (H.K.) Ltd. The individual concentrated herbal medicine granules will be prepared in sachet form. The modified Wuzi Yanzong Pill (五子衍宗丸) will be composed of Lycii Fructus 枸杞子 2.4g, Rubi Fructus 覆盆子 3g, Cuscutae Chinensis Semen 菟絲子 2.4g, Rehmanniae Glutinosae Conquitae Radix 熟地黃 3g, Polygonati Rhizoma 黃精 3g, Cistanches Deserticolae Herba 肉蓯蓉 2g, Epimedii Herba 仙靈脾 2g, Plantaginis Semen 車前子 2g, and Cornus Cervi Colla 鹿角膠 1.6g, totally 21.4g divide into two doses per day. For oral administration, the sachets at designated daily dose are mixed to combine each Chinese medicine. 

Description for medicine or protocol of treatment in detail：

the individual concentrated herbal medicine granules prepared from standardized decoction methods using state-of-art concentration technologies in GMP standard will be obtained from PuraPharm International (H.K.) Ltd. The individual concentrated herbal medicine granules will be prepared in sachet form. The modified Wuzi Yanzong Pill (五子衍宗丸) will be composed of Lycii Fructus 枸杞子 2.4g, Rubi Fructus 覆盆子 3g, Cuscutae Chinensis Semen 菟絲子 2.4g, Rehmanniae Glutinosae Conquitae Radix 熟地黃 3g, Polygonati Rhizoma 黃精 3g, Cistanches Deserticolae Herba 肉蓯蓉 2g, Epimedii Herba 仙靈脾 2g, Plantaginis Semen 車前子 2g, and Cornus Cervi Colla 鹿角膠 1.6g, totally 21.4g divide into two doses per day. For oral administration, the sachets at designated daily dose are mixed to combine each Chinese medicine. 

纳入标准：

Patients with one or more sub-optimal semen paremeters (Not satisfying WHO reference values in motility, morphology, concentration and total sperm count (any one of them).

Inclusion criteria

Patients with one or more sub-optimal semen paremeters (Not satisfying WHO reference values in motility, morphology, concentration and total sperm count (any one of them).

排除标准：

1. male infertility due to one testicle had been removed, history of undescended testis, previous chemotherapy, testicular torsion;
2. Patients with azoospermia;
3. Patients with normal WHO (Version 5) in all parameters.

Exclusion criteria：

1. male infertility due to one testicle had been removed, history of undescended testis, previous chemotherapy, testicular torsion;
2. Patients with azoospermia;
3. Patients with normal WHO (Version 5) in all parameters.

研究实施时间：

Study execute time：

从 From 1990-01-01 00:00:00至 To 1990-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2017-03-03 00:00:00 至 To 1990-01-01 00:00:00

干预措施：

Interventions：

组别：

Two groups

样本量：

 286

Group：

Two groups

Sample size：

干预措施：

traditional Chinese medication modified Wuzi Yanzong Pill (五子衍宗丸), Granules of herbal medicine in sachet form. taken by oral two doses per day, 3 months versus placebo

干预措施代码：

Intervention：

traditional Chinese medication modified Wuzi Yanzong Pill, Granules of herbal medicine in sachet form. taken by oral two doses per day, 3 months versus placebo

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 Prince of wales hospital 

单位级别：

 Prince of wales hospital 

Institution
hospital：

Prince of wales hospital

Level of the institution：

Prince of wales hospital

测量指标：

Outcomes：

指标中文名：

Does WYP improve semen quality in patient with abnormal semen parameters? Are overall parameters improved?

指标类型：

主要指标

Outcome：

Does WYP improve semen quality in patient with abnormal semen parameters? Are overall parameters improved?

Type：

Primary indicator

测量时间点：

before TCM/ placebo taken, after 6 weeks and 3 months of taking TCM/ placebo

测量方法：

semen analysis

Measure time point of outcome：

before TCM/ placebo taken, after 6 weeks and 3 months of taking TCM/ placebo

Measure method：

semen analysis

指标中文名：

Does modified WYP alter FSH and free androgen index in men with suboptimal semen parameters?

指标类型：

次要指标

Outcome：

Does modified WYP alter FSH and free androgen index in men with suboptimal semen parameters?

Type：

Secondary indicator

测量时间点：

before and after TCM/ placebo taken

测量方法：

blood taking for hormonal test or other biochemical molecules

Measure time point of outcome：

before and after TCM/ placebo taken

Measure method：

blood taking for hormonal test or other biochemical molecules

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 70 岁 years

性别：

男性

Gender：

Male

随机方法（请说明由何人用什么方法产生随机序列）：

Randomized

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

Randomized

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Blinding：

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

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）：

Not stated

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

Not stated

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：

Not stated

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

Not stated

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2017-03-05 15:31:32