八子补肾胶囊抗衰老随机、双盲、安慰剂对照、多中心临床研究

注册号:

Registration number:

ITMCTR2200005803

最近更新日期:

Date of Last Refreshed on:

2022-04-04

注册时间:

Date of Registration:

2022-04-04

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

八子补肾胶囊抗衰老随机、双盲、安慰剂对照、多中心临床研究

Public title:

Randomized, double-blind, placebo-controlled, multicenter clinical study of Bazi Bushen Capsules in anti-aging.

注册题目简写:

English Acronym:

研究课题的正式科学名称:

八子补肾胶囊抗衰老随机、双盲、安慰剂对照、多中心临床研究

Scientific title:

Randomized, double-blind, placebo-controlled, multicenter clinical study of Bazi Bushen Capsules in anti-aging.

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:

ChiCTR2200058262 ; ChiMCTR2200005803

申请注册联系人:

徐凤芹

研究负责人:

徐凤芹

Applicant:

Fengqin Xu

Study leader:

Fengqin Xu

申请注册联系人电话:

Applicant telephone:

19832188333

研究负责人电话:

Study leader's telephone:

18800021979

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:

ylm322@126.com

研究负责人电子邮件:

Study leader's E-mail:

ylm322@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1号

研究负责人通讯地址:

北京市海淀区西苑操场1号

Applicant address:

No. 1 Xiyuan Playground, Haidian District, Beijing

Study leader's address:

No. 1 Xiyuan Playground, Haidian District, Beijing

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, Chinese Academy of Chinese Medical Sciences

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:

中国中医科学院西苑医院医学伦理委员会2022XLA034-2

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:

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

伦理委员会批准日期:

Date of approved by ethic committee:

2022/3/25 0:00:00

伦理委员会联系人:

訾明杰

Contact Name of the ethic committee:

Mingjie Zi

伦理委员会联系地址:

北京市海淀区西苑操场1号

Contact Address of the ethic committee:

No. 1 Xiyuan Playground, Haidian District, Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

010-62835646

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, Chinese Academy of Chinese Medical Sciences

研究实施负责(组长)单位地址:

北京市海淀区西苑操场1号

Primary sponsor's address:

No. 1 Xiyuan Playground, 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):

上海

市(区县):

Country:

CHINA

Province:

SHANGHAI

City:

单位(医院):

上海交通大学附属瑞金医院

具体地址:

上海市黄浦区瑞金二路197号

Institution
hospital:

Ruijin Hospital Affiliated to Shanghai Jiaotong University

Address:

197 Ruijin 2nd Road, Huangpu District, Shanghai

国家:

中国

省(直辖市):

北京市

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国中医科学院西苑医院

具体地址:

北京市海淀区西苑操场1号

Institution
hospital:

Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences

Address:

No. 1 Xiyuan Playground, Haidian District, Beijing

经费或物资来源:

石家庄以岭药业股份有限公司

Source(s) of funding:

Shijiazhuang Yiling Pharmaceutical Co, Ltd.

研究疾病:

肾精亏虚症患者,早衰人群

研究疾病代码:

Target disease:

Kidney-essence deficiency patients, premature aging population

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.评价八子补肾胶囊对不同年龄段肾精亏虚证人群症状的改善作用; 2.评价八子补肾胶囊在抗衰老方面的有效性和安全性; 3.评价八子补肾胶囊对衰老标志物的影响; 4.评价八子补肾胶囊对皮肤衰老的改善作用。

Objectives of Study:

1. To evaluate the improvement effect of Bazi Bushen Capsule on the symptoms of people with kidney-essence deficiency syndrome in different age groups; 2. To evaluate the effectiveness and safety of Bazi Bushen Capsules in anti-aging; 3. To evaluate the effect of Bazi Bushen Capsules on aging markers; 4. To evaluate the improvement effect of Bazi Bushen Capsule on skin aging.

药物成份或治疗方案详述:

【药品名称】:八子补肾胶囊 【成分】:菟丝子、枸杞子、五味子、蛇床子、金樱子、覆盆子、韭菜子、川楝子、淫羊藿、巴戟天、肉苁蓉、地黄、川牛膝、人参、鹿茸、海马。 试验分两组,治疗组组和对照组。 服药方案: 治疗组 八子补肾胶囊2粒/次,3次/日, 对照组 八子补肾胶囊安慰剂2粒/次,3次/日,

Description for medicine or protocol of treatment in detail:

Drug Name:Bazi Bushen Capsule Element:Dodder, wolfberry, schisandra, cnidium, golden cherry, raspberry, leek, Sichuan neem, epimedium, morinda, Cistanche, rehmannia, Achyranthes, ginseng, velvet, hippocampus. The test was divided into two groups: the treatment group and the control group. Medication plan: therapy group Bazi Bushen Capsules 2 capsules/time, 3 times/day, control group Bazi Bushen Capsules placebo 2 capsules/time, 3 times/day.

纳入标准:

1. 符合中医肾精亏虚证诊断标准; 2. 中医肾精亏虚证核心症状衰老评价量表表现积分≥10分; 3. 年龄≥30岁且≤80周岁,男女不限; 4. 自愿参加本研究,并签署书面知情同意书。

Inclusion criteria

1. Meet the diagnostic criteria of traditional Chinese medicine for kidney-essence deficiency syndrome; 2. The performance score of the core symptom aging evaluation scale of TCM kidney-essence deficiency syndrome ≥10 points; 3. Age ≥30 years old and ≤80 years old, male or female; 4. Voluntarily participate in this study and sign the written informed consent.

排除标准:

整体排除标准: 1. 患有重要脏器的增龄性改变导致的严重疾病或疾病状态不稳定者; 2. 患有严重肝肾功能不全、恶性肿瘤、血液病等循环、呼吸、神经(中重度PD/AD)等系统疾病者; 3. 患有严重精神类疾病或认识功能障碍者; 4. 患有身体残疾疾病者; 5. 符合肝阳上亢证、实热证,湿热证,阴虚内热证等诊断标准或平素符合以上体质者; 6. 筛选入组前1年内有酗酒或药物滥用史的患者; 7. 筛选入组前1个月内参加其他药物临床试验者; 8. 已知或怀疑对试验药及其辅料有过敏史或过敏体质者; 9. 怀孕或哺乳期的女性患者; 10. 由于可能违反试验方案或任何其他影响其安全性的情况,研究者认为不适合参与研究的患者。

Exclusion criteria:

Overall Exclusion Criteria: 1. Those with severe disease or unstable disease state caused by age-related changes of important organs; 2. Patients with severe liver and kidney insufficiency, malignant tumors, blood diseases and other system diseases such as circulation, respiration, nerve (moderate and severe PD/AD); 3. Those with severe mental illness or cognitive dysfunction; 4. Persons with physical disabilities; 5. Those who meet the diagnostic criteria of liver-yang hyperactivity syndrome, excess heat syndrome, damp-heat syndrome, and internal heat syndrome due to yin deficiency, or those who normally meet the above constitutions; 6. Screen patients with a history of alcohol or drug abuse within 1 year before enrollment; 7. Screen those who participated in clinical trials of other drugs within 1 month before enrollment; 8. Known or suspected to have a history of allergy or allergic constitution to the test drug and its excipients; 9. Pregnant or breastfeeding female patients; 10. Patients deemed unsuitable for participation in the study by the investigator due to possible violation of the trial protocol or any other circumstances affecting its safety.

研究实施时间:

Study execute time:

From 2022-03-25

To      2023-12-31

征募观察对象时间:

Recruiting time:

From 2022-04-01

To      2023-09-30

干预措施:

Interventions:

组别:

对照组

样本量:

240

Group:

control group

Sample size:

干预措施:

八子补肾胶囊安慰剂

干预措施代码:

Intervention:

Bazi Bushen capsule placebo

Intervention code:

组别:

治疗组

样本量:

240

Group:

therapy group

Sample size:

干预措施:

八子补肾胶囊

干预措施代码:

Intervention:

Bazi Bushen Capsule

Intervention code:

样本总量 Total sample size : 480

研究实施地点:

Countries of recruitment
and research settings:

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:

三级甲等

Institution/hospital:

Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences

Level of the institution:

tertiary first class

测量指标:

Outcomes:

指标中文名:

5次起坐时间、6分钟步行距离等

指标类型:

次要指标

Outcome:

5 sitting times, 6-minute walking distance, etc

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗12周后中文版Tilburg衰弱评估量表(TFI)积分的变化

指标类型:

主要指标

Outcome:

Changes in Chinese version of Tilburg Frailty Assessment Scale (TFI) scores after 12 weeks of treatment

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

头皮

指标类型:

次要指标

Outcome:

scalp

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

运动功能测试

指标类型:

次要指标

Outcome:

Motor function test

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

皮肤

指标类型:

次要指标

Outcome:

skin

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

头发

指标类型:

次要指标

Outcome:

Hair

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

计算机人脸识别年龄

指标类型:

次要指标

Outcome:

Computer face recognition age

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗12周后中医肾精亏虚证核心症状衰老评价量表评分的变化

指标类型:

主要指标

Outcome:

Changes in the core symptom aging evaluation scale of traditional Chinese medicine kidney-essence deficiency syndrome after 12 weeks of treatment

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清性激素水平等指标

指标类型:

次要指标

Outcome:

Serum sex hormone level and other indicators

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量评价量表(SF-36)

指标类型:

次要指标

Outcome:

Quality of life rating scale (SF-36)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

外周血衰老标志物

指标类型:

次要指标

Outcome:

Peripheral blood aging markers

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:

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 30
Min age years
最大 80
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

本试验采用中央随机化系统(IWRS)进行随机,随机盲底和编药盲底由统计单位(北京灵迅医药科技有限公司)通过SAS软件产生并导入IWRS。受试者筛选合格以后,研究人员登录IWRS,录入受试者信息,获取随机号和药物编号,根据药物编号发放药物。

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

The trial was randomized by the central randomization system (IWRS). The blind base of randomization and the blind base of drug compilation were generated by the statistical unit (Beijing Lingxun Pharmaceutical Technology Co., Ltd.) through SAS software and imported into IWRS. After the subjects are screened and

盲法:

盲法 ① 盲法设计:双盲,即研究者和受试者在整个临床试验过程中均处于盲态中。 ② 编盲:药物现场编盲由统计单位人员和申办单位与本试验无关人员参加,将已形成的药物编号粘贴在标签上。编盲过程形成编盲记录保存。

Blinding:

Blind ① Blind design: double-blind, that is, the investigator and the subjects are blinded throughout the clinical trial. ② Blind coding: The on-site blind coding of drugs was attended by the personnel of the statistical unit and the sponsor unrelated to the trial, and the formed drug number was pasted on the label. The process of compiling blindness forms the record keeping of compiling blindness.

是否共享原始数据:

IPD sharing:

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):

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

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:

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

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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