A randomized, double-blind, placebo-controlled clinical trial of Yigongsan in improving anemia of low-risk myelodysplastic syndrome of spleen deficiency

注册号:

Registration number:

ITMCTR1900002690

最近更新日期:

Date of Last Refreshed on:

2019-10-21

注册时间:

Date of Registration:

2019-10-21

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

异功散改善脾虚型低危骨髓增生异常综合征贫血的随机、双盲、安慰剂对照临床试验

Public title:

A randomized, double-blind, placebo-controlled clinical trial of Yigongsan in improving anemia of low-risk myelodysplastic syndrome of spleen deficiency

注册题目简写:

English Acronym:

研究课题的正式科学名称:

异功散改善脾虚型低危骨髓增生异常综合征贫血的随机、双盲、安慰剂对照临床试验

Scientific title:

A randomized, double-blind, placebo-controlled clinical trial of Yigongsan in improving anemia of low-risk myelodysplastic syndrome of spleen deficiency

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:

ChiCTR1900026774 ; ChiMCTR1900002690

申请注册联系人:

郑秦

研究负责人:

郑秦

Applicant:

Zheng Qin

Study leader:

Zheng Qin

申请注册联系人电话:

Applicant telephone:

+86 13162822636

研究负责人电话:

Study leader's telephone:

+86 13162822636

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:

m13162822636@163.com

研究负责人电子邮件:

Study leader's E-mail:

m13162822636@163.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:

上海市宝山区友谊路181号

研究负责人通讯地址:

上海市宝山区友谊路181号

Applicant address:

181 Youyi Road, Baoshan District, Shanghai, China

Study leader's address:

181 Youyi Road, Baoshan 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:

上海市宝山区中西医结合医院(上海中医药大学附属曙光医院宝山分院)

Applicant's institution:

Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine (Baoshan Branch of 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:

201809-01

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:

宝山区中西结合医院伦理委员会

Name of the ethic committee:

Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicinel Ethics Committee

伦理委员会批准日期:

Date of approved by ethic committee:

2018/10/12 0:00:00

伦理委员会联系人:

杨柳

Contact Name of the ethic committee:

Young Liu

伦理委员会联系地址:

上海市宝山区友谊路181号

Contact Address of the ethic committee:

181 Youyi Road, Baoshan District, Shanghai, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 021-56692719 / 56177192

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:

上海市宝山区中西医结合医院(上海中医药大学附属曙光医院宝山分院)

Primary sponsor:

Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine (Baoshan Branch of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine)

研究实施负责(组长)单位地址:

上海市宝山区友谊路181号

Primary sponsor's address:

181 Youyi Road, Baoshan 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):

上海市宝山区中西医结合医院(上海中医药大学附属曙光医院宝山分院)

具体地址:

宝山区友谊路181号

Institution
hospital:

Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine (Baoshan Branch of Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine)

Address:

181 Youyi Road, Baoshan District

经费或物资来源:

上海市卫生与计划生育委员会

Source(s) of funding:

Project of Shanghai Municipal Health and Family Planning Commission

研究疾病:

骨髓增生异常综合征

研究疾病代码:

Target disease:

myelodysplastic syndrome

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:

探讨异功散改善脾虚型低危骨髓增生异常综合征(MDS)贫血的临床疗效。

Objectives of Study:

To explore the clinical efficacy of Yigong San in improving the low-risk myelodysplastic syndrome(MDS) anemia of spleen deficiency.

药物成份或治疗方案详述:

根据纳入标准收集脾虚型低危MDS贫血病人,随机分为西药常规治疗+安慰剂组和西药常规治疗组加异功散组,采集患者服药前后的临床资料、中医症候积分以及血清,本研究主要研究指标为中医症候评分、血红蛋白,次要研究指标为铁代谢、hepcidin与,炎症因子(IL-6、IL-1、肿瘤坏死因子)。分析比较两组治疗前后患者主要研究指标的差异,明确YGS疗效;分析比较次要指标与疗效间的相关性探讨YGS可能的作用机制。

Description for medicine or protocol of treatment in detail:

According to the inclusion criteria, patients with low-risk MDS anemia with spleen deficiency were randomly divided into western medicine routine treatment + placebo group and western medicine routine treatment group + Yigong San group. The clinical data, TCM symptom scores and serum before and after taking the patients were collected. The research indicators were TCM symptom scores and hemoglobin. Secondary research indicators were iron metabolism, hepcidin and inflammatory factors (IL-6, IL-1, tumor necrosis factor). The differences between the main research indicators of the two groups before and after treatment were analyzed and compared, and the efficacy of YGS was determined. The correlation between the secondary indicators and the efficacy was analyzed to explore the possible mechanism of action of YGS.

纳入标准:

明确诊断为脾虚型低危MDS贫血患者并签署知情同意书。

Inclusion criteria

Clear diagnosis of spleen deficiency type low-risk MDS anemia patients and signed informed consent.

排除标准:

1. MDS合并5q-者; 2. 有输血依赖(WHO规定4个月内至少每8周输1U红细胞); 3. 肝肾功能不全(血谷草转氨酶、谷丙转氨酶、肌酐浓度超出正常值上线3倍以上); 4. 除本课题所限定的治疗药物还需其他药物治疗者; 5. 近期参加其他药物临床试验(中药2周内,西药7个半衰期内); 6. 入选后不能完成规定的观察项目者; 7. 不配合者。

Exclusion criteria:

1. MDS combined with 5q-; 2. Blood transfusion dependence (WHO requires at least every 1 week to lose 1U red blood cells within 4 months); 3. Liver and kidney dysfunction (blood aspartate aminotransferase, alanine aminotransferase, creatinine concentration exceeds normal value more than 3 times online). 4. In addition to the treatment of drugs defined in this topic, other drugs need to be treated. 5. Recently participated in other drug clinical trials (within 2 weeks of Chinese medicine, 7 half-life periods of western medicine) 6. Those who could not complete the prescribed observations after being selected were not coordinated.

研究实施时间:

Study execute time:

From 2019-01-01

To      2021-12-31

征募观察对象时间:

Recruiting time:

From 2019-11-01

To      2021-09-01

干预措施:

Interventions:

组别:

对照组

样本量:

28

Group:

control group

Sample size:

干预措施:

西药常规治疗+安慰剂

干预措施代码:

Intervention:

western medicine routine treatment combined with placebo

Intervention code:

组别:

试验组

样本量:

28

Group:

experimental group

Sample size:

干预措施:

西药常规治疗组加异功散

干预措施代码:

Intervention:

western medicine routine treatment group combined with Yigongsan

Intervention code:

样本总量 Total sample size : 56

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):

上海交通大学附属第六人民医院

单位级别:

三级甲等

Institution/hospital:

The Sixth People's Hospital affiliated to Shanghai University School of Medicine

Level of the institution:

Tertiary A

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北院

单位级别:

三级甲等

Institution/hospital:

North Hospital of Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

上海

市(区县):

宝山

Country:

China

Province:

Shanghai

City:

Baoshan District

单位(医院):

上海市宝山区中西医结合医院(上海中医药大学附属曙光医院宝山分院)

单位级别:

三级甲等

Institution/hospital:

Shanghai Baoshan Hospital of Integrated Traditional Chinese and Western Medicine (Baoshan Branch of 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:

铁调素

指标类型:

次要指标

Outcome:

hepcidin

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血红蛋白

指标类型:

主要指标

Outcome:

hemoglobin

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

炎症因子

指标类型:

次要指标

Outcome:

inflammatory factors

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

铁代谢相关指标

指标类型:

次要指标

Outcome:

iron metabolism

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医症候评分

指标类型:

主要指标

Outcome:

TCM symptom scores

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:

血清

组织:

Sample Name:

serum

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 18
Min age years
最大
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):

运用SPSS 22.0软件产生随机数。

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

SPSS 22.0 software was used to generate random numbers, random numbers were ranked and sorted, and randomly divided into 2 groups.

盲法:

遵循双盲原则。

Blinding:

Double blind

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):

临床试验公共管理平台(ResMan), http://www.medresman.org.cn

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

ResMan Research Manager, http://www.medresman.org.cn

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:

1.为病例记录表 2.电子采集和管理系统(ResMan)

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

1.Case Record Form, CRF 2. Electronic Data Capture, EDC (ResMan research Manager)

数据管理委员会:

Data Managemen Committee:

暂未确定

Not yet

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