益骨汤通过循环miRNA(C-miR)调控 骨稳态参与骨质疏松症的分子机制研究

注册号:

Registration number:

ITMCTR2024000042

最近更新日期:

Date of Last Refreshed on:

2024-04-02

注册时间:

Date of Registration:

2024-04-02

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

益骨汤通过循环miRNA(C-miR)调控 骨稳态参与骨质疏松症的分子机制研究

Public title:

Regulation of bone homeostasis by circulating miRNAs (C-miR) in Yi Bone Broth: a molecular mechanism of osteoporosis

注册题目简写:

English Acronym:

研究课题的正式科学名称:

益骨汤通过循环miRNA(C-miR)调控 骨稳态参与骨质疏松症的分子机制研究

Scientific title:

Regulation of bone homeostasis by circulating miRNAs (C-miR) in Yi Bone Broth: a molecular mechanism of osteoporosis

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:

陈海峰

研究负责人:

陈智能

Applicant:

Chen Haifeng

Study leader:

Chen Zhineng

申请注册联系人电话:

Applicant telephone:

+86 138 5755 5192

研究负责人电话:

Study leader's telephone:

+86 137 7738 1630

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:

986434770@qq.com

研究负责人电子邮件:

Study leader's E-mail:

czneng@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:

浙江省杭州市西湖区莫干山路219号

研究负责人通讯地址:

浙江省杭州市西湖区莫干山路219号

Applicant address:

219 Moganshan Road, Xihu District, Hangzhou,

Study leader's address:

219 Moganshan Road, Xihu District, Hangzhou,

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:

浙江中医药大学附属第三医院

Applicant's institution:

The Third Affiliated Hospital of Zhejiang Chinese Medical University

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:

ZSLL-KY-2022-019-01

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:

浙江中医药大学附属第三医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of The Third Affiliated Hospital of Zhejiang Chinese Medical University

伦理委员会批准日期:

Date of approved by ethic committee:

2022/4/16 0:00:00

伦理委员会联系人:

闫坤

Contact Name of the ethic committee:

Yan Kun

伦理委员会联系地址:

浙江省杭州市西湖区莫干山路219号

Contact Address of the ethic committee:

219 Moganshan Road, Xihu District, Hangzhou, Zhejiang

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 88393504

伦理委员会联系人邮箱:

Contact email of the ethic committee:

ykzcmu@163.com

研究实施负责(组长)单位:

浙江中医药大学附属第三医院

Primary sponsor:

The Third Affiliated Hospital of Zhejiang Chinese Medical University

研究实施负责(组长)单位地址:

浙江省杭州市西湖区莫干山路219号

Primary sponsor's address:

219 Moganshan Road, Xihu District, Hangzhou, Zhejiang

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

浙江

市(区县):

杭州

Country:

China

Province:

Zhejiang

City:

单位(医院):

浙江中医药大学附属第三医院

具体地址:

浙江省杭州市西湖区莫干山路219号

Institution
hospital:

The Third Affiliated Hospital of Zhejiang Chinese Medical University

Address:

219 Moganshan Road, Xihu District, Hangzhou, Zhejiang

经费或物资来源:

浙江省中医药管理局计划项目

Source(s) of funding:

Planned project of Zhejiang Administration of traditional Chinese Medicine

研究疾病:

骨质疏松

研究疾病代码:

Target disease:

Osteoporosis

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:

通过随机对照试验观察益骨汤对OP患者的临床疗效,并探究益骨汤调控miRNA参与骨代谢的相关机制。

Objectives of Study:

Observing the clinical efficacy of Yigu Tang on OP patients through randomized controlled trials, and exploring the relevant mechanisms of Yigu Tang regulating miRNA participation in bone metabolism.

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)符合本课题诊断标准及年龄标准 (2)3月内未服用抗骨质疏松药物等治疗的为纳入标准; (3)愿意服用中药汤剂治疗的患者; (4)符合正常身高/体重指数,活动水平(身体活动量,Physical Activity Scale,PAS)≤180分,无不良嗜好; (5)签署临床研究知情同意书。

Inclusion criteria

(1) Meet the diagnostic criteria and age standards of this project (2) Inclusion criteria include those who have not taken anti osteoporosis drugs or other treatments within 3 months; (3) Patients willing to take traditional Chinese medicine decoction for treatment; (4) Meets normal height/body mass index, physical activity scale (PAS) ≤ 180 points, and has no bad habits; (5) Sign the informed consent form for clinical research.

排除标准:

(1)非原发性骨质疏松的患者:①内分泌性皮质醇增多症、甲状腺功能亢进症、原发性甲状旁腺功能亢进症、肢端肥大症、性腺功能低下、糖尿病等。②营养性 蛋白质缺乏、维生素C缺乏、低钙饮食、酒精中毒等。③遗传性成骨不全染色体异常。④肝脏病。⑤肾脏病 慢性肾炎血液透析。⑥药物皮质类固醇、抗癫痛药、抗肿瘤药(如甲氨蝶呤)、肝素等。⑦废用性全身性骨质疏松见于长期卧床、截瘫、太空飞行等;局部性的见于骨折后、Sudecks骨萎缩、伤后骨萎缩等。⑧胃肠性吸收不良胃切除。⑨类风湿性关节炎。⑩肿瘤多发性骨髓瘤转移癌、单核细胞性白血病、Mast-Cell病等。⑪其他原因骨质减少、短暂性或迁徙性骨质疏松。 (2)原始资料记录不完整的患者; (3)合并有心脑血管、肝、肾、呼吸系统和造血系统等严重慢性原发性疾病,精神病患者; (4) 近一个月使用过治疗骨质疏松症中药者; (5) 合并新鲜骨折及严重多处骨折患者;

Exclusion criteria:

(1) Patients with non primary osteoporosis: ① endocrine cortisol, hyperthyroidism, primary hyperparathyroidism, acromegaly, hypogonadism, diabetes, etc. ② Nutritional protein deficiency, vitamin C deficiency, low calcium diet, alcoholism, etc Chromosomal abnormalities in hereditary osteogenesis imperfecta. ④ Liver disease. ⑤ Hemodialysis for chronic nephritis caused by kidney disease. ⑥ Medications such as corticosteroids, antiepileptic drugs, anti-tumor drugs (such as methotrexate), heparin, etc Sporadic systemic osteoporosis can be seen in long-term bed rest, paraplegia, space flight, etc; Localized bone atrophy can be seen after fractures, Sudecks bone atrophy, and post injury bone atrophy Gastrectomy for gastrointestinal malabsorption Rheumatoid arthritis Multiple myeloma metastasis, monocytic leukemia, Mast Cell disease, etc Other causes include bone loss, transient or migratory osteoporosis. (2) Patients with incomplete original data records; (3) Patients with severe chronic primary diseases such as cardiovascular, cerebrovascular, liver, kidney, respiratory, and hematopoietic systems, as well as mental illness; (4) Those who have used traditional Chinese medicine to treat osteoporosis in the past month; (5) Patients with combined fresh fractures and severe multiple fractures;

研究实施时间:

Study execute time:

From 2022-04-16

To      2025-04-16

征募观察对象时间:

Recruiting time:

From 2023-09-01

To      2024-06-01

干预措施:

Interventions:

组别:

对照组

样本量:

35

Group:

Control group

Sample size:

干预措施:

钙剂+维生素D+阿仑膦酸钠

干预措施代码:

Intervention:

Calcium+Vitamin D+Alendronate Sodiumg

Intervention code:

组别:

治疗组

样本量:

35

Group:

Treatment

Sample size:

干预措施:

钙剂+维生素D+阿仑膦酸钠+益骨汤

干预措施代码:

Intervention:

Calcium+Vitamin D+Alendronate Sodium+Yigu Decoction

Intervention code:

样本总量 Total sample size : 70

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

浙江

市(区县):

Country:

China

Province:

Zhejiang

City:

单位(医院):

浙江中医药大学附属第三医院

单位级别:

三甲

Institution/hospital:

The Third Affiliated Hospital of Zhejiang Chinese Medical University

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

miRNA

指标类型:

次要指标

Outcome:

miRNA

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医证候评分

指标类型:

次要指标

Outcome:

Traditional Chinese Medicine Syndrome Score

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

骨密度

指标类型:

主要指标

Outcome:

Bone mineral density

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:

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:

正在进行

Recruiting

年龄范围:

最小 55
Min age years
最大 95
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):

随机数字法

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

Random number method

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):

ResMan临床试验公共管理平台“http://www.medresman.org.cn/uc/index.aspx”

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

ResMan Clinical Trial Public Management Platform http://www.medresman.org.cn/uc/index.aspx ”

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:

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)

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

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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