To explore the clinical effect of Gubao pill on postmenopausal osteoporosis based on "kidney main bone"

注册号:

Registration number:

ITMCTR2024000303

最近更新日期:

Date of Last Refreshed on:

2024-08-26

注册时间:

Date of Registration:

2024-08-26

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

基于“肾主骨”探讨骨宝丸治疗绝经后骨质疏松的临床治疗

Public title:

To explore the clinical effect of Gubao pill on postmenopausal osteoporosis based on "kidney main bone"

注册题目简写:

English Acronym:

研究课题的正式科学名称:

基于“肾主骨”探讨骨宝丸治疗绝经后骨质疏松的临床治疗

Scientific title:

To explore the clinical effect of Gubao pill on postmenopausal osteoporosis based on "kidney main bone"

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:

李怡

研究负责人:

李怡

Applicant:

liyi

Study leader:

liyi

申请注册联系人电话:

Applicant telephone:

13823463216

研究负责人电话:

Study leader's telephone:

13823463216

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:

820319421@qq.com

研究负责人电子邮件:

Study leader's E-mail:

820319421@qq.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:

佛山市禅城区人民西路11号

研究负责人通讯地址:

佛山市禅城区人民西路11号

Applicant address:

Renmin West Road,Chancheng District,Foshan City,Guangdong Province

Study leader's address:

Renmin West Road,Chancheng District,Foshan City,Guangdong Province

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:

佛山市妇幼保健院

Applicant's institution:

Foshan Women And Children Hospital

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:

FSFY-MEC-2024-102

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:

佛山市妇幼保健院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of Foshan Women And Children Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2024/7/29 0:00:00

伦理委员会联系人:

叶少欣

Contact Name of the ethic committee:

Ye Shaoxin

伦理委员会联系地址:

佛山市禅城区人民西路11号

Contact Address of the ethic committee:

Renmin West Road,Chancheng District,Foshan City,Guangdong Province

伦理委员会联系人电话:

Contact phone of the ethic committee:

18038831226

伦理委员会联系人邮箱:

Contact email of the ethic committee:

897056529@qq.com

研究实施负责(组长)单位:

佛山市妇幼保健院

Primary sponsor:

Foshan Women And Children Hospital

研究实施负责(组长)单位地址:

佛山市禅城区人民西路11号

Primary sponsor's address:

Renmin West Road,Chancheng District,Foshan City,Guangdong Province

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东省

市(区县):

佛山市

Country:

China

Province:

Guangdong Province

City:

Foshan City

单位(医院):

佛山市妇幼保健院

具体地址:

佛山市禅城区人民西路11号

Institution
hospital:

Foshan Women And Children Hospital

Address:

Renmin West Road,Chancheng District,Foshan City,Guangdong Province

经费或物资来源:

个人自筹

Source(s) of funding:

Self-funded

研究疾病:

绝经后骨质疏松

研究疾病代码:

Target disease:

Postmenopausal 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:

探索性研究/预试验

Pilot clinical trial

研究目的:

基于“肾主骨”探讨骨宝丸治疗绝经后骨质疏松的临床疗效

Objectives of Study:

To explore the clinical effect of Gubao pill on postmenopausal osteoporosis based on "kidney main bone"

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

①50-65岁的妇女,已自然绝经,且绝经最少2年以上; ②符合西医PMOP诊断标准,排除严重OP患者; ③符合中医脾阴阳两虚证诊断标准; ④受试者思维清晰,具有良好的沟通性和依从性,能够很好的配合数据采集工作; ⑤受试者符合以上诊断标准,并自愿签订知情同意书。

Inclusion criteria

(1) Women aged 50-65 who have been naturally postmenopausal and have been menopausal for at least 2 years; (2) Meet the diagnostic criteria of PMOP in Western medicine and exclude patients with severe OP; (3) Meet the diagnostic criteria of spleen, yin and yang deficiency syndrome in traditional Chinese medicine; (4) The subjects have clear thinking, good communication and compliance, and can cooperate well with data collection; (5) The subject meets the above diagnostic criteria and voluntarily signs the informed consent form.

排除标准:

①受试者在半年内曾使用激素或其它影响骨代谢的药物; ②受试者骨骼发生畸形,丧失劳动能力; ③受试者患有严重骨科手术后遗症、创伤或脊柱侧弯等影响骨密度测定的疾病; ④受试者患有椎体结核等骨骼系统疾病; ⑤受试者合并有糖尿病、甲状旁腺功能亢进等可能导致继发性骨质疏松的疾病; ⑥受试者合并有心脑血管、肝肾或血液系统等严重疾病; ⑦患有精神性疾病或其他影响依从性疾病的受试者; ⑧恶性肿瘤患者; ⑨嗜烟酒及过敏体质者。

Exclusion criteria:

(1) The subject has used hormones or other drugs that affect bone metabolism within half a year; (2) The subject's bones are deformed and he loses his ability to work; (3) The subject suffers from severe orthopedic surgery sequelae, trauma or scoliosis and other diseases that affect bone densitometry; (4) The subject suffers from skeletal system diseases such as vertebral tuberculosis; (5) Subjects have diabetes, hyperparathyroidism and other diseases that may lead to secondary osteoporosis; (6) Subjects have serious diseases such as cardiovascular and cerebrovascular, liver and kidney, or blood system; (7) Subjects with psychiatric disorders or other disorders that affect compliance; (8) Patients with malignant tumors; (9) People who are addicted to tobacco and alcohol and have allergies.

研究实施时间:

Study execute time:

From 2024-08-27

To      2025-12-31

征募观察对象时间:

Recruiting time:

From 2024-08-27

To      2025-12-31

干预措施:

Interventions:

组别:

治疗组

样本量:

66

Group:

Treatment group

Sample size:

干预措施:

在对照组常规治疗的基础上加用骨宝丸汤剂煎服

干预措施代码:

Intervention:

In the control group routinely On the basis of treatment, add Gubao Pill decoction

Intervention code:

组别:

对照组

样本量:

66

Group:

Control group

Sample size:

干预措施:

口服碳酸钙 D3 片和 阿仑膦酸钠肠溶片,每周 1 次

干预措施代码:

Intervention:

Oral calcium carbonate D3 tablets and alendronate enteric-coated tablets 1 time a week

Intervention code:

样本总量 Total sample size : 132

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

广东省

市(区县):

佛山市

Country:

中国

Province:

Guangdong Province

City:

Foshan City

单位(医院):

佛山市妇幼保健院

单位级别:

Institution/hospital:

Level of the institution:

测量指标:

Outcomes:

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:

治疗前和治疗3个月后

测量方法:

Measure time point of outcome:

Before treatment and after 3 months of treatment

Measure method:

指标中文名:

肝功能

指标类型:

次要指标

Outcome:

Liver function

Type:

Secondary indicator

测量时间点:

治疗前和治疗3个月后

测量方法:

Measure time point of outcome:

Before treatment and after 3 months of treatment

Measure method:

指标中文名:

生活质量评价量表 SF-36 评分

指标类型:

次要指标

Outcome:

Quality of life rating scale SF-36 score

Type:

Secondary indicator

测量时间点:

治疗前和治疗3个月后

测量方法:

Measure time point of outcome:

Before treatment and after 3 months of treatment

Measure method:

指标中文名:

VAS疼痛评分

指标类型:

次要指标

Outcome:

VAS pain score

Type:

Secondary indicator

测量时间点:

治疗前和治疗3个月后

测量方法:

Measure time point of outcome:

Before treatment and after 3 months of treatment

Measure method:

指标中文名:

尿常规

指标类型:

次要指标

Outcome:

Urinalysis

Type:

Secondary indicator

测量时间点:

治疗前和治疗3个月后

测量方法:

Measure time point of outcome:

Before treatment and after 3 months of treatment

Measure method:

指标中文名:

汉密尔顿焦虑量表(HAMA)评分

指标类型:

次要指标

Outcome:

Hamilton Anxiety Inventory (HAMA) score

Type:

Secondary indicator

测量时间点:

治疗前和治疗3个月后

测量方法:

Measure time point of outcome:

Before treatment and after 3 months of treatment

Measure method:

指标中文名:

血常规

指标类型:

次要指标

Outcome:

Complete blood count

Type:

Secondary indicator

测量时间点:

治疗前和治疗3个月后

测量方法:

Measure time point of outcome:

Before treatment and after 3 months of treatment

Measure method:

指标中文名:

腹泻、头晕、头痛、皮疹

指标类型:

副作用指标

Outcome:

diarrhea dizziness headache rash

Type:

Adverse events

测量时间点:

治疗过程中

测量方法:

Measure time point of outcome:

During treatment

Measure method:

指标中文名:

肾功能

指标类型:

次要指标

Outcome:

Kidney function

Type:

Secondary indicator

测量时间点:

治疗前和治疗3个月后

测量方法:

Measure time point of outcome:

Before treatment and after 3 months of treatment

Measure method:

指标中文名:

大便常规

指标类型:

次要指标

Outcome:

Fecal routine

Type:

Secondary indicator

测量时间点:

治疗前和治疗3个月后

测量方法:

Measure time point of outcome:

Before treatment and after 3 months of treatment

Measure method:

指标中文名:

四大生命体征

指标类型:

次要指标

Outcome:

Four vital signs

Type:

Secondary indicator

测量时间点:

治疗前和治疗3个月后

测量方法:

Measure time point of outcome:

Before treatment and after 3 months of treatment

Measure method:

指标中文名:

中医症状量表评分

指标类型:

次要指标

Outcome:

TCM symptom scale score

Type:

Secondary indicator

测量时间点:

治疗前和治疗3个月后

测量方法:

Measure time point of outcome:

Before treatment and after 3 months of treatment

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

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 50
Min age years
最大 65
Max age years

Recruiting status:

Participant age:

性别:

Gender:

女性

Female

随机方法(请说明由何人用什么方法产生随机序列):

由本课题组成员采用统计软件包SPSS 26.0生成随机数字表(输入样本数132),输出随机分配结果,产生随机数字表,各研究对象按照随机数字表进行随机分为对照组和观察组,每组66例。

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

The members of the research group used the statistical software package SPSS 26.0 to generate a random number table (input sample number 132), output the random allocation results, and generate a random number table, and each research object was randomly divided into control group and observation group according to the random number table, with 66 cases in each group.

盲法:

Blinding:

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):

不公开

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

Not public

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:

不公开

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

Not public

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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