红精起痿方治疗2型糖尿病勃起功能障碍(肾虚血瘀型)的随机、对照临床观察

注册号:

Registration number:

ITMCTR2024000095

最近更新日期:

Date of Last Refreshed on:

2024-06-06

注册时间:

Date of Registration:

2024-06-06

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

红精起痿方治疗2型糖尿病勃起功能障碍(肾虚血瘀型)的随机、对照临床观察

Public title:

Efficacy of Hong jing qi wei formula for the treatment of type 2 diabetes mellitus erectile dysfunction: a randomized, controlled trail

注册题目简写:

English Acronym:

研究课题的正式科学名称:

红精起痿方治疗2型糖尿病勃起功能障碍(肾虚血瘀型)的随机、对照临床观察

Scientific title:

Efficacy of Hong jing qi wei formula for the treatment of type 2 diabetes mellitus erectile dysfunction: a randomized, controlled trail

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:

王浩

研究负责人:

郭军

Applicant:

Wang Hao

Study leader:

Guo Jun

申请注册联系人电话:

Applicant telephone:

+86 10 6283 5135

研究负责人电话:

Study leader's telephone:

+86 10 6283 5135

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:

wanghao0066@126.com

研究负责人电子邮件:

Study leader's E-mail:

guojun1126@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一号

研究负责人通讯地址:

北京市海淀区西苑操场一号

Applicant address:

1 Xiyuan Playground, Haidian District, Beijing

Study leader's address:

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:

2024XLA056-2

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:

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

伦理委员会批准日期:

Date of approved by ethic committee:

2024/4/24 0:00:00

伦理委员会联系人:

訾明杰

Contact Name of the ethic committee:

Zi Mingjie

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:

1 Xiyuan Playground, Haidian District, Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 10 6283 5646

伦理委员会联系人邮箱:

Contact email of the ethic committee:

xiyuanlunli@163.com

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:

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):

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

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:

1 Xiyuan Playground, Haidian District, Beijing

经费或物资来源:

国家中医药管理局中医药传承与创新“百千万”人才工程 岐黄学者资助项目

Source(s) of funding:

the Hundred Million Talent Project of Chinese Medicine Inheritance and Innovation of the State Administration of Traditional Chinese Medicine (QI Huang Scholars Grant Project)

研究疾病:

2型糖尿病勃起功能障碍

研究疾病代码:

Target disease:

type 2 diabetes mellitus erectile dysfunction

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:

评价红精起痿方治疗2型糖尿病性勃起功能障碍(肾虚血瘀型)的有效性和安全性。

Objectives of Study:

To evaluate the efficacy and safety of Hong jing qi wei formula for the treatment of type 2 diabetic erectile dysfunction.

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 2 型糖尿病和 ED 的西医诊断标准,且 2 型糖尿病发生于确诊 ED 之前; ②符合中医肾虚血瘀辨证标准; ③年龄:22≤年龄≤65 周岁; ④糖化血红蛋白<7%; ⑤IIEF-5 分值≤21 分; ⑥有固定的性伴侣和稳定的性生活,且在研究期间仍期望与性伴侣保持活跃 性生活,每周至少 1 次性生活; ⑦自愿参加本研究并签署知情同意书。

Inclusion criteria

(1) Meet the western medical diagnostic criteria for type 2 diabetes mellitus and ED, and type 2 diabetes mellitus occurs before the diagnosis of ED; (2) Meet the TCM diagnostic criteria of kidney deficiency and blood stasis syndrome; (3) Age: 22 ≤ age ≤ 65 years old; (4)Glycosylated hemoglobin <7%; (5)IIEF-5 score ≤21; (6) have a regular sexual partner and stable sex life, and still expect to maintain an active sex life with the sexual partner during the study period, at least 1 time per week; (7) Voluntarily participate in the study and sign the informed consent form.

排除标准:

①严重精神心理性因素或精神系统疾病病史者,或 SAS>69 分或 SDS>72 分或无法保证在试验期间停用抗焦虑、抑郁药物者; ②研究者判定的有临床意义的阴茎解剖或结构异常(包括但不限于):如小阴茎、阴茎先天性弯曲、阴茎海绵体纤维化等; ③由于其它性功能紊乱疾病(如射精障碍、早泄)或不可治愈的内分泌疾病引起的本病患者(例如性腺功能减退症、高泌乳素血症、甲状腺功能亢进/减退、Cushing’s 病或垂体功能减退症等); ④由于脊髓/神经损伤或前列腺癌根治术或其它外伤、手术、放疗引起的勃起障碍; ⑤具有以下一项心脏病病史 a 近 6 个月内出现过心肌梗死、休克或危及生命的心律失常; b 过去 3 个月内出现过不稳定性心绞痛,或既往性交过程中出现过心绞痛; c 近 3 个月内接受过冠状动脉旁边路移植手术,或接受过经皮冠状动脉介入治疗; d 过去 6 个月内发生过纽约心脏学会(NYHA)≥Ⅱ级心力衰竭; ⑥存在显著的肝或肾功能异常(肝功能 ALT 和/或 AST 大于正常值上限 1.5 倍、 或肌酐超过正常值上限 20%); ⑦既往 6 个月内具有严重的中枢神经系统损伤(脑缺血或出血等脑血管疾病, 脑炎或脑膜炎等脑部炎症性疾病,颅脑外伤或脊髓损伤)病史或外周肌肉神经系 统性疾病; ⑧已知患有色觉异常、色素性视网膜炎、黄斑变性、非动脉炎性前部缺血性 视神经病变眼部疾病; ⑨恶性肿瘤病史者; ⑩已知既往发生过突发性听力下降或听力丧失者; ⑪安装阴茎假体者; ⑫服用 PDE5i 类药物过敏,或用其治疗勃起功能障碍无效或发生不良反应导 致停药者; ⑬目前正在规律使用(时间 1 个月以上)且研究期间无法停用硝酸酯类或 NO 供体类、抗雄性激素类、鸟苷酸环化酶激动剂,或其它治疗勃起障碍的药物或治 疗手段者; ⑭患者性伴侣处于哺乳期或孕期或备孕阶段,或在妇科疾病治疗期而限制性 活动; ⑮近 3 个月参加其他试验课题者;

Exclusion criteria:

(1) People with severe psychosomatic factors or history of psychiatric disorders, or those with SAS > 69 or SDS > 72 or those who are unable to guarantee that they will stop using anti-anxiety or depression medication during the trial period; (2) Clinically significant penile anatomical or structural abnormalities (including but not limited to) as determined by the investigator: e.g., small penis, congenital curvature of the penis, penile cavernous fibrosis; (3) Patients with this disease due to other sexual dysfunction disorders (e.g., ejaculatory disorders, premature ejaculation) or incurable endocrine disorders (e.g., hypogonadism, hyperprolactinemia, hyper/hypothyroidism, Cushing's disease, or hypopituitarism, etc.); (4) Erectile dysfunction due to spinal cord/nerve injury or radical prostate cancer or other trauma, surgery, or radiation therapy; (5) A history of one of the following cardiac conditions a Myocardial infarction, shock, or life-threatening arrhythmia within the last 6 months; b Unstable angina pectoris within the last 3 months or previous angina pectoris during sexual intercourse; c Coronary artery bypass grafting within the last 3 months, or percutaneous coronary intervention; d New York Heart Association (NYHA) ≥ Class II heart failure within the past 6 months; (6) Significant hepatic or renal dysfunction (liver function ALT and/or AST greater than 1.5 times the upper limit of normal, or creatinine greater than 20% of the upper limit of normal); (7) History of severe central nervous system injury (cerebrovascular disease such as cerebral ischemia or hemorrhage, inflammatory brain disease such as encephalitis or meningitis, craniocerebral trauma or spinal cord injury) or peripheral muscular neurological disease within the past 6 months; (8) Known to have abnormal color vision, pigmentary retinitis, macular degeneration, non-arteritic anterior ischemic optic neuropathy ocular diseases; (9) Persons with a history of malignant tumors; (10) Persons with a known prior history of sudden hearing loss or hearing loss; (11) Penile prosthesis installers; (12) Those who are allergic to PDE5i drugs, or whose treatment for erectile dysfunction is ineffective or who have had adverse reactions that led to the discontinuation of the drug; (13) Those who are currently using the drug regularly (for more than 1 month) and are unable to stop the use of nitrates or NO donors, anti-androgens, guanylate cyclase agonists, or other drugs or treatments for erectile dysfunction during the study period; (14) The patient's sexual partner is breastfeeding or pregnant or preparing for pregnancy, or is undergoing treatment for a gynecological condition that restricts sexual activity; (15) Participation in other trials in the last 3 months.

研究实施时间:

Study execute time:

From 2024-06-20

To      2025-03-20

征募观察对象时间:

Recruiting time:

From 2024-06-20

To      2025-03-20

干预措施:

Interventions:

组别:

试验组

样本量:

38

Group:

Experimental group

Sample size:

干预措施:

红精起痿方+他达拉非

干预措施代码:

Intervention:

Hong jing qi wei formula and tadalafil

Intervention code:

组别:

对照组

样本量:

38

Group:

Control group

Sample size:

干预措施:

他达拉非+红精起痿方模拟剂

干预措施代码:

Intervention:

tadalafil

Intervention code:

样本总量 Total sample size : 76

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:

三甲

Institution/hospital:

Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

性生活日记问题3

指标类型:

次要指标

Outcome:

Sexual Encounter Profile question 3

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

勃起硬度分级

指标类型:

次要指标

Outcome:

Erection Hardness 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:

国际勃起功能简化量表-5

指标类型:

主要指标

Outcome:

International Index of Erectile Function-5

Type:

Primary 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:

Chinese Medicine Symptom 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:

性生活日记问题2

指标类型:

次要指标

Outcome:

Sexual Encounter Profile question 2

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 22
Min age years
最大 65
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男性

Male

随机方法(请说明由何人用什么方法产生随机序列):

运用SAS统计软件,按照病例分配数及随机比例生成随机数字分组表。

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

Using SAS statistical software, a random number grouping table was generated according to the number of cases assigned and the random proportion.

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):

研究结束后通过论文形式共享原始数据

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

Sharing of raw data in the form of a paper at the end of the study

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:

为了确保结果评估和数据收集的准确性,所有医生、评估员和研究助理将在试验开始前参加培训研讨会。所有研究人员必须遵循标准操作程序。所有临床试验信息应准确、完整地记录,并在适当情况下拍照。建立一个包含两名数据研究助理(非研究人员)的数据管理和质量控制团队。试验数据将由两名助手独立输入电子表格。对于每个异常或缺失的数据点,将向研究人员发送查询。

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

To ensure the accuracy of the outcome assessment and data collection, all physicians, assessors, and research assistants will attend training workshops before the start of the trial. A standard operating procedure must be followed by all investigators. All clinical trial information should be accurately and completely recorded and, if appropriate, photographed. Establish a data management and quality control team containing two data research assistants (non-researchers). The trial data will be entered into a spreadsheet by two assistants independently. For each exception or missing data point, a query will be sent to the researcher. The assistants and statistical analysts will be kept blinded during the trial until statistical analyses are performed. The principal investigator will coordinate and monitor all recruitment, intervention, and follow-up procedures.

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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