育肾养卵方联合针刺治疗肾虚型卵巢储备功能减退患者的随机对照研究

注册号:

Registration number:

ITMCTR2024000249

最近更新日期:

Date of Last Refreshed on:

2024-08-16

注册时间:

Date of Registration:

2024-08-16

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

育肾养卵方联合针刺治疗肾虚型卵巢储备功能减退患者的随机对照研究

Public title:

A randomized controlled study on the combination of Yushen Yangluan Prescription and acupuncture treatment for patients with kidney deficiency type ovarian reserve dysfunction

注册题目简写:

English Acronym:

研究课题的正式科学名称:

一项随机对照单盲试验:育肾养卵方联合针刺疗法对肾虚型卵巢储备功能减退的疗效研究

Scientific title:

A single blind randomized controlled trial: the effect of Yushen Yangluan Prescription combined with acupuncture therapy on kidney deficiency type of ovarian reserve dysfunction

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:

宁婧

研究负责人:

陈静

Applicant:

Ning Jing

Study leader:

Chen Jing

申请注册联系人电话:

Applicant telephone:

15706903200

研究负责人电话:

Study leader's telephone:

15921440609

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:

1109150461@qq.com

研究负责人电子邮件:

Study leader's E-mail:

cj1275@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:

上海市静安区芷江中路274号

研究负责人通讯地址:

上海市静安区芷江中路274号

Applicant address:

274 Zhijiang Middle Road, Jing'an District, Shanghai

Study leader's address:

274 Zhijiang Middle Road, Jing'an District, Shanghai

申请注册联系人邮政编码:

Applicant postcode:

200040

研究负责人邮政编码:

Study leader's postcode:

200040

申请人所在单位:

上海市中医医院

Applicant's institution:

Shanghai Traditional Chinese Medicine 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:

2024SHL-KL-46-01

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:

上海市中医医院伦理委员会

Name of the ethic committee:

Ethics Committee of Shanghai Traditional Chinese medicine hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2024/3/1 0:00:00

伦理委员会联系人:

凌丽

Contact Name of the ethic committee:

Ling Li

伦理委员会联系地址:

上海市静安区芷江中路274号

Contact Address of the ethic committee:

274 Zhijiang Middle Road, Jing'an District, Shanghai

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 21 5662 8310

伦理委员会联系人邮箱:

Contact email of the ethic committee:

shszyyyec@126.com

研究实施负责(组长)单位:

上海市中医医院

Primary sponsor:

Shanghai Traditional Chinese Medicine Hospital

研究实施负责(组长)单位地址:

上海市静安区芷江中路274号

Primary sponsor's address:

274 Zhijiang Middle Road, Jing'an District, Shanghai

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

市(区县):

Country:

China

Province:

Shanghai

City:

单位(医院):

上海市中医医院

具体地址:

上海市静安区芷江中路274号

Institution
hospital:

Shanghai Traditional Chinese Medicine Hospital

Address:

274 Zhijiang Middle Road, Jing'an District, Shanghai

经费或物资来源:

上海市 2020 年度“科技创新行动计划”医学创新研究专项项目(20Z21900400);上海申康医院中心临床三年行动计划项目(SHDC2020CR4056);上海市科学技术委员会科技计划项目(20Z21900400);2023年上海医学创新发展基金会未来计划(WL-HBMS-2022006K)

Source(s) of funding:

Shanghai 2020 "Science and Technology Innovation Action Plan" Medical Innovation Research Special Project(20Z21900400);Shanghai Shenkang Hospital Center Clinical Three Year Action Plan Project(SHDC2020CR4056);Science and Technology Plan Project of Shanghai Municipal Commission of Science and Technology(20Z21900400);Future Plan of Shanghai Medical Innovation Development Foundation in 2023(WL-HBMS-2022006K)

研究疾病:

卵巢储备功能减退

研究疾病代码:

Target disease:

Diminished ovarian reserve,DOR

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:

制订半标准化的针药治疗方案,明确针刺、育肾养卵方、针刺联合育肾养卵方对卵巢储备功能减退患者的临床疗效,为卵巢储备功能减退的中医治疗指南提供重要循证医学证据。

Objectives of Study:

Develop a semi standardized acupuncture and medication treatment plan, clarify the clinical efficacy of acupuncture, kidney and egg nourishing formula, and acupuncture combined with kidney and egg nourishing formula for patients with ovarian reserve dysfunction, and provide important evidence-based medicine guidelines for the treatment of ovarian reserve dysfunction in traditional Chinese medicine.

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年龄18-45岁。 ②符合本病西医诊断卵巢储备功能减退标准及中医诊断肾虚证标准者。 ③未合并使用其它药物治疗者。 ④1年内未接受过针灸治疗。 ⑤患者愿意参加本研究并能积极配合复诊,完成临床观察者。 ⑥患者签署知情同意书。

Inclusion criteria

① Age range: 18-45 years old. ② Those who meet the criteria for Western medicine diagnosis of ovarian reserve dysfunction and traditional Chinese medicine diagnosis of kidney deficiency syndrome. ③ Not combined with other medications for treatment. ④ He has not received acupuncture and moxibustion treatment within one year. ⑤ The patient is willing to participate in this study and actively cooperate with follow-up visits to complete clinical observation. ⑥ The patient signs an informed consent form.

排除标准:

①哺乳期妇女。 ②合并无法控制的内科疾病,可能干扰或影响研究结果者, 如严重的肝、肾、心、脑疾病,未经控制的高血压病、糖尿病等。 ③合并其他内分泌疾病,如多囊卵巢综合征、甲状腺功能异常、高泌乳素血症等。 ④双侧卵巢或单侧卵巢切除引起的卵巢功能早衰。 ⑤精神病患者。 ⑥过敏体质或对受试药物过敏者。 ⑦对针灸不能耐受, 甚至晕针者。 ⑧三个月内合并使用治疗卵巢功能药物者(如服用辅酶Q10、脱氢表雄甾酮(DHEA)、黄体酮激素、戊酸雌二醇片激素类药物等) ⑨正在参加或近3个月内曾参加过其他临床试验者 ⑩异常子宫出血者。

Exclusion criteria:

① Breastfeeding women. ② Those with uncontrollable medical diseases that may interfere with or affect the research results, such as serious liver, kidney, heart, brain diseases, uncontrolled hypertension, diabetes, etc. ③ Merge with other endocrine disorders, such as polycystic ovary syndrome, thyroid dysfunction, hyperprolactinemia, etc. ④ Premature ovarian failure caused by bilateral or unilateral oophorectomy. ⑤ Psychiatric patients. ⑥ Individuals with allergies or those who are allergic to the test drug. ⑦ Those who can not tolerate acupuncture and moxibustion, or even fainting. ⑧ Combination use of ovarian function medications within three months (such as taking coenzyme Q10, dehydroepiandrosterone (DHEA), progesterone hormone, estradiol valerate tablets, etc.) ⑨ Participants who are currently participating or have participated in other clinical trials within the past 3 months ⑩ Abnormal uterine bleeding.

研究实施时间:

Study execute time:

From 2024-03-01

To      2025-07-01

征募观察对象时间:

Recruiting time:

From 2024-03-01

To      2025-07-01

干预措施:

Interventions:

组别:

育肾养卵方联合针刺组

样本量:

74

Group:

Yushen Yangluan Prescription combined with acupuncture group

Sample size:

干预措施:

育肾养卵方&针刺疗法

干预措施代码:

Intervention:

Yushen Yangluan Prescription&Acupuncture

Intervention code:

组别:

育肾养卵方联合假针刺组

样本量:

74

Group:

Yushen Yangluan Prescription combined with Fake Acupuncture group

Sample size:

干预措施:

育肾养卵方&假针刺疗法

干预措施代码:

Intervention:

Yushen Yangluan Prescription&Fake Acupuncture

Intervention code:

样本总量 Total sample size : 148

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):

静安区

Country:

中国

Province:

上海

City:

静安区

单位(医院):

上海市中医医院

单位级别:

三甲

Institution/hospital:

Shanghai Traditional Chinese Medicine Hospital

Level of the institution:

Class A

测量指标:

Outcomes:

指标中文名:

子宫动脉血流检查

指标类型:

次要指标

Outcome:

CDFI

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

基础卵泡刺激素

指标类型:

次要指标

Outcome:

FSH

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医证候积分

指标类型:

次要指标

Outcome:

Traditional Chinese Medicine Syndrome Points

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

促黄体生成素

指标类型:

次要指标

Outcome:

LH

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

汉密尔顿焦虑量表

指标类型:

次要指标

Outcome:

Hamilton Anxiety Scale

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

月经失血图

指标类型:

次要指标

Outcome:

PBAC

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

阿森斯失眠量表

指标类型:

次要指标

Outcome:

Athens Insomnia Scale, AIS

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

双侧卵巢窦卵泡数

指标类型:

次要指标

Outcome:

AFC

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

匹兹堡睡眠质量指数量表

指标类型:

次要指标

Outcome:

(Pittsburgh Sleep Quality Index, PSQI)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抗缪勒管激素

指标类型:

主要指标

Outcome:

AMH

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:

阴道分泌物

组织:

Sample Name:

vaginal secretions

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:

正在进行

Recruiting

年龄范围:

最小 18
Min age years
最大 45
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):

本试验采用随机对照方法进行分组,通过操作SPSS 26.0软件得出随机数字,并制成随机分配卡片,用不透明信封密封,信封序号与卡片序号相同。病例按其就诊的先后次序拆号码相同的信封,按信封内卡规定的分组将所观察的病例随机分为育肾养卵方+针刺组、育肾养卵方+假针刺各74例,该研究将在上海市中医医院妇科门诊及住院部完成148例病人收录。

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

This trial used a randomized controlled method for grouping, obtained random numbers through the operation of SPSS 26.0 software, and made random allocation cards, sealed with opaque envelopes with the same serial number as the card. Cases were opened according to their order of visit, and the same number of envelopes were sealed. The observed cases were randomly divided into the Yushen Yangluan Prescription + acupuncture group and the Yushen Yangluan Prescription + sham acupuncture group, with 74 cases in each group. The study will include 148 patients in the gynecology outpatient department and inpatient department of Shanghai Hospital of Traditional Chinese Medicine.

盲法:

本试验采用受试者被盲的单盲研究方法。受试者对自己是分配到2组中的哪一组并不知情,只有针灸医师清楚受试者的群体分配情况,但对受试者其他信息均不知情。为了增加盲法效度,针灸治疗将在单独的房间中进行并佩戴眼罩。同时在整个试验过程中,将最大限度避免针灸师与受试者之间,以及受试者与受试者之间的关于针灸治疗方面的交流。在试验实施前各研究人员将多次接受有关本研究规范实施的培训,均严格遵守各部门分离原则。

Blinding:

In this study, the single blind study method of blind subjects was used. The subjects did not know which of the two groups they were assigned to. Only the acupuncturist knew the group allocation of the subjects, but did not know other information about the subjects. In order to increase the blind validity, acupuncture treatment will be carried out in a separate room with an eye mask. At the same time, communication on acupuncture treatment between acupuncturists and subjects, as well as between subjects and subjects, will be avoided to the greatest extent during the whole experiment. Before the implementation of the experiment, all researchers will receive training on the implementation of this research specification for many times, and strictly abide by the principle of separation of departments.

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):

No

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:

数据采集和管理由两部分组成,一为病例记录表,二为电子采集和管理系统。

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

A standard data collection and management system include a CRF and an electronic data capture.anged.

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):

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