灸药调治滑胎再孕前脾肾两虚型卵泡发育不良的前瞻性、多中心、对照、真实世界临床研究

注册号:

Registration number:

ITMCTR2200006495

最近更新日期:

Date of Last Refreshed on:

2022-08-15

注册时间:

Date of Registration:

2022-08-15

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

灸药调治滑胎再孕前脾肾两虚型卵泡发育不良的前瞻性、多中心、对照、真实世界临床研究

Public title:

A prospective, multicenter, controlled, real-world clinical study of moxibustion combined with traditional Chinese medicine in the treatment of follicular dysplasia of spleen and kidney deficiency typ

注册题目简写:

English Acronym:

研究课题的正式科学名称:

灸药调治滑胎再孕前脾肾两虚型卵泡发育不良的前瞻性、多中心、对照、真实世界临床研究

Scientific title:

A prospective, multicenter, controlled, real-world clinical study of moxibustion combined with traditional Chinese medicine in the treatment of follicular dysplasia of spleen and kidney deficiency typ

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:

ChiCTR2200062696 ; ChiMCTR2200006495

申请注册联系人:

黄玉

研究负责人:

姜丽娟

Applicant:

Yu Huang

Study leader:

Lijuan Jiang

申请注册联系人电话:

Applicant telephone:

15808711207

研究负责人电话:

Study leader's telephone:

13668781266

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:

huangyu_km@163.com

研究负责人电子邮件:

Study leader's E-mail:

Jianglijuan0825@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:

云南昆明华晨路1号

研究负责人通讯地址:

云南昆明华晨路1号

Applicant address:

No. 1, Huachen Road, Kunming, Yunnan

Study leader's address:

No. 1, Huachen Road, Kunming, Yunnan

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:

云南中医药大学第一附属医院(云南省中医医院)

Applicant's institution:

Yunnan Provincial Hospital 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:

YL[2022]伦审字(016)-02

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:

云南省中医医院医学伦理委员会

Name of the ethic committee:

Medical ethics committee of Yunnan Provincial Hospital of Traditional Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

1990/1/1 0:00:00

伦理委员会联系人:

Contact Name of the ethic committee:

伦理委员会联系地址:

Contact Address of the ethic committee:

伦理委员会联系人电话:

Contact phone of the ethic committee:

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:

云南省中医医院

Primary sponsor:

Yunnan Provincial Hospital of Traditional Chinese Medicine

研究实施负责(组长)单位地址:

云南昆明华晨路1号

Primary sponsor's address:

No. 1, Huachen Road, Kunming, Yunnan

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

云南省

市(区县):

昆明市

Country:

China

Province:

Yunnan

City:

Kunming

单位(医院):

云南省中医医院

具体地址:

云南昆明华晨路1号

Institution
hospital:

Yunnan Provincial Hospital of Traditional Chinese Medicine

Address:

No. 1, Huachen Road, Kunming, Yunnan

经费或物资来源:

云南省科技厅重大科技专项计划项目(项目编号:202102AA100008)

Source(s) of funding:

Major science and technology special plan project of Yunnan Provincial Department of science and Technology (Project No.: 202102aa100008)

研究疾病:

滑胎再孕前脾肾虚型卵泡发育不良

研究疾病代码:

Target disease:

Follicular dysplasia of

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

非随机对照试验

Non randomized control

研究所处阶段:

Study phase:

其它

Others

研究目的:

评估灸法联合滋肾育泡汤调治滑胎再孕前脾肾两虚型卵泡发育不良的临床疗效及安全性。

Objectives of Study:

To evaluate the clinical efficacy and safety of moxibustion combined with Zishen Yupao Decoction in the treatment of follicular dysplasia of spleen and kidney deficiency type before habitual abortion pregnancy.

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)已婚女性,20岁≤年龄≤40岁; 2)身体质量指数(BMI)18-26(Kg/m2)(含边界值); 3)符合西医复发性流产、卵泡发育不良诊断标准及中医脾肾两虚证诊断标准; 4)依从性好,愿意参加并配合研究人员完成研究者; 5)试验前已经详细了解试验性质、意义、可能的获益,可能带来的不便和潜在的风险与不适,并自愿参加本项临床试验,且签署了书面知情同意书。

Inclusion criteria

1) Married female, 20 years old ≤ age ≤ 40 years old; 2) Body mass index (BMI) 18-26 (kg/m2) (including boundary value); 3) It meets the diagnostic criteria of recurrent abortion and follicular dysplasia in western medicine and the diagnostic criteria of spleen and kidney deficiency in traditional Chinese medicine; 4) Good compliance, willing to participate in and cooperate with researchers to complete the study; 5) The nature, significance, possible benefits, possible inconvenience and potential risks and discomfort of the trial have been understood in detail before the trial, and they have voluntarily participated in the clinical trial and signed a written informed consent.

排除标准:

1)不符合上述诊断标准者; 2)年龄<24岁或>40岁者; 3)身体质量指数(BMI)<18或>26(Kg/m2)者; 4)生殖器官先天畸形或有器质性病变者,如子宫纵隔、残角子宫、卵巢囊肿等影响卵泡发育、排卵者; 5)下丘脑、垂体因素影响卵泡发育、排卵者; 6)恶性肿瘤造成的卵巢组织破坏,放射、手术或炎症对卵巢的损害,影响卵泡发育、排卵者; 7)有严重的心血管、肝、肾及全身性严重疾病者; 8)意识模糊不清、无法准确表达不适症状者; 9)已知对研究药物(包括本研究药物辅料)或其类似物过敏者,或过敏体质者(如对两种或两种以上药物、食物和花粉过敏者); 10)敏感性皮肤、皮肤过敏症、急/慢性荨麻疹等皮肤疾病患者等。

Exclusion criteria:

1) Those who do not meet the above diagnostic criteria; 2) Age <24 years old or > 40 years old; 3) Body mass index (BMI) < 18 or > 26 (kg/m2); 4) Congenital malformations or organic diseases of reproductive organs, such as uterine mediastinum, residual horn uterus, ovarian cyst, etc., which affect follicular development and ovulation; 5) Hypothalamic and pituitary factors affect follicular development and ovulation; 6) Ovarian tissue damage caused by malignant tumors, radiation, surgery or inflammation damage to the ovary, affecting follicular development and ovulation; 7) Have serious cardiovascular, liver, kidney and systemic diseases; 8) Vague consciousness and unable to accurately express discomfort symptoms; 9) Those who are known to be allergic to the study drug (including the excipients of the study drug) or its analogues, or those with allergic constitution (such as those who are allergic to two or more drugs, food and pollen); 10) Patients with sensitive skin, skin allergy, acute / chronic urticaria and other skin diseases.

研究实施时间:

Study execute time:

From 2022-08-01

To      2023-12-31

征募观察对象时间:

Recruiting time:

From 2022-08-01

To      2023-09-30

干预措施:

Interventions:

组别:

试验组

样本量:

150

Group:

Test group

Sample size:

干预措施:

灸法治疗联合滋肾育泡汤

干预措施代码:

Intervention:

moxibustion combined with Zishen Yupao Decoction

Intervention code:

组别:

对照组

样本量:

150

Group:

control group

Sample size:

干预措施:

滋肾育泡汤

干预措施代码:

Intervention:

Zishen Yupao Decoction

Intervention code:

样本总量 Total sample size : 300

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

云南

市(区县):

普洱

Country:

China

Province:

Yunnan

City:

Pu'er

单位(医院):

普洱市中医医院

单位级别:

三级甲等

Institution/hospital:

Pu'er Hospital of Traditional Chinese Medicine

Level of the institution:

Level III Class A

国家:

中国

省(直辖市):

云南省

市(区县):

昆明市

Country:

China

Province:

Yunnan

City:

Kunming

单位(医院):

云南省中医医院

单位级别:

三级甲等

Institution/hospital:

Yunnan Provincial Hospital of Traditional Chinese Medicine

Level of the institution:

Level III Class A

国家:

中国

省(直辖市):

云南

市(区县):

宣威

Country:

China

Province:

Yunnan

City:

Xuanwei

单位(医院):

宣威市中医院

单位级别:

三级甲等

Institution/hospital:

Xuanwei Hospital of Traditional Chinese Medicine

Level of the institution:

Level III Class A

国家:

中国

省(直辖市):

云南

市(区县):

腾冲

Country:

China

Province:

Yunnan

City:

Tengchong

单位(医院):

腾冲市中医医院

单位级别:

二级甲等

Institution/hospital:

Tengchong Hospital of Traditional Chinese Medicine

Level of the institution:

Level II Class A

国家:

中国

省(直辖市):

云南

市(区县):

昭通

Country:

China

Province:

Yunnan

City:

单位(医院):

昭通市中医医院

单位级别:

三级甲等

Institution/hospital:

Zhaotong Hospital of Traditional Chinese Medicine

Level of the institution:

Level III Class A

测量指标:

Outcomes:

指标中文名:

卵泡最大直径

指标类型:

次要指标

Outcome:

Maximum follicle diameter

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医临床症状积分

指标类型:

主要指标

Outcome:

TCM clinical symptom score

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

围排卵期子宫内膜厚度

指标类型:

次要指标

Outcome:

Periovulatory endometrial thickness

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血清FSH、LH、E2、AMH

指标类型:

次要指标

Outcome:

FSH、LH、E2、AMH

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:

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
Min age years
最大
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):

非随机

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

Nonrandom

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):

暂未确定

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

Not yet

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:

暂未确定

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

Not yet

数据管理委员会:

Data Managemen Committee:

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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