Clinical Study on the Treatment of Immune-Related Recurrent Spontaneous Abortion with Kidney-Tonifying and Blood-Activating Therapy

注册号:

Registration number:

ITMCTR2025000201

最近更新日期:

Date of Last Refreshed on:

2025-01-28

注册时间:

Date of Registration:

2025-01-28

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

补肾活血法治疗免疫相关性复发性流产的临床研究

Public title:

Clinical Study on the Treatment of Immune-Related Recurrent Spontaneous Abortion with Kidney-Tonifying and Blood-Activating Therapy

注册题目简写:

English Acronym:

研究课题的正式科学名称:

补肾活血法治疗免疫相关性复发性流产的临床研究

Scientific title:

Clinical Study on the Treatment of Immune-Related Recurrent Spontaneous Abortion with Kidney-Tonifying and Blood-Activating Therapy

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:

马飞

研究负责人:

马飞

Applicant:

Ma Fei

Study leader:

Ma Fei

申请注册联系人电话:

Applicant telephone:

18898607015

研究负责人电话:

Study leader's telephone:

18898607015

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:

593529863@qq.com

研究负责人电子邮件:

Study leader's E-mail:

593529863@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:

深圳市福田区福强路3012号

研究负责人通讯地址:

深圳市福田区福强路3012号

Applicant address:

No. 3012 Fuzhong Road Futian District Shenzhen City.

Study leader's address:

No. 3012 Fuzhong Road Futian District Shenzhen City.

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:

深圳市妇幼保健院

Applicant's institution:

Shenzhen Maternity & Child Healthcare 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:

SFYLS[2024]011

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:

深圳市妇幼保健院科研伦理委员会

Name of the ethic committee:

Research Ethics Committee of Shenzhen Maternal and Child Health Care Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2024/4/26 0:00:00

伦理委员会联系人:

戴宇婷

Contact Name of the ethic committee:

Dai Yuting

伦理委员会联系地址:

深圳市福田区红荔路2004号深圳市妇幼保健院

Contact Address of the ethic committee:

Shenzhen Maternity and Child Healthcare Hospital No. 2004 Hongli Road Futian District Shenzhen City

伦理委员会联系人电话:

Contact phone of the ethic committee:

82869849

伦理委员会联系人邮箱:

Contact email of the ethic committee:

szfygcpll@163.com

研究实施负责(组长)单位:

深圳市妇幼保健院

Primary sponsor:

Shenzhen Maternity & Child Healthcare Hospital

研究实施负责(组长)单位地址:

深圳市福田区红荔路2004号 深圳市妇幼保健院

Primary sponsor's address:

Shenzhen Maternity and Child Healthcare Hospital No. 2004 Hongli Road Futian District Shenzhen City

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):

深圳市

Country:

China

Province:

Guangdong

City:

Shenzhen

单位(医院):

深圳市妇幼保健院

具体地址:

深圳市福田区红荔路2004号 深圳市妇幼保健院

Institution
hospital:

Shenzhen Maternity & Child Healthcare Hospital

Address:

Shenzhen Maternity and Child Healthcare Hospital No. 2004 Hongli Road Futian District Shenzhen City

经费或物资来源:

深圳市妇幼保健院

Source(s) of funding:

Shenzhen Maternity & Child Healthcare Hospital

研究疾病:

肾虚血瘀型免疫相关性复发性流产

研究疾病代码:

Target disease:

Kidney Deficiency and Blood Stasis Type Immune-Related Recurrent Spontaneous Abortion

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:

发现补肾活血中药治疗免疫相关复发性流产、改善妊娠结局、改善肾 虚血瘀证侯的临床疗效及安全性,明确安子调冲汤改善母胎免疫耐受 免疫微环境的作用,阐明安子调冲汤调节 TolDC/Treg 发挥治疗 APS/RSA 作用,形成具有中医特色、安全、有效的治疗方案。

Objectives of Study:

Discovering the clinical efficacy and safety of kidney-tonifying and blood-activating Chinese herbs in treating immune-related recurrent miscarriage, improving pregnancy outcomes, and alleviating symptoms of kidney deficiency and blood stasis, clarifying the role of Anzi Diaochong Tang in improving maternal-fetal immune tolerance and the immunological microenvironment, elucidating the mechanism by which Anzi Diaochong Tang regulates TolDC/Treg to play a therapeutic role in APS/RSA, and forming a treatment plan with Chinese medicine characteristics that is safe and effective.

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符合免疫相关复发性流产诊断标准,辨证属肾虚血瘀证; ②此次受孕为自然受孕或 IVF-ET; ③年龄在 20-40 岁; ④卵泡期 FSH≤10mIU/L; ⑤免疫因素 RSA 为自身免疫型或同种免疫型; ⑥签署知情同意书; ⑦能够稳定随访者; ⑧能够接受中药或免疫抑制剂治疗者。

Inclusion criteria

1. Meets the diagnostic criteria for immune-related recurrent miscarriage and is identified as having kidney deficiency and blood stasis syndrome 2. The current pregnancy is either natural conception or resulting from IVF-ET (In Vitro Fertilization-Embryo Transfer) 3. Age is between 20 and 40 years old 4. FSH (Follicle Stimulating Hormone) level is ≤10 mIU/L during the follicular phase 5. Immunological factors in RSA (Recurrent Spontaneous Abortion) are either autoimmune or allogeneic 6. Have signed an informed consent form 7. Are capable of stable follow-up 8. Are willing to accept treatment with traditional Chinese medicine or immunosuppressive agents

排除标准:

① 合并有子宫结构异常、先天性血栓前状态、内分泌功能异常。 ② 有严重药物过敏史者。 ③有遗传因素如夫妇一方存在染色体异常所致复发性流产。 ④ 有感染因素所致复发性流产。

Exclusion criteria:

1. Combined with uterine structural abnormalities congenital pre-thrombotic state and endocrine dysfunction. 2. Those with a history of severe drug allergies. 3. With genetic factors such as recurrent miscarriage caused by chromosomal abnormalities in one of the spouses. 4. Recurrent miscarriage caused by infectious factors.

研究实施时间:

Study execute time:

From 2023-10-01

To      2026-09-30

征募观察对象时间:

Recruiting time:

From 2024-04-26

To      2025-04-26

干预措施:

Interventions:

组别:

对照组

样本量:

40

Group:

control group

Sample size:

干预措施:

纳入本研究后于孕 5 周开始服予低分子肝素:速碧林 0.4ml 皮下注射 qd 至孕 11 周结束后停药。

干预措施代码:

Intervention:

After being included in this study participants began to take low molecular weight heparin: Fraxiparine 0.4ml subcutaneous injection once daily (qd) from the 5th week of pregnancy until the end of the 11th week after which the medication was discontinued.

Intervention code:

组别:

观察组

样本量:

40

Group:

observation group

Sample size:

干预措施:

纳入本研究后于孕 5 周开始服用安子调冲汤至孕 11 周 结束后停药。每天 1 剂,水冲服。饭后 1 小时服用。

干预措施代码:

Intervention:

After being included in this study participants began taking Anzi Diaochong Tang starting from the 5th week of pregnancy until the end of the 11th week then discontinued the medication. One dose per day taken with water. It should be taken 1 hour after meals.

Intervention code:

样本总量 Total sample size : 80

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

广东

市(区县):

深圳

Country:

China

Province:

Guangdong

City:

Shenzhen

单位(医院):

深圳市妇幼保健院

单位级别:

三级甲等

Institution/hospital:

Shenzhen Maternity & Child Healthcare Hospital

Level of the institution:

Tertiary Grade A Hospital

测量指标:

Outcomes:

指标中文名:

免疫球蛋白IgA

指标类型:

次要指标

Outcome:

Immunoglobulin A

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

补体C4

指标类型:

次要指标

Outcome:

Complement 4

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

类风湿因子

指标类型:

次要指标

Outcome:

Rheumatoid factor

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

总T淋巴细胞百分比

指标类型:

次要指标

Outcome:

Total T cells (CD3+)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抗心磷脂抗体IgG

指标类型:

次要指标

Outcome:

Anti-Cardiolipin Antibody IgG

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

人绒毛膜促性腺激素

指标类型:

主要指标

Outcome:

Human Chorionic Gonadotropin

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抗β2糖蛋白Ⅰ抗体IgG

指标类型:

次要指标

Outcome:

Anti-beta 2 Glycoprotein I IgG

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

耐受性树突状细胞检测

指标类型:

主要指标

Outcome:

Tolerogenic Dendritic Cells (tolDCs) Detection

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抗核糖核蛋白70抗体IgG

指标类型:

次要指标

Outcome:

Anti-RNP70 IgG

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

孕酮

指标类型:

主要指标

Outcome:

Progesterone

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CD86分子检测

指标类型:

主要指标

Outcome:

CD86 molecule detection

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Foxp3

指标类型:

主要指标

Outcome:

Forkhead box P3

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

蛋白S

指标类型:

次要指标

Outcome:

Protein S

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

活化部分凝血活酶时间

指标类型:

次要指标

Outcome:

Activated Partial Thromboplastin Time

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

辅助性T淋巴细胞百分比

指标类型:

次要指标

Outcome:

CD3+CD4+ T cells

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CD83分子检测

指标类型:

主要指标

Outcome:

CD83 molecule detection

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抗核抗体

指标类型:

次要指标

Outcome:

Anti-Nuclear Antibody

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

C-反应蛋白

指标类型:

次要指标

Outcome:

C-reactive protein

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

雌二醇

指标类型:

主要指标

Outcome:

Estradiol

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

D-二聚体

指标类型:

次要指标

Outcome:

D-Dimer

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

转化生长因子β

指标类型:

主要指标

Outcome:

Transforming Growth Factor-beta

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

免疫球蛋白IgG

指标类型:

次要指标

Outcome:

Immunoglobulin G

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

血浆纤维蛋白原

指标类型:

次要指标

Outcome:

Fibrinogen

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

凝血酶原时间

指标类型:

次要指标

Outcome:

Prothrombin Time

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

补体C3

指标类型:

次要指标

Outcome:

Complement 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:

抗SSB抗体

指标类型:

次要指标

Outcome:

anti-SSB antibody

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

辅助/抑制T淋巴细胞比值

指标类型:

次要指标

Outcome:

CD4/CD8 Ratio

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肿瘤坏死因子α

指标类型:

主要指标

Outcome:

Tumor Necrosis Factor-alpha

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抗β2糖蛋白Ⅰ抗体IgA

指标类型:

次要指标

Outcome:

Anti-beta 2 Glycoprotein I IgA

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β2糖蛋白Ⅰ抗体IgM

指标类型:

次要指标

Outcome:

Anti-beta 2 Glycoprotein I IgM

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抑制性T淋巴细胞百分比

指标类型:

次要指标

Outcome:

CD3+CD8+ T cells

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

同型半胱氨酸

指标类型:

次要指标

Outcome:

Homocysteine

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

B淋巴细胞百分比

指标类型:

次要指标

Outcome:

B-lymphocytes (CD19+)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

蛋白C

指标类型:

次要指标

Outcome:

Protein C

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抗链球菌溶血素“O”

指标类型:

次要指标

Outcome:

Anti-Streptolysin O

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

自然杀伤细胞百分比

指标类型:

次要指标

Outcome:

Natural killer (CD16+56+, CD3-)

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抗心磷脂抗体IgM

指标类型:

次要指标

Outcome:

Anti-Cardiolipin Antibody IgM

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抗心磷脂抗体IgA

指标类型:

次要指标

Outcome:

Anti-Cardiolipin Antibody IgA

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Foxp3+调节T细胞检测

指标类型:

主要指标

Outcome:

FOXP3+ Regulatory T Cell Detection

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

凝血酶时间

指标类型:

次要指标

Outcome:

Thrombin Time

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抗双链DNA抗体IgG

指标类型:

次要指标

Outcome:

Anti-double stranded DNA antibody, IgG

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

免疫球蛋白IgM

指标类型:

次要指标

Outcome:

Immunoglobulin M

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Sm抗体IgG

指标类型:

次要指标

Outcome:

Anti-Smith (Sm) Antibody, IgG

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SSA抗体

指标类型:

次要指标

Outcome:

anti-SSA antibody

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

CD80分子检测

指标类型:

主要指标

Outcome:

CD80 molecule detection

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:

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:

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:

征募研究对象情况:

正在进行

Recruiting

年龄范围:

最小 20
Min age years
最大 40
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):

由研究者先依次编写好的数字顺序表(此顺 序即为以后进入临床试验的合格受试者的序号),通过 SAS 统计软件 的 PROC PLAN 过程编程产生随机数字。首先设定产生随机数字的参数 包括初值(seed)、分层(stratum)和分段(block),按照试验组∶ 对照组=1∶1 的随机分组,将受试者分配至治疗组和对照组,运行 SAS 统计软件的 PROC PLAN 过程生成随机分配结果。

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

The researcher first creates a sequential list of numbers (this sequence will be the serial numbers for eligible subjects entering the clinical trial in the future). Random numbers are then generated using the PROC PLAN procedure in SAS statistical software. Initially parameters for generating random numbers are set including the initial value (seed) stratification (stratum) and blocking (block). Subjects are randomly assigned to the treatment group and the control group in a 1:1 ratio. The random allocation results are generated by running the PROC PLAN procedure in SAS statistical software.

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):

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):

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:

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

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):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above