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Effect of oral administration of traditional Chinese medicine for promoting blood circulation and removing blood stasis plus Enema on fertility after tubal pregnancy

注册号：

Registration number：

ITMCTR2022000053

最近更新日期：

Date of Last Refreshed on：

2022-07-30

注册时间：

Date of Registration：

2022-06-21

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

活血化瘀中药口服加灌肠治疗对输卵管妊娠术后生育力影响的疗效观察

Public title：

Effect of oral administration of traditional Chinese medicine for promoting blood circulation and removing blood stasis plus Enema on fertility after tubal pregnancy

注册题目简写：

English Acronym：

研究课题的正式科学名称：

活血化瘀中药口服加灌肠治疗对输卵管妊娠术后生育力影响的疗效观察

Scientific title：

Effect of oral administration of traditional Chinese medicine for promoting blood circulation and removing blood stasis plus Enema on fertility after tubal pregnancy

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：

ChiCTR2200062224 ; ChiMCTR2200006398

申请注册联系人：

魏萌

研究负责人：

程玲

Applicant：

WEIMENG

Study leader：

CHENGLING

申请注册联系人电话：

Applicant telephone：

13811667467

研究负责人电话：

Study leader's telephone：

13601382208

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：

weimeng890703@sina.com

研究负责人电子邮件：

Study leader's E-mail：

chengling2208@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：

北京市朝阳区中环南路6号望京医院

研究负责人通讯地址：

北京市朝阳区中环南路6号望京医院

Applicant address：

Wangjing hospital, No. 6, Zhonghuan South Road, Chaoyang District, Beijing

Study leader's address：

Wangjing hospital, No. 6, Zhonghuan South Road, Chaoyang 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：

中国中医科学院望京医院

Applicant's institution：

Wangjing hospital, Chinese Academy 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：

WJEC-KT-2022-003-P002

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：

中国中医科学院望京医院医学伦理委员会

Name of the ethic committee：

Medical ethics committee of Wangjing hospital, Chinese Academy of traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2022/4/7 0:00:00

伦理委员会联系人：

王浩

Contact Name of the ethic committee：

WANGHAO

伦理委员会联系地址：

北京市朝阳区中环南路6号望京医院

Contact Address of the ethic committee：

Wangjing hospital, No. 6, Zhonghuan South Road, Chaoyang District, Beijing

伦理委员会联系人电话：

Contact phone of the ethic committee：

010-84739618

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：

中国中医科学院望京医院

Primary sponsor：

Wangjing hospital, Chinese Academy of traditional Chinese Medicine

研究实施负责（组长）单位地址：

北京市朝阳区中环南路6号望京医院

Primary sponsor's address：

Wangjing hospital, No. 6, Zhonghuan South Road, Chaoyang 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

市(区县)：

Country：

CHINA

Province：

BEIJING

City：

单位(医院)：

中国中医科学院望京医院

具体地址：

北京市朝阳区中环南路6号望京医院

Institution
hospital：

Wangjing hospital, Chinese Academy of traditional Chinese Medicine

Address：

Wangjing hospital, No. 6, Zhonghuan South Road, Chaoyang District, Beijing

经费或物资来源：

中国中医科学院

Source(s) of funding：

Chinese Academy of traditional Chinese Medicine

研究疾病：

异位妊娠

研究疾病代码：

Target disease：

Ectopic pregnancy

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

横断面

Cross-sectional

研究所处阶段：

Study phase：

I期临床试验

Phase I clinical trial

研究目的：

1、通过临床研究，探讨活血化瘀中药口服加灌肠综合治疗输卵管妊娠术后的临床疗效，并观察其安全性； 2、对输卵管妊娠术后如何有效减轻血瘀证、提高术后输卵管通畅率、避免持续性异位妊娠及重复异位妊娠的发生进行探讨，为临床提供理论依据。

Objectives of Study：

1. Through clinical research, to explore the clinical effect of oral administration of traditional Chinese medicine for promoting blood circulation and removing blood stasis plus Enema on postoperative fallopian tube pregnancy The efficacy and safety were observed; 2. How to effectively reduce the blood stasis syndrome, improve the patency rate of fallopian tube and avoid persistence; To explore the occurrence of ectopic pregnancy and repeated ectopic pregnancy, so as to provide theoretical basis for clinical practice.

药物成份或治疗方案详述：

对符合纳入标准的患者,运用 SAS 9.1.2 统计软件按照样本量计算所得的病例分配数及两组比例生成随机数字分组表，按预期病例数进行分配，试验组30例，对照组30例。两组均给予以基础治疗：氨甲环酸氯化钠注射液、葡葡萄糖氯化钠注射液、维生素C注射液、维生素B6注射液等止血补液对症治疗2天，对照组术后不用中药；试验组于手术后 1 天、可正常饮水时开始口服中药，灌肠中药于手术后恢复正常排便、阴道流血停止后开始使用，经期暂停，口服及灌肠每个月治疗14天为1疗程，共 3 个疗程。 （1）试验组口服中药：桃仁 12g、红花 12g、当归 15g、川芎 10g、熟地黄 15g、丹皮 10g、赤芍 15g、桂枝 10g、茯苓 15g、三棱 10g、莪术 10g。（药物由望京医院草药房统一煎制，日1剂，早晚分服 200ml） 随症加减：失血量多，失血伤气，头晕心悸等气血两虚者可加黄芪 30g、党参 15g、白术15g；盆腔粘连较重者可加败酱草 15g、大血藤 15g。 （2）试验组中药灌肠：三棱 15g、莪术 15g、水蛭 15g、路路通 10g、虎杖 15g、大血藤 20g、败酱草15g、土鳖虫 10g、昆布 15g、白花蛇舌草 20g、桂枝 15g、附子 15g、细辛6g、羌活 10g。（药物由望京医院草药房统一浓煎 100ml，日1剂，保留灌肠）

Description for medicine or protocol of treatment in detail：

For the patients who meet the inclusion criteria, SAS 9.1.2 statistical software is used to generate a random number grouping table according to the case allocation number calculated by the sample size and the proportion of the two groups, and they are allocated according to the expected number of cases. There are 30 cases in the test group and 30 cases in the control group. Both groups were given basic treatment: hemostasis and rehydration for 2 days, such as tranexamic acid sodium chloride injection, glucose sodium chloride injection, vitamin C injection, vitamin B6 injection, etc. the control group did not use traditional Chinese medicine after operation; The experimental group began to take oral Chinese medicine when they could drink water normally one day after the operation. The enema Chinese medicine was used after the normal defecation and vaginal bleeding stopped after the operation. The menstrual period was suspended. Oral and enema treatment for 14 days a month was a course of treatment, a total of 3 courses. (1) The experimental group took oral Chinese medicine: peach kernel 12g, safflower 12g, angelica 15g, Ligusticum chuanxiong 10g, Rehmannia glutinosa 15g, cortex moutan 10g, red peony 15g, Cinnamon Twig 10g, Poria cocos 15g, Rhizoma sparganii 10g, zedoary turmeric 10g. (the medicine is uniformly decocted by the herbal medicine room of Wangjing hospital, 1 dose per day, 200ml in the morning and evening) Add or subtract with symptoms: 30g Astragalus membranaceus, 15g Codonopsis pilosula and 15g Atractylodes macrocephala can be added to those with deficiency of both qi and blood, such as excessive blood loss, blood loss and Qi damage, dizziness and palpitation; 15g Patrinia villosa and 15g Caulis Spatholobi can be added to patients with severe pelvic adhesion. (2) Chinese herbal enema in the experimental group: Sparganium tuberosum 15g, zedoary turmeric 15g, leech 15g, LULUTONG 10g, Polygonum cuspidatum 15g, spatholobus Spatholobi 20g, Patrinia villosa 15g, ground beetle bug 10g, Laminaria japonica 15g, Hedyotis diffusa 20g, Cinnamon Twig 15g, aconite 15g, asarum 6G, notopterygium notopterygium 10g. (the medicine is uniformly decocted in 100ml by the herbal medicine room of Wangjing hospital, 1 dose per day, retention enema)

纳入标准：

（1）符合西医输卵管妊娠及中医血瘀证诊断标准。 （2）年龄在 20-40 岁，经腹腔镜保守性手术术后的患者。

Inclusion criteria

(1) It meets the diagnostic criteria of fallopian tube pregnancy in western medicine and blood stasis syndrome in traditional Chinese medicine. (2) Patients aged 20-40 years after laparoscopic conservative surgery.

排除标准：

（1）年龄＜20岁或＞40岁者，合并心脑血管、肝、肾和造血系统等严重疾病者、精神病患者。 （2）先天性输卵管畸形者。 （3）输卵管妊娠合并宫内妊娠者，非输卵管妊娠的异位妊娠者，术后持续性异位妊娠患者。 （4）由于各种原因患者要求切除或结扎双侧输卵管者。 （5）过敏体质或对研究方药中已知药物过敏者。 （6）不符合纳入标准，依从性差，无法判断疗效或资料不全者。

Exclusion criteria：

(1) Those aged ＜ 20 years or ＞ 40 years, with serious diseases such as cardiovascular, cerebrovascular, liver, kidney and hematopoietic system, and psychotic patients. (2) Congenital tubal malformation. (3) Tubal pregnancy with intrauterine pregnancy, ectopic pregnancy without tubal pregnancy, and postoperative persistent ectopic pregnancy. (4) Patients who require resection or ligation of bilateral fallopian tubes for various reasons. (5) Allergic constitution or allergy to known drugs in the study prescription. (6) Those who do not meet the inclusion criteria, have poor compliance, cannot judge the efficacy or have incomplete data.

研究实施时间：

Study execute time：

从From 2021-03-01

至To      2024-10-01

征募观察对象时间：

Recruiting time：

从From 2022-08-01

至To      2024-10-01

干预措施：

Interventions：

组别：

对照组

样本量：

30

Group：

Control group

Sample size：

干预措施：

无特殊干预措施，仅术后对症治疗

干预措施代码：

Intervention：

Postoperative symptomatic treatment

Intervention code：

组别：

治疗组

样本量：

30

Group：

Treatment group

Sample size：

干预措施：

活血化瘀中药口服及灌肠治疗

干预措施代码：

Intervention：

Oral and enema therapy with traditional Chinese medicine for promoting blood circulation and removing blood stasis

Intervention code：

样本总量 Total sample size ： 60

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

北京市

市(区县)：

Country：

CHINA

Province：

BEIJING

City：

单位(医院)：

中国中医科学院望京医院

单位级别：

三级甲等

Institution/hospital：

Wangjing hospital, Chinese Academy of traditional Chinese Medicine

Level of the institution：

Class III class A

测量指标：

Outcomes：

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：

术后第1天、第3天、第10天

测量方法：

静脉采血

Measure time point of outcome：

Day 1, 3 and 10 after operation

Measure method：

Venous blood collection

指标中文名：

输卵管通畅度

指标类型：

主要指标

Outcome：

Tubal patency

Type：

Primary indicator

测量时间点：

术后3个月

测量方法：

输卵管超声造影

Measure time point of outcome：

3 months after operation

Measure method：

Sonography of fallopian tube

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 20 岁
Min age years
最大 40 岁
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）：

对符合纳入标准的患者,运用 SAS 9.1.2 统计软件按照样本量计算所得的病例分配数及两组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)：

For patients who meet the inclusion criteria, a random number grouping table is generated by using SAS 9.1.2 statistical software according to the number of cases allocated and the proportion of the two groups calculated according to the sample size

盲法：

Blinding：

是否共享原始数据：

IPD sharing：

否

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）：

无

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：

病例记录表

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

Case Record Form

数据管理委员会：

Data Managemen Committee：

有

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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