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循经火龙罐对肾虚血瘀型子宫内膜异位性疾病患者慢性盆腔疼痛的效果研究

注册号：

Registration number：

ITMCTR2025001402

最近更新日期：

Date of Last Refreshed on：

2025-07-14

注册时间：

Date of Registration：

2025-07-14

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

循经火龙罐对肾虚血瘀型子宫内膜异位性疾病患者慢性盆腔疼痛的效果研究

Public title：

Study on the Effect of Xunjing Huolong Cupping on chronic Pelvic Pain in patients with endometriosis of Kidney Deficiency and Blood Stasis Type

注册题目简写：

English Acronym：

研究课题的正式科学名称：

循经火龙罐对肾虚血瘀型子宫内膜异位性患者慢性盆腔疼痛的效果研究

Scientific title：

Study on the Effect of Xunjing Huolong Cupping on chronic Pelvic Pain in patients with endometriosis of Kidney Deficiency and Blood Stasis Type

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：

秦铭莉

研究负责人：

江秀敏

Applicant：

Qinmingli

Study leader：

Jiangxiumin

申请注册联系人电话：

Applicant telephone：

18249488380

研究负责人电话：

Study leader's telephone：

13960850518

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：

1533067671@qq.com

研究负责人电子邮件：

Study leader's E-mail：

jiangxiumin@fjsfy.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：

福建省福州市鼓楼区华大街道福建中医药大学屏山校区

研究负责人通讯地址：

福建省福州市鼓楼区道山路18号

Applicant address：

Pingshan Campus Fujian University of Traditional Chinese Medicine Huada Sub-district Gulou District Fuzhou City Fujian Province

Study leader's address：

No. 18 Daoshan Road Gulou District Fuzhou City Fujian Province2025

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：

福建中医药大学

Applicant's institution：

Fujian University 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：

2025KY091-02

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：

福建省妇幼保健院伦理委员会

Name of the ethic committee：

Ethics Committee of Fujian Provincial Maternal and Child Health Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2025/4/9 0:00:00

伦理委员会联系人：

叶丽频

Contact Name of the ethic committee：

Yelipin

伦理委员会联系地址：

福建省福州市鼓楼区道山路18号

Contact Address of the ethic committee：

Maternity and Child Care Centers in Fujian Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

88312052

伦理委员会联系人邮箱：

Contact email of the ethic committee：

fjsfyll@163.com

研究实施负责（组长）单位：

福建省妇幼保健院

Primary sponsor：

Maternity and Child Care Centers in Fujian Province

研究实施负责（组长）单位地址：

福建省福州市鼓楼区道山路18号

Primary sponsor's address：

No. 18 Daoshan Road Gulou District Fuzhou City Fujian Province2025

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

福建省

市(区县)：

福州市

Country：

China

Province：

Fujian Province

City：

Fuzhou City

单位(医院)：

福建省妇幼保健院

具体地址：

福建省福州市鼓楼区道山路18号

Institution
hospital：

Maternity and Child Care Centers in Fujian Province

Address：

No. 18 Daoshan Road Gulou District Fuzhou City Fujian Province2025

经费或物资来源：

自筹

Source(s) of funding：

self raised fund

研究疾病：

子宫内膜异位性疾病

研究疾病代码：

Target disease：

Endometriotic disease

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：

本研究旨在探寻循经火龙罐对改善肾虚血瘀型子宫内膜异位性疾病患者慢性盆腔疼痛的干预效果，以评价循经火龙罐对改善慢性盆腔疼痛的有效性及临床应用的价值。

Objectives of Study：

This study aims to explore the intervention effect of the meridian-based fire dragon cupping on improving chronic pelvic pain in patients with endometriosis of kidney deficiency and blood stasis type so as to evaluate the effectiveness of the meridian-based fire dragon cupping in improving chronic pelvic pain and its value in clinical application.

药物成份或治疗方案详述：

对照组进行中医常规治疗及护理：常规治疗保持原先的中药治疗，如少腹逐瘀汤、归肾丸合桃红四物汤等行补肾活血，化瘀止痛，每日一剂，300ml水煎，早晚各一次，服药期间避免食用生冷、油腻、辛辣等刺激性食物。常规护理嘱患者养成规律的生活作息习惯，注意休息及腰腹部保暖，避免重体力劳动；以清淡易消化饮食为主，忌烟酒、咖啡、浓茶及辛辣刺激食物，避免进食生冷、寒凉食物；可指导患者进行瑜伽、慢跑等舒缓运动；嘱患者注意个人卫生，保持会阴清洁、干燥，避免人工流产等宫腔手术；向患者主动方介绍疾病相关知识，鼓励患者坚持治疗，减少复发率。 干预组在对照组的基础上采用循经火龙罐干预。选取任脉、督脉、足太阳膀胱经为干预部位，保持室内温度适宜，协助患者脱去衣物，卧位，对患者施罐部位涂以润滑油，选择大小合适的火龙罐，将罐内艾柱点燃，使其充分燃烧，施罐前摸一下罐口温度，防止烫伤患者，以手掌小鱼际接触皮肤后再进行落罐操作。沿着患者的督脉自下而上运罐，在施罐过程中，对特定穴位运用点、按、揉等手法刺激以皮肤红润为宜。接着沿两侧膀胱经由上而下施罐，施罐过程中观察患者皮肤状态，以微微发红，患者感觉温热为宜。随后用火龙罐对下腹部进行纵向推拿按摩，施罐结束后，用纸巾擦净皮肤上的精油，嘱咐患者饮用一杯温开水，休息片刻后再离开。

Description for medicine or protocol of treatment in detail：

The control group received conventional traditional Chinese medicine treatment and care: The conventional treatment maintained the original Chinese herbal therapy such as Shaofu Zhuyu Decoction Guishen Pills and Tao Hong Siwu Decoction etc. to tonify the kidney promote blood circulation remove blood stasis and relieve pain. One dose was taken daily with 300ml decocted in water once in the morning and once in the evening. During the medication period avoid eating raw cold greasy spicy and other irritating foods. Routine care instructs patients to develop regular living and working habits pay attention to rest and keep the waist and abdomen warm and avoid heavy physical labor. The diet should mainly be light and easy to digest. Avoid smoking alcohol coffee strong tea and spicy and stimulating foods. Also avoid eating raw cold and cool foods. Patients can be guided to do gentle exercises such as yoga and jogging. Instruct the patient to pay attention to personal hygiene keep the perineum clean and dry and avoid uterine cavity surgeries such as induced abortion. Introduce disease-related knowledge to patients proactively encourage them to adhere to treatment and reduce the recurrence rate. The intervention group was intervened with the meridian-following Fire Dragon cupping on the basis of the control group. Select the Ren Meridian Governor Meridian and Foot-Sun Bladder Meridian as the intervention sites keep the indoor temperature appropriate assist the patient in taking off their clothes and lying down apply lubricating oil to the cupping site of the patient choose a fire dragon cupping of appropriate size light the mugmoxa stick inside the cupping to make it burn fully feel the temperature of the cupping mouth before cupping to prevent scalding the patient and then touch the skin with the small fish area of the palm before performing the cupping operation. The cupping is performed from bottom to top along the patient's Governor vessel. During the cupping process specific acupoints are stimulated by techniques such as tapping pressing and kneading until the skin becomes rosy. Then cupping is applied from top to bottom along both sides of the bladder. During the cupping process observe the patient's skin condition. It is appropriate when it is slightly red and the patient feels warm. Then use the fire Dragon cupping to perform longitudinal massage on the lower abdomen. After the cupping is done wipe off the essential oil on the skin with a paper towel and instruct the patient to drink a cup of warm water rest for a while and then leave.

纳入标准：

①符合中医肾虚血瘀型子宫内膜异位性疾病诊断标准； ②符合西医子宫内膜异位性疾病诊断标准； ③腹痛程度VAS值≥4； ④18～44岁有性生活史的女性患者； ⑤月经周期规律（28±7）天； ⑥沟通知情后签署知情同意书自愿参加本次研究者。

Inclusion criteria

① It meets the diagnostic criteria for endometriosis of the kidney deficiency and blood stasis type in traditional Chinese medicine; ② Meet the diagnostic criteria for endometriotic diseases in Western medicine; ③ The VAS value of abdominal pain degree is ≥4; Female patients aged 18 to 44 with a history of sexual life; ⑤ The menstrual cycle is regular (28±7) days; ⑥ After communicating and being informed sign the informed consent form voluntarily to participate in this research.

排除标准：

①合并心、脑 、肝、肾等系统严重疾病者； ②妊娠期或近期准备妊娠的妇女，哺乳期妇女； ③合并其他妇科恶性肿瘤相关疾病如卵巢恶性肿瘤、子宫内膜恶性肿瘤、盆腔恶性肿瘤； ④巧克力囊肿直径≥5cm者，AM患者单个腺肌瘤直径大于5cm者； ⑤近3个月参加过其他临床试验的患者； ⑥近3个月接受其他镇痛治疗者； ⑦局部皮肤有破损、溃疡、炎症、感染者； ⑧患有出血性疾病者； ⑨艾草致敏者。

Exclusion criteria：

① Patients with severe diseases in the heart brain liver kidney and other systems; ② Pregnant women or those planning to become pregnant in the near future and lactating women; ③ Patients with other gynecological malignant tumor-related diseases such as ovarian malignant tumors endometrial malignant tumors and pelvic malignant tumors; ④ Patients with chocolate cysts larger than or equal to 5 cm in diameter and patients with adenomyosis with a single adenomyoma larger than 5 cm in diameter; ⑤ Patients who have participated in other clinical trials in the past 3 months; ⑥ Patients who have received other analgesic treatments in the past 3 months; ⑦ Patients with local skin damage ulcers inflammation or infection; ⑧ Patients with bleeding disorders; ⑨ Patients allergic to mugwort.

研究实施时间：

Study execute time：

从From 2025-04-12

至To      2025-12-31

征募观察对象时间：

Recruiting time：

从From 2025-05-14

至To      2025-12-31

干预措施：

Interventions：

组别：

干预组

样本量：

45

Group：

intervention group

Sample size：

干预措施：

在对照组基础上进行循经火龙罐疗法

干预措施代码：

Intervention：

Based on the control group, carry out the Meridian Fire Dragon Cupping Therapy.

Intervention code：

组别：

对照组

样本量：

45

Group：

Control group

Sample size：

干预措施：

中医常规治疗及护理

干预措施代码：

Intervention：

Conventional treatment and care in Traditional Chinese Medicine

Intervention code：

样本总量 Total sample size ： 90

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

福建省

市(区县)：

福州市

Country：

China

Province：

Fujian Province

City：

Fuzhou City

单位(医院)：

福建省妇幼保健院

单位级别：

三甲医院

Institution/hospital：

Maternity and Child Care Centers in Fujian Province

Level of the institution：

top three hospitals

测量指标：

Outcomes：

指标中文名：

中医证候积分

指标类型：

次要指标

Outcome：

Chinese medicine symptom complex 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：

子宫内膜异位症生存质量专用评价量表

指标类型：

次要指标

Outcome：

The Endometriosis Health Profile - 5

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

疼痛焦虑症状量表

指标类型：

次要指标

Outcome：

Pain Anxiety Symptoms 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：

视觉模拟评分表

指标类型：

主要指标

Outcome：

Visual Simulation scoring sheet

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：

征募研究对象情况：

正在进行

Recruiting

年龄范围：

最小 18 岁
Min age years
最大 44 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）：

采用IBM SPSS Statistics 26.0软件进行随机分组，将纳入研究对象分为干预组与对照组 各45例。具体方法如下：（1）取种子数12345运用SPSS26.0 产生90个随机数，对这90个随机数编秩次1~90 后，90个随机数随机装新封条备用。（2）将研究对象按就诊先后顺序依次随机抽取信封得到随机数，秩次为1~45、46~90号的随机数对应的研究对象分别进入干预组和对照组。

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

The IBM SPSS Statistics 26.0 software was used for random grouping, and the subjects included in the study were divided into an intervention group and a control group, with 45 cases in each group. The specific methods are as follows: (1) The seed number 12345 was taken, and 90 random numbers were generated using SPSS 26.0. After ranking these 90 random numbers from 1 to 90, the 90 random numbers were randomly sealed with new seals for standby. (2) The subjects were randomly assigned to draw envelopes in the order of their medical visits to obtain random numbers. The subjects corresponding to the random numbers with ranks from 1 to 45 entered the intervention group, and the subjects corresponding to the random numbers with ranks from 46 to 90 entered the control group.

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)：

None

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：

征得三级甲等医院相关部门和科室负责人同意后，由经过统一培训的调查员发放调查问卷，收集肾虚血瘀型患者中医证候积分、VAS疼痛评分、EHP-5 量表、疼痛焦虑症状量表、综合疗效评定、妇科超声下卵巢囊肿、内异病灶大小情况、实验室检查CA-125等数据。在发放调查问卷，调查员向患者解释本次研究目的和意义，说明本次调查的匿名性，向其承诺资料仅作学术研究，绝对不向他人泄露或另作他用，取得其知情同意后开始资料收集。问卷使用纸质形式发放，使用患者编号作为唯一的识别标识，调查员检查问卷完整性，如有遗漏，则及时请受试者补全、修改，以确保资料完整性。调查员收回数据后检查是否收集完整，以确保资料完整性。纸质版数据录入时，必须采用双人双录入的方式，录入后随机抽取5%复核，以确保数据录入的正确性。所有原始数据，由专人保管，接受伦理委员会定期的审查。研究人员应及时地核对、补录数据，确保各个指标均录入系统。

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

After obtaining the consent of the heads of relevant departments and departments of tertiary hospitals the questionnaires will be issued by uniformly trained investigators to collect data such as TCM syndrome scores VAS pain scores EHP-5 scales pain and anxiety symptom scales comprehensive efficacy evaluations ovarian cysts under gynecological ultrasound the size of internal heterogeneous lesions and laboratory examination CA-125 for patients with kidney deficiency and blood stasis. After distributing the questionnaire the investigator explained the purpose and significance of the study to the patients explained the anonymity of the survey promised them that the data would only be used for academic research and would never be disclosed to others or used for other purposes and that the data collection would begin after obtaining their informed consent. The questionnaire is issued in paper form using the patient number as a unique identification identifier and the investigator checks the completeness of the questionnaire and if there is any omission the subject is asked to complete and modify it in time to ensure the integrity of the data. The investigator retrieved the data and checked that the data were collected to ensure completeness. When the paper version of the data is entered it must be entered in two people and 5% will be randomly selected for review after entry to ensure the correctness of data entry. All raw data is kept by a dedicated person and subject to regular review by the Ethics Committee. Researchers should check and supplement data in a timely manner to ensure that all indicators are entered into the system.

数据管理委员会：

Data Managemen Committee：

无

No

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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