ChiCTR2200062297 版本V1.0 版本创建时间2022/08/01 11:04:03 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2200062297 

最近更新日期：

Date of Last Refreshed on：

 2022-08-01 11:03:54 

注册时间：

Date of Registration：

 2022-08-01 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

温通消痈方热敷治疗破溃期非哺乳期乳腺炎的临床研究

Public title：

Clinical study on the treatment of non-lactation mastitis in ulcerative stage with warm compress of Wentongxiaoyong formula

注册题目简写：

English Acronym：

研究课题的正式科学名称：

温通消痈方热敷治疗破溃期非哺乳期乳腺炎的临床研究

Scientific title：

Clinical study on the treatment of non-lactation mastitis in ulcerative stage with warm compress of Wentongxiaoyong formula

研究课题代号(代码)：

Study subject ID：

 CI2021A01902

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：

郑丽 

研究负责人：

郑丽 

Applicant：

ZHENG Li 

Study leader：

ZHENG Li 

申请注册联系人电话：

Applicant telephone：

 13911124228

研究负责人电话：

Study leader's
telephone：

13911124228

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：

 ZHENGL64@163.COM

研究负责人电子邮件：

Study leader's E-mail：

 ZHENGL64@163.COM

申请单位网址(自愿提供)：

Applicant 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：

北京市海淀区西苑操场1号西苑医院16病区医生办

研究负责人通讯地址：

北京市海淀区西苑操场1号西苑医院16病区医生办

Applicant address：

Doctor's Office, Ward 16, Xiyuan Hospital, No. 1 Xiyuan Playground, Haidian District, Beijing

Study leader's address：

Doctor's Office, Ward 16, Xiyuan Hospital, No. 1 Xiyuan Playground, Haidian 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：

中国中医科学院西苑医院

Applicant's institution：

Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences

研究负责人所在单位：

Affiliation of the Leader：

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2022XLA097-2

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

中国中医科学院西苑医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-06-06 00:00:00

伦理委员会联系人：

訾明杰

Contact Name of the ethic committee：

ZI Ming-jie

伦理委员会联系地址：

北京市海淀区西苑操场1号西苑医院临床药理基地医学伦理办公室

Contact Address of the ethic committee：

Medical Ethics Office, Clinical Pharmacology Base, Xiyuan Hospital, No. 1 Xiyuan Playground, Haidian District, Beijing

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：

中国中医科学院西苑医院

Primary sponsor：

Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences

研究实施负责（组长）单位地址：

北京市海淀区西苑操场1号

Primary sponsor's address：

No. 1 Xiyuan Playground, Haidian 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(区县)：

Country：

China

Province：

Peking

City：

单位(医院)：

中国中医科学院

具体地址：

东城区东直门内南小街16号

Institution
hospital：

China Academy of Chinese Medical Sciences

Address：

16 Nanxiao Street, Inside Dongzhimen, Dongcheng District

经费或物资来源：

中国中医科学院科技创新工程项目

Source(s) of funding：

Science and Technology Innovation Project of China Academy of Chinese Medical Sciences

研究疾病：

非哺乳期乳腺炎  

Target disease：

non-lactation mastitis

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

通过温通消痈方外用联合消痈散结汤口服治疗非哺乳期乳腺炎，观察肿块、破溃、疼痛、肤色的改善情况，分析温通消痈方外用在促进愈合、消散肿块、改善疼痛、肤色方面的疗效，记录其安全性。  

Objectives of Study：

Non-lactation mastitis was treated by external application of Wentong Xiaoyong Formula combined with oral administration of Xiaoyong Sanjie Decoction. The improvement of lump, ulceration, pain and skin color was observed, and the external application of Wentong Xiaoyong Formula in promoting healing, dissipating lumps and improving pain was analyzed. Recording its safety.

药物成份或治疗方案详述：

治疗方案 入组患者均采用消痈散结汤加减汤剂口服为基础治疗，基础方如下： 生黄芪15g 土茯苓15g 夏枯草15g 蛇舌草15g 石见穿10g 路路通15g 所有草药均由我院中药房提供，煎药方法为：草药放入煎药锅后，加水至水面没过药物，大火煮开后，小火煎煮30分钟，每次煎汤至200ml。每剂两煎各于早、晚餐后1小时温服。 在此基础上，治疗组应用温通消痈方进行药渣外敷，温通消痈方的处方如下： 蛇舌草15g 夏枯草15g 路路通15g 红花10g 僵蚕15g 艾叶10g 透骨草15g 外敷方法：于我院中药房取中药饮片，煎汤后留取药渣，以单层纱布包裹40摄氏度左右湿度适中的药渣，接触患处热敷，热敷范围包含破溃处及皮肤红肿处，敷药边缘需超过病损范围1cm，厚度以盖住病损颜色为准，每次30分钟，每日2次。热敷结束后，以4层6.5cm*6.5cm无菌纱布覆盖破溃处，直至下次治疗。 本研究拟行随机对照试验，观察时间为4个月。试验组接受4个月“消痈散结汤”口服联合温通消痈方药渣外敷治疗，对照组接受4个月“消痈散结汤”口服治疗。 调查内容 ①患者的疾病相关一般信息，包括知情同意书的签署、人口统计学、病史、舌脉、既往病史、治疗情况等； ②观察指标：破溃范围、肿块大小、乳房疼痛程度、皮肤颜色。 疗效评价方法 ①破溃（切口）范围（以最大径计）： 参照国家中医药管理局1995年发布的中医药行业标准《中医病证诊断疗效标准》慢性创面疗效评定标准制定： 痊愈：创面完全愈合； 显效：创面缩小达70%以上； 好转：创面缩小达30%以上，70%以下； 无效：创面缩小不足30%，或根本无缩小，或有扩大趋势 ②肿块大小（由临床医师触诊决定，以最大径计）： 0级：0分 无 1级：1 分 <2*2cm2 2级：2 分 >2*2cm2, ≤5*5cm2 3级：3 分 >5*5cm2 ③皮肤颜色： 0级：0分 局部皮肤正常 1级：1分 局部皮肤暗红 2级：2分 局部皮肤潮红 3级：3分 局部皮肤鲜红 ④乳房疼痛：采用视觉模拟评分法(VAS) 患者根据自己的痛觉对照“标尺”上分级程度的数字用笔圈出自己疼痛程度。 0级：无痛； l～3级：轻微隐痛、触痛； 4～6级：疼痛较重，胀痛、钝痛或窜痛，尚能忍受； 7～10级：痛甚，坠痛或刺痛不能近衣。 无痛 剧痛 0 1 2 3 4 5 6 7 8 9 10 评价标准 分别统计两组创面痊愈、显效、好转率，并进行率的比较；比较两组肿块大小、皮肤颜色、疼痛的改善情况。疾病痊愈标准：破溃愈合，且肿块消散。 观察方法 患者每2周填写受试者症状日志（其中包含破溃愈合情况），记录患者接受治疗期间的病情变化情况。 ①治疗前、治疗1个月、2个月、4个月时，分别记录破溃范围、肿块大小、皮肤颜色、乳房疼痛程度。如观察期间患者获得痊愈，则停药，随访至观察期结束；如观察期结束未痊愈，则复查安全性指标，并继续相关治疗，随访至痊愈。 ②治疗前、治疗第1个月、第4个月检查血常规（WBC、RBC、HGB、PLT、NE、）、肝肾功能（ALT、AST、TBIL、DBIL、IBIL、BUN、CREA）、心电图； ③如实记录患者治疗期间出现的不良反应和处理方法、转归； ④比较两组创面愈合率、肿块大小、皮肤颜色、疼痛改善情况； ⑤对脱落患者应进行随访，如实记录脱落原因和病损情况。  

Description for medicine or protocol of treatment in detail：

Treatment plan All patients in the group were treated with oral supplementation of Xiaoyong Sanjie Decoction. The basic prescriptions are as follows: Raw Astragalus 15g, Tuckahoe 15g, Prunella 15g, Hedyotis diffusa 15g Iwami wear 10g Passepartout 15g All herbs are provided by the Chinese pharmacy of our hospital. The decoction method is as follows: after the herbs are put into the decoction pot, add water until the water surface does not cover the medicines, boil on high heat, and decoct on low heat for 30 minutes, and decoct the soup to 200ml each time. Each dose of two decoctions should be taken warmly 1 hour after breakfast and dinner. On this basis, the treatment group applied Wentongxiaoyong Formula for external application of medicinal residues. The prescription of Wentongxiaoyong Formula was as follows: Hedyotis diffusa 15g, Prunella 15g, Passepartout 15g, safflower 10g silkworm15g, mugwort 10g, persimmon 15g External application method: Take Chinese herbal decoction pieces from the Chinese pharmacy of our hospital, take the medicinal residues after decoction, wrap the medicinal residues with a moderate humidity of about 40 degrees Celsius with a single layer of gauze, and apply hot compresses to the affected area. The edge of the medicine should exceed the scope of the lesion by 1cm, and the thickness should be based on the color of the lesion, 30 minutes each time, 2 times a day. After the hot compress, cover the ulcerated area with 4 layers of 6.5cm*6.5cm sterile gauze until the next treatment. This study plans to conduct a randomized controlled trial with an observation time of 4 months. The experimental group received 4 months of oral administration of "Xiaoyong Sanjie Decoction" combined with the external application of Wentong Xiaoyong Formula, while the control group received 4 months of oral treatment of "Xiaoyong Sanjie Decoction". Investigation content ① General information about the patient's disease, including the signature of the informed consent, demographics, medical history, tongue and pulse, past medical history, treatment, etc.; ②Observation indicators: the extent of ulceration, the size of the lump, the degree of breast pain, and the color of the skin. Efficacy evaluation methods ①Break (cut) range (measured by the largest diameter): According to the traditional Chinese medicine industry standard "Traditional Chinese Medicine Syndrome Diagnosis and Efficacy Standard" issued by the State Administration of Traditional Chinese Medicine in 1995, the evaluation standard of chronic wound efficacy was formulated: Healing: the wound is completely healed; Significantly effective: the wound surface is reduced by more than 70%; Improvement: the wound area is reduced by more than 30% and less than 70%; Invalid: The wound has been reduced by less than 30%, or not reduced at all, or has a tendency to expand. ②The size of the mass (determined by the clinician's palpation, measured by the largest diameter): Level 0: 0 points None Level 1: 1 point <2*2cm2 Level 2: 2 points >2*2cm2, ≤5*5cm2 Level 3: 3 points >5*5cm2 ③Skin color: Level 0: 0 points, local skin is normal Level 1: 1 point: Local skin is dark red Grade 2: 2 points Local skin flushing Level 3: 3 points, localized bright red skin ④ Breast pain: using visual analog scale (VAS) The patient circles his pain level with a pen according to the number of graded degrees on the "ruler" according to his own pain control. Grade 0: painless; Level 1 to 3: slight dull pain and tenderness; Grade 4 to 6: The pain is severe, distending, dull or channeling pain, which is still tolerable; Level 7-10: The pain is severe, and the falling pain or stinging pain cannot be close to the clothes. painless severe pain 0 1 2 3 4 5 6 7 8 9 10 Evaluation Criteria The wound healing, marked effect, and improvement rates of the two groups were counted respectively, and the rates were compared; the improvement of lump size, skin color, and pain were compared between the two groups. Criteria for recovery from the disease: the ulcer healed and the mass dissipated. Observation methods Patients fill in the subject symptom log (including ulcer healing) every 2 weeks to record the changes in the patient's condition during treatment. ①Before treatment, 1 month, 2 months, and 4 months after treatment, the extent of ulceration, the size of the lump, the color of the skin, and the degree of breast pain were recorded respectively. If the patient recovered during the observation period, the drug was discontinued, and the follow-up was followed until the end of the observation period; if the patient did not recover after the observation period, the safety indicators were rechecked, and the relevant treatment was continued, and the follow-up was followed until the recovery. ②Check blood routine (WBC, RBC, HGB, PLT, NE, ), liver and kidney function (ALT, AST, TBIL, DBIL, IBIL, BUN, CREA), and electrocardiogram before treatment, the first month and the fourth month of treatment ; ③Truthfully record the adverse reactions, treatment methods and outcomes of the patients during treatment; ④Compare the wound healing rate, tumor size, skin color, and pain improvement between the two groups; ⑤Follow-up should be carried out for the patients who fall off, and the reasons for falling off and the lesions should be recorded truthfully. Statistics and analysis methods The wound healing within 1 month, 2 months, and 4 months of treatment was counted, and the curative effects of the treatment group and the control group in terms of wound healing rate, mass size, skin color, and pain improvement were compared, and the recovery rates of the two groups were compared. Continuous variables were analyzed by variance analysis, count data were analyzed by X2 test, and rank data were analyzed by rank sum test. Compare and analyze the curative effects of the two treatments. 

纳入标准：

1.中医诊断标准
参照2012年《中医外科常见病诊疗指南》粉刺性乳痈的诊断标准：
1.1临床表现：
多发于非哺乳期或非妊娠期的女性，单侧乳房发病多见，大多伴有先天性乳头全部或部分凹陷，并有白色带臭味的粉渣样分泌物。临床表现复杂多样，常分溢液期、肿块期、化脓期、瘘管期。初起肿块位于乳晕部，红肿疼痛，化脓。破溃后，脓中夹杂粉渣样物质，久不收口；或反复红肿溃破，形成瘘管，常与输乳孔相通。若反复发作，形成瘢痕，残留僵块，则乳头凹陷更明显。红肿化脓时，一般可伴轻度恶寒发热等症状。
1.2辅助检查：
实验室检查：部分病例可见血清泌乳素水平明显增高。
影像学检查：B超：在病灶处见不规则片状低回声，内见增强光点，如有多处低回声时，说明瘘管可互相连通。
乳腺X线钼靶摄片：在乳晕周围及其他部位有密度不均匀性增高影，边界不清，其中夹有条索状致密影，乳晕周围皮肤增厚。
CT增强：见不均匀强化，病灶处有低密度影。
病理学检查：乳腺肿块细针穿刺细胞学检查：可见多种细胞混杂，以炎性细胞为主，亦有其他炎性细胞。
2西医诊断标准
以病理学检查为标准：MDE/PDM镜下可见乳腺导管高度扩张，囊腔内充满粉红色颗粒状浓稠物质；扩张导管周围可见淋巴细胞、浆细胞和中性粒细胞浸润。GLM最主要的特征表现为以乳腺小叶单位为中心的非干酪样肉芽肿，呈多灶性分布，大小不等，伴或不伴微脓肿。
3纳入标准
①同时符合上述中医粉刺性乳痈诊断标准的三项以上（必须符合第一项）在西苑医院就诊的患者；
②经病理诊断为浆细胞性乳腺炎或肉芽肿性小叶性乳腺炎等非哺乳期乳腺炎；
③女性患者，年龄在18-49岁；
④病灶处于破溃阶段（含破溃尚未愈合、或手术、引流等操作后切口未愈合）；
⑤同意参与本临床试验，愿意配合完成本研究。

Inclusion criteria

1.TCM diagnostic criteria
Referring to the 2012 "Guidelines for Diagnosis and Treatment of Common Diseases in Traditional Chinese Medicine Surgery", the diagnostic criteria for acne mastitis:
1.1 Clinical manifestations:
Mostly in women who are not lactating or non-pregnant, unilateral breast disease is more common, and most of them are accompanied by congenital nipples that are all or partially sunken, and have white and smelly powder-like secretions. The clinical manifestations are complex and diverse, and are often divided into discharge stage, mass stage, suppurative stage, and fistula stage. The initial mass was located in the areola, red, swollen, painful, and purulent. After the rupture, the pus is mixed with powder and slag-like substances, and the mouth does not close for a long time;If the attack is repeated, scarring is formed, and there is residual stiffness, the nipple depression will be more obvious. Symptoms such as mild aversion to cold and fever are generally associated with redness, swelling and purulence.
1.2 Auxiliary inspection:
Laboratory tests: Serum prolactin levels were significantly increased in some cases. Imaging examination: B-ultrasound: Irregular sheet-like hypoechoic and enhanced light spots are seen in the lesion. If there are multiple hypoechoic spots, it means that the fistulas can be connected to each other.Mammographic mammography: There are unevenly increased density shadows around the areola and other parts, the boundary is unclear, there are cord-like dense shadows, and the skin around the areola is thickened. CT enhancement: see heterogeneous enhancement, low density shadow in the lesion. Pathological examination: fine needle aspiration cytology examination of breast mass: a variety of cells can be seen mixed, mainly inflammatory cells, and other inflammatory cells.
2 Western medicine diagnostic criteria
Based on pathological examination, the mammary ducts were highly dilated under MDE/PDM, and the cysts were filled with pink granular thick substances; lymphocytes, plasma cells and neutrophils were infiltrated around the dilated ducts.
The most prominent feature of GLM is noncaseating granulomas centered on the lobular unit of the mammary gland, which are multifocal in distribution and vary in size, with or without microabscesses.
3 Inclusion criteria
① Patients who meet three or more of the above-mentioned diagnostic criteria for acne mammary carbuncle (must meet the first item) at the same time in Xiyuan Hospital;
②The pathological diagnosis of non-lactation mastitis such as plasma cell mastitis or granulomatous lobular mastitis;
③ Female patients, aged 18-49;
④ The lesion is in the stage of rupture (including the rupture has not healed, or the incision has not healed after surgery, drainage, etc.);
⑤ Agree to participate in this clinical trial and be willing to cooperate with the completion of this research.

排除标准：

①病理确认组织中含有结核及恶性肿瘤细胞；
②孕期及哺乳期；
③同时参与其他临床研究者；
④严重心、肝、肾功能异常；
⑤严重精神疾患；
⑥双侧乳腺同时患有非哺乳期乳腺炎。

Exclusion criteria：

① Pathologically confirmed that the tissue contains tuberculosis and malignant tumor cells;
② Pregnancy and lactation;
③ Participate in other clinical investigators at the same time;
④ Severe heart, liver and kidney dysfunction;
⑤ Serious mental illness;
⑥ Both breasts suffer from non-lactation mastitis at the same time.

研究实施时间：

Study execute time：

从 From 2022-07-25 00:00:00至 To 2024-10-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-07-25 00:00:00 至 To 2024-10-31 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 64

Group：

experimental group

Sample size：

干预措施：

温通消痈方外用联合消痈散结汤口服

干预措施代码：

Intervention：

External application of Wentong Xiaoyong Formula combined with oral administration of Xiaoyong Sanjie Decoction

Intervention code：

组别：

对照组

样本量：

 64

Group：

control group

Sample size：

干预措施：

消痈散结汤口服

干预措施代码：

Intervention：

Take Xiaoyong Sanjie Decoction orally

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

  

Country：

China

Province：

Beijing

City：

单位(医院)：

 中国中医科学院西苑医院 

单位级别：

 三甲 

Institution
hospital：

Xiyuan Hospital, Chinese Academy of Chinese Medical Sciences

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

肿块

指标类型：

主要指标

Outcome：

lump

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

破溃

指标类型：

主要指标

Outcome：

wound surface

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

疼痛

指标类型：

次要指标

Outcome：

pain

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

皮肤颜色

指标类型：

次要指标

Outcome：

skin color

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：

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：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 49 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

第三方制作128个随机密封信封，依照入组顺序依次拆封

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

A third party made 128 random sealed envelopes and unsealed them in the order of entry.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

无盲法

Blinding：

No blinding

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

no IPD sharing

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

no IPD sharing

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,SPSS 12.0

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

Case Record Form, SPSS12.0

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2022-08-01 11:03:54