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Clinical Study on Suitable Syndromes of Acupoint Application

注册号：

Registration number：

ITMCTR2200005624

最近更新日期：

Date of Last Refreshed on：

2022-02-09

注册时间：

Date of Registration：

2022-02-09

注册号状态：

Registration Status：

预注册

Prospective registration

注册题目：

穴位贴敷适宜病证的临床研究

Public title：

Clinical Study on Suitable Syndromes of Acupoint Application

注册题目简写：

English Acronym：

研究课题的正式科学名称：

穴位贴敷治疗带状疱疹后遗神经痛的随机、双盲、安慰剂对照、多中心临床研究

Scientific title：

Randomized, double-blind, placebo-controlled, multicenter clinical study on acupoint application in the treatment of postherpetic neuralgia

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：

ChiCTR2200056614 ; ChiMCTR2200005624

申请注册联系人：

蒲炳宇

研究负责人：

王健

Applicant：

Pu Bingyu

Study leader：

Wang Jian

申请注册联系人电话：

Applicant telephone：

15194180196

研究负责人电话：

Study leader's telephone：

15965622883

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：

pubingyu98@163.com

研究负责人电子邮件：

Study leader's E-mail：

wangjianj7@126.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：

山东省济南市经十路16369号

研究负责人通讯地址：

山东省济南市经十路16369号

Applicant address：

16369 jingshi road, jinan city, shandong province

Study leader's address：

16369 jingshi road, jinan city, shandong province

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：

山东中医药大学附属医院

Applicant's institution：

The affiliated hospital of shandong university of TCM

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：

（2022）伦审第（002）号-XY

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：

山东中医药大学附属医院伦理委员会

Name of the ethic committee：

Ethics committee of the affiliated hospital of shandong university of TCM

伦理委员会批准日期：

Date of approved by ethic committee：

2022/1/20 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：

山东中医药大学附属医院

Primary sponsor：

The affiliated hospital of shandong university of TCM

研究实施负责（组长）单位地址：

山东省济南市经十路16369号

Primary sponsor's address：

16369 jingshi road, jinan city, shandong province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

山东省

市(区县)：

济南

Country：

China

Province：

Shandong province

City：

Jinan city

单位(医院)：

山东中医药大学附属医院

具体地址：

山东省济南市经十路16369号

Institution
hospital：

The affiliated hospital of shandong university of TCM

Address：

16369 jingshi road, jinan city, shandong province

经费或物资来源：

亚宝药业集团股份有限公司

Source(s) of funding：

Yabao Pharmaceutical Group Co., Ltd

研究疾病：

带状疱疹后遗神经痛

研究疾病代码：

Target disease：

postherpetic neuralgia

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：

探索性研究/预试验

Pilot clinical trial

研究目的：

本研究拟采用临床试验方法，开展消肿止痛贴+中药细粉穴位贴敷治疗带状疱疹后遗神经痛的前瞻性、多中心、随机双盲、安慰剂平行对照临床研究，为临床治疗带状疱疹后遗神经痛提供客观、有效的循证证据。

Objectives of Study：

In this study, a prospective, multi-center, randomized, double-blind, placebo-controlled clinical study was carried out on the treatment of postherpetic neuralgia with Xiaozhong Zhitong plaster + fine powder of traditional Chinese medicine, providing objective and effective evidence for clinical treatment of postherpetic neuralgia.

药物成份或治疗方案详述：

一、消肿止痛贴药贴成分： 沙蒿子、薄荷脑、水蔓菁。 二、中药粉： 白芥子、细辛、高良姜、芒硝、石菖蒲、川芎。 三、治疗方案： （一）敷贴的制备 1.试验药： 消肿止痛贴及药粉原材料由亚宝药业集团股份有限公司提供。规格：药贴0.4g/贴，药液2mL/支；用法：穴位贴敷。保存方法：密封、常温储存。 2.安慰剂 安慰剂贴剂，由亚宝药业集团股份有限公司负责制备，根据消肿止痛贴的颜色和气味，将沙蒿子饼、药液及中药粉用焦糖、赋形剂等工艺制作成颜色、形状、气味等与消肿止痛贴完全相同的安慰剂贴剂，而无消肿止痛贴的中药有效成分，且规格、用法和保存方法与试验药一致。 （二）入组前筛选 1.符合诊断标准及纳入标准； 2.签署知情同意书； 3.完善基本信息：一般资料、带状疱疹后遗神经痛诊断及治疗史、既往病史及现存其他病史、手术史、过敏史等； 4.完善基线检查：入组前进行体格检查并查血常规、尿常规、大便常规、肝肾功、心电图。 （三）入组治疗 本次研究采用随机对照设计，严格遵从带状疱疹后遗神经痛的诊断标准与研究设计纳入标准，选择有意向参与本次研究并且筛选结果为阳性的带状疱疹后遗神经痛患者共134人，治疗方式采用消肿止痛贴+中药细粉穴位贴敷或安慰剂贴剂+安慰剂细粉穴位贴敷。 患者入组后，签署知情同意书，研究者对患者进行为期3天的敷贴储存、使用方法、可能出现的不良反应及相应处理方法的培训。患者同时加入受试者微信交流群，群内定期分享SDP操作视频，受试者需将每日用药情况以视频形式打卡上传至微信交流群。保证患者能够准确定位，熟悉贴敷操作流程及方法，提高患者用药依从性。 1.穴位选取 根据中华人民共和国国家标准《腧穴名称与定位》GB/T12346-2006 选定三阴交穴、神阙穴；根据人民卫生出版社“十三五”规划教材《经络腧穴学》选定阿是穴。 三阴交穴：在小腿内侧，内踝尖上3寸，胫骨内侧缘后际。 神阙穴：在脐区，脐中央。 阿是穴：以按压或其他反应点定位，选取2处。 2.干预措施 试验组与对照组患者均进行带状疱疹后遗神经痛病的健康生活知识教育包括低盐饮食、清淡饮食、规律作息、戒烟限酒、适度运动等，试验组选用消肿止痛贴+中药细粉穴位贴敷，对照组选用安慰剂贴剂+安慰剂细粉穴位贴敷。 3.贴敷流程 3.1门诊贴敷流程 （1）调制前的准备 消肿止痛贴、消肿止痛贴安慰剂贴剂、中药粉、安慰剂中药粉、医用消毒棉签、75%医用酒精/碘伏消毒液、5ml一次性注射器、调药碗、调药勺、手掌秤（型号：XSZC-01；生产商：凯丰集团有限公司）、密封袋。 （2）定穴：依次找准三阴交穴（双侧）、阿是穴（2处）、神阙穴。 （3）贴敷方法 ①调配药粉 各穴位用药剂量：三阴交穴（单侧量）细辛、白芥子各0.25g，阿是穴（单侧量）高良姜、芒硝各0.25g，神阙穴石菖蒲、川芎各0.25g。药粉选用50g规格棕色瓶装存，分别在瓶身贴好标签：“A组细辛”“A组白芥子”“A组高良姜”“A组芒硝”“A组石菖蒲”“A组川芎”“B组细辛”“B组白芥子”“B组高良姜”“B组芒硝”“B组石菖蒲”“B组川芎”。（A组或B组为试验组中药粉或对照组中药粉。） 提前将每穴所需的2种药粉装入同1个密封袋内。以“阿是穴”为例，选择标有“A 组高良姜”“A 组芒硝”或“B 组高良姜”“B 组芒硝”的棕色瓶，用手掌秤称取各 0.25g 药粉，装入名为“阿是穴”的密封袋，混匀。余穴同前。 ②贴敷操作 A.制备药贴：揭开消肿止痛贴背衬纸条，用5ml注射器抽取约2/3支左右的消肿止痛液，由中心向四周螺旋状均匀喷洒到沙蒿子药贴上，边缘留2mm左右的干燥范围，防止药液流失。打开标有“阿是穴”的密封袋，将其内的药粉倒入备好的小碗内，并加入剩余的1/3支左右的消肿止痛液，单方向旋转搅拌，调制为半流动糊状药浆。将调制好的药浆置于喷洒好药液的药贴中心，均匀摊铺至药贴浸湿区域备用。 B.皮肤清洁消毒：用消毒棉签蘸取75%医用酒精/碘伏消毒液对三阴交穴及周围部位擦拭，一方面可以起到对局部消毒，并清除皮肤表面皮屑的作用，以防黏贴不牢固；另一方面可以利用酒精/碘伏清除皮肤表面皮脂，以利于贴剂中药物成分的吸收，加快起效时间。 C.贴敷固定方法：将调制好的药贴对准穴位，轻拉贴膜边缘，保持适当弹性，由下至上进行穴位贴敷，避免药浆下淌。选取对应穴位的药粉在神阙穴以同样的操作步骤进行贴敷。 D.贴敷时间：阿是穴（2处）、神阙穴，每日1次，每次6～8h。三阴交穴（双侧），每周1次，每次30min。 ③疗程：2周为1个疗程，共治疗2个疗程。 4.注意事项 （1）受试者需在治疗期前2周前往门诊操作，并培训贴敷操作流程、规范操作步骤，2周贴敷完成后由患者在家自行贴敷阿是穴（2处）、神阙穴。三阴交穴（双侧）在每次随访时于门诊进行操作。 （2）保护贴敷部位，并确保药贴与皮肤的紧密接触，防止药贴提前掉落； （3）由于穴位贴敷自身的特点，贴敷局部皮肤可出现潮红、灼热、刺痛、瘙痒及皮肤色素沉着等反应，部分患者还可出现小水泡，极少数可能出现大水泡。穴位贴敷后，如果局部皮肤出现潮红、灼热、刺痛、瘙痒、小水泡及色素沉着等，属于该疗法的正常反应，一般不必特殊处理；少数患者出现大水泡，需到医院联系课题组大夫，或者到附近医院，由医生用消毒针具挑破水泡底部，排尽液体，做消毒处理后，外用无菌纱布包扎，以防感染；对于自行溃破的水泡，避免抓挠，可涂搽烫伤软膏、万花油、红霉素软膏等保护创面。如果极少数患者出现皮肤感染的情况，需及时到医院，就诊处理。 （4）饮食以清淡为主，忌生冷辛辣、高蛋白及刺激性食物，如牛奶、水果、油炸食品等，以免影响贴敷疗效； （5）遵医嘱按疗程贴敷。 5.不良反应记录 患者贴敷前后可自行观察敷贴覆盖处皮肤有无红肿、皮疹、破溃、水疱、瘙痒感等异常反应。若出现异常反应，及时向研究员反映，以便采取相关干预措施。 6.合并用药 （1）除规定用药外，试验期间尽量不使用其它治带状疱疹后遗神经痛的药物，疼痛严重时可以服用止痛药物，但需如实记录； （2）对试验开始前即已有合并疾病或症状（除本病以外的症状）所必需继续使用的药物或其它治疗应详细记录药名（或其它疗法）、用法、用量和时间等，以便总结时加以分析和报告； （3）试验开始后出现的任何合并疾病，应被视为不良事件而详细地记录在“不良事件”表上；其使用的药物记录于“合并用药”表上。

Description for medicine or protocol of treatment in detail：

1. Components of swelling relieving pain plaster : Artemisia scoparia, menthol, water vine. 2. Traditional Chinese medicine powder : White mustard, asarum, ginger, mirabilite, calamus, Chuanxiong. 3. Treatment plan : ( 1 ) Preparation of paste 1. Test drugs : The raw materials of swelling relieving pain paste and powder were provided by Yabao Pharmaceutical Group Co., Ltd. Specification : 0.4 g / patch, 2 mL / branch ; usage : acupoint application. Storage method : sealed, room temperature storage. 2. placebos The placebo patch was prepared by Yabao Pharmaceutical Group Co., Ltd. According to the color and odor of Xiaozhongzhitong patch, the artemisia seed cake, liquid and powder of traditional Chinese medicine were prepared by caramel and excipients to form the placebo patch with the same color, shape and odor as Xiaozhongzhitong patch, without the effective components of traditional Chinese medicine, and the specifications, usage and preservation methods were consistent with those of the test drugs. ( 2 ) Screening before grouping 1. Compliance with diagnostic criteria and inclusion criteria ; 2. Signing of an informed consent ; 3. Perfect basic information : general information, diagnosis and treatment history of postherpetic neuralgia, past medical history and other existing medical history, surgical history, allergic history, etc. 4.Perfect baseline examination : physical examination and blood routine, urine routine, stool routine, liver and kidney function, electrocardiogram before enrollment. ( 3 ) Group treatment In this study, a randomized controlled design was used to strictly follow the diagnostic criteria and the inclusion criteria of research design for postherpetic neuralgia. A total of 134 patients with postherpetic neuralgia who were willing to participate in this study and the screening results were positive were selected. The treatment methods were Xiaozhong Zhitong plaster + Chinese medicine powder or placebo plaster + placebo powder . After the patients were enrolled, the informed consent was signed, and the researchers trained the patients for 3 days in application storage, use methods, possible adverse reactions and corresponding treatment methods. The patients also joined the WeChat communication group of the subjects, and the SDP operation videos were regularly shared within the group. The subjects needed to upload the daily medication in the form of video cards to the WeChat communication group. Ensure accurate positioning of patients, familiar with the application process and methods, improve patient compliance. 1. Acupoint selection According to the national standard of the People 's Republic of China 's name and location of acupoints ' GB / T12346-2006, Sanyinjiao and Shenque acupoints were selected ; according to the People ' s Health Press ' 13th Five-Year ' planning textbook ' meridian acupoints ' selected Ashi points. Sanyinjiao point : in the medial leg, medial malleolus tip3inches, posterior tibial medial edge. Shenque point : in the umbilical area, umbilical center. Ashi point : press or other reaction point positioning, select two. 2.Intervention measures The patients in the experimental group and the control group were given health knowledge education of postherpetic neuralgia, including low salt diet, light diet, regular work and rest, smoking cessation and alcohol restriction, moderate exercise, etc. The experimental group was treated with Xiaozhong Zhitong paste + Chinese medicine fine powder acupoint application, and the control group was treated with placebo paste + placebo fine powder acupoint application. 3.Sticking process 3.1 Process of outpatient application ( 1 ) Preparation before modulation Xiaozhong Zhitong Patch, Xiaozhong Zhitong Patch placebo patch, Chinese medicine powder, placebo Chinese medicine powder, medical disinfection cotton swab, 75 % medical alcohol / iodophor disinfectant, 5ml disposable syringe, dispensing bowl, dispensing spoon, palm scale ( model : XSZC-01 ) ; manufacturer : Kaifeng Group Co., Ltd. ), sealed bags. ( 2 ) Ding point : in turn to find Sanyinjiao point ( bilateral ), Ashi point ( 2 ), Shenque point. ( 3 ) Application method ① Dispensing powder Dosage of each point : Sanyinjiao ( unilateral amount ) asarum, white mustard 0.25 g, Ashi ( unilateral amount ) galanga, mirabilite 0.25 g, Shenque Shichangpu, Chuanxiong 0.25 g. The powder was stored in a 50g brown bottle and labeled as ' group A asarum ', ' group A white mustard ', ' group A galanga ', ' group A mirabilite ', ' group A calamus ', ' group A Rhizoma Chuanxiong ', ' group B asarum ', ' group B white mustard ', ' group B galanga ', ' group B mirabilite ', ' group B Rhizoma Chuanxiong '. ( A group or B group is the test group powder or control group powder. ) Put two kinds of powder for each hole in the same sealed bag in advance. Taking ' Ashi point ' as an example, brown bottles marked with ' group A galange ', ' group A mirabilite ' or ' group B galange ' and ' group B mirabilite ' were selected and weighed by palm scale. Each 0.25 g powder was loaded into a sealed bag called ' Ashi point ' and mixed. The cave ahead. ② Application operation A. Preparation of drug paste : Uncovering the anti-tumescence and pain paste backing note, using5ml syringe to extract about2 / 3of the anti-tumescence and pain liquid, from the center to the surrounding spiral evenly sprayed to artemisia seed paste, the edge of about2mm drying range, to prevent the loss of liquid. Open the sealed bag marked ' Ashi point ', pour its powder into the prepared small bowl, and add about 1 / 3 of the remaining swelling analgesic solution, single direction rotation stirring, modulation for half flow paste. The prepared slurry was placed in the center of the patch sprayed with good solution and evenly spread to the wet area of the patch for further use. B. Skin cleaning and disinfection : 75 % medical alcohol / iodophor disinfectant was dipped into the disinfection cotton swab to wipe Sanyinjiao acupoint and its surrounding parts, on the one hand, it can play a role in local disinfection and remove skin debris on the surface of the skin, in order to prevent sticky ; on the other hand, alcohol / iodophor can be used to remove the skin surface sebum to facilitate the absorption of drug ingredients in the patch and accelerate the onset time. C. Patching fixed method : the modulation of the drug paste is aligned to the acupoint, gently pull the edge of the film, maintain appropriate elasticity, from bottom to top acupoint application, to avoid the drops of the slurry. Select the corresponding points of powder in Shenque acupoint with the same operation steps. D. Application time : Ashi point ( 2 ), Shenque point, once a day, 6-8 hours each time. Sanyinjiao ( bilateral ), once a week, 30min each time. 3 Course of treatment : 2 weeks for a course of treatment, a total of 2 courses of treatment. 4. Notes ( 1 ) The subjects need to go to the outpatient operation in the first two weeks of the treatment period, and train the application operation process and standardize the operation steps. After 2 weeks of application, the patients apply Ashi point ( 2 points ) and Shenque point at home. Sanyinjiao ( bilateral ) was operated at the clinic at each follow-up. ( 2 ) Protect the application site and ensure the close contact between the patch and the skin to prevent the patch from falling in advance ; ( 3 ) Due to the characteristics of acupoint application, local skin can appear red tide, burning, prickle, itching and skin pigmentation reactions, some patients can also appear small blisters, few may appear large blisters. After acupoint application, if the local skin appears red tide, burning, prickle, itching, small blisters and pigmentation, etc., belongs to the normal response of the therapy, generally do not need special treatment ; a small number of patients with large blisters need to contact the doctor of the research group in the hospital, or to the nearby hospital. The doctor uses disinfection needles to break the bottom of the blister, drains the liquid, and after disinfection, uses sterile gauze for external use to prevent infection. For self-broken blisters, avoid scratching, can be applied scald ointment, wanhua oil, erythromycin ointment to protect the wound. If a very small number of patients have skin infection, they need to be in hospital in time for treatment. ( 4 ) Diet mainly light, avoid cold and spicy, high protein and stimulating food, such as milk, fruit, fried food, etc., so as not to affect the curative effect ; ( 5 ) Apply according to the doctor s advice according to the course of treatment. 5. Record of adverse reactions Before and after the application, the patients could observe whether there were any abnormal reactions such as redness and swelling, rash, ulceration, blisters and itching on the skin at the coating site. If abnormal reactions occur, they should be reflected to the researchers in time to take relevant intervention measures. 6. Combined medication ( 1 ) In addition to prescribed medications, no other medications for postherpetic neuralgia shall be used during the trial, and analgesics may be taken when the pain is serious, subject to truthful records ; ( 2 ) The drug name ( or other therapy ), usage, dosage and time should be recorded in detail in order to analyze and report when summarizing the drugs or other treatments that must be continued to be used before the beginning of the test, i. e., those that have combined diseases or symptoms ( except symptoms of this disease ) ; ( 3 ) Any combined disease after the start of the test should be recorded in the adverse event table in detail as adverse events ; the drugs used were recorded in the ' combined medication ' table.

纳入标准：

1.符合带状疱疹后遗神经痛诊断标准； 2.VAS≥4分； 3.年龄18～75岁； 4.病程＞30天，≤180天 5.患者及家属签署知情同意书。

Inclusion criteria

1.In line with the diagnostic criteria of postherpetic neuralgia ; 2. 2. VAS ≥ 4 points ; 3. Age 18-75 years ; 4. Course of disease > 30 days, ≤ 180 days 5. Patients and their families sign informed consent.

排除标准：

1.合并肝肾功能衰竭者； 2.对研究药物过敏者； 3.有凝血功能障碍者； 4.有认知功能障碍，不能配合者； 5.妊娠或哺乳期妇女，有精神神经系统疾病者； 6.一直服用其他镇痛药物者。

Exclusion criteria：

1. Patients with liver and kidney failure ; 2. For those studying drug allergy ; 3. Persons with coagulation disorders ; 4. Persons with cognitive impairment who cannot cooperate ; 5. pregnant or lactating women with mental and nervous system diseases ; 6. Always taking other analgesics.

研究实施时间：

Study execute time：

从From 2022-01-21

至To      2023-05-31

征募观察对象时间：

Recruiting time：

从From 2022-02-09

至To      2023-04-30

干预措施：

Interventions：

组别：

对照组

样本量：

67

Group：

Control group

Sample size：

干预措施：

安慰剂贴剂+安慰剂细粉穴位贴敷

干预措施代码：

Intervention：

placebo patch + placebo powder

Intervention code：

组别：

试验组

样本量：

67

Group：

Test group

Sample size：

干预措施：

消肿止痛贴+中药细粉穴位贴敷

干预措施代码：

Intervention：

Xiaozhong Zhitong plaster + traditional Chinese medicine powder

Intervention code：

样本总量 Total sample size ： 134

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

山东省

市(区县)：

济南市

Country：

China

Province：

shandong province

City：

jinan city

单位(医院)：

山东大学第二医院

单位级别：

三级医院

Institution/hospital：

The second hospital of shandong university

Level of the institution：

tertiary hospital

国家：

中国

省(直辖市)：

山东省

市(区县)：

济南市

Country：

China

Province：

shandong province

City：

jinan city

单位(医院)：

山东省中医药研究院附属医院

单位级别：

三级医院

Institution/hospital：

Affiliated Hospital of Shandong Academy of TCM

Level of the institution：

tertiary hospital

国家：

中国

省(直辖市)：

山东省

市(区县)：

潍坊市

Country：

China

Province：

shandong province

City：

weifang city

单位(医院)：

潍坊市中医药

单位级别：

三级医院

Institution/hospital：

weifang hospital of traditional chinese medicine

Level of the institution：

tertiary hospital

国家：

中国

省(直辖市)：

山东省

市(区县)：

济南

Country：

China

Province：

shandong province

City：

单位(医院)：

山东中医药大学附属医院

单位级别：

三级医院

Institution/hospital：

The affiliated hospital of shandong university of TCM

Level of the institution：

tertiary hospital

国家：

中国

省(直辖市)：

山东省

市(区县)：

枣庄市

Country：

China

Province：

shandong province

City：

zaozhuang city

单位(医院)：

北京中医药大学枣庄医院

单位级别：

三级医院

Institution/hospital：

Zaozhuang Hospital of Beijing University of Traditional Chinese Medicine

Level of the institution：

tertiary hospital

测量指标：

Outcomes：

指标中文名：

CD8

指标类型：

次要指标

Outcome：

Cluster of differentiation 8

Type：

Secondary indicator

测量时间点：

治疗前、治疗后

测量方法：

采血后使用试剂盒检验

Measure time point of outcome：

Before and after treatment

Measure method：

Use kit test after blood collection

指标中文名：

生存质量评分

指标类型：

次要指标

Outcome：

SF-36 scale

Type：

Secondary indicator

测量时间点：

治疗前、治疗期、治疗后及访视

测量方法：

评分量表

Measure time point of outcome：

Treatment before, during, after and visit

Measure method：

marking scales

指标中文名：

CD4

指标类型：

次要指标

Outcome：

Cluster of differentiation 4

Type：

Secondary indicator

测量时间点：

治疗前、治疗后

测量方法：

采血后使用试剂盒检验

Measure time point of outcome：

Before and after treatment

Measure method：

Use kit test after blood collection

指标中文名：

P物质

指标类型：

次要指标

Outcome：

SP

Type：

Secondary indicator

测量时间点：

治疗前、治疗后

测量方法：

采血后使用试剂盒检验

Measure time point of outcome：

Before and after treatment

Measure method：

Use kit test after blood collection

指标中文名：

白介素6

指标类型：

次要指标

Outcome：

IL-6

Type：

Secondary indicator

测量时间点：

治疗前、治疗后

测量方法：

采血后使用试剂盒检验

Measure time point of outcome：

Before and after treatment

Measure method：

Use kit test after blood collection

指标中文名：

肿瘤坏死因子α

指标类型：

次要指标

Outcome：

TNF-α

Type：

Secondary indicator

测量时间点：

治疗前、治疗后

测量方法：

采血后使用试剂盒检验

Measure time point of outcome：

Before and after treatment

Measure method：

Use kit test after blood collection

指标中文名：

单核细胞趋化蛋白-1

指标类型：

次要指标

Outcome：

MCP-1

Type：

Secondary indicator

测量时间点：

治疗前、治疗后

测量方法：

采血后使用试剂盒检验

Measure time point of outcome：

Before and after treatment

Measure method：

Use kit test after blood collection

指标中文名：

疼痛量表

指标类型：

主要指标

Outcome：

pain scale

Type：

Primary indicator

测量时间点：

治疗前、治疗期、治疗后及访视

测量方法：

评分量表

Measure time point of outcome：

Treatment before, during, after and visit

Measure method：

marking scales

指标中文名：

五羟色胺

指标类型：

次要指标

Outcome：

5-HT

Type：

Secondary indicator

测量时间点：

治疗前、治疗后

测量方法：

采血后使用试剂盒检验

Measure time point of outcome：

Before and after treatment

Measure method：

Use kit test after blood collection

指标中文名：

β-内啡肽

指标类型：

次要指标

Outcome：

β-Endorphin

Type：

Secondary indicator

测量时间点：

治疗前、治疗后

测量方法：

采血后使用试剂盒检验

Measure time point of outcome：

Before and after treatment

Measure method：

Use kit test after blood collection

指标中文名：

CD3

指标类型：

次要指标

Outcome：

Cluster of differentiation 3

Type：

Secondary indicator

测量时间点：

治疗前、治疗后

测量方法：

采血后使用试剂盒检验

Measure time point of outcome：

Before and after treatment

Measure method：

Use kit test after blood collection

指标中文名：

中医证候积分

指标类型：

次要指标

Outcome：

chinese medicine syndrome scores

Type：

Secondary indicator

测量时间点：

治疗前、治疗期、治疗后及访视

测量方法：

评分量表

Measure time point of outcome：

Treatment before, during, after and visit

Measure method：

marking scales

指标中文名：

匹兹堡睡眠质量指数

指标类型：

次要指标

Outcome：

Pittsurgh sleep quality in-dex

Type：

Secondary indicator

测量时间点：

治疗前、治疗期、治疗后及访视

测量方法：

评分量表

Measure time point of outcome：

Treatment before, during, after and visit

Measure method：

marking scales

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

静脉

Sample Name：

Blood

Tissue：

Vein

人体标本去向

使用后保存

说明

为后续研究做保存

Fate of sample 

Preservation after use

Note：

Preserved for subsequent research

征募研究对象情况：

尚未开始

Not yet recruiting

年龄范围：

最小 18 岁
Min age years
最大 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男女均可

Both

随机方法（请说明由何人用什么方法产生随机序列）：

将筛选病例作为受试对象，由第三方运用SPSS统计软件，按各参加单位的病例分配数及随机比例生成随机数字分组表进行随机化，以保证组间均衡性。采用信封法施行随机方案的隐藏：将随机数字按设计要求分组后，在每个不透光的信封内装入一个随机数字和分组类别，发放给各参加单位，信封封面只显示入组的流水序号。受试者入选后，由研究者打开信封查看分组结果，分入相应组别，按照受试者进入研究的先后顺序，发放相应编号药品，各单位不得随意更改分配顺序。

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

The screened cases were taken as the subjects, and the third party used SPSS statistical software to generate random number grouping table according to the case allocation number and random proportion of each participating unit for randomization to ensure the balance between groups. The envelope method is used&

盲法：

本试验采用双盲试验，双盲对象为患者和研究者，试验结束后揭盲。采用两级设盲法。 ①一级设盲: 即试验药物设盲。对试验药和对照药进行统一包装， 同时保证试验药和对照药从外观、颜色、气味上以及贴敷后的皮肤感受无差异。 ②二级设盲: 即药品包装设盲。在随机化分组完成后，分发的药品包装上也有与患者编号一一对应的药物编号，研究设计者依据留存的盲底在有编号的药品包装内分装试验药物或对照药物，同时仅给药物管理员提供标有药物编号的药品，患者和研究者不知道分组和用药情况。此外，为每位患者准备一个应急信封，信封上标记患者的编号， 信封内封存的信纸上注明患者的用药情况，供紧急揭盲用。

Blinding：

In this study, a double-blind trial was conducted. The double-blind subjects were patients and researchers. The blind was uncovered after the experiment. Two-stage blinding method is adopted. 1 Blinding level 1 : Blinding test drugs. Pack the test drug and control drug uniformly, and ensure that the test drug and control drug have no difference in appearance, color, smell and skin feeling after application. ( 2 ) Secondary blinding : drug packaging blinding. After the completion of the randomization grouping, there are also drug numbers corresponding to the patient number on the distribution of drug packaging. The research designer separates the test drug or the control drug in the numbered drug packaging based on the remaining blind base, and only provides the drug administrator with the drug numbered drug. Patients and researchers do not know the grouping and medication. In addition, an emergency envelope was prepared for each patient. The number of the patient was marked on the envelope, and the medication of the patient was indicated on the letter paper enclosed in the envelope for emergency debunk.

是否共享原始数据：

IPD sharing：

是

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）：

不共享原始数据

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

Not sharing raw data

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：

使用CRF表记录原始数据，并通过Excel建立数据库进行管理

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

Record raw data using CRF and manage it through Excel

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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