今天是:2022-05-24 星期二

中医耳穴贴丸缓解新冠病毒疫苗注射后疼痛性、 乏力性及胃肠道性不良反应疗效评价的临床研究
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注册号:

Registration number:

ChiCTR2100043210 

最近更新日期:

Date of Last Refreshed on:

2021-05-24 

注册时间:

Date of Registration:

2021-02-08 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

中医耳穴贴丸缓解新冠病毒疫苗注射后疼痛性、 乏力性及胃肠道性不良反应疗效评价的临床研究 

Public title:

Clinical study on the efficacy evaluation of traditional Chinese medicine auricular point acupressure in alleviating pain, fatigue and gastrointestinal adverse reactions after injection of novel coronavirus-19 vaccines 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中医耳穴贴丸缓解新型冠状病毒疫苗注射后疼痛性、 乏力性及胃肠道性不良反应:一项多中心、三臂、单盲的前瞻性随机对照试验 

Scientific title:

Traditional Chinese medicine auricular point acupressure for the relief of pain, fatigue, and gastrointestinal adverse reactions after the injection of novel coronavirus-19 vaccines: a multicentre, three-arm, single-blind, prospective randomized controlled trial 

研究课题代号(代码):

Study subject ID:

21LL2X03; 2021KL-015 

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:

ChiMCTR2100004879 

申请注册联系人:

傅勤为 

研究负责人:

张勤修 

Applicant:

Fu Qinwei 

Study leader:

Zhang Qinxiu 

申请注册联系人电话:

Applicant telephone:

+86 17702856801 

研究负责人电话:

Study leader's telephone:

+86 18980880173 

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:

fuqinweitcm@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zhqinxiu@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

http://sctcm120.cdutcm.edu.cn/ 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

http://sctcm120.cdutcm.edu.cn/ 

申请注册联系人通讯地址:

中国四川省成都市金牛区十二桥路39号成都中医药大学附属医院 

研究负责人通讯地址:

中国四川省成都市金牛区十二桥路39号成都中医药大学附属医院 

Applicant address:

39 Shierqiao Road, Jinniu District, Chengdu, Sichuan, China 

Study leader's address:

39 Shierqiao Road, Jinniu District, Chengdu, Sichuan, China 

申请注册联系人邮政编码:

Applicant postcode:

610075 

研究负责人邮政编码:

Study leader's postcode:

610075 

申请人所在单位:

成都中医药大学附属医院 

Applicant's institution:

Hospital of Chengdu University of Traditional Chinese Medicine 

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:

2021KL-015 

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:

成都中医药大学附属医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Hospital of Chengdu University of Traditional Chinese Medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2021-02-04 

伦理委员会联系人:

何清 

Contact Name of the ethic committee:

He Qing 

伦理委员会联系地址:

中国四川省成都市金牛区十二桥路39号成都中医药大学附属医院伦理委员会 

Contact Address of the ethic committee:

Medical Ethics Committee, Hospital of Chengdu University of Traditional Chinese Medicine, 39 Shierqiao Road, Jinniu District, Chengdu, Sichuan, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 28-87783142 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

ethicscd@126.com 

研究实施负责(组长)单位:

成都中医药大学附属医院 

Primary sponsor:

Hospital of Chengdu University of Traditional Chinese Medicine 

研究实施负责(组长)单位地址:

中国四川省成都市金牛区十二桥路39号成都中医药大学附属医院 

Primary sponsor's address:

39 Shierqiao Road, Jinniu District, Chengdu, Sichuan, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

四川

市(区县):

成都

Country:

China

Province:

Sichuan

City:

Chengdu

单位(医院):

成都中医药大学附属医院

具体地址:

金牛区十二桥路39号

Institution
hospital:

Hospital of Chengdu University of Traditional Chinese Medicine

Address:

39 Shierqiao Road, Jinniu District

经费或物资来源:

医院院级科研项目 

Source(s) of funding:

Hospital level scientific research project 

研究疾病:

新型冠状病毒疫苗注射后疼痛性、 乏力性及胃肠道性不良反应 

Target disease:

pain, fatigue and gastrointestinal adverse reactions after injection of novel coronavirus-19 vaccines 

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:

其它 

Study phase:

N/A 

研究目的:

研究中医耳穴贴丸是否能够减轻、减少新型冠状病毒疫苗注射后疼痛性(包括注射部位疼痛、头痛、其它肌肉关节疼痛)、乏力性、及胃肠道性(包括恶心呕吐、腹泻)不良反应,以及其所能减轻的程度。 

Objectives of Study:

To investigate whether traditional Chinese medicine auricular point acupressure can alleviate and (or) reduce the pain (including injection site pain, headache, other muscle and joint pain), fatigue, and gastrointestinal adverse reactions (including nausea, vomiting, diarrhea), and the degree of the alleviation, after the injection of novel coronavirus-19 vaccines. 

药物成份或治疗方案详述:

1.中医耳穴贴丸 耳穴贴丸组与假耳穴贴丸组均使用“子彧”牌耳穴贴丸,其中间贴有小的王不留行籽。王不留行籽为黑色、圆形、极小且无特殊气味物。由河北贺氏医疗器械有限公司生产,批号:Q/HHS 01-2016,有效期:3年。 2.耳穴选择 ①耳穴贴丸组:在临床试验开始之前,将依据国际标准耳穴指南、专家共识意见与前期临床研究发现的可能的新冠疫苗注射后常见不良反应选取的耳部穴位标记于耳穴简笔图上。耳穴贴丸组所选取耳穴包括(每次皆双侧贴丸): 神门(TF4)、脾(CO13)、心(CO15)、皮质下(AT4)、交感(AH6a) ②假耳穴贴丸组:在临床试验开始之前,将依据国际标准耳穴指南、专家咨询意见与前期临床研究发现的可能的新冠疫苗注射后常见不良反应选取与新型冠状病毒疫苗注射后常见不良反应无关的耳部区域标记于耳穴简笔图上。假耳穴贴丸组所选取耳穴包括(每次皆双侧贴丸): 肛门(HX5)、尿道(HX3)、轮1(HX9)、轮2(HX10)、轮3(HX11) ③空白对照组:新冠疫苗注射后不进行特殊干预,与前两组同时随访观察。 3.耳穴贴丸与按压操作方法 研究人员依据已经标记好的耳穴简笔图进行耳穴贴丸。首先使用消毒棉签蘸取75%医用消毒酒精擦拭受试者耳部拟贴丸处,并使用干消毒棉签蘸干。然后使用医用镊子夹取耳穴贴丸轻轻贴于耳穴上,并稍用力按压。 耳穴贴丸组与假耳穴贴丸组共贴丸两次,第一次为新冠疫苗注射后立即耳穴贴丸,第二次为第二针新冠疫苗注射后再次立即双侧耳穴贴丸。贴完后嘱受试者每日自行耳部按压3-4次,每次1分钟左右。每次耳穴贴丸贴好后保留时间为5天。空白对照组则在新冠疫苗注射后不进行特殊干预,与前两组同时随访观察。 4.其它注意事项 ①受试者在接受耳穴贴丸后,注意嘱其对称轻轻用力按压贴丸处,但不可揉搓或用力过大;注意防止胶布潮湿或污染,以免引发皮肤炎症; ②若出现贴丸处严重疼痛或局部胶布过敏,应立即轻轻撕下耳贴,及时上报,注意观察,酌情处理。 

Description for medicine or protocol of treatment in detail:

1.Traditional Chinese medicine auricular point plasters The "Ziyu" brand auricular point sticking plasters will be used in both auricular point acupressure group and sham auricular point acupressure group with a small spherical vaccaria seeds in center of plasters. The seeds are black, circular shape, minimal, and did not leave any smell. It is produced by Hebei Heshi medical device Co., Ltd., batch number: Q / HHS 01-2016, validity: 3 years. 2.Traditional Chinese medicine auricular points selection (1)Auricular point acupressure group: Before the beginning of the clinical trial, the auricular points were selected according to the international standard auricular point guidelines, expert consensus and possible adverse reactions after the injection of coronavirus-19 vaccines, which have been found in previous clinical studies. The selected auricular acupoints were marked on the diagram of auricular acupoints, including (bilateral): Shenmen (TF4), Spleen (CO13), Heart (CO15), Subcortex (AT4), Sympathesis (AH6a) (2)Sham auricular point acupressure group: Before the beginning of the clinical trial, the auricular points were selected according to the international standard auricular point guidelines, expert consensus, which are not related to the possible adverse reactions after the injection of coronavirus-19 vaccines according to previous clinical studies. The selected auricular acupoints were marked on the diagram of auricular acupoints, including (bilateral): Anus (HX5), Urethra (HX3), Helix 1 (HX9), Helix 2 (HX10), Helix 3 (Hx11) (3)Blank control group: No intervention after the injection of coronavirus-19 vaccines, and the participants will be followed up at the same time as the two groups. 3.Operation method of traditional Chinese medicine auricular point plasters sticking and acupressure Researchers will apply auricular point plaster sticking according to the marked the diagram of auricular acupoints. First of all, 75% medical disinfectant alcohol was dipped with a sterile cotton swab to wipe the place where plasters were to be pasted on the auricular points of participants, and dry the points with a dry sterile cotton swab. Then use medical tweezers to clip the auricular point plasters, stick it on the auricular point gently, and press it with a little force. auricular point acupressure group and sham auricular point acupressure group will be sticked twice. The first time will be after the injection of coronavirus-19 vaccines immediately, and the second time will be after the second injection of coronavirus-19 vaccines again immediately. After pasting, the subjects will be asked to press their auricular point plasters 3-4 times a day, about 1 minute each time. The retention time of each auricular point plaster sticking is 5 days. No intervention after the injection of coronavirus-19 vaccines, and the participants will be followed up at the same time as the two groups. 4.Other precautions (1)After receiving the auricular points plasters sticking, the subjects will be instructed to press the place of plasters sticking symmetrically and gently, but not to rub or use too much force. They will be told to pay attention to prevent the plasters from being wet or contaminated, so as not to cause skin inflammation. (2)In case of severe pain or local adhesive allergy, subjects will be told to tear off the auricular points plasters immediately and gently, report in time, pay attention to it and handle as appropriate. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

①符合新冠疫苗注射条件,无新冠疫苗注射禁忌症,详情以所使用新冠疫苗说明书及医疗机构声明为准;完成第一针新冠疫苗注射且从注射后到入组时≤24小时; ②无耳部皮肤或软组织红肿、损伤、感染等不适宜耳穴贴丸的情况; ③无酒精及胶布体表接触过敏史; ④18-59周岁,性别不限; ⑤能够于注射第一、第二针疫苗时及分别于注射第一、第二针疫苗后第3、7、15天独立完成本研究调查问卷者; ⑥同意参加本次试验并签署知情同意书者;能够认真遵守新冠疫苗注射后注意事项及中医耳穴贴丸需知。 

Inclusion criteria

1. Vaccinators meets the conditions of coronavirus-19 vaccines injection and has no contraindications to it. The details shall be subject to the instructions of the coronavirus-19 vaccines used and the statement of medical institutions. The first dose of coronavirus-19 vaccines injection shall be completed within 24 hours from the time of injection to the time of enrollment; 2. No redness, swelling, injury or infection of the skin or soft tissue of both ears, which is not suitable for auricular points plasters sticking; 3. No history of alcohol and adhesive tape contact allergy; 4. Aged 18-59 years old; 5. Those who were able to complete the questionnaire independently at the time of the first and second dose of vaccine and on the 3rd, 7th and 15th day after the first and second dose of vaccine respectively; 6. Those who agree to participate in the trial and sign the informed consent, and can seriously abide by the precautions after the injection of coronavirus-19 vaccines and the requirements of traditional Chinese medicine auricular point plasters sticking and acupressure. 

排除标准:

①因属于新冠疫苗注射禁忌或慎用人群,而暂时不宜接种新冠疫苗者; ②本研究开始前4周内曾参加过其他临床试验; ③近1周内出现头痛≥3次且其疼痛程度对日常生活造成影响;或受试者自述有以下头痛类疾病:如原发性头痛如偏头痛、紧张性头痛、颈源性头痛,及其它导致继发性头痛的疾病;或受试者有长期慢性头痛病史(>3个月),但未明确诊断或原因不明; ④近1周内出现全身其它部位肌肉或关节疼痛≥3次且其疼痛程度对日常生活造成影响;或受试者自述现有肌肉或关节疼痛类疾病:如肩关节周围炎疼痛期、肌腱炎、肩袖损伤、腱鞘炎、骨滑囊炎、肌肉或关节损伤、风湿或类风湿性关节炎疼痛期,以及伴有疼痛的肌肉或关节劳损、颈椎病、椎间盘突出症;或受试者有长期慢性肌肉或关节疼痛病史(>3个月),但未明确诊断或原因不明; ⑤近1周内出现原因不明的明显疲乏/乏力感≥3次,且疲乏/乏力程度对日常生活造成影响;或受试者自述有以下疲乏/乏力感相关疾病:如恶性肿瘤(癌症)、低血压、慢性疲劳综合征、贫血、肺源性心脏病、慢性阻塞性肺疾病、感冒、甲状腺功能减退症、低血糖、心衰、糖尿病等;或受试者有长期疲乏/乏力病史(>3个月),但未明确诊断或原因不明; ⑥近1周内出现原因不明的腹泻≥3次且对日常生活造成影响;或受试者自述有以下腹泻相关疾病:如肠炎、甲亢、糖尿病、消化道恶性肿瘤、克隆病、肠结核、肠道真菌感染、慢性细菌性痢疾等;或受试者有长期腹泻病史(>3周),但未明确诊断或原因不明; ⑦近1周内出现原因不明的恶心/反胃、干呕或呕吐≥4次且对日常生活造成影响;或受试者自述有以下恶心/反胃、干呕或呕吐相关疾病:如美尼尔氏综合征、前庭神经炎、胃炎、肠炎、胃食管反流病、肠梗阻、肠套叠、晕动病、甲亢、消化道恶性肿瘤等;或受试者有长期恶心/反胃、干呕或呕吐病史(>1月),但未明确诊断或原因不明; ⑧正在使用或本试验开始前2周内曾接受中医耳穴贴丸治疗者; ⑨孕妇或哺乳期妇女; ⑩合并有其它严重原发性疾病及精神病者。 

Exclusion criteria:

1. Those who are not suitable to be vaccinated because they belong to the contraindication or cautious population; 2. Those who have participated in other clinical trials within 4 weeks before the start of this study; 3. Headache occurred more than 3 times in the past week, and the degree of pain affected daily life; Or the subjects reported the following headache diseases: such as primary headache (migraine, tension headache, cervicogenic headache), and other diseases leading to secondary headache; Or the subjects had a long-term history of chronic headache (> 3 months), but the diagnosis was not clear or the cause was unknown; 4. Muscle or joint pain in other parts of the body occurred more than 3 times in the past week, and the degree of pain had an impact on daily life; Or the subjects reported the existing muscle or joint pain diseases, such as periarthritis of shoulder, tendinitis, rotator cuff injury, tenosynovitis, tenosynovitis, muscle or joint injury, rheumatoid arthritis or rheumatoid arthritis pain, and muscle with pain; Or the patients had a long history of chronic muscle or joint pain (> 3 months), but the diagnosis was not clear or the cause was unknown; 5. There were more than 3 times of unexplained obvious fatigue in the past week, and the degree of fatigue had an impact on daily life; Or the subjects reported the following fatigue related diseases: malignant tumor (cancer), hypotension, chronic fatigue syndrome, anemia, pulmonary heart disease, chronic obstructive pulmonary disease, cold, hypothyroidism, hypoglycemia, heart failure, diabetes, etc.; Or subjects with a long-term history of fatigue (> 3 months), but no clear diagnosis or unknown cause; 6. There were more than 3 times of unexplained diarrhea in the past week, which affected daily life; Or the subjects reported the following diarrhea related diseases: enteritis, hyperthyroidism, diabetes, gastrointestinal cancer, Crohn's disease, intestinal tuberculosis, intestinal fungal infection, chronic bacillary dysentery, etc.; Or the subjects had a long history of diarrhea (> 3 weeks), but the diagnosis was not clear or the cause was unknown; 7. Nausea, retching or vomiting of unknown cause occurred for more than 4 times in the past week, which affected daily life; Or the subjects reported the following nausea, retching or vomiting related diseases: such as Meniere's syndrome, vestibular neuritis, gastritis, enteritis, gastroesophageal reflux disease, intestinal obstruction, intussusception, motion sickness, hyperthyroidism, gastrointestinal cancer, etc.; Or the subjects had Long term history of nausea, retching or vomiting (> 1 month), but no definite diagnosis or unknown cause; 8. Those who are in use or have received traditional Chinese medicine auricular point plasters sticking and acupressure within 2 weeks before the trial; 9. Pregnant or lactating women; 10. Patients with other serious primary diseases and psychosis. 

研究实施时间:

Study execute time:

From2021-02-20To 2021-04-29 

征募观察对象时间:

Recruiting time:

From2021-02-20To 2021-03-20 

干预措施:

Interventions:

组别:

耳穴贴丸组

样本量:

120

Group:

Auricular point acupressure group

Sample size:

干预措施:

双侧对症耳穴中医耳穴贴丸

干预措施代码:

Intervention:

Bilateral, symptom-specific, traditional Chinese medicine auricular point acupressure

Intervention code:

组别:

假耳穴贴丸组

样本量:

120

Group:

Sham auricular point acupressure group

Sample size:

干预措施:

双侧非对症假耳穴耳穴贴丸

干预措施代码:

Intervention:

Bilateral, none symptom-specific, sham, auricular point acupressure

Intervention code:

组别:

空白对照组

样本量:

120

Group:

Blank control group

Sample size:

干预措施:

非干预空白对照

干预措施代码:

Intervention:

Non-intervention blank control

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

成都中医药大学附属医院 

单位级别:

三级甲等 

Institution
hospital:

Hospital of Chengdu University of Traditional Chinese Medicine  

Level of the institution:

Tertiary A 

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

金牛区西安路社区卫生服务中心 

单位级别:

初级 

Institution
hospital:

Xi'an Road Community Health Service Center of Jinniu District  

Level of the institution:

Primary 

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

武侯区望江路社区卫生服务中心 

单位级别:

初级 

Institution
hospital:

Wangjiang Road Community Health Service Center of Wuhou District  

Level of the institution:

Primary 

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

P.R.China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

武侯区浆洗街社区卫生服务中心 

单位级别:

初级 

Institution
hospital:

Community Health Service Center of Jiangxi Street, Wuhou District  

Level of the institution:

Primary 

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

青羊区太升社区卫生服务中心 

单位级别:

初级 

Institution
hospital:

Taisheng Community Health Service Center of Qingyang District  

Level of the institution:

Primary 

国家:

中国 

省(直辖市):

四川 

市(区县):

成都 

Country:

China 

Province:

Sichuan 

City:

Chengdu 

单位(医院):

青羊区草堂社区服务中心 

单位级别:

初级 

Institution
hospital:

Caotang Community Service Center of Qingyang District  

Level of the institution:

Primary 

测量指标:

Outcomes:

指标中文名:

疫苗注射部位疼痛VAS评分

指标类型:

主要指标 

Outcome:

VAS score of pain at injection site

Type:

Primary indicator 

测量时间点:

1.第一针疫苗注射后立即(基线资料评估); 2.第一针疫苗注射后第3天; 3.第一针疫苗注射后第7天; 4.第一针疫苗注射后第15天; 5.第二针疫苗注射后立即(基线资料评估); 6.第二针疫苗注射后第3天; 7.第二针疫苗注射后第7天; 8.第二针疫苗注射后第15天

测量方法:

基于患者主观判断的视觉模拟评分(VAS)法

Measure time point of outcome:

1.Immiedlately after first injection of the vaccine (Baseline assessment); 2.Three days after first injection of the vaccine; 3.Seven days after first injection of the vaccine; 4.Fifteen days after first injection of the vaccine; 5.Immiedlately after second injection of the vaccine (Baseline assessment).

Measure method:

Visual analogue scale (VAS) based on subjective judgment of participants

指标中文名:

头痛VAS评分

指标类型:

主要指标 

Outcome:

VAS score of headache

Type:

Primary indicator 

测量时间点:

1.第一针疫苗注射后立即(基线资料评估); 2.第一针疫苗注射后第3天; 3.第一针疫苗注射后第7天; 4.第一针疫苗注射后第15天; 5.第二针疫苗注射后立即(基线资料评估); 6.第二针疫苗注射后第3天; 7.第二针疫苗注射后第7天; 8.第二针疫苗注射后第15天

测量方法:

基于患者主观判断的视觉模拟评分(VAS)法

Measure time point of outcome:

1.Immiedlately after first injection of the vaccine (Baseline assessment); 2.Three days after first injection of the vaccine; 3.Seven days after first injection of the vaccine; 4.Fifteen days after first injection of the vaccine; 5.Immiedlately after second injection of the vaccine (Baseline assessment).

Measure method:

Visual analogue scale (VAS) based on subjective judgment of participants

指标中文名:

肌肉关节疼痛VAS评分

指标类型:

主要指标 

Outcome:

VAS score of muscle and joint pain

Type:

Primary indicator 

测量时间点:

1.第一针疫苗注射后立即(基线资料评估); 2.第一针疫苗注射后第3天; 3.第一针疫苗注射后第7天; 4.第一针疫苗注射后第15天; 5.第二针疫苗注射后立即(基线资料评估); 6.第二针疫苗注射后第3天; 7.第二针疫苗注射后第7天; 8.第二针疫苗注射后第15天

测量方法:

基于患者主观判断的视觉模拟评分(VAS)法

Measure time point of outcome:

1.Immiedlately after first injection of the vaccine (Baseline assessment); 2.Three days after first injection of the vaccine; 3.Seven days after first injection of the vaccine; 4.Fifteen days after first injection of the vaccine; 5.Immiedlately after second injection of the vaccine (Baseline assessment).

Measure method:

Visual analogue scale (VAS) based on subjective judgment of participants

指标中文名:

疲乏/乏力感VAS评分

指标类型:

主要指标 

Outcome:

VAS score of fatigue

Type:

Primary indicator 

测量时间点:

1.第一针疫苗注射后立即(基线资料评估); 2.第一针疫苗注射后第3天; 3.第一针疫苗注射后第7天; 4.第一针疫苗注射后第15天; 5.第二针疫苗注射后立即(基线资料评估); 6.第二针疫苗注射后第3天; 7.第二针疫苗注射后第7天; 8.第二针疫苗注射后第15天

测量方法:

基于患者主观判断的视觉模拟评分(VAS)法

Measure time point of outcome:

1.Immiedlately after first injection of the vaccine (Baseline assessment); 2.Three days after first injection of the vaccine; 3.Seven days after first injection of the vaccine; 4.Fifteen days after first injection of the vaccine; 5.Immiedlately after second injection of the vaccine (Baseline assessment).

Measure method:

Visual analogue scale (VAS) based on subjective judgment of participants

指标中文名:

恶心、反胃感VAS评分

指标类型:

主要指标 

Outcome:

VAS score of nausea

Type:

Primary indicator 

测量时间点:

1.第一针疫苗注射后立即(基线资料评估); 2.第一针疫苗注射后第3天; 3.第一针疫苗注射后第7天; 4.第一针疫苗注射后第15天; 5.第二针疫苗注射后立即(基线资料评估); 6.第二针疫苗注射后第3天; 7.第二针疫苗注射后第7天; 8.第二针疫苗注射后第15天

测量方法:

基于患者主观判断的视觉模拟评分(VAS)法

Measure time point of outcome:

1.Immiedlately after first injection of the vaccine (Baseline assessment); 2.Three days after first injection of the vaccine; 3.Seven days after first injection of the vaccine; 4.Fifteen days after first injection of the vaccine; 5.Immiedlately after second injection of the vaccine (Baseline assessment).

Measure method:

Visual analogue scale (VAS) based on subjective judgment of participants

指标中文名:

干呕VAS评分

指标类型:

主要指标 

Outcome:

VAS score of retching

Type:

Primary indicator 

测量时间点:

1.第一针疫苗注射后立即(基线资料评估); 2.第一针疫苗注射后第3天; 3.第一针疫苗注射后第7天; 4.第一针疫苗注射后第15天; 5.第二针疫苗注射后立即(基线资料评估); 6.第二针疫苗注射后第3天; 7.第二针疫苗注射后第7天; 8.第二针疫苗注射后第15天

测量方法:

基于患者主观判断的视觉模拟评分(VAS)法

Measure time point of outcome:

1.Immiedlately after first injection of the vaccine (Baseline assessment); 2.Three days after first injection of the vaccine; 3.Seven days after first injection of the vaccine; 4.Fifteen days after first injection of the vaccine; 5.Immiedlately after second injection of the vaccine (Baseline assessment).

Measure method:

Visual analogue scale (VAS) based on subjective judgment of participants

指标中文名:

呕吐VAS评分

指标类型:

主要指标 

Outcome:

VAS score of vomitting

Type:

Primary indicator 

测量时间点:

1.第一针疫苗注射后立即(基线资料评估); 2.第一针疫苗注射后第3天; 3.第一针疫苗注射后第7天; 4.第一针疫苗注射后第15天; 5.第二针疫苗注射后立即(基线资料评估); 6.第二针疫苗注射后第3天; 7.第二针疫苗注射后第7天; 8.第二针疫苗注射后第15天

测量方法:

基于患者主观判断的视觉模拟评分(VAS)法

Measure time point of outcome:

1.Immiedlately after first injection of the vaccine (Baseline assessment); 2.Three days after first injection of the vaccine; 3.Seven days after first injection of the vaccine; 4.Fifteen days after first injection of the vaccine; 5.Immiedlately after second injection of the vaccine (Baseline assessment).

Measure method:

Visual analogue scale (VAS) based on subjective judgment of participants

指标中文名:

腹泻VAS评分

指标类型:

主要指标 

Outcome:

VAS score of diarrhea

Type:

Primary indicator 

测量时间点:

1.第一针疫苗注射后立即(基线资料评估); 2.第一针疫苗注射后第3天; 3.第一针疫苗注射后第7天; 4.第一针疫苗注射后第15天; 5.第二针疫苗注射后立即(基线资料评估); 6.第二针疫苗注射后第3天; 7.第二针疫苗注射后第7天; 8.第二针疫苗注射后第15天

测量方法:

基于患者主观判断的视觉模拟评分(VAS)法

Measure time point of outcome:

1.Immiedlately after first injection of the vaccine (Baseline assessment); 2.Three days after first injection of the vaccine; 3.Seven days after first injection of the vaccine; 4.Fifteen days after first injection of the vaccine; 5.Immiedlately after second injection of the vaccine (Baseline assessment).

Measure method:

Visual analogue scale (VAS) based on subjective judgment of participants

指标中文名:

接种者对疫苗接种后可能产生的不良反应的了解程度

指标类型:

附加指标 

Outcome:

The degree of knowledge of the vaccinator about the possible adverse reactions after vaccination

Type:

Additional indicator 

测量时间点:

1.第一针疫苗注射后立即(基线资料评估);2.第二针疫苗注射后立即(基线资料评估)

测量方法:

基于患者主观判断的视觉模拟评分(VAS)法

Measure time point of outcome:

1.Immiedlately after first injection of the vaccine (Baseline assessment); 2.Immiedlately after second injection of the vaccine (Baseline assessment).

Measure method:

Visual analogue scale (VAS) based on subjective judgment of participants

指标中文名:

接种者对疫苗接种后可能产生的不良反应的担忧程度

指标类型:

附加指标 

Outcome:

The degree of concern of the vaccinator about the possible adverse reactions after vaccination

Type:

Additional indicator 

测量时间点:

1.第一针疫苗注射后立即(基线资料评估);2.第二针疫苗注射后立即(基线资料评估)

测量方法:

基于患者主观判断的视觉模拟评分(VAS)法

Measure time point of outcome:

1.Immiedlately after first injection of the vaccine (Baseline assessment); 2.Immiedlately after second injection of the vaccine (Baseline assessment).

Measure method:

Visual analogue scale (VAS) based on subjective judgment of participants

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 59 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

在受试者纳入后,将由组长单位指导使用计算机随机数字生成器以各个分中心为独立样本进行三组的随机分组。随机分组将由经过特殊试验前培训的研究人员进行,他们将不参与耳穴贴丸的操作或结果评估。

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

After the subjects included, they will be randomly divided into three groups through computerized random number generator with each sub center as an independent sample under the guidance of the team leader. Randomization will be carried out by researchers with special pre-trial training.

盲法:

在受试者被纳入研究时,每一位受试者都会被分配一个一独一无二的受试者信息代码。在经过随机分组后,该代码即被记录。信息代码的生成者、记录者不参与耳穴贴丸、数据提取、结果分析等其它临床试验步骤。信息代码的解读规则被该生产者保密直至研究结束或因紧急情况而需要的揭盲。 需要说明的是,可能有经验丰富的耳穴贴丸操作者能够仅仅凭借耳穴部位认出穴位,进而了解该耳穴的功效。尽管如此,考虑到耳穴贴丸这种中医外治法的特殊性,我们拟采用这种分配隐藏方法来尽量对耳穴贴丸操作者施盲,尽量减少可能的偏倚。 综上所述,尽管我们通过信息代码分配隐藏拟对耳穴贴丸操作者和信息采集及统计评价者施盲,但是考虑到可能有经验丰富的耳穴贴丸操作者能够仅仅凭借耳穴部位认出穴位进而了解该耳穴的功效,本研究被定义为中医耳穴贴丸组与中医假耳穴贴丸组之间的单盲(受试者、信息采集及统计评价者)更加谨慎。

Blinding:

When subjects are included in the study, each subject will be assigned a unique subject information code. After randomization, the code is recorded. The producers and recorders of the information code will not participate in other clinical trial steps, such as auricular point acupressure, data extraction, result analysis, etc.. The interpretation rules of the information code are kept secret by the producer until the end of the study or because of the need of emergency to cancel the blind method. It should be noted that there may be experienced operators of traditional Chinese medicine auricular point plasters sticking who can recognize the acupoints only by their auricular points, and then understand the efficacy of the points. However, considering the particularity of the auricular point plasters sticking as an external treatment of traditional Chinese medicine, we plan to use this method of distribution concealment to blind the operators of auricular point plasters sticking as much as possible and minimize the possible bias. To sum up, although we intend to blind the operators and information collection and statistical evaluators through information code allocation and hiding, considering that the experienced auricular point plasters sticking operators may be able to recognize the auricular point only by relying on the auricular point location to understand the function of the auricular point, this study is defined as blind between auricular point acupressure group and sham auricular point acupressure group among participants, information collectors and statistical evaluators, which is more cautious.

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):

本研究原始数据将在研究随访结束3个月内上传至本平台(中国临床试验注册中心)用于公众共享。

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

The original data of this study will be uploaded to the platform (China Clinical Trial Registry) for public sharing within 3 months after the end of follow-up.

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:

1.病例记录表;2.电子采集和管理系统。

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

1.Case Record Form, CRF; 2.Electronic Data Capture, EDC.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-02-08
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