ChiCTR2100052704 版本V1.2 版本创建时间2022/04/27 20:11:55 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：

 ChiCTR2100052704 

最近更新日期：

Date of Last Refreshed on：

 2022-04-27 19:57:29 

注册时间：

Date of Registration：

 2021-11-03 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

肿痛安联合甲钴胺片治疗灼口综合征的临床疗效研究

Public title：

Clinical effect of Zhongtong'an combined with methylcobalamin tablets in the treatment of burning mouth syndrome

注册题目简写：

English Acronym：

研究课题的正式科学名称：

肿痛安联合甲钴胺片治疗灼口综合征的临床疗效研究

Scientific title：

Clinical effect of Zhongtong'an combined with methylcobalamin tablets in the treatment of burning mouth syndrome

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：

杨彬 

研究负责人：

孙陈 

Applicant：

Yang Bin 

Study leader：

Sun Chen 

申请注册联系人电话：

Applicant telephone：

 +86 18282455340

研究负责人电话：

Study leader's
telephone：

+86 18308310796

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：

 1658713496@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 676067464@qq.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：

四川省泸州市龙马潭区蜀泸大道33号

研究负责人通讯地址：

四川省泸州市江阳区江阳南路2号

Applicant address：

33 Shulu Avenue, Longmatan District, Luzhou, Sichuan

Study leader's address：

2 Jiangyang Road South, Jiangyang District, Luzhou, Sichuan

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：

西南医科大学

Applicant's institution：

Southwest Medical University

研究负责人所在单位：

西南医科大学附属口腔医院

Affiliation of the Leader：

Affiliated Stomatological Hospital of Southwest Medical University

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：

 20210820003

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：

西南医科大学附属口腔医院伦理委员会

Name of the ethic committee：

Ethics Committee of Stomatological Hospital Affiliated to Southwest Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2021-08-24 00:00:00

伦理委员会联系人：

王小雪

Contact Name of the ethic committee：

Wang Xiaoxue

伦理委员会联系地址：

四川省泸州市江阳区江阳南路2号

Contact Address of the ethic committee：

2 Jiangyang Road South, Jiangyang District, Luzhou, Sichuan

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：

西南医科大学附属口腔医院

Primary sponsor：

Affiliated Stomatological Hospital of Southwest Medical University

研究实施负责（组长）单位地址：

四川省泸州市江阳区江阳南路2号

Primary sponsor's address：

2 Jiangyang Road South, Jiangyang District, Luzhou, Sichuan

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)：

泸州

Country：

China

Province：

Sichuan

City：

Luzhou

单位(医院)：

西南医科大学

具体地址：

龙马潭区相邻路1段1号

Institution
hospital：

Southwest Medical University

Address：

1 1st Section of Xianglin Road, Longmatan District

经费或物资来源：

西南医科大学大学生创新创业项目资助

Source(s) of funding：

Supported by the innovation and entrepreneurship project of college students of Southwest Medical University

研究疾病：

灼口综合征  

Target disease：

burning mouth syndrome

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：

 I期临床试验 

Study phase：

1

研究设计：

整群随机分组 

Study design：

Cluster randomization 

研究目的：

（1）本研究项目拟采用肿痛安胶囊联合甲钴胺对BMS患者的治疗效果及安全性进行研究，探究肿痛安对于治疗BMS的临床疗效，进而为临床用药提供一定的理论依据； （2）为能够进一步完善BMS患者的治疗方案提供理论依据，缓解其疼痛，改善其生活质量。  

Objectives of Study：

（1） This research project plans to study the therapeutic effect and safety of Zhongtong 'an Capsule combined with mecobalamin on BMS patients, and explore the clinical efficacy of Zhongtong 'an in treating BMS, so as to provide certain theoretical basis for clinical medication; (2) To provide theoretical basis for further improving the treatment plan of BMS patients, relieve their pain and improve their quality of life.

药物成份或治疗方案详述：

肿痛安的主要成分包括三七、僵蚕、天麻、防风﹑羌活、白附子（制）、天南星（制）、白芷。具备活血化瘀、缓解疼痛、抗抑郁、提高机体免疫力、神经营养修复、帮助睡眠等功能. 治疗方案：将受试者分为试验组和对照组。试验组服用肿痛安（一天2次一次两粒）和甲钴胺片（一天三次，一次一粒），持续30天。对照组服用相同剂量的安慰剂（淀粉胶囊）和甲钴胺片。 

Description for medicine or protocol of treatment in detail：

The main components of Zhongtongan include Panax notoginseng, Bombyx Batryticatus, Gastrodia elata, Radix Saposhnikoviae, Notopterygii Rhizoma, Rhizoma Typhonii (processed), Rhizoma Arisaematis (processed), and Radix Angelicae Dahuricae. It has the functions of promoting blood circulation, removing blood stasis, relieving pain, resisting depression, improving immunity, repairing nerve nutrition and helping sleep. Treatment plan: The subjects were divided into test group and control group. The experimental group was given Zhongtongan (two tablets twice a day) and mecobalamin tablets (one tablet three times a day) for 30 days. The control group was given the same dose of placebo (starch capsule) and mecobalamin tablets. 

纳入标准：

①根据病史和临床检查，诊断为BMS患者[visual analogue scale（VAS）值≥4]的患者；
②年龄18-60周岁；
③血常规，肝肾功能，空腹血糖基本正常；
④患者治疗期间未接受方案以外的其他药物治疗；
⑤患者自愿参加，签署知情同意书及提供个人病史，能按时参加试验并能完成整个研究步骤，能按照要求定期来院复诊并严格遵循医嘱。

Inclusion criteria

① according to the medical history and clinical examination, patients diagnosed as BMS patients [visual analog scale (vas) ≥4];
② 18-60 years old;
③ Blood routine, liver and kidney function and fasting blood glucose were basically normal;
④ The patients did not receive other drugs besides the plan during treatment.
⑤ Patients voluntarily participate, sign informed consent and provide personal medical history, can participate in the trial on time and complete the whole research step, and can come to the hospital for follow-up visit regularly according to the requirements and strictly follow the doctor's advice.

排除标准：

①已患确诊的其他口腔黏膜病或牙周炎；
②孕期及育龄期女性；
③患有严重的系统性疾病（如糖尿病，骨质疏松，胃肠道出血）或肿瘤患者；
④过敏体质者或有药物过敏史；
⑤有吸烟，酗酒史、药物滥用史、吸毒史者；
⑥确诊为精神疾病；
⑦不配合治疗或不按规定用药者；
⑧筛选前1个月内参加过或正在参加其他临床试验者；

Exclusion criteria：

(1) has been diagnosed with other oral mucosal diseases or periodontitis;
② Women during pregnancy and childbearing age;
③ Patients with severe systemic diseases (such as diabetes, osteoporosis, gastrointestinal bleeding) or tumors;
4 allergic people may have a history of drug allergy;
⑤ Those who have a history of smoking, alcoholism, drug abuse and drug abuse;
⑥ Diagnosed as mental illness;
⑦ Those who do not cooperate with treatment or use drugs according to regulations;
⑧ Those who have participated in or are participating in other clinical trials within one month before screening;

研究实施时间：

Study execute time：

从 From 2021-07-01 00:00:00至 To 2022-07-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-11-20 00:00:00 至 To 2022-05-01 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 24

Group：

Experimental group

Sample size：

干预措施：

服用甲钴胺片和中成药肿痛安

干预措施代码：

Intervention：

Taking methylcobalamin tablets and Chinese patent medicine Zhongtong'an

Intervention code：

组别：

对照组

样本量：

 24

Group：

Control group

Sample size：

干预措施：

服用甲钴胺片和安慰剂

干预措施代码：

Intervention：

Taking methylcobalamin tablets and a placebo

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)：

 泸州 

Country：

China

Province：

Sichuan

City：

Luzhou

单位(医院)：

 西南医科大学附属口腔医院 

单位级别：

 三级甲等 

Institution
hospital：

Affiliated Stomatological Hospital of Southwest Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

疼痛

指标类型：

主要指标

Outcome：

pain

Type：

Primary indicator

测量时间点：

每天清晨起床后

测量方法：

在纸上面划一条10 cm的横线，横线的一端为0，表示无痛；另一端为10，表示剧痛；中间部分表示不同程度的疼痛。让患者根据自我感觉在横线上划一记号，表示疼痛的程度。

Measure time point of outcome：

Every morning after getting up

Measure method：

Draw a 10 cm horizontal line on the paper. One end of the horizontal line is 0, indicating no pain; the other end is 10, indicating severe pain; the middle part indicates pain of different degrees. Ask the patient to draw a mark on the horizontal line according to their own feelings to i

指标中文名：

麻木

指标类型：

次要指标

Outcome：

numbness

Type：

Secondary indicator

测量时间点：

治疗开始第一天、第十五天、第三十天以及治疗后一个月

测量方法：

用一条长10cm带刻度的直线，两端分别代表无麻木和剧烈麻木，患者在其中画线以表示其麻木程度，根据所划刻度换算成积分0—10分。

Measure time point of outcome：

The first day, fifteenth day, thirtieth day and one month after treatment

Measure method：

Use a 10cm long straight line with scale, with both ends representing no numbness and severe numbness respectively. The patient draws a line in it to show the degree of numbness, which is converted into an integral of 0-10 points according to the marked scale.

指标中文名：

生活质量

指标类型：

次要指标

Outcome：

quality of life

Type：

Secondary indicator

测量时间点：

治疗开始第一天、第十五天、第三十天以及治疗后一个月

测量方法：

受试者填写生活质量量表，然后分析结果。

Measure time point of outcome：

The first day, fifteenth day, thirtieth day and one month after treatment

Measure method：

The subjects filled out the quality of life scale and analyzed the results.

指标中文名：

抑郁情况

指标类型：

次要指标

Outcome：

depression situation

Type：

Secondary indicator

测量时间点：

治疗开始第一天、第十五天、第三十天以及治疗后一个月

测量方法：

受试者填写HAMILTON抑郁量表-21，然后分析结果。

Measure time point of outcome：

The first day, fifteenth day, thirtieth day and one month after treatment

Measure method：

The subjects completed HAMILTON Depression Scale -21, and then analyzed the results.

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：

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 60 岁 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）：

由研究人员以外的人员使用完全随机方法，采用SPSS 生成随机数，定义seed=20210602。

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

A completely random method was used by people other than researchers, and SPSS was used to generate random numbers, defining seed=20210602.

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：

双盲：受试者和研究者不清楚治疗组的分配情况。

Blinding：

Double Blind Subjects and researchers are unclear about the distribution of treatment groups.

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

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）：

试验结束后，在Resman平台（http://www.medresman.org.cn/）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)：

After the test, share the original data on Resman platform (http://www.medresman.org.cn/).

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：

数据采集：由研究者在试验开始的第一、十五、三十及六十天收集受试者情况并填写CRF 数据管理：使用Resman进行数据管理（http://www.medresman.org.cn/） 1）数据库的创建与录入。 2）交接已完成的CRF,交接双方清点CRF数量,确认无误后签字; 3）由两名录入员分别录入本次接收的所有CRF,录入完成后进行双录入的程序比对,不同之处要查阅CRF进行修改,直至双录入比对无差异。 4）待所有CRF已录入并已完成双录入比对后,利用核查程序对数据库进行随机化、计算、逻辑等方面的核查,核查出的问题,先查阅CRF,若属录入错误可直接对数据库进行修改,若录入无误,则应就此问题发出疑问表,疑问表的基本内容应包括问题所在CRF的试验药物编号、问题所在位置、问题描述、研究者修改项、签字项及时间。 5）数据库所有疑问均返回,重复程序核查无问题后,则可将数据递交生物统计人员。 数据采集：由研究者在试验开始的第一、十五、三十及六十天收集受试者情况并填写CRF 数据管理：使用Resman进行数据管理（http://www.medresman.org.cn/） 1）数据库的创建与录入。 2）交接已完成的CRF,交接双方清点CRF数量,确认无误后签字; 3）由两名录入员分别录入本次接收的所有CRF,录入完成后进行双录入的程序比对,不同之处要查阅CRF进行修改,直至双录入比对无差异。 4）待所有CRF已录入并已完成双录入比对后,利用核查程序对数据库进行随机化、计算、逻辑等方面的核查,核查出的问题,先查阅CRF,若属录入错误可直接对数据库进行修改,若录入无误,则应就此问题发出疑问表,疑问表的基本内容应包括问题所在CRF的试验药物编号、问题所在位置、问题描述、研究者修改项、签字项及时间。 5）数据库所有疑问均返回,重复程序核查无问题后,则可将数据递交生物统计人员。

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

Data collection: the researcher collects the situation of the subjects and fills in CRF on the first, fifteenth, thirty and sixty days after the trial begins Data management: using Resman for data management (http://www.medresman.org.cn/) 1) creation and entry of database. 2) The completed CRF shall be handed over, and both parties shall count the number of CRF, and sign it after confirmation; 3) All CRFs received this time are entered by two operators respectively. After the entry is completed, the double entry procedures are compared, and the differences should be modified by referring to CRF until there is no difference in the double entry comparison. 4) After all CRFs have been entered and double entry comparison has been completed, the database shall be checked in randomization, calculation, logic, etc. If the problems are checked, the database can be modified directly. If the entries are correct, a question form shall be issued for this problem. The basic contents of the question form shall include the test drug number of the CRF where the problem is located, the problem description, the researcher's modification items, the signature items and the time 5) All questions in the database are returned, and the data can be submitted to the biostatistics personnel after the repeated procedures verify that there is no problem. Data collection: the researcher collects the situation of the subjects and fills in CRF on the first, fifteenth, thirty and sixty days after the trial begins Data management: using Resman for data management (http://www.medresman.org.cn/) 1) creation and entry of database. 2) The completed CRF shall be handed over, and both parties shall count the number of CRF, and sign it after confirmation; 3) All CRFs received this time are entered by two operators respectively. After the entry is completed, the double entry procedures are compared, and the differences should be modified by referring to CRF until there is no difference in the double entry comparison. 4) After all CRFs have been entered and double entry comparison has been completed, the database shall be checked in randomization, calculation, logic, etc. If the problems are checked, the database can be modified directly. If the entries are correct, a question form shall be issued for this problem. The basic contents of the question form shall include the test drug number of the CRF where the problem is located, the problem description, the researcher's modification items, the signature items and the time 5) All questions in the database are returned, and the data can be submitted to the biostatistics personnel after the repeated procedures verify that there is no problem.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-11-03 22:49:06