ChiCTR2200063072 版本V1.3 版本创建时间2022/08/30 15:21:35 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：

 ChiCTR2200063072 

最近更新日期：

Date of Last Refreshed on：

 2022-08-30 15:16:56 

注册时间：

Date of Registration：

 2022-08-30 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

藏医药防治新型冠状病毒肺炎无症状感染者和轻症患者的临床疗效评价研究

Public title：

Clinical study on the treatment of asymptomatic and mild patients with COVID-19 by Tibetan Medicine

注册题目简写：

English Acronym：

研究课题的正式科学名称：

评价藏医药防治新型冠状病毒肺炎无症状感染者和轻症患者疗效的临床对照研究

Scientific title：

A controlled clinical study to evaluate the efficacy of Tibetan medicine in the prevention and treatment of asymptomatic COVID-19 infection and mild COVID-19 patients

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：

ChiMCTR2200006549

申请注册联系人：

赛悟杰 

研究负责人：

银巴 

Applicant：

Sai Wujie 

Study leader：

YinBa 

申请注册联系人电话：

Applicant telephone：

 15889003854

研究负责人电话：

Study leader's
telephone：

13989991693

申请注册联系人传真 ：

Applicant Fax：

 0891-6323428

研究负责人传真：

Study leader's fax：

 0891-6323428

申请注册联系人电子邮件：

Applicant E-mail：

 407431642@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 mzkymb@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：

西藏自治区拉萨市城关区娘热路26号

研究负责人通讯地址：

西藏自治区拉萨市城关区娘热路26号

Applicant address：

26 Niangre Road, Chengguan District, Lhasa City, Tibet Autonomous Region, China

Study leader's address：

26 Niangre Road, Chengguan District, Lhasa City, Tibet Autonomous Region, China

申请注册联系人邮政编码：

Applicant postcode：

 850000

研究负责人邮政编码：

Study leader's postcode：

 850000

申请人所在单位：

西藏自治区藏医院

Applicant's institution：

Tibetan Hospital Mentsee Khang of Tibet Autonomous Region

研究负责人所在单位：

西藏自治区藏医院

Affiliation of the Leader：

Tibetan Hospital Mentsee Khang of Tibet Autonomous Region

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：

 QZZY2022-IRBPJ-14

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：

西藏自治区藏医院伦理审查委员会

Name of the ethic committee：

Ethical Review Committee of Tibetan Hospital Mentsee Khang of Tibet Autonomous Region

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-08-17 00:00:00

伦理委员会联系人：

德吉措姆

Contact Name of the ethic committee：

DeJi Cuomu

伦理委员会联系地址：

西藏自治区拉萨市城关区娘热路26号

Contact Address of the ethic committee：

26 Niangre Road, Chengguan District, Lhasa City, Tibet Autonomous Region, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 13908993154

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 djcm0713@163.com

研究实施负责（组长）单位：

西藏自治区藏医院

Primary sponsor：

Tibetan Hospital Mentsee Khang of Tibet Autonomous Region

研究实施负责（组长）单位地址：

西藏自治区拉萨市城关区娘热路26号

Primary sponsor's address：

26 Niangre Road, Chengguan District, Lhasa City, Tibet Autonomous Region, 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)：

西藏自治区

市(区县)：

拉萨

Country：

China

Province：

Tibet Autonomous Region

City：

Lhasa

单位(医院)：

西藏自治区藏医院

具体地址：

城关区娘热路26号

Institution
hospital：

Tibetan Hospital Mentsee Khang of Tibet Autonomous Region

Address：

26 Niangre Road, Chengguan District

经费或物资来源：

国家中医药管理局

Source(s) of funding：

National Administration of Traditional Chinese Medicine (NATCM)

研究疾病：

轻症和无症状新冠肺炎  

Target disease：

Mild and asymptomatic COVID-19

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

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

评价藏药治疗新型冠状肺炎无症状感染者和轻症患者临床疗效评价和安全性为主要目的。进一步阐释和验证藏医药治疗（奥密克戎）新冠肺炎的治病机理及用药方法，规范藏医药治疗新冠肺炎的诊疗技术和行为，优化形成藏医药治疗新冠肺炎的最佳诊疗方案，探索建立藏医药治疗新冠肺炎的疗效评价方法及体系，更好地评估高原地区新冠肺炎患者的整体康复情况，提升藏医药防治新冠肺炎的临床疗效，为中医药（藏医药）防治新冠肺炎提供科学依据和数据基础。  

Objectives of Study：

The main purpose is to evaluate the clinical efficacy and safety of Tibetan medicines in the treatment of asymptomatic COVID-19 patients and mild patients. To further explain and verify the therapeutic mechanism and medication method of the Tibetan medicine treatment (Omicron) for COVID-19, standardize the diagnosis and treatment technology and behavior of the Tibetan medicine treatment for COVID-19, optimize the formation of the best diagnosis and treatment plan of the Tibetan medicine treatment for COVID-19, and explore the establishment of the efficacy evaluation method and system of the Tibetan medicine treatment for COVID-19. To better evaluate the overall recovery of COVID-19 patients in plateau areas, improve the clinical efficacy of Tibetan medicine in the prevention and treatment of COVID-19, and provide a scientific basis and data basis for the prevention and treatment of COVID-19 with traditional Chinese medicine (Tibetan medicine).

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.符合新型冠状病毒无症状感染诊断标准
西藏自治区新型冠状病毒肺炎藏医药诊疗方案(试行第三版)。
新型冠状病毒肺炎核酸检测阳性。未经临床表现及影像学肺炎表现等。
2.符合新型冠状病毒轻症诊断标准；
轻型患者可表现为发热、干咳、头痛、咽喉疼痛等。临床症状轻微，影像学未见肺炎表现。
2.1一般检查
发病早期外周血白细胞总数正常或减少，可见淋巴细胞计数减少，部分患者可出现肝酶、乳酸脱氢酶、肌酶、肌红蛋白、肌钙蛋白和铁蛋白增高。多数患者 C 反应蛋白（CRP）和血沉升高，降钙素原（PCT）正常。重型、危重型患者可见 D-二聚体升高、外周血淋巴细胞进行性减少，炎症因子升高。
2.2病原学及血清学检查
2.2.1病原学检查:采用核酸扩增检测方法在鼻、口咽拭子、痰和其他下呼吸道分泌物、粪便等标本检测新型冠状病毒核酸。核酸检测会受到病程、标本采集、检测过程、检测试剂等因素的影响，为提高检测准确性，应规范采集标本，标本采集后尽快送检。
2.2.2血清学检查:新型冠状病毒特异性 IgM 抗体、IgG抗体阳性，发病 1 周内阳性率均较低。
2.3胸部影像学
早期呈现多发小斑片影及间质改变，以肺外带明显。进而发展为双肺多发磨玻璃影、浸润影，严重者可出现肺实变，胸腔积液少见。MIS-C 时，心功能不全患者可见心影增大和肺水肿。
3.符合藏医疫病不成熟热及成熟热相关发展阶段标准；
西藏自治区新型冠状病毒肺炎藏医药诊疗方案(试行第四版)。
3.1疫病症状
未熟热期：表现为头痛乏力、四肢酸痛、哈欠频发、体颤多梦、寒战、发热、两耳失聪、喜向阳暴晒、口苦、不思饮食、萎靡不振，尤以初夜疼痛加剧。脉象细数、有时动摇，尿色浑浊。
熟热期：发热、乏力、多汗、目赤、舌苔黄腻、头痛烦渴、神志恍惚等。脉象细紧而数，尿色红黄、味浓气大。
寒热交界期：腰酸骨痛、多汗少眠、头昏耳鸣、舌红干糙、频作空呕、谵语、偶有身颤、体表发烧。脉象虚而数，尿色赤清澈、泡沫大。
3.2特异性症状
疫病侵及肺部时表现为：胸肋背痛、喘憋气促、咳嗽、咯赤黄痰、味嗅觉不敏等多种症状。以咽痛、咽部不适、咳嗽、咳白色泡沫样痰、乏力为主要表现。部分患者可以鼻塞、流涕、咽痛、嗅觉味觉减退或丧失、结膜炎、肌痛和腹泻等为主要表现。因个体差异，部分患者无明显临床症状，需结合辅助检查进行确诊。
4.年龄16-70周岁患者；
5.告知知情同意内容，并同意参加临床研究者。

Inclusion criteria

1. Meet the novel coronavirus diagnostic criteria for asymptomatic infection

Tibetan Medicine Diagnosis and Treatment Plan for COVID-19 in Tibet Autonomous Region (trial version 3).

The COVID-19 nucleic acid test was positive. No clinical manifestations or imaging manifestations of pneumonia.

2. Meet the novel coronavirus diagnostic criteria for mild coronavirus;

Mild cases may present with fever, dry cough, headache, sore throat, etc. The clinical symptoms were mild, and imaging showed no signs of pneumonia.

2.1 General Inspection

In the early stage of the disease, the total number of peripheral blood white blood cells is normal or decreased, and the lymphocyte count is decreased. Some patients may have increased liver enzymes, lactate dehydrogenase, muscle enzymes, myoglobin, troponin and ferritin. C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR) were elevated in most patients, while procalcitonin (PCT) was normal. In severe and critical patients, D-dimer increased, peripheral blood lymphocytes decreased progressively, and inflammatory factors increased.

2.2 Etiological and serological examination

2.2.1 Pathogenic examination: Test novel coronavirus nucleic acid on nose and oropharyngeal swabs, sputum and other lower respiratory tract secretions, and feces by nucleic acid amplification test. Nucleic acid detection will be affected by the course of disease, specimen collection, detection process, detection reagents and other factors. In order to improve the accuracy of detection, the collection of specimens should be standardized, and specimens should be submitted to test as soon as possible after collection.

2.2.2 Serological examination: novel coronavirus specific IgM and IgG antibodies are positive, and the positive rate within 1 week after onset is low.

2.3 Chest Imaging

In the early stage, multiple small patches and interstitial changes were observed, especially in the outer lung zone. Further, it develops into multiple ground-glass shadows and infiltrating shadows in both lungs. In severe cases, lung consolidation may occur, and pleural effusion is rare. At MIS-C, cardiac shadow enlargement and pulmonary edema can be seen in patients with cardiac dysfunction.

3. It meets the development stage standards of immature fever and mature fever of Tibetan medical diseases;

Tibetan Medicine Diagnosis and Treatment Plan for COVID-19 in Tibet Autonomous Region (trial version 4).

3.1 Symptoms of disease

Immature heat stage: manifested as headache, fatigue, limb pain, frequent yawn, body shivering, dream, chills, fever, deafness of both ears, like sun exposure, bitter mouth, do not think about food, malaise, especially the first night pain. The pulse is fine and sometimes shaken, and the urine is cloudy.

Ripe heat stage: fever, fatigue, sweating, red eyes, yellow and greasy tongue coating, headache, polydipsia, wandering consciousness, etc. Pulse fine tight and number, red and yellow urine color, strong taste gas.

Cold and hot junction period: lumbar acid bone pain, sweating less sleep, dizziness, tinnitus, red and dry tongue rough, frequent empty vomiting, delirium, occasional body trembling, body surface fever. Pulse virtual and number, urine red clear, foam.

3.2 Specific symptoms

When the disease invaded the lungs, it was manifested as chest, ribs and back pain, shortness of breath, cough, red and yellow phlegm, smell and other symptoms. The main manifestations were sore throat, pharyngeal discomfort, cough, cough of white foamy sputum and fatigue. Some patients can have nasal congestion, runny nose, sore throat, hypoxia or loss of smell and taste, conjunctivitis, myalgia and diarrhea as the main manifestations. Due to individual differences, some patients have no obvious clinical symptoms and need to be confirmed by auxiliary examination.

4. Patients aged 16-70 years;

5. Inform the content of informed consent and agree to participate in the clinical investigator.

排除标准：

1.合并心、脑、肝、肾和造血系统等严重疾病者；
2.过敏体质或对多种药物过敏者。

Exclusion criteria：

1. Patients with serious diseases of heart, brain, liver, kidney and hematopoietic system;

2. Allergic constitution or allergic to a variety of drugs.

研究实施时间：

Study execute time：

从 From 2022-08-16 00:00:00至 To 2023-09-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-08-28 00:00:00 至 To 2023-09-30 00:00:00

干预措施：

Interventions：

组别：

A组

样本量：

 200

Group：

Group A

Sample size：

干预措施：

藏药干预1

干预措施代码：

Intervention：

Tibetan medicine intervention 1

Intervention code：

组别：

B组

样本量：

 200

Group：

Group B

Sample size：

干预措施：

藏药干预2

干预措施代码：

Intervention：

Tibetan medicine intervention 2

Intervention code：

组别：

C组

样本量：

 200

Group：

Group C

Sample size：

干预措施：

藏药干预3

干预措施代码：

Intervention：

Tibetan medicine intervention 3

Intervention code：

组别：

D组

样本量：

 200

Group：

Group D

Sample size：

干预措施：

藏药干预4

干预措施代码：

Intervention：

Tibetan medicine intervention 4

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 西藏自治区 

市(区县)：

 拉萨 

Country：

China

Province：

Tibet Autonomous Region

City：

Lhasa

单位(医院)：

 西藏自治区藏医院 

单位级别：

 城关区娘热路26号 

Institution
hospital：

Tibetan Hospital Mentsee Khang of Tibet Autonomous Region

Level of the institution：

26 Niangre Road, Chengguan District

测量指标：

Outcomes：

指标中文名：

核酸转阴时间：观察核酸阳性指标转变为阴性的时间周期。

指标类型：

主要指标

Outcome：

Nucleic acid turn negative time: observe the time period when nucleic acid positive indicators turn negative

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

核酸CT值的变化：核酸检测N基因和ORF基因Ct值的变化情况。

指标类型：

主要指标

Outcome：

Changes in CT value of nucleic acid: Changes in CT value of N gene and ORF gene detected by nucleic acid

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

藏医症状指标：观察藏医的各项症状指标的缓解情况。

指标类型：

次要指标

Outcome：

Symptom indicators of Tibetan medicine: Observe the relief of symptom indicators of Tibetan medicine

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

无症状核酸转阴时间：观察核酸阳性指标转变为阴性的时间周期，7天内核酸阳性转为阴性。

指标类型：

主要指标

Outcome：

Asymptomatic nucleic acid turn negative time: observe the time period of nucleic acid positive indicators to turn negative, nucleic acid positive to negative within 7 days

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

无症状核酸CT值的变化

指标类型：

次要指标

Outcome：

Changes in asymptomatic nucleic acid CT values

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

无症状转重率

指标类型：

次要指标

Outcome：

Asymptomatic conversion rate

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

轻症核酸转阴时间

指标类型：

主要指标

Outcome：

Mild nucleic acid negative time

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

轻症核酸CT值的变化

指标类型：

主要指标

Outcome：

Changes in mild nucleic acid CT value

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

临床症状

指标类型：

次要指标

Outcome：

Clinical symptoms

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

轻症转重率

指标类型：

次要指标

Outcome：

Mild to severe rate

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

不良事件

指标类型：

副作用指标

Outcome：

Adverse events

Type：

Adverse events

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：

鼻咽分泌物

组织：

Sample Name：

Nasopharyngeal secretions

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：

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 16 岁 years
最大 Max age 70 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）：

由课题组成员进行区组随机，通过统计学随机方法进行随机序列。 seed=20220828 blocksize = 8 N = 1000 set.seed(seed) block = rep(1:ceiling(N/blocksize), each = blocksize) a1 = data.frame(block, rand=runif(length(block)), envelope= 1: length(block)) a2 = a1[order(a1$block,a1$rand),] a2$group = rep(c("A", "B", "C", "D"),times = length(block)/4) assign = a2[order(a2$envelope),] head(assign,1000)

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

Block randomization was performed by the members of the research group, and random sequence was performed by statistical randomization method. seed=20220828 blocksize = 8 N = 1000 set.seed(seed) block = rep(1:ceiling(N/blocksize), each = blocksize) a1 = data.frame(block, rand=runif(length(block)), envelope= 1: length(block)) a2 = a1[order(a1$block

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：

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）：

无

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

Nothing

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：

用病例报告表采集信息，医院GCP管理者进行质量控制，最后由统计员统一统计分析。

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

The case report form was used to collect information, the GCP manager of the hospital carried out quality control, and finally the statistician unified statistical analysis.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2022-08-30 15:08:01