我要注册
立即登录
中文/English
平台介绍|试验检索|关于我们

注册号：

Registration number：

ITMCTR2024000048

最近更新日期：

Date of Last Refreshed on：

2024-04-21

注册时间：

Date of Registration：

2024-04-21

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

Public title：

A Clinical Trial of Thai Herbal Medicine as Post-exposure Prophylaxis for COVID-19: A pilot study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Scientific title：

A Clinical Trial of Thai Herbal Medicine as Post-exposure Prophylaxis for COVID-19: A pilot study

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：

申请注册联系人：

研究负责人：

Applicant：

Suppachai Tiyaworanant

Study leader：

Suppachai Tiyaworanant

申请注册联系人电话：

Applicant telephone：

+66885630564

研究负责人电话：

Study leader's telephone：

+66885630564

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：

suptiy@kku.ac.th

研究负责人电子邮件：

Study leader's E-mail：

suptiy@kku.ac.th

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：

研究负责人通讯地址：

Applicant address：

Faculty of Pharmaceutical Sciences, Khon Kaen University, Khon Kaen, Thailand

Study leader's address：

Department of Pharmacognosy and Toxicology

申请注册联系人邮政编码：

Applicant postcode：

40002

研究负责人邮政编码：

Study leader's postcode：

40002

申请人所在单位：

Applicant's institution：

Khon Kaen University

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：

4.1.01:48/2564 and 4.5.02:43/2565

伦理委员会批件附件：

Approved file of Ethical Committee：

查看附件

批准本研究的伦理委员会名称：

Name of the ethic committee：

Khon Kaen University Ethics Committee for Human Research

伦理委员会批准日期：

Date of approved by ethic committee：

2022/11/9 0:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

Office of the Khon Kaen University Ethics Committee for Human Research

伦理委员会联系地址：

Contact Address of the ethic committee：

Wadwichakarn Building, 3rd Floor, Room 5317 Faculty of Medicine, Khon Kaen University, Thailand 40002

伦理委员会联系人电话：

Contact phone of the ethic committee：

+66897141913

伦理委员会联系人邮箱：

Contact email of the ethic committee：

echr@kku.ac.th

研究实施负责（组长）单位：

Primary sponsor：

Suppachai Tiyaworanant and all other members of the research group

研究实施负责（组长）单位地址：

Primary sponsor's address：

Faculty of Pharmaceutical Sciences, Khon Kaen University

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

省(直辖市)：

市(区县)：

Country：

Thailand

Province：

Khon Kaen

City：

Kranuan

单位(医院)：

具体地址：

Institution
hospital：

Kranuan Crown Prince Hospital

Address：

Kranuan, Khon Kaen 40170

经费或物资来源：

Source(s) of funding：

National Science Research and Innovation Fund (NSRF)

研究疾病：

研究疾病代码：

Target disease：

COVID-19

Target disease code：

研究类型：

Study type：

预防性研究

Prevention

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：

Objectives of Study：

1. To investigate the effectiveness of reducing the positivity rate of the 2019 coronavirus test using the RT-PCR test method. 2. To investigate the effectiveness of reducing hospital admission rates. 3. To investigate the efficacy of reducing the severity of symptoms in high-risk individuals. 4. To investigate the safety of drugs by recording adverse reactions resulting from their use.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

Name of Medicine: AYW-KK-04 Herbal Capsule Composition: The AYW-KK-04 herbal capsule is a proprietary blend of 22 traditional medicinal herbs, carefully selected for their therapeutic properties. Each capsule contains 500 mg of powdered herbal mixture. Preparation: The medicinal herbs are meticulously ground into a fine powder and encapsulated to ensure consistency and ease of administration. 500 mg per capsule, 8 capsules must be administered at a time and administered 2 times a day, before breakfast and dinner. Manufacturing Details: The AYW-KK-04 herbal capsules are manufactured by Phra Arjan Phun Hospital Manufacturing, a trusted facility known for adhering to stringent quality standards in pharmaceutical production.

纳入标准：

Inclusion criteria

1. Male or female aged 18 years and over. 2. The individual must have been in close contact with a patient confirmed to have COVID-19 (referred to as the reference patient) for no more than 7 days 3. While in close contact with a with a patient confirmed to have COVID-19 and did not wear a mask. (High risk) with one of the following characteristics 3.1 Provide close care to reference patients 3.2 Physical close contact with reference patients 3.3 Living with the reference patient 3.4 Sitting with a reference patient in an enclosed space, at a distance of no more than 2 meters, with or without direct contact for at least 1 hour. 3.5 Direct contact with body secretions of reference patients, such as mucus, saliva, tears, urine, and feces. 4. Have complete awareness and be able to know, understand and make decisions.

排除标准：

Exclusion criteria：

1. was diagnosed and required hospital treatment 2. Tested with RT-PCR and confirmed to be infected with COVID-19. 3. Have a history of allergic reaction to herbs that are ingredients in the recipe 4. Have a history of allergic reaction to the proteins that make up the capsules 5. Are pregnant or have had a positive pregnancy test result 6. Having complete blood count, liver and kidney function that is abnormal from the standard values that the hospital considers or according to the doctor's opinion that such values are abnormal cannot be entered into the research process. 7. Intend to use other herbal medicines for treatment such as Andrographis paniculata and Krachai.

研究实施时间：

Study execute time：

从From 2021-11-22

至To      2023-11-09

征募观察对象时间：

Recruiting time：

从From 2022-01-06

至To      2022-05-10

干预措施：

Interventions：

组别：

样本量：

50

Group：

Treatment

Sample size：

干预措施：

干预措施代码：

Intervention：

AYW-KK-04 herbal capsule 4 g twice a day

Intervention code：

组别：

样本量：

50

Group：

Control

Sample size：

干预措施：

干预措施代码：

Intervention：

Placebo capsule 4 g twice a day

Intervention code：

样本总量 Total sample size ： 100

研究实施地点：

Countries of recruitment
and research settings：

国家：

省(直辖市)：

市(区县)：

Country：

Thailand

Province：

Khon Kaen

City：

Kranuan

单位(医院)：

单位级别：

Institution/hospital：

Kranuan Crown Prince Hospital

Level of the institution：

Secondary Care

测量指标：

Outcomes：

指标中文名：

指标类型：

附加指标

Outcome：

the severity of symptoms in high-risk individuals

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

7-14, 30

Measure method：

指标中文名：

指标类型：

主要指标

Outcome：

The primary outcome of this clinical trial is the COVID-19 polymerase chain reaction (PCR) test result of research participants.

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

7-14 days

Measure method：

RT-PCR

指标中文名：

指标类型：

副作用指标

Outcome：

adverse reactions resulting from their use

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

7-14

Measure method：

指标中文名：

指标类型：

附加指标

Outcome：

hospital admission rates

Type：

Additional indicator

测量时间点：

测量方法：

Measure time point of outcome：

7-14

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

组织：

Sample Name：

Nasal Swab Sampling

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：

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：

结束

Completed

年龄范围：

最小 18 岁
Min age years
最大 68 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）：

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

Stratified randomization is performed based on gender, age, and vaccination status to ensure balanced representation across groups. Block randomization is employed to account for random sampling in small groups, ensuring an equal distribution of participants. The sampling list is generated by researchers in the Faculty of Pharmacy and maintained by the project leader.

盲法：

Blinding：

Blinding Procedures: The study adopts a double-blind design, ensuring that neither the treating doctor, the prescriber, nor the participant knows whether they are receiving the medication or the placebo. This ensures that the allocation of participants remains concealed throughout the study duration, preventing any potential bias in treatment allocation or assessment of outcomes.

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）：

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

-

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：

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

-

数据管理委员会：

Data Managemen Committee：

暂未确定

Not yet

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):

返回
平台信息
平台简介
关于我们
试验注册
常见问题
伦理审查
公共服务
试验检索
参与我们
国际传统医学临床试验注册平台 京ICP备07032215号-5 提示：推荐使用IE8.0以上版本 宽屏显示分辨率下使用系统