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The anti-inflammatory effects of Mahajak oil in patients with acute gout attack; Pilot study

注册号：

Registration number：

ITMCTR2024000032

最近更新日期：

Date of Last Refreshed on：

2024-03-17

注册时间：

Date of Registration：

2024-03-17

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

Public title：

The anti-inflammatory effects of Mahajak oil in patients with acute gout attack; Pilot study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Scientific title：

The anti-inflammatory effects of Mahajak oil in patients with acute gout attack; 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：

Artina Pinta

申请注册联系人电话：

Applicant telephone：

+66885630564

研究负责人电话：

Study leader's telephone：

+66985567690

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：

finny_ff@hotmail.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：

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：

Kranuan Crown Prince Hospital, Kranuan, Khon Kaen, Thailand

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：

40170

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：

4.4.01:19/2564 and 4.5.02:19/2565

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：

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：

2021/5/24 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：

Artina Pinta and all other members of the research group

研究实施负责（组长）单位地址：

Primary sponsor's address：

-Kranuan Crown Prince Hospital, Kranuan, Khon Kaen, Thailand

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：

Khon Kaen

单位(医院)：

具体地址：

Institution
hospital：

Faculty of Pharmaceutical Sciences, Khon Kaen University

Address：

Department of Pharmacognosy and Toxicology

经费或物资来源：

Source(s) of funding：

-

研究疾病：

研究疾病代码：

Target disease：

acute gout attack

Target disease code：

研究类型：

Study type：

治疗研究

Treatment 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：

Objectives of Study：

To evaluate the efficacy and safety of Mahajak Oil in combination with colchicine in acute gout arthritis patients

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

Patients were eligible for the trial if they had been clinically diagnosed with acute gout arthritis according to the Rome criteria for gout, i.e. with at least 2 of the following 4 criteria: (1) serum urate (SU) level >7 mg/dL in men or >6 mg/dL in women; (2) presence of tophi; (3) presence of monosodium urate (MSU) crystals in synovial fluid or tissues; (4) history of painful joint swelling with abrupt onset and remission within 2 weeks.11 Male or female patients aged 20 years or above, without any diseases or contraindications to the interventions, no skin diseases, and no prior joint accidents were included. Patients were required to give written informed consent and to agree to follow the protocol.

排除标准：

Exclusion criteria：

Patients with secondary gout or other types of arthritis such as rheumatoid arthritis, osteoarthritis, or septic arthritis, as well as those suffering from SLE were excluded from the study. Patients with a history of hypersensitivity to herbal medicines were also excluded.

研究实施时间：

Study execute time：

从From 2021-05-24

至To      2023-05-04

征募观察对象时间：

Recruiting time：

从From 2021-06-01

至To      2022-08-31

干预措施：

Interventions：

组别：

样本量：

25

Group：

Control

Sample size：

干预措施：

干预措施代码：

Intervention：

Placebo + 0.6 mg Oral Colchicine

Intervention code：

组别：

样本量：

25

Group：

Treatment

Sample size：

干预措施：

干预措施代码：

Intervention：

Mahajak Oil + 0.6 mg Oral Colchicine

Intervention code：

样本总量 Total sample size ： 50

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：

主要指标

Outcome：

Pain Score

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Every 15 min. for 120 min

Measure method：

Visual Analogue Pain Scale

指标中文名：

指标类型：

次要指标

Outcome：

Joint Circumference

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Every 15 min. for 120 min

Measure method：

Circumference Perimeter

指标中文名：

指标类型：

次要指标

Outcome：

Joint Motion Angle

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Every 15 min. for 120 min

Measure method：

Universal Goniometer

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

结束

Completed

年龄范围：

最小 31 岁
Min age years
最大 85 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)：

Primary Investigator generates the random number sequence by simple randomization method

盲法：

Blinding：

Placebo Preparation: The placebo is prepared using mineral oil as the base. Artificial scents and colors are added to mimic the appearance and smell of the active intervention, in this case, Mahajak oil. The placebo is formulated to be indistinguishable from the active intervention to ensure blinding. Identical Packaging: Both the active intervention (Mahajak oil) and the placebo are packaged in identical containers or packaging to prevent participants and researchers from discerning between the two. Administration: Participants are randomly assigned to receive either the active intervention or the placebo. They are instructed to apply the assigned treatment (either Mahajak oil or the placebo) as directed by the study protocol. Blinding Maintenance: Throughout the study duration, participants, investigators, and other study personnel are kept blind to the treatment assignments. This is done to minimize bias in the assessment of outcomes. Unblinding Procedures: Unblinding procedures are put in place in case of emergencies or situations where knowledge of the treatment assignment is necessary for participant safety or management.

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):

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