A Pilot, Open-Labelled, Randomised Controlled Trial Of Povidone-Iodine Vs Essential Oil And Tap Water Gargling For COVID-19 Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Number of Participants With Early Viral Clearance
研究概览
简要总结
The purpose of this study is to assess the ability of regular gargling to eliminate severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in the throat and nasopharynx. This 4 arms interventional study compares the effect of gargling using povidone-iodine, essential oils- based, tap water with control (no intervention) among Stage 1 coronavirus disease-2019 (COVID-19) patients.
Findings from this study will provide new insight into the importance of gargling in the treatment and prevention of COVID-19.
详细描述
Experimental plan
After consent is taken, all groups will be briefed regarding the study protocol separately.
- Group A will be briefed on the correct procedures of gargling with Betadine®. The participants will be instructed to take 10ml of povidone-iodine (PVP-I), tilt their heads backward and gargle for 30 seconds, three times per day for 7 days
- Group B will be briefed on the correct technique of gargling with Listerine®. The participants will be instructed to take 20ml of essential oils, tilt their heads backward and gargle for 30 seconds, three times per day for 7 days
- Group C will be briefed on the correct technique of gargling with hydrogen peroxide. The participants will be instructed to take 10ml of hydrogen peroxide, tilt their heads backward and gargle for 30 seconds, three times per day for 7 days
- Group D will be briefed about the involvement in this study. They will be managed according to the standard protocol of the hospital with no additional intervention.
Monitoring
- Oropharyngeal and nasopharyngeal swabs will be taken on day 4, 6 of intervention, and day 12 post-intervention. The swabs will be subjected to detection of SARS-CoV-2 by real-time reverse transcriptase-polymerase chain reaction (rt RT-PCR).
- Patients will be given a chart for them to record their gargling practice and symptoms (if any) during the intervention period ( 7 days)
- Clinical data collection sheet will be provided to attending clinicians. The required information includes demographic data, daily vital signs, serial absolute lymphocytic count, LDH, chest radiograph, and symptoms. Clinical monitoring will be done until day 14 of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult aged 18 years and above
- •able to understand instructions
- •Stage 1 COVID-19
- •< 5 days of illness or diagnosis
排除标准
- •Less than 18 years old
- •Unable to understand instructions
- •Stage 2 & 3 COVID-19
- •Respiratory symptoms or fever on admission
- •Abnormal chest radiograph or computed tomography (CT) findings on admission
研究组 & 干预措施
Povidone-iodine
gargle with povidone-iodine 10mL, 30 seconds, 3 times per day, 7 days
干预措施: Povidone-Iodine (Drug)
Essential Oils
gargle with essential oils 20mL, 30 seconds, 3 times per day, 7 days
干预措施: Essential oils (Drug)
Tap water
gargle with tap water 100 mL, 30 seconds, 3 times per day, 7 days
干预措施: Tap water (Other)
结局指标
主要结局
Number of Participants With Early Viral Clearance
时间窗: Day 6
Viral clearance is defined as two negative RT-PCR (of swabs from oropharynx and nasopharynx) results at least 24 hours apart
次要结局
- Number of Participants With Negative RT-PCR Results(Day 12)
- Number of Patients That Progress to More Severe Disease(Day 12)
- Number of Patients With Abnormal Radiological Findings(Day 0-14)
- Number of Patients With Abnormal Laboratory Findings(Day 0-14)
研究者
NURUL AZMAWATI MOHAMED
Dr
Universiti Sains Islam Malaysia