Official Title
A Pilot, Open-Labelled, Randomised Controlled Trial Of Povidone-Iodine Vs Essential Oil And Tap Water Gargling For COVID-19 Patients
Brief Summary

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.

Detailed Description

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

1. 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).

2. Patients will be given a chart for them to record their gargling practice and symptoms
(if any) during the intervention period ( 7 days)

3. 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.

Completed
COVID-19

Drug: Povidone-Iodine

Gargle
Other Name: Betadine

Drug: Essential oils

Gargle
Other Name: Listerine

Other: Tap water

Gargle

Eligibility Criteria

Inclusion Criteria:

1. adult aged 18 years and above

2. able to understand instructions

3. Stage 1 COVID-19

4. < 5 days of illness or diagnosis

Exclusion Criteria:

1. Less than 18 years old

2. Unable to understand instructions

3. Stage 2 & 3 COVID-19

4. Respiratory symptoms or fever on admission

5. Abnormal chest radiograph or computed tomography (CT) findings on admission

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Malaysia
Locations

Universiti Kebangsaan Malaysia Medical Centre
Bandar Tun Razak, Wilayah Persekutuan Kuala Lumpur, Malaysia

NURUL A MOHAMED, Principal Investigator
Universiti Sains Islam Malaysia

Universiti Kebangsaan Malaysia Medical Centre
NCT Number
Keywords
gargle
povidone-iodine
essential oils
tap water
MeSH Terms
COVID-19
Povidone-Iodine
Listerine
Povidone