Completed

GARGLESA Pilot, Open-Labelled, Randomised Controlled Trial Of Povidone-Iodine Vs Essential Oil And Tap Water Gargling For COVID-19 Patients

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What is being tested

Povidone-Iodine

+ Essential oils

+ Tap water

DrugOther
Who is being recruted

COVID-19+9

+ Coronaviridae Infections

+ Infections

Over 18 Years
+9 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: June 2020
See protocol details

Summary

Principal SponsorUniversiti Sains Islam Malaysia
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 22, 2020

Actual date on which the first participant was enrolled.

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.

Official TitleA Pilot, Open-Labelled, Randomised Controlled Trial Of Povidone-Iodine Vs Essential Oil And Tap Water Gargling For COVID-19 Patients
NCT04410159
Principal SponsorUniversiti Sains Islam Malaysia
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

COVID-19Coronaviridae InfectionsInfectionsLung DiseasesPneumoniaPneumonia, ViralRespiratory Tract DiseasesRespiratory Tract InfectionsRNA Virus InfectionsVirus DiseasesCoronavirus InfectionsNidovirales Infections

Criteria

4 inclusion criteria required to participate
adult aged 18 years and above

able to understand instructions

Stage 1 COVID-19

5 days of illness or diagnosis

5 exclusion criteria prevent from participating
Less than 18 years old

Unable to understand instructions

Stage 2 & 3 COVID-19

Respiratory symptoms or fever on admission

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
gargle with povidone-iodine 10mL, 30 seconds, 3 times per day, 7 days

Group II

Experimental
gargle with essential oils 20mL, 30 seconds, 3 times per day, 7 days

Group III

Experimental
gargle with tap water 100 mL, 30 seconds, 3 times per day, 7 days

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Universiti Kebangsaan Malaysia Medical Centre

Bandar Tun Razak, MalaysiaOpen Universiti Kebangsaan Malaysia Medical Centre in Google Maps
CompletedOne Study Center
GARGLES | A Pilot, Open-Labelled, Randomised Controlled Trial Of Povidone-Iodine Vs Essential Oil And Tap Water Gargling For COVID-19 Patients | PatLynk