Skip to main content
OpenTrials
Completed

NCT Number: NCT04410159

Povidone-Iodine Vs Essential Oil Vs Tap Water Gargling For COVID-19 Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universiti Kebangsaan Malaysia Medical Centre

Bandar Tun Razak, Kuala Lumpur, 56000, Malaysia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult aged 18 years and above
  • able to understand instructions
  • Stage 1 COVID-19
  • < 5 days of illness or diagnosis

Exclusion criteria

  • 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

Treatment and study plan

Povidone-Iodine

Drug

Gargle

Other names: Betadine

Essential oils

Drug

Gargle

Other names: Listerine

Tap water

Other

Gargle

Primary outcomes

  1. Number of Participants With Early Viral Clearance

    Time frame: Day 6

    Viral clearance is defined as two negative RT-PCR (of swabs from oropharynx and nasopharynx) results at least 24 hours apart

Secondary outcomes

  1. Number of Participants With Negative RT-PCR Results

    Time frame: Day 12

    RT-PCR (swabs from oropharynx and nasopharynx) taken at day 12

  2. Number of Patients That Progress to More Severe Disease

    Time frame: Day 12

    Presence of signs and symptoms of more severe COVID19 Based symptoms diary and clinical evaluation

  3. Number of Patients With Abnormal Radiological Findings

    Time frame: Day 0-14

    abnormal chest x-ray or CT scan

  4. Number of Patients With Abnormal Laboratory Findings

    Time frame: Day 0-14

    Abnormal absolute lymphocytic count Abnormal C-reactive protein

Sponsors and collaborators

Lead sponsor

Universiti Sains Islam Malaysia

Other

Collaborators

  • Universiti Kebangsaan Malaysia Medical Centre

Registry information

Official study title

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

Acronym: GARGLES

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jun 1, 2020
Registry last updated
Jul 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.