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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04410159
Recruitment Status : Recruiting
First Posted : June 1, 2020
Last Update Posted : June 25, 2020
Sponsor:
Collaborator:
Universiti Kebangsaan Malaysia Medical Centre
Information provided by (Responsible Party):
NURUL AZMAWATI MOHAMED, Universiti Sains Islam Malaysia

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.


Condition or disease Intervention/treatment Phase
COVID-19 Drug: Povidone-Iodine Drug: Essential oils Other: Tap water Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

4 arms

  1. Gargle with povidone-iodine
  2. Gargle with essential oils
  3. Gargle with tap water
  4. Control
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot, Open-Labelled, Randomised Controlled Trial Of Povidone-Iodine Vs Essential Oil And Tap Water Gargling For COVID-19 Patients
Actual Study Start Date : June 22, 2020
Estimated Primary Completion Date : July 15, 2020
Estimated Study Completion Date : August 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
Experimental: Povidone-iodine
gargle with povidone-iodine 10mL, 30 seconds, 3 times per day, 7 days
Drug: Povidone-Iodine
Gargle
Other Name: Betadine

Experimental: Essential Oils
gargle with essential oils 20mL, 30 seconds, 3 times per day, 7 days
Drug: Essential oils
Gargle
Other Name: Listerine

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

No Intervention: Control
This group will receive the standard treatment protocol without any additional intervention



Primary Outcome Measures :
  1. Early Viral Clearance [ Time Frame: Day 6 ]
    Swabs from oropharynx and nasopharynx will be taken at day 6 of intervention.


Secondary Outcome Measures :
  1. Late viral clearance [ Time Frame: Day 12 ]
    Swabs from oropharynx and nasopharynx will be taken at day 12

  2. Symptoms progression [ Time Frame: Day 0-7 ]
    Progression will be monitored by symptoms diary for 7 days

  3. Disease Progression [ Time Frame: Day 0-14 ]
    Progression will be monitored by clinical data for 14 days

  4. Disease Progression 2 [ Time Frame: Day 0-14 ]
    Progression will be monitored by laboratory data for 14 days



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04410159


Contacts
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Contact: NURUL A MOHAMED +60129646276 drnurul@usim.edu.my
Contact: WAN SHAHIDA WAN SULAIMAN +60193628630 wanshahida@usim.edu.my

Locations
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Malaysia
Universiti Kebangsaan Malaysia Medical Centre Recruiting
Bandar Tun Razak, Wilayah Persekutuan Kuala Lumpur, Malaysia, 56000
Contact: PETRICK PERIYASAMY    +60196603503    petrick.periyasamy@gmail.com   
Contact: NAJMA KORI    +60139990235    najmakori@gmail.com   
Sponsors and Collaborators
Universiti Sains Islam Malaysia
Universiti Kebangsaan Malaysia Medical Centre
Investigators
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Principal Investigator: NURUL A MOHAMED Universiti Sains Islam Malaysia
Publications of Results:
Other Publications:
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Responsible Party: NURUL AZMAWATI MOHAMED, Dr, Universiti Sains Islam Malaysia
ClinicalTrials.gov Identifier: NCT04410159    
Other Study ID Numbers: USIMalaysia
First Posted: June 1, 2020    Key Record Dates
Last Update Posted: June 25, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The participant data from the final research dataset used in the published manuscript will be shared upon reasonable request. The protocol and data analysis will be shared in clinicaltrial
Supporting Materials: Study Protocol
Informed Consent Form (ICF)
Time Frame: September to December 2020
Access Criteria: email to drnurul@usim.edu.my

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NURUL AZMAWATI MOHAMED, Universiti Sains Islam Malaysia:
gargle
povidone-iodine
essential oils
tap water
Additional relevant MeSH terms:
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Povidone-Iodine
Listerine
Povidone
Plasma Substitutes
Blood Substitutes
Anti-Infective Agents, Local
Anti-Infective Agents