Povidone-Iodine Vs Essential Oil Vs Tap Water Gargling For COVID-19 Patients (GARGLES)
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|ClinicalTrials.gov Identifier: NCT04410159|
Recruitment Status : Completed
First Posted : June 1, 2020
Results First Posted : July 21, 2020
Last Update Posted : July 21, 2020
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|
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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||June 29, 2020|
|Actual Study Completion Date :||July 6, 2020|
gargle with povidone-iodine 10mL, 30 seconds, 3 times per day, 7 days
Other Name: Betadine
Experimental: Essential Oils
gargle with essential oils 20mL, 30 seconds, 3 times per day, 7 days
Drug: Essential oils
Other Name: Listerine
Experimental: Tap water
gargle with tap water 100 mL, 30 seconds, 3 times per day, 7 days
Other: Tap water
No Intervention: Control
This group will receive the standard treatment protocol without any additional intervention
- 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
- Number of Participants With Negative RT-PCR Results [ Time Frame: Day 12 ]RT-PCR (swabs from oropharynx and nasopharynx) taken at day 12
- 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
- Number of Patients With Abnormal Radiological Findings [ Time Frame: Day 0-14 ]abnormal chest x-ray or CT scan
- Number of Patients With Abnormal Laboratory Findings [ Time Frame: Day 0-14 ]Abnormal absolute lymphocytic count Abnormal C-reactive protein
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
|Universiti Kebangsaan Malaysia Medical Centre|
|Bandar Tun Razak, Wilayah Persekutuan Kuala Lumpur, Malaysia, 56000|
|Principal Investigator:||NURUL A MOHAMED||Universiti Sains Islam Malaysia|