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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-22

Study Completion Date

2020-07-06

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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COVID-19

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

4 arms

1. Gargle with povidone-iodine
2. Gargle with essential oils
3. Gargle with tap water
4. Control

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Povidone-iodine

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

Group Type EXPERIMENTAL

Povidone-Iodine

Intervention Type DRUG

Gargle

Essential Oils

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

Group Type EXPERIMENTAL

Essential oils

Intervention Type DRUG

Gargle

Tap water

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

Group Type EXPERIMENTAL

Tap water

Intervention Type OTHER

Gargle

Control

This group will receive the standard treatment protocol without any additional intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Povidone-Iodine

Gargle

Intervention Type DRUG

Essential oils

Gargle

Intervention Type DRUG

Tap water

Gargle

Intervention Type OTHER

Other Intervention Names

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Betadine Listerine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No