Eucalyptus Oil as Adjuvant Therapy for Coronavirus Disease 19 (COVID-19)

NCT05398965 | Completed Phase 2

• 1 other identifier: 3105221321
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

Background : Based on several clinical trials, eucalyptus oil can suppress edema formation and reduce inflammation, where the effect of 1,8-cineole is due to the inhibition of cytokine secretion by T lymphocytes. This but not limited to the reduction of interleukin (IL) of IL-4, IL-5, and IL-10 in nasal lavage fluids and levels of IL- 1β, IL-6, Tumor Necrosis Factor-α (TNF-α), and Interferon-γ (IFN-γ) in lung tissue of mice infected with influenza virus. Hence the researchers assume that Eucalyptus may possess benefits in COVID-19 as adjuvant therapy. Objectives : The primary objective of this study is to evaluate the efficacy of Eucalyptus oil as adjuvant therapy in mild-moderate COVID-19 patients. Hypothesis : Eucalyptus oil may reduce the inflammatory cytokines which eventually improves clinical symptoms

Conditions

COVID-19

Keywords

COVID-19; Eucalyptus; Viral Clearance; Cytokine Level; Clinical Improvement

Outcome Measures

Primary Outcomes (3)

• Clinical Symptoms

  The patient will be asked for clinical improvement (three symptoms, sore throat, anosmia and cough) with a 6-likert scale question for each symptoms. Higher number (5) indicates very severe symptoms whereas 0 indicates no symptoms.

  change of score for each symptoms from baseline to day 15

• Viral clearance

  level of Severe Acute Respiratory Corona Virus 2 (SARS-COV2) on nasopharyngeal sample measured by RT-PCR in Cycle Threshold Unit (CT)

  change of CT Value from baseline to day 15

• Neutrophil-Lymphocyte Ratio (NLR)

  This ratio is used as a marker of subclinical inflammation. It is calculated by dividing the number of neutrophils by number of lymphocytes from the blood sample

  change of NLR from baseline to day 15

Secondary Outcomes (2)

• Radiology improvement

  change of radiology feature from baseline to day 15

• Cytokine level

  change of cytokine level from baseline to day 15

Study Arms (2)

Intervention Group

EXPERIMENTAL

The group will receive standard COVID medication + Eucalyptus oil on external use for 14 days

Drug: Eucalyptus Oil; Drug: Standard COVID medication

Comparator Group

ACTIVE COMPARATOR

The group will receive standard COVID medication only

Drug: Standard COVID medication

Interventions

Eucalyptus Oil DRUG

The Eucalyptus Oil pack contains Oleum Eucalyptus citriodora, Oleum Eucalyptus globulus, and Peppermint oil, given 4 times daily for 45 minutes each frequency, applied to the mask.

Also known as: Herbal Roll On

Intervention Group

Standard COVID medication DRUG

This standard treatment is personalized according to the severity but is not limited to standard antiviral therapy, azithromycin 500 mg a day, vitamin C 500 mg 8 hourly a day, zinc 20 mg a day, tablet of complex vitamin B, and other symptomatic treatments.

Also known as: COVID Medication

Comparator Group; Intervention Group

Eligibility Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• SARS-COV-2 infections were confirmed by real-time reverse transcription-polymerase chain reaction (RT-PCR) from the nasopharyngeal swab.
• Mild to moderate clinical symptoms or with nasal cannula oxygen modality maximal oxygen 4 liters/minute (Moderate COVID-19 patients mean patients with clinical signs of pneumonia (fever, cough, shortness of breath, rapid breathing) but no signs of severe pneumonia including Oxygen Saturation ≥ 95%)
• Sign the informed consent
• Have not received the COVID-19 medicine yet

You may not qualify if:

• They have or develop severe COVID-19 symptoms according to the COVID-19 diagnosis and treatment guidelines of Indonesian society of respiratory; respiratory distress (RR ≥30 breaths/min, oxygen saturation \<95% at a rest state)
• History of hepatitis or impaired liver function
• Patients with or had a history of comorbid such as coronary heart disease, congestive heart disease, renal insufficiency, chronic liver disease, diabetes mellitus, uncontrolled hypertension or grade II hypertension or hypertensive crisis, immunocompromised, Central Nervous System disorders (such as stroke, epilepsy, Alzheimer's, and meningitis)
• Pregnant or lactating women
• Allergy to any of the components of the test product
• Participated in other clinical studies
• Withdraw from the study:
• The protocol treatment will be discontinued if the patient
• Withdraw their consent based on the patient's demand
• Patient's compliance of the use of test product \<90% or \>5 times not using the product according to the predetermined schedule
• Severe adverse events occurred
• After undergoing clinical trials, the patient experienced things that caused him/her to no longer meet the criteria set out in this protocol.

Sponsors & Collaborators

• Hasanuddin University: lead
• Ministry of Agriculture, Republic of Indonesia: collaborator

Study Sites (1)

Hasanuddin University Hospital

Makassar, South Sulawesi, 90245, Indonesia

Location

MeSH Terms

Conditions

COVID-19

Interventions

Eucalyptus Oil

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Plant Oils; Oils; Lipids; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Arif Santoso, MD, Ph.D

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

• Idrus Paturusi, Prof.

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

• Nasrum Massi, Prof.

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

• Idrianti Idrus, MD

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

• Firdaus Hamid, MD. PhD

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

• Andi Rofian Sultan, MD. Ph.D

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

• Munawir Munawir, MD

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

• Rasiha Rasiha

  Hasanuddin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer

Model Details: Patients will be randomized into 2 study groups before starting their medication. The first group was only given standard COVID-19 therapy. While the treated group will be given standard COVID-19 along with adjuvant therapy (Eucalyptus oil on external use)

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 1, 2022
• Study Start: November 18, 2020
• Primary Completion: January 28, 2021
• Study Completion: March 1, 2022
• Last Updated: June 1, 2022

Record last verified: 2022-05

Locations

ID (1)