NCT05398965

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

Eucalyptus Oil as Adjuvant Therapy for Coronavirus Disease 19 (COVID-19), a Randomized Open-label Clinical Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Hasanuddin University · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

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

Detailed description

Detailed Objectives : 1. To assess the safety of Eucalyptus oil as an adjuvant to the standard of care in treating patients with mild to moderate COVID-19 symptoms. 2. To document the effect of Eucalyptus oil on clinical symptoms improvement, including cough, anosmia, and sore throat. 3. To assess the effect of Eucalyptus oil on viral load indirectly reflected by the Real Time-Polymerase Chain Reaction/RT-PCR cycle threshold (CT) 4. To assess the effect of Eucalyptus oil on NLR, Interleukin-6, Interleukin-10, and Tumor Growth Factor-β (TGF-β) as inflammatory marker 5. To assess the effect of Eucalyptus oil on immunoglobulin (Ig) M and G in patient's serum Target population: Patients with mild-moderate COVID-19 Setting: Hospital and outpatient care Intervention: External use of Eucalyptus oil Subject Recruitment and Screening : 1. A written, signed, and dated (ICF) consent form will be obtained from the patient before the study's inclusion. Assessment and records of patient's clinical report forms including demographic data, comorbidities and concurrent medications, symptoms experienced by the patient, body weight, height of the body, body mass index, vital signs, and fingertip oxygen saturation. 2. Baseline laboratory tests including complete blood count (CBC), neutrophil-lymphocyte ratio (NLR), liver (alanine aminotransferase (ALT), aspartate aminotransferase (AST), kidney function tests (serum creatinine), serum ferritin, blood glucose, coagulation test (prothrombin time and activated partial thromboplastin time), cytokine level (IL-6, IL-10, and TGF-β) will be assessed. On admission, computed tomography (CT) scan of the chest will also be performed. Detailed procedures : Eucalyptus oil will be applied to the surgery mask, 4 times a day, which is 45 minutes duration in each session for 14 days. Clinical assessment and vital signs, and follow-up RT-PCR tests by nasopharyngeal swab will be documented on days 5, 10, and 15. Follow-up laboratory results for blood, liver function, kidney function, blood glucose, cytokine level, and CT scan will be performed on Day 15. If moderate COVID-19 patients confirmed negative RT-PCR test results in 2 consecutive tests, the patient is allowed to be discharged and continue their adjuvant treatment at home (in the intervention group). Sample size estimation : following the sample size estimation of two different means 1. Type 1 error 5% 2. Power of study 80% 3. superiority trial hypothesis 4. equal allocation for two arms f. effect size is estimated at 0.7 total sample required : 52 Statistical Analysis 1. Intention to treat 2. Descriptive statistic 3. Repeated measurement analysis using mixed model analysis.

Conditions

• COVID-19

Interventions

Type	Name	Description
DRUG	Eucalyptus Oil	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.
DRUG	Standard COVID medication	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.

Timeline

• Start date: 2020-11-18
• Primary completion: 2021-01-28
• Completion: 2022-03-01
• First posted: 2022-06-01
• Last updated: 2022-06-01

Locations

1 site across 1 country: Indonesia