Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05398965 |
Other study ID # |
3105221321 |
Secondary ID |
|
Status |
Completed |
Phase |
Phase 2
|
First received |
|
Last updated |
|
Start date |
November 18, 2020 |
Est. completion date |
March 1, 2022 |
Study information
Verified date |
May 2022 |
Source |
Hasanuddin University |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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
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.