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

• Status: Completed
• Trial end date: 2022-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hasanuddin University
• Collaborator: Ministry of Agriculture, Republic of Indonesia

Criteria

Inclusion Criteria:

1. SARS-COV-2 infections were confirmed by real-time reverse transcription-polymerase chain reaction (RT-PCR) from the nasopharyngeal swab.

2. 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%)

3. Sign the informed consent

4. Have not received the COVID-19 medicine yet

Exclusion Criteria:

1. 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)

2. History of hepatitis or impaired liver function

3. 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)

4. Pregnant or lactating women

5. Allergy to any of the components of the test product

6. Participated in other clinical studies

Withdraw from the study:

The protocol treatment will be discontinued if the patient

1. Withdraw their consent based on the patient's demand

2. Patient's compliance of the use of test product <90% or >5 times not using the product according to the predetermined schedule

3. Severe adverse events occurred

4. After undergoing clinical trials, the patient experienced things that caused him/her to no longer meet the criteria set out in this protocol.