Status:
COMPLETED
Eucalyptus Oil as Adjuvant Therapy for Coronavirus Disease 19 (COVID-19)
Lead Sponsor:
Hasanuddin University
Collaborating Sponsors:
Ministry of Agriculture, Republic of Indonesia
Conditions:
COVID-19
Eligibility:
All Genders
18-59 years
Phase:
PHASE2
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...
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 Eucal...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
November 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT05398965
Start Date
November 18 2020
End Date
March 1 2022
Last Update
June 1 2022
Active Locations (1)
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1
Hasanuddin University Hospital
Makassar, South Sulawesi, Indonesia, 90245