Eucalyptus Oil as Adjuvant Therapy for Coronavirus Disease 19 (COVID-19), a Randomized Open-label Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Clinical Symptoms
研究概览
简要总结
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
详细描述
Detailed Objectives :
- 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.
- To document the effect of Eucalyptus oil on clinical symptoms improvement, including cough, anosmia, and sore throat.
- To assess the effect of Eucalyptus oil on viral load indirectly reflected by the Real Time-Polymerase Chain Reaction/RT-PCR cycle threshold (CT)
- To assess the effect of Eucalyptus oil on NLR, Interleukin-6, Interleukin-10, and Tumor Growth Factor-β (TGF-β) as inflammatory marker
- 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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Intervention Group
The group will receive standard COVID medication + Eucalyptus oil on external use for 14 days
干预措施: Eucalyptus Oil (Drug)
Intervention Group
The group will receive standard COVID medication + Eucalyptus oil on external use for 14 days
干预措施: Standard COVID medication (Drug)
Comparator Group
The group will receive standard COVID medication only
干预措施: Standard COVID medication (Drug)
结局指标
主要结局
Clinical Symptoms
时间窗: change of score for each symptoms from baseline to day 15
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.
Neutrophil-Lymphocyte Ratio (NLR)
时间窗: change of NLR from baseline to day 15
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
Viral clearance
时间窗: change of CT Value from baseline to day 15
level of Severe Acute Respiratory Corona Virus 2 (SARS-COV2) on nasopharyngeal sample measured by RT-PCR in Cycle Threshold Unit (CT)
次要结局
- Radiology improvement(change of radiology feature from baseline to day 15)
- Cytokine level(change of cytokine level from baseline to day 15)
研究者
Bumi Herman
Assistant Lecturer
Hasanuddin University