A Multicentre, Randomised, Prospective Study Investigating the Efficacy and Safety of an Essential Oil-Based Preparation Administered to Mild and Moderately Severe COVID-19 Positive Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 280
- 试验地点
- 20
- 主要终点
- TClinical and virological cure rate in patients with PCR-confirmed mild to moderate symptomatic COVID-19 Positive infection treated with an essential oil-based product.
研究概览
简要总结
The aim of this study was to compare the efficacy and safety of the essential oil-based product in patients with mild to moderate symptomatic COVID-19 Positive infection confirmed by PCR. A computational simulation approach of the molecular interaction (binding) of the main components of essential oils exhibiting antiviral activity with known intracellular protein targets of SARS-CoV-2 (nsp5: Main Protease) was adopted as a rationale for this study. SARS-CoV-2, a single-stranded RNA virus, has four major structural proteins Spike (S), Membrane (M), Envelope glycoprotein (E) and Nucleocapsid (N) protein and non-structural proteins (nsp). These non-structural proteins, of which there are 16 in total in the genome of the virus, play key roles in the mechanisms of the virus life cycle, including replication, transcription, protein synthesis and modification of RNA. Main protease (Main protease, Mpro, 3CLpro), virus Since they are directly involved in the maturation of these nsp proteins, which have an important role in many mechanisms of the life cycle, they have been the target enzyme in the development of new antiviral drugs for the treatment of COVID-19. In this study, our main rationale is to investigate the effect of essential oils on nsp5: Main Protease enzyme activations.
详细描述
The indiscriminate use of antimicrobial agents has led to the emergence of a number of drug-resistant bacteria, fungi and viruses. To overcome the increasing resistance of pathogenic microbes, more effective antimicrobial agents with new modes of action must be developed.
Medicinal plants used in traditional medicines to treat infectious diseases are an abundant source of new bioactive secondary metabolites. Therefore, in the last few years, various medicinal plants and plant extracts have been screened for their antimicrobial activities . Essential oils obtained from aromatic medicinal plants (e.g. fennel (Foeniculum vulgare), mint (Mentha piperita), thyme (Thymus vulgaris)) have been shown to have antimicrobial activity against gram-positive and gram-negative bacteria as well as yeasts, It has been reported to be active against fungi and viruses. They are mixtures of different lipophilic and volatile substances such as monoterpenes, sesquiterpenes and/or phenylpropanoids and have a pleasant odour. They are also part of the pre-formed defence system of higher plants are thought to be . Monoterpenes have been widely studied, especially for their antiviral properties.
Nowadays, the use of essential oils is becoming increasingly widespread both in pharmacies and in various stores. The use of essential oils for therapeutic purposes is expanding. The molecules that make up certain essential oils have shown various antiviral properties:
- Either by neutralising the virus before it enters the cell,
- By changing the capsid or envelope of the virus,
- Either by binding to receptors used by viruses and preventing their access to cells.
Herbal products are an important source of herbal remedies and other medicines. Essential oils have shown various pharmacological activities, such as antiviral activity, and have therefore been implicated in SARS-CoV- It has been suggested to have potential activity against 2. Essential oils can easily penetrate the viral membrane due to their lipophilicity and can cause rupture of the viral membrane.
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
- Single (Outcomes Assessor)
盲法说明
Double Blind
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be between 18<X< 65 years of age.
- •The participant must be willing and able to give written informed consent. The volunteer must provide his/her consent on his or her behalf, a legally acceptable representative (i.e., an International Harmonization Council [ICH] and adopted by local law as appropriate can be used) must give informed consent on his/her behalf.
- •PCR test COVID-19 positive diagnosis and mild to moderate disease stage is required.
- •The participant must agree not to receive vaccines administered for COVID-19 during the study.
排除标准
- •Patients < 18 years of age,
- •Positive diagnosis of severe COVID-19 with symptoms of basic severity: patients with respiratory distress, signs of mental confusion and impaired consciousness that develop depending on the severity of the stage of the disease,
- •Patients on active antiviral therapy,
- •Patients with creatine clearance < 30 ml/min and renal impairment,
- •NYHA III-IV, Stage D heart failure patients requiring frequent hospitalization,
- •Uncontrolled coagulopathy,
- •Patients with advanced liver failure,
- •Patients with active infections such as hepatitis B, hepatitis C and HIV, diseases requiring systemic treatment,
- •Patients with active malignancy and known history of cancer,
- •Those who do not have sufficient psychic state to disrupt working rounds,
- •Active drug users,
- •Known hypersensitivity and allergic reaction to the components of the preparation,
- •Current participation in another interventional treatment study with an investigational agent,
- •Recent use of the investigational product within 28 days of the first dose of the investigational product use or presence of a research device during screening,
- •Pregnant or breastfeeding women,
- •Patients who did not give written informed consent.
结局指标
主要结局
TClinical and virological cure rate in patients with PCR-confirmed mild to moderate symptomatic COVID-19 Positive infection treated with an essential oil-based product.
时间窗: 20th Day
Day 20 Participant symptoms and quantitative PCR of viral load
Clinical recovery defined by the absence of clinical signs of infection
时间窗: 20th Day
Clinical signs of acute respiratory infection disappearance (cough and difficulty breathing),Fever within normal temperature ranges, clinical improvement, although the participant has pseudo-symptoms
Clinical and virological cure rate in patients with PCR-confirmed mild to moderate symptomatic COVID-19 Positive infection treated with an essential oil-based product
时间窗: 10th Day
Day 10 Participant symptoms and quantitative PCR of viral load
Aggravation of the clinical picture
时间窗: 20th Day
Appearance of a new sign that was not present at the beginning (not requiring hospitalization),Indicator of hospitalization during the study period,Hospitalization,Hospitalization with oxygen requirement,Hospitalization in intensive care, Death due to COVID-19
Virological evaluation
时间窗: 20th Day
Qualitative PCR Test and Quantitative PCR Test
次要结局
- Incidence of adverse events and serious advers event(20th Day)
- Evaluation of time from inclusion to recovery in days(20th Day)