Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06452069
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-06
Brief Title:
Efficacy and Safety Study of Essential Oil-Based Preparation Administered to COVID-19 Patients
Sponsor:
Biodex SA
Organization:
Biodex SA
Study Overview
Official Title:
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 eg 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 andor 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
In addition crude essential oils often have many active components that can act on different parts of the virus including cell entry translation transcription and assembly Anti-inflammatory immune regulation on the respiratory system of the host have other beneficial pharmacological effects including bronchiectasis and mucolytics
Essential oils have many advantages because they promise volatile antiviral molecules making them useful either alone or in combination with other chemotherapeutic drugs making them potential drug targets for the prevention and treatment of COVID-19
In this study 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 Master Protease was adopted as a rationale A single-chain
The RNA virus SARS-CoV-2 has four main structural proteins Spike S Membrane M Envelope glycoprotein E and Nucleoapsid N proteins and non-structural proteins nsp
These non-structural proteins of which there are 16 in total in the genome of the virus play a key role in the mechanisms of the virus life cycle including replication transcription protein synthesis and modification of RNA Main protease Mpro 3CLpro has been the target enzyme for the development of new antiviral drugs for the treatment of COVID-19 as they are directly involved in the maturation of these nsp proteins which have an important role in many mechanisms of the virus life cycle Our main rationale in this study is to investigate the effect of essential oils on nsp5 Main Protease enzyme activations
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 eg 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 andor 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
In addition crude essential oils often have many active components that can act on different parts of the virus including cell entry translation transcription and assembly Anti-inflammatory immune regulation on the respiratory system of the host have other beneficial pharmacological effects including bronchiectasis and mucolytics
Essential oils have many advantages because they promise volatile antiviral molecules making them useful either alone or in combination with other chemotherapeutic drugs making them potential drug targets for the prevention and treatment of COVID-19
In this study 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 Master Protease was adopted as a rationale A single-chain
The RNA virus SARS-CoV-2 has four main structural proteins Spike S Membrane M Envelope glycoprotein E and Nucleoapsid N proteins and non-structural proteins nsp
These non-structural proteins of which there are 16 in total in the genome of the virus play a key role in the mechanisms of the virus life cycle including replication transcription protein synthesis and modification of RNA Main protease Mpro 3CLpro has been the target enzyme for the development of new antiviral drugs for the treatment of COVID-19 as they are directly involved in the maturation of these nsp proteins which have an important role in many mechanisms of the virus life cycle Our main rationale in this study is to investigate the effect of essential oils on nsp5 Main Protease enzyme activations
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None