GB2622130A - Composition - Google Patents

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Publication number
GB2622130A
GB2622130A GB2309785.0A GB202309785A GB2622130A GB 2622130 A GB2622130 A GB 2622130A GB 202309785 A GB202309785 A GB 202309785A GB 2622130 A GB2622130 A GB 2622130A
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extract
rhus
composition
typhina
glabra
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GB202309785D0 (en
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Hasson Sidgi
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Liverpool John Moores Univ
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Liverpool John Moores Univ
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Publication of GB2622130A publication Critical patent/GB2622130A/en
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • A61K36/285Aucklandia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/13Amines
    • A61K31/14Quaternary ammonium compounds, e.g. edrophonium, choline
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/11Pteridophyta or Filicophyta (ferns)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/22Anacardiaceae (Sumac family), e.g. smoketree, sumac or poison oak
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K36/00Medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicines
    • A61K36/18Magnoliophyta (angiosperms)
    • A61K36/185Magnoliopsida (dicotyledons)
    • A61K36/28Asteraceae or Compositae (Aster or Sunflower family), e.g. chamomile, feverfew, yarrow or echinacea
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/12Antivirals
    • A61P31/14Antivirals for RNA viruses
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2236/00Isolation or extraction methods of medicinal preparations of undetermined constitution containing material from algae, lichens, fungi or plants, or derivatives thereof, e.g. traditional herbal medicine
    • A61K2236/30Extraction of the material
    • A61K2236/33Extraction of the material involving extraction with hydrophilic solvents, e.g. lower alcohols, esters or ketones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/20Pills, tablets, discs, rods

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  • Health & Medical Sciences (AREA)
  • Natural Medicines & Medicinal Plants (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical & Material Sciences (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Botany (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Medical Informatics (AREA)
  • Biotechnology (AREA)
  • Alternative & Traditional Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Virology (AREA)
  • Zoology (AREA)
  • Molecular Biology (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicines Containing Plant Substances (AREA)

Abstract

A composition comprising an extract of Aucklandia lappa Decne, an extract of Punica granatum and an extract of at least one of Rhus coriaria L., Rhus glabra and Rhus typhina. A method of preparing a lozenge comprising admixing a therapeutically effective amount of the extract composition with a lozenge base and forming a lozenge, and a kit for providing a medicament comprising packaging comprising the extract composition and instructions for administering the medicament are also included. The extracts of A. lappa and P. granatum may be in a ratio between 4:1 and 1:1. The A. lappa extract is preferably an aqueous root extract and the P. granatum extract is preferably an aqueous peel extract. The composition may comprise an extract of each of R. coriaria L., R. glabra and R. typhina, which may be in a 1:1:1 ratio. The composition may consist essentially of an extract of each of A. lappa, P. granatum, R. coriaria L., R. glabra and R. typhina. The composition may be for oral administration and may be for use as a medicament, preferably for use in treatment of respiratory tract infections and particularly for use in treatment of coronavirus infections, such as SARS-CoV and SARS-CoV-2 (COVID-19).

Description

Composition
FIELD
The present invention relates to a composition comprising plant extracts, which composition may be useful as a medicament.
BACKGROUND
Infections, including bacterial, viral and fungal infections, are relatively common illnesses and represent serious health challenges Examples of infections that are particularly challenging include respiratory infections, such as infections of the upper respiratory tract, especially chronic rhinosinusitis (CRS).
Recently, severe acute respiratory syndrome coronavirus 2 (SARS-CoV2) has emerged as a novel coronavirus, which is a highly transmittable and pathogenic viral infection. SARS-CoV2 causes coronavirus disease (COVID-19 disease), which is a highly infectious respiratory illness. COVID-19 disease was declared a pandemic by the World Health Organization and can lead to respiratory failure.
There is a desire to provide effective therapies for treating infections, including respiratory infections, such as CRS and COVID-19 disease, that offer patients improved outcomes, including the potential for reducing morbidity and mortality.
Plant-derived medicaments remain an important resource, especially in developing countries, to combat serious diseases. There has been increasing interest in natural products from different sources particularly from higher plants for the discovery of new antimicrobial and antioxidant agents, such as tannins, terpenoids, alkaloids, and flavonoids, which have been demonstrated to have in vitro antimicrobial properties.
It is an aim of the present invention to provide a plant-derived medicament that may be used to treat infections such as respiratory infections and improve on the prior art.
SUMMARY
The present invention provides a composition asset forth in the appended claims. Other features of the invention will be apparent from the dependent claims, and the description, which follows.
According to the present invention, there is provided a composition comprising: (i) an extract of Aucklandia lappa Decne; (ii) an extract of Punica granatum; and (Di) an extract of one or more of Rhus coriaria L., Rhus glabra and Rhus typhina.
As used herein, the term "extract" means a substance (for example a pharmaceutically active substance) obtained by extracting (or removing) that substance from a raw material. The extracts described herein may therefore be referred to as an extracted substance. Extracts may comprise a single (extracted) substance or multiple (extracted) substances. Typically, an extract comprises multiple (extracted) substances. References herein to extracts refer to both the substance obtained directly from the extraction process and to extracts that are further purified following extraction from a raw material.
The extracts as discussed herein may be provided in any suitable form, such as a liquid, paste or powder (such as a dried powder, for example a freeze-dried powder).
The extracts as discussed herein may be obtained by any suitable extraction method. Suitable extraction methods would be known to persons skilled in the art and include solvent extraction.
The extracts as discussed herein may be obtained by a solvent extraction method. Any suitable extraction solvent may be used in a solvent extraction method. For example, the extraction solvent may comprise water, in which case the extract may be referred to as an aqueous extract.
Suitable extraction solvents may be selected from water, an alcohol, and an ether, and mixtures thereof. For example, suitable extraction solvents may be selected from water, a Cl to 04 or a C2 to C4 alcohol, and a dialkyl ether (such as a C2 to C5 or C2 to C4 dialkyl ether), and mixtures thereof.
Suitable extraction solvents may comprise water. In this case, the extract may be referred to as an aqueous extract.
Suitable extraction solvents may comprise an alcohol, such as a Cl to C4 or a 02 to 04 alcohol, for example methanol or ethanol (suitably ethanol). In this case, the extract may be referred to as an alcoholic extract, for example an ethanolic extract.
Suitable extraction solvents may comprise water and an alcohol, such as a Cl to 04 or a 02 to 04 alcohol. For example, a suitable extraction solvent may comprise water and methanol. For example, a suitable extraction solvent may comprise water and ethanol. In this case, the extract may be referred to as an aqueous alcoholic extract, for example an aqueous ethanolic extract.
Suitable extraction solvents may comprise water and an alcohol in any suitable proportions, as would be determined by a person skilled in the art. For example, a suitable extraction solvent may comprise from 2 to 8 wt% water and from 92 to 98 wt% alcohol (such as a Cl to C4 or a C2 to C4 alcohol, for example methanol or ethanol, suitably ethanol).
Suitably the extract is an aqueous extract, for example an aqueous alcoholic extract, such as an aqueous ethanolic extract.
Suitable extraction solvents may comprise an ether, such as a dialkyl ether, for example a C2 to C5 or C2 to C4 dialkyl ether. For example, a suitable extraction solvent may have the formula R10R2 wherein each of R1 and R2 is independently a C2 to C5 or C2 to C4 alkyl group. For example, a suitable extraction solvent may comprise diethyl ether, dibutyl ether and/or combinations thereof In this case, the extract may be referred to as an ether extract.
An extract such as an aqueous extract may be used directly in the form in which it is prepared, or may be modified to provide another suitable form of the extract, For example, the extract may be a dehydrated extract, in which case the extract (for example aqueous extract) is subjected to dehydration. For example, the dehydrated extract may be a lyophilised (or "freeze-dried") extract. The extract may be a reconstituted dehydrated extract, in which case the dehydrated extract is reconstituted in water.
The composition comprises (i) an extract of Aucklandia lappa Decne.
Aucklandia lappa Decne, otherwise known as Saussurea lappa (Decne), is a traditional herb containing approximately 1 to 2.5 wt% of refined oils. Aucklandia lappa Decne is commonly referred to as AID.
Suitably the extract of Aucklandia lappa Decne is an extract of the root of Aucklandia lappa Decne.
Suitably the extract of Aucklandia lappa Decne is an aqueous extract of Aucklandia lappa Decne. Suitably the extract of Aucklandia lappa Decne is an alcoholic extract of Aucklandia lappa Decne. Suitably the extract of Aucklandia lappa Decne is an aqueous alcoholic extract of Aucklandia lappa Decne. Suitably the extract of Aucklandia lappa Decne is an aqueous ethanol ic extract of Aucklandia lappa Decne.
Suitably the extract of Aucklandia lappa Decne is an aqueous extract of the root of Aucklandia lappa Decne. Suitably the extract of Aucklandia lappa Decne is an alcoholic extract of the root of Aucklandia lappa Decne. Suitably the extract of Aucklandia lappa Decne is an aqueous alcoholic extract of the root of Aucklandia lappa Decne. Suitably the extract of Aucklandia lappa Decne is an aqueous ethanolic extract of the root of Aucklandia lappa Decne.
Suitably the extract of Aucklandia lappa Decne is an ether extract of Aucklandia lappa Decne.
Suitably the extract of Aucklandia lappa Decne is a dialkyl ether (for example a 02 to 05 or C2 to 04 dialkyl ether) extract of Aucklandia lappa Decne. Suitably the extract of Aucklandia lappa Decne is a diethyl ether or dibutyl ether extract of Aucklandia lappa Decne.
Suitably the extract of Aucklandia lappa Decne is an ether extract of the root of Aucklandia lappa Decne. Suitably the extract of Aucklandia lappa Decne is a dialkyl ether (for example a C2 to C5 or C2 to C4 dialkyl ether) extract of the root of Aucklandia lappa Decne. Suitably the extract of Aucklandia lappa Decne is a diethyl ether or dibutyl ether extract of the root of Aucklandia lappa Decne.
The extract of Aucklandia lappa Decne may be provided in powdered form, such as in lyophilized powder form.
The composition comprises (ii) an extract of Punica granatum.
Punica granatum is a widely cultivated deciduous shrub grown for its fruits and known simply as "pomegranate".
Suitably the extract of Punica granatum is an extract of the peel of Punica granatum.
Suitably the extract of Punica granatum is an aqueous extract of Punica granatum. Suitably the extract of Punica granatum is an alcoholic extract of Punica granatum. Suitably the extract of Punica granatum is an aqueous alcoholic extract of Punica granatum. Suitably the extract of Punica granatum is an aqueous ethanolic extract of Punica granatum.
Suitably the extract of Punica granatum is an aqueous extract of the peel of Punica granatum.
Suitably the extract of Punica granatum is an alcoholic extract of the peel of Punica granatum. Suitably the extract of Punica granatum is an aqueous alcoholic extract of the peel of Punica granatum. Suitably the extract of Punica granatum is an aqueous ethanolic extract of the peel of Punica granatum.
Suitably the extract of Punica granatum is an ether extract of Punica granatum. Suitably the extract of Punica granatum is a dialkyl ether (for example a 02 to C5 or 02 to 04 dialkyl ether) extract of Punica granatum. Suitably the extract of Punica granatum is a diethyl ether or dibutyl ether extract of Punica granatum.
Suitably the extract of Punica granatum is an ether extract of the peel of Punica granatum. Suitably the extract of Punica granatum is a dialkyl ether (for example a C2 to C5 or C2 to C4 dialkyl ether) extract of the peel of Punica granatum. Suitably the extract of Punica granatum is a diethyl ether or dibutyl ether extract of the peel of Punica granatum.
The extract of Aucklandia lappa Decne and the extract of Punica granatum may be suitably provided in the composition in a weight ratio of from 5:1 to 1:1, such as from 4:1 to 1:1, for example in a weight ratio of 4:1.
The extract of Punica granatum may be provided in powdered form, such as in lyophilized powdered form.
The extract of Aucklandia lappa Decne and the extract of Punica granatum may both be provided in lyophilized powder form.
The composition comprises (iii) one or more extracts of Rhus coriaria L., Rhus glabra and Rhus typhina.
Rhus coriaria L., commonly called Sicilian sumac, tanner's sumach, or elm-leaved sumach, is a deciduous shrub to small tree in the cashew family Anacardiaceae. It is native to southern Europe and western Asia.
Rhus glabra, also known as the smooth sumac, white sumac, upland sumac, or scarlet sumac, is a species of sumac in the family Anacardiaceae. It is native to North America.
Rhus typhina, commonly known as the staghorn sumac, is a species of flowering plant in the family Anacardiaceae. It is native to eastern North America.
Suitably the extracts of Rhus coriaria L., Rhus glabra and Rhus typhina are extracts of the fruit of Rhus coriaria L., Rhus glabra and Rhus typhina.
The one or more extracts of Rhus coriaria L., Rhus glabra and Rhus typhina may be provided in powdered form.
The composition may comprise extracts of Rhus coriaria L. and Rhus glabra, and optionally an extract of Rhus typhina.
The composition may comprise extracts of Rhus coriaria L. and Rhus typhina, and optionally an extract of Rhus glabra.
The composition may comprise extracts of Rhus glabra and Rhus typhina, and optionally an extract of Rhus coriaria L. The composition may comprise extracts of Rhus coriaria L, Rhus glabra and Rhus typhina.
Suitably the extract of Rhus coriaria L. is an aqueous extract of Rhus coriaria L. Suitably the extract of Rhus coriaria L is an alcoholic extract of Rhus coriaria L. Suitably the extract of Rhus coriaria L. is an aqueous alcoholic extract of Rhus coriaria L. Suitably the extract of Rhus coriaria L. is an aqueous ethanolic extract of Rhus coriaria L. Suitably the extract of Rhus coriaria L. is an ether extract of Rhus coriaria L. Suitably the extract of Rhus coriaria L. is a dialkyl ether (for example a C2 to C5 or C2 to C4 dialkyl ether) extract of Rhus coriaria L. Suitably the extract of Rhus coriaria L. is a diethyl ether or dibutyl ether extract of Rhus coriaria L. Suitably the extract of Rhus glabra is an aqueous extract of Rhus glabra. Suitably the extract of Rhus glabra is an alcoholic extract of Rhus glabra. Suitably the extract of Rhus glabra is an aqueous alcoholic extract of Rhus glabra. Suitably the extract of Rhus glabra is an aqueous ethanolic extract of Rhus glabra.
Suitably the extract of Rhus glabra is an ether extract of Rhus glabra. Suitably the extract of Rhus glabra is a dialkyl ether (for example a C2 to C5 or C2 to C4 dialkyl ether) extract of Rhus glabra. Suitably the extract of Rhus glabra is a diethyl ether or dibutyl ether extract of Rhus glabra.
Suitably the extract of Rhus typhina is an aqueous extract of Rhus typhina. Suitably the extract of Rhus typhina is an alcoholic extract of Rhus typhina. Suitably the extract of Rhus typhina is an aqueous alcoholic extract of Rhus typhina. Suitably the extract of Rhus typhina is an aqueous ethanolic extract of Rhus typhina.
Suitably the extract of Rhus typhina is an ether extract of Rhus typhina. Suitably the extract of Rhus typhina is a dialkyl ether (for example a C2 to C5 or C2 to C4 dialkyl ether) extract of Rhus typhina. Suitably the extract of Rhus typhina is a diethyl ether or dibutyl ether extract of Rhus typhina.
Suitably the extract of Rhus coriaria L. is an aqueous extract of the fruit of Rhus coriaria L. Suitably the extract of Rhus coriaria L. is an alcoholic extract of the fruit of Rhus coriaria L. Suitably the extract of Rhus coriaria L is an aqueous alcoholic extract of the fruit of Rhus coriaria L. Suitably the extract of Rhus coriaria L. is an aqueous ethanolic extract of the fruit of Rhus coriaria L. Suitably the extract of Rhus coriaria L. is an ether extract of the fruit of Rhus coriaria L. Suitably the extract of Rhus coriaria L. is a dialkyl ether (for example a 02 to 05 or C2 to 04 dialkyl ether) extract of the fruit of Rhus coriaria L. Suitably the extract of Rhus coriaria L. is a diethyl ether or dibutyl ether extract of the fruit of Rhus coriaria L. Suitably the extract of Rhus glabra is an aqueous extract of the fruit of Rhus glabra. Suitably the extract of Rhus glabra is an alcoholic extract of the fruit of Rhus glabra. Suitably the extract of Rhus glabra is an aqueous alcoholic extract of the fruit of Rhus glabra. Suitably the extract of Rhus glabra is an aqueous ethanolic extract of the fruit of Rhus glabra.
Suitably the extract of Rhus glabra is an ether extract of the fruit of Rhus glabra. Suitably the extract of Rhus glabra is a dialkyl ether (for example a 02 to 05 or 02 to 04 dialkyl ether) extract of the fruit of Rhus glabra. Suitably the extract of Rhus glabra is a diethyl ether or dibutyl ether extract of the fruit of Rhus glabra.
Suitably the extract of Rhus typhina is an aqueous extract of the fruit of Rhus typhina. Suitably the extract of Rhus typhina is an alcoholic extract of the fruit of Rhus typhina. Suitably the extract of Rhus typhina is an aqueous alcoholic extract of the fruit of Rhus typhina. Suitably the extract of Rhus typhina is an aqueous ethanolic extract of the fruit of Rhus typhina.
Suitably the extract of Rhus typhina is an ether extract of the fruit of Rhus typhina. Suitably the extract of Rhus typhina is a dialkyl ether (for example a 02 to C5 or C2 to 04 dialkyl ether) extract of the fruit of Rhus typhina. Suitably the extract of Rhus typhina is a diethyl ether or dibutyl ether extract of the fruit of Rhus typhina.
The composition may comprise an aqueous extract of Rhus coriaria L, Rhus glabra and Rhus typhina.
The composition may comprise an alcoholic extract of Rhus coriaria L., Rhus glabra and Rhus typhina.
The composition may comprise an aqueous alcoholic extract of Rhus coriaria L., Rhus glabra and Rhus typhina.
The composition may comprise an aqueous ethanolic extract of Rhus coriaria L., Rhus glabra and Rhus typhina.
B
The composition may comprise an aqueous extract of the fruit of Rhus coriaria L., Rhus glabra and Rhus typhina.
The composition may comprise an alcoholic extract of the fruit of Rhus coriaria L., Rhus glabra 5 and Rhus typhina.
The composition may comprise an aqueous alcoholic extract of the fruit of Rhus coriaria L., Rhus glabra and Rhus typhina.
The composition may comprise an aqueous ethanolic extract of the fruit of Rhus coriaria L, Rhus glabra and Rhus typhina.
The composition may comprise an ether extract of Rhus coriaria L., Rhus glabra and Rhus typhina.
The composition may comprise a dialkyl ether (for example a C2 to C5 or C2 to C4 dialkyl ether) extract of Rhus coriaria L., Rhus glabra and Rhus typhina.
The composition may comprise a diethyl ether or dibutyl ether extract of Rhus coriaria L., Rhus 20 glabra and Rhus typhina.
The composition may comprise an ether extract of the fruit of Rhus coriaria L. Rhus glabra and Rhus typhina.
The composition may comprise a dialkyl ether (for example a C2 to C5 or C2 to C4 dialkyl ether) extract of the fruit of Rhus coriaria L., Rhus glabra and Rhus typhina.
The composition may comprise a diethyl ether or dibutyl ether extract of the fruit of Rhus coriaria L., Rhus glabra and Rhus typhina.
The composition may comprise (as component (iii)) an extract of Rhus coriaria L, Rhus glabra and Rhus typhina in a 1:1:1 weight ratio.
The composition may comprise (i) an extract of Aucklandia lappa Decne, OD an extract of Punica granatum and (Hi) an extract of one or more of Rhus coriaria L., Rhus glabra and Rhus typhina in a weight ratio (i.e. of (i):(ii);(iii)) of from 5:1:4 to 1:1:1, such as from 4:1:3 to 1:1:1, for example in a weight ratio of 4:1:3.
The composition may comprise the extracts (i), (ii) and (Hi) in an amount of 40 to 60 wt % of extract (i), 10 to 15 wt % of extract (H) and 30 to 45 wt % of extract (iii).
The present invention may provide a composition that consists essentially of: (i) an extract of Aucklandia lappa Decne; (ii) an extract of Punica granatum; and (iii) an extract of one or more of Rhus coriaria L., Rhus glabra and Rhus typhina.
The present invention may provide a composition that consists of: (i) an extract of Aucklandia lappa Decne; (ii) an extract of Punica granatum; and (iii) an extract of one or more of Rhus coriaria L., Rhus glabra and Rhus typhina.
The present invention may provide a composition that consists essentially of: (i) an extract of Aucklandia lappa Decne; (ii) an extract of Punica granatum; and (iii) an extract of Rhus coriaria L, Rhus glabra and Rhus typhina.
The present invention may provide a composition that consists of: (i) an extract of Aucklandia lappa Decne; (ii) an extract of Punica granatum; and (iii) an extract of Rhus coriaria L., Rhus glabra and Rhus typhina.
The composition of the invention may be in a form suitable for oral, topical or parental administration or for administration by inhalation.
The composition of the invention may be in a form suitable for oral or topical administration. The composition of the invention may be in a form suitable for inhalation or parenteral administration. Oral administration may involve swallowing, so that the composition enters the gastrointestinal tract, or buccal or sublingual administration may be employed by which the composition enters the blood steam directly from the mouth. Administration by inhalation may be as a finely divided powder or a liquid aerosol (for example for delivery by means of an inhaler or nebulizer device). Parenteral administration may be as a sterile aqueous or oily solution for intravenous, subcutaneous, intramuscular dosing or a suppository for rectal dosing. Compositions suitable for topical administration may be applied to any suitable skin surface.
Compositions suitable for oral administration include solid and liquid compositions. Suitable solid compositions include tablets, capsules (for example containing particulates, liquids, or powders), lozenges (including liquid-filled), chews (including chewing gums); multi-and nano-particulates, gels pastes, solid solution, liposome, films and sprays. Suitable liquid compositions include suspensions, solutions, syrups and elixirs. Such compositions may be employed as fillers in soft or hard capsules and typically comprise a carrier, for example, water, ethanol, polyethylene glycol, propylene glycol, methylcellulose, or a suitable oil, and one or more emulsifying agents and/or suspending agents. Liquid compositions may also be prepared by the reconstitution of a solid composition, for example, from a sachet.
The composition of the invention may be orally administered once per day.
The composition of the invention may be orally administered more than once per day, such as 2 to 10 times, for example 4 to 8 times a day.
Suitably, the composition of the invention may be formulated as a chew (such as a chewing gum), as particulates (such as to form a filling for a sachet), a mouthwash, a toothpaste, a pastille, a lozenge, a boiled sweet, a jelly or a powder.
The composition of the invention may be formulated as a chewing gum. This may alternatively be referred to as a chicle. The chewing gum may be an acidulated chewing gum. The chewing gum may be a non-acidulated chewing gum.
The compositions of the invention may be obtained by conventional procedures using conventional methods in the art.
The compositions of the invention may comprise additional ingredients, such as a colouring, sweetening, flavouring, softening and/or preservative agent. The compositions of the invention may comprise a filler and/or carrier.
When the composition of the invention comprises additional ingredients, the composition may comprise from 20 to 80 wt % of the extracts (i), (ii) and (iii) and from 80 to 20 wt % of the additional ingredients.
Suitable colouring agents comprise natural food dyes or artificial colourings, such as Fast green (E143), Allura red (E129), brilliant blue (E133), Erythrosine (pink) (E127), tartrazine (E102), sunset yellow (El 10) and indigotine (El 32).
Suitable softening agents comprise waxes, such as natural and synthetic waxes, hydrogenated vegetable oils, petroleum waxes for example, paraffin waxes, microcrystalline waxes polyurethane waxes and polyethylene waxes.
The compositions of the invention for oral administration may comprise a flavouring agent such as a taste covering agent. Such taste covering agents may, for example, comprise menthol or peppermint oil.
The flavouring agent, when present, may be present in an amount of from 1 to 5 wt%, such as from Ito 3 wt%.
The compositions of the invention for oral administration may comprise a sweetening agent, such as a natural or artificial sweetener. Examples of suitable sweeteners may include aspartame and polyol sweeteners, such as (crystalline) xylitol, sorbitol, mannitol and erythritol.
Further examples of suitable sweeteners include sucrose, lactose, dextrose, maltose, dextrin, dried inverted sugar, fructose, levulose, galactose, corn syrup, hydrogenated starch hydrolysates, maltitol, sucralose, aspartame, salts of acesulfame potassium, alitame, saccharin and its salts, cyclamic acid and its salts, glycyrrhizin, dihydrochalcones, thaumatin and monellin.
The sweetening agent, when present, may be present in an amount of from Ito 5 wt%, such as from 1 to 3 wt%.
When the composition of the invention is formulated as a chewing gum, the chewing gum suitably comprises a composition according to the invention and a chewing gum base. The chewing gum base may comprise natural latex, vegetable gum, arabian gum and/or mastic gum. The chewing gum base may be present in an amount of from 8 to 25 wt% of the chewing gum. The chewing gum may further comprise a sugar, artificial sweetener, and/or wax coating.
The composition of the invention may be formulated as a sachet filling. By a sachet we mean a container (such as an envelope or bag) which contains the sachet filing. The sachet filing may be in the form of a granulate, particulates or spheronised particles. Suitably, the sachet filling may be added to liquid, for example, water, for oral ingestion. When formulated as a sachet filing, the composition suitably has long storage stability.
The composition of the invention may be formulated as a mouthwash. A mouthwash is an oral hygiene product. Suitably the mouthwash is a liquid composition. A mouthwash may comprise a carrier, for example an alcohol compound.
The composition of the invention may be formulated as a toothpaste. Toothpaste is an oral hygiene product. Suitably the toothpaste is formulated as a paste or gel. The toothpaste may comprise an abrasive, fluoride, a flavouring agent and a detergent. The toothpaste may further comprise a surfactant.
The composition of the invention may be formulated as a lozenge. Lozenges are solid preparations that contain one or more active ingredients, usually in a flavoured, sweetened base, that are intended to dissolve or disintegrate slowly in the mouth. Lozenges can be prepared by molding (gelatin and/or fused sucrose and sorbitol base) or by compression of sugar-based tablets. Moulded lozenges are sometimes alternatively referred to as pastilles, whereas compressed lozenges may be alternatively referred to as troches.
The composition of the invention may be formulated as a boiled sweet or hard candy. Typically, boiled sweets are a sugar candy prepared from one or more sugar-based syrups that are heated to a temperature of 160°C.
The composition of the invention may be formulated as a jelly or jello, which typically comprise gelatin. The jelly may comprise further additives such as gelling agents, colouring agents, artificial sweeteners, emulsifiers and antioxidants.
The composition of the invention may be formulated as a powder. Suitably the powder may be added to foods or liquids (such as drinks) for ingestion.
The composition of the invention may be an anti-microbial composition. The anti-microbial composition may be useful for disinfecting surfaces, including the skin. Thus, the present invention may provide an anti-microbial composition comprising a composition as described herein. The anti-microbial composition may comprise a personal hygiene composition, such as a cleansing composition (for example a soap or shampoo composition).
The composition of the invention may be a nutritional supplement composition. The nutritional supplement composition may be useful for strengthening the immune system against bacterial, fungal and/or viral infections. Thus, the present invention may provide a nutritional supplement composition comprising a composition as described herein.
According to the present invention, there is provided the composition as described herein for use as a medicament.
According to the present invention, there is provided the composition as described herein for use as an anti-microbial.
According to the present invention, there is provided the composition as described herein for use as an immune boost agent, i.e. to strengthen the immune system against bacterial, fungal and/or viral infections.
According to the present invention, there is provided the composition as described herein for use in the treatment of an infection, such as a bacterial, fungal or viral infection. According to the present invention, there is provided the composition as described herein for use in the treatment of a viral infection. For example, the infection referred to herein may be an infection of the throat, skin, oral cavity, nasal cavity and/or ear cavity.
According to the present invention, there is provided the composition as described herein for use in the treatment of a respiratory tract infection, for example an upper and/or lower respiratory tract infection.
According to the present invention, there is provided the composition as described herein for use in the treatment of an infection of the upper respiratory tract, such as chronic rhinosinusitis (CRS).
According to the present invention, there is provided the composition as described herein for use in the treatment of a coronavirus infection, such as severe acute respiratory syndrome coronavirus (SARS-CoV) and/or severe acute respiratory syndrome coronavirus 2 (SARS-00V2).
According to the present invention, there is provided a method for strengthening the immune system against bacterial, fungal and/or viral infections in a warm-blooded animal, which comprises administering to said warm-blooded animal a composition as described herein.
According to the present invention, there is provided a method for treating an infection, such as a bacterial, fungal or viral infection, in a warm-blooded animal, which comprises administering to said warm-blooded animal a composition as described herein.
According to the present invention, there is provided a method for treating a viral infection in a warm-blooded animal, which comprises administering to said warm-blooded animal a composition as described herein.
According to the present invention, there is provided a method for treating a respiratory viral infection in a warm-blooded animal, which comprises administering to said warm-blooded animal a composition as described herein.
According to the present invention, there is provided a method for treating an infection of the upper respiratory tract, such as chronic rhinosinusitis (CRS), in a warm-blooded animal, which comprises administering to said warm-blooded animal a composition as described herein.
According to the present invention, there is provided a method for treating a coronavirus infection, such as severe acute respiratory syndrome coronavirus (SARS-CoV) and/or severe acute respiratory syndrome coronavirus 2 (SARS-00V-2) infection, in a warm-blooded animal, which comprises administering to said warm-blooded animal a composition as described herein.
The amount of the extracts as described herein (i.e. the active ingredient) and the specific ratios thereof that is included in a single dosage of the composition will necessarily vary depending on the patient being treated and the particular route of administration.
A therapeutically effective amount of the components (i), (ii) and (iii) of the composition of the invention, for example to treat an infection, may be as follows wherein the effective amounts may be administered as one or more doses: (i) Extract of Aucklandia lappa Decne: 250 mg to 2. Og, preferably 125 mg to 1 g (ii) Extract of Punica granatum: 250 mg to 1 g, preferably 31.25 mg to 250 mg (iii) Extract of one or more of Rhus coriaria L., Rhus glabra, and Rhus typhina: 250 mg to 1 g, preferably 31.25mg to 250 mg The composition for use as described herein may treat and/or relieve symptoms including fever, thrombosis, impaired immune system, chills, cough, nasal congestion, sore throat, tiredness, nausea/vomiting, fatigue, muscle/body pain, diarrhoea, headache, loss of appetite, loss of taste, loss of smell, loss of concentration, dyspnoea, breath shortness, and/or sleep difficulty.
The composition of the invention may be administered as a sole therapy, or may be administered in combination with an additional therapeutic agent. Additional therapeutic agent(s) may be administered simultaneously, separately or sequentially with the composition of the invention.
According to the present invention, there is provided a method of preparing a lozenge comprising: admixing a therapeutically effective amount of a composition of the invention with a lozenge base to provide a lozenge composition; and forming the lozenge composition into a lozenge.
According to the present invention, there is provided a method of preparing a chewing gum 35 comprising: admixing a therapeutically effective amount of a composition of the invention with a chewing gum base to provide a chewing gum composition; and forming the chewing gum composition into a chewing gum.
The lozenge may be formed by any suitable method, such as by moulding or compressing.
According to the present invention, there is provided a kit for providing a medicament for oral administration, the kit comprising packaging containing (i) an extract of Aucklandia lappa Decne; (ii) an extract of Punica granatum; and (iii) an extract of one or more of Rhus coriaria L., Rhus glabra and Rhus typhina; and instructions for administration of the medicament.
The term "comprising" or "comprises" means including the component(s) specified but not to the exclusion of the presence of other components. The term "consisting essentially of or "consists essentially of means including the components specified but excluding other components except for materials present as impurities, unavoidable materials present as a result of processes used to provide the components, and components added for a purpose other than achieving the technical effect of the invention. The term "consisting of or "consists of means including the components specified but excluding other components.
Whenever appropriate, depending upon the context, the use of the term "comprises" or "comprising" may also be taken to include the meaning "consists essentially of' or "consisting essentially of', and may also be taken to include the meaning "consists of' or "consisting of.
The optional features set out herein may be used either individually or in combination with each other where appropriate and particularly in the combinations as set out in the accompanying claims. The optional features for each aspect or exemplary embodiment of the invention, as set out herein are also applicable to all other aspects or exemplary embodiments of the invention, where appropriate. In other words, the skilled person reading this specification should consider the optional features for each aspect or exemplary embodiment of the invention as interchangeable and combinable between different aspects and exemplary embodiments.
References to "treating" or "treatment" include prophylaxis as well as the alleviation of established symptoms of a disease or medical condition. "Treating" or "treatment" of a disease or medical condition therefore includes: (1) preventing or delaying the appearance of clinical symptoms of the disease or medical condition developing in a human that may be afflicted with or predisposed to the disease or medical condition but does not yet experience or display clinical or subclinical symptoms thereof, (2) inhibiting the disease or medical condition, Le. arresting, reducing or delaying the development of the disease or medical condition, or a relapse thereof an case of maintenance treatment) or at least one clinical or subclinical symptom thereof, or (3) relieving or attenuating the disease, Le. causing regression of the disease or medical condition or at least one of its clinical or subclinical symptoms.
A "therapeutically effective amount" means the amount of a compound that, when administered to a mammal for treating a disease, is sufficient to effect such treatment for the disease. The "therapeutically effective amount" will vary depending on the compound, the disease and its severity, the mode of administration and the age, weight, etc. of the mammal to be treated.
EXAMPLES
The invention will now be illustrated by the following non-limiting examples.
Example 1 Preparation of the Extracts 120g of each of the root of Aucklandia lappa Decne (herein "AID"), the peel of Punica granatum (herein pomegranate or "PgP"), the beads of Rhus coriaria L. Therein "Ron, Rhus Glabra Therein "RG"), and Rhus typhina (herein "Rt") were weighed and washed thoroughly in de- ionized water, "saline water" (i.e. 100g of granule salt in 1 L of deionized water) and again in de-ionized water to remove any dirt, soil and/or undesirable contaminants, and then allowed to dry in an oven at 45°C overnight. The dried materials were then weighed and ground into a powdered state using a "Professional Spice Grinder" model no. WSG30K.
The following extraction procedures were carried out for each individual ground (powdered) plant material: Ethanolic extraction Each powdered material was mixed with an extraction solvent comprising 95% v/v of (F.C.C.) Food Grade Ethanol and 5% v/v water to form a suspension. The suspension was incubated at room temperature for 72 hours under continuous vigorous shaking. The suspension was then filtered, and the filtrate was dried at a temperature of about 60°C (using a rotary evaporator) until it became viscous to provide a crude extract. The crude extract was resuspended in an extraction solvent comprising 95% v/v of (FCC) Food Grade Ethanol and 5% v/v water and incubated overnight at a temperature of 75°C to 85°C on a conventional magnetic heat block with the magnetic stirrer. The suspension was then cooled on ice for 15 minutes, which allowed a solid crystal-like material to be formed in the suspension solution. The solid was then removed by filtration, and the filtrate was further dried at 60°C (using a rotary evaporator) and then lyophilized using freeze-drying. The lyophilized powder obtained from each plant was then re-weighed and recorded accordingly as shown below: 120g of the Aucklandia lappa Decne (AID) raw material gave 5.8g of the filtrate extracted material 120g of the Punica granatum (PgP) raw material gave 3.1g of the filtrate extracted material 120g of Rhus coriaria L. (RcL) raw material gave 4.0g of the filtrate extracted material 120g of Rhus glabra (RG) raw material gave 3.9g of the filtrate extracted material 120g of "Rhus typhina (Rt) raw material gave 3.7.g of the filtrate extracted material Further extraction solvents The same extraction process as for the ethanolic extraction above was carried out using deionised water as the extraction solvent in the place of the ethanolic solvent.
The same process was also carried out as for the ethanolic extraction above using diethyl ether or dibutyl ether as the extraction solvent in the place of the ethanolic solvent, except that several process parameters were changed. The process using diethyl ether or dibutyl ether was as follows: Each powdered material was mixed with the extraction solvent to form a suspension. The suspension was incubated at 4°C for 72 hours under continuous vigorous shaking. The suspension was then filtered, and the filtrate was dried at a temperature of about 30°C (using a rotary evaporator) until it became viscous to provide a crude extract. The crude extract was resuspended in the extraction solvent incubated overnight at room temperature with the magnetic stirrer. The suspension was then cooled on ice for 15 minutes, which allowed a solid crystal-like material to be formed in the suspension solution. The solid was then removed by filtration, and the filtrate was further dried at 30°C (using a rotary evaporator) and then lyophilized using freeze-drying. The lyophilized powder obtained from each plant was then re-weighed and recorded accordingly The range of amounts of extracted material in lyophilized powder form obtained from each plant using the extraction solvents deionised water, diethyl ether or dibutyl ether is shown below: 1kg of Aucklandia lappa Decne (AID) raw material gave 111-120g of the filtrate extracted material lkg of Punica granatum (PgP) raw material gave 98-117g of the filtrate extracted material 1kg of Rhus coriaria L. (RcL) raw material gave 123-140g of the filtrate extracted material 1kg of Rhus glabra (RG) raw material gave 145-165g of the filtrate extracted material 1kg of "Rhus typhina (Rt) raw material gave 87-115g of the filtrate extracted material Example 2 Preparation of a medicament in a lozenge formulation Each "lozenge" (or chicle) comprises a total of 250 mg of the substances as illustrated in Table 1 below (wherein the extracts were prepared according to Example 1 using the ethanolic extraction method).
Table 1
Component Common Name Weight Aucklandia lappa Decne root extract Aucklandia or Costus 125mg Punica granatum peel extract Pomegranate peel 31.25mg Rhus coriaria L. extract Sicilian sumac 31.25mg Rhus glabra extract Smooth sumac 31.25mg Rhus typhina extract Staghom sumac 31.25mg Stevia Sweetener 625mg Glycol El 520 Flavour 12.5mg The lyophilized powder obtained for each plant extract from Examp e 1 was used and weighed according to Table 1 (in a weight ratio of 4:1:1:1:1 in the order listed in Table 1).
12.5g of Stevia was mixed with 500m1 of water in a glass beaker with a magnetic stirrer on a heat block at 80°C. Once the solution became viscous, a mixture 2.5g AID and 0.625g of each of PgP, RcL, RG and Rt were added, followed by adding 0.25g Glycol E1520. The temperature was adjusted to 60°C with continuous stirring. When the mixture was well mixed the resulting composition was poured into a "lozenge silicone mould" (comprising a plurality of lozenge compartments) and allowed to cool to room temperature for 2 to 3 hours until the mixture solidified. For sterilization and health and safety purposes, the procedure was carried out under a Class II cell culture fume hood.
An effective dosage of the lozenges against COVID-19 was found to be 4 to 8 lozenges per day for 2 to 3 days depending on the infection status of the subject and the clinician's advice.
EXAMPLE 3 Preparation of a medicament in a Sachet (or infused-bag) Formulation A sachet was filled with the following extracts (mixed as powders) obtained as described in Example 1 (using the ethanolic extraction method), as shown in the Table 2 below.
Table 2
Components and Scientific name Common Name Weight Aucklandia lappa Decne root extract Aucklandia or Costus 1g Punica granatum peel extract Pomegranate peel 250mg Rhus coriaria L. extract Sicilian sumac 250mg Rhus glabra extract Smooth sumac 250mg Rims &prune extract Staghorn sumac 250mg Stevia Sweetener 0.7g Glycol E1520 Flavour 125mg For use the sachet content was emptied into a cup of 100m1-150m1 boiled water and left for 10 minutes prior to oral intake.
The prepared composition in a sachet form can be given to a patient at a dosage of 2 to 3 sachets per day.
EXAMPLE 4 Clinical Trial A clinical trial was conducted as follows: Safety Aspects: Safety was strictly followed in all aspects of the clinical trial and in accordance with international safety rules and regulations. Clinicians and professional scientists followed strictly all safety aspects throughout the entire investigation including medicament preparation and its use as well as COVID-19 patient's safety aspects.
Clinical Trial: A total of 200 COVID-19 volunteers (male and female) patients were involved in the clinical trial.
The 200 subjects were equally divided into two groups A and B. Group A was treated with the medicament in lozenge formulation according to Example 2 whereas group B was treated with the medicament in sachet formulation according to Example 3. No groups were treated with a placebo due to ethical issues. All patients came into the clinics due to COVID-19 with initial symptoms such as itching in the throat, sore throat, nasal congestion, dry cough, high temperature, shortness of breath, loss of smell and taste. The patients were all adults (as stated below) with no other serious medical complications (except two patients who experienced wet gangrene and an ischemic stroke, respectively). All patients were confirmed to be infected with SARS-CoV-2 by PCR testing. The patients were monitored carefully by the senior consultants in charge before the clinical trial started as well as after treatment. Patients were carefully monitored under closed supervision and evaluated by a team of clinicians and nurses.
Evaluation of patients' health status was regularly and continuously assessed by the in charge consultant who monitored the administration of the therapy as required.
Patients' Criteria: All patients enrolled in this clinical trial were registered and monitored for a minimum of 7 days, unless otherwise stated (three days of which were under the new therapy).
Inclusion and Exclusion Criteria: Inclusion criteria: Any adult patient who is SARS-CoV-2 positive, from any nationality, was accepted Exclusion Criteria: Pregnant women and children (less than 16 years old) were excluded.
Patients were chosen according to the following criteria: The patients agreed voluntarily to use the medicament of Example 2 or 3 and in accordance with the international ethics practice.
Patient's Observation and Evaluation: Patients were carefully observed and evaluated according to the following measures: * Patients were required to take a PCR test and CT-Scan to indicate the presence of the SARS-CoV-2 initially and after the therapy ended.
* Complete diagnostic records were recorded/maintained, including physical signs and pulse conditions.
* Clinical monitoring and follow-up were performed by the in-charge medical consultants of both groups.
Criteria for Curative Effect: The various criteria were divided according to the scientific research plan and categorized as follows: Recovery: -If SARS-CoV-2 testing PCR and/or RT-PCR is negative.
-There are no symptoms, no physical signs, and no other complaints.
Evident Effect: If SARS-CoV-2 appears negative or undetectable and the symptoms and physical signs recover fundamentally back to normal.
With Effect: If SARS-CoV-2 testing PCR appears positive, but the symptoms and physical signs are relieved.
No Effect: If there are no dramatic changes in the SARS-CoV-2 status and the symptoms get worse, or The patient requires further medical care in the hospital.
Note: Each SARS-CoV-2 positive patient case was studied on its own and carefully followed and continuously assessed by the professional medical team.
The strategy of the regime therapy is summarized as follows: * A comprehensive analysis of the curative effect according to the clinical symptoms was studied, evaluated, and recorded.
* The SARS-CoV-2 infection was confirmed by the available testing assays.
* The profile of the patient, including the period of the disease was examined at the start of the clinical trial and after the completion of the trial.
Pre-Treatment Status -Physical Examination: All the COVID-19 patients were examined for common COVID-19 symptoms and symptoms of depression, weakness, and weight loss associated with loss of appetite, and developed fever.
Treatment with the Medicament:
SUBJECTS
Two hundred (200) human subjects were qualified to partake if they are otherwise healthy or COVID-19 free, have at least moderate manifestation severity, and report side effects and/or symptoms of 48 hours or less duration. Symptoms are COVID-19 symptoms; headache, fever, tiredness, and dry cough symptoms, in particular, fever, pain, weakness, dryness, and/or inflammation of the throat.
Ethics and Consent form Although the medicament is a food supplement in its nature full consent in parallel with ethical approval has been given to the clinicians by the patient prior to the start of the clinical trial.
STUDY MEDICATIONS
Both, group A and group B were given the medicament in their assigned formulation as stated earlier i.e., group A received the medicament in a lozenge form and group B received the medicament in a sachet form. Instruction for dosage was stated clearly in EXAMPLE 2 and EXAMPLE 3.
STUDY PROCEDURES
All participated patients involved in this clinical phase trial were between the age of 25 to 80 years. The patients were confirmed to have COVID-19 clinically by their association with the symptoms stated above as well as confirmed by the PCR and/or CT scan tests.
RESULTS
Results showed that all patients in both groups found that some of their symptoms stated above were relieved within a period of 4 to 8 hours (Table 3 and Table 4) after receiving the medicament.
Table 3 shows the results for group A and Table 4 shows the results for group B. The Tables show the number of patients whose symptoms were relieved for each symptom and sign after the dosages stated.
Table 3
Serial code No. Record of improvement in clinical features and investigations with treatment 1. Symptom and Sign DOSE improved Day 1 Day 2 Day 3 Day 4 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 1.1. Fever 47 44 18 2 1.2. Chills 32 15 1.3. Cough 38 35 27 14 7 l.4 Nasal congestion 28 16 4 2 1.5. Sore throat 45 14 6 1 1.6. Tiredness 36 34 17 15 13 4 1.7. Nausea/Vomiting 19 5 2 1 1.8. Fatigue 41 3 14 3 1 1.9. Muscle/body pain 39 29 151 7 3 1.10. Diarrhea 14 3 1.11. Headache 31 16 3 1.12. Appetite 44 41 26 15 6 1.13. Taste 22 19 15 11 1.14. Smell 25 19 14 10 1.15. Concentration 31 22 13 3 1.16. Dyspnoea 33 28 13 4 1 1.17. Breath shortness 45 33 24 11 1 1.18. Chest pressure 23 12 4 1.19 Normal breathing 8 17 37 46 47 1.20. Sleep better 19 33 45 48 1.21 Sp02 90 93 96 2. Record of investigations Days Since Starting Treatment 4 7 14 21 CBC* 88 14 2.2. CRP** +Ve 98 Normal 2.3. RFT- Normal 2.4. PCR**** +Ve 100 -ye 100 2.5. Chest X-Ray +Ve 100 -ye 100 2.6. CT Scan +Ve 100 *CBC = complete blood count test **CRP = C-reactive protein test *""RFT = renal function test **""PCR = SARS-CoV-2 PCR test
Table 4
Serial code No. Record of improvement in clinical features and investigations with treatment 1. Symptom and Sign DOSE improved Day 1 Day 2 Day 3 Day 4 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 1.1. Fever 85 28 17 5 1.2. Chills67 64 33 17 2 1.3. Cough 77 51 42 37 17 9 5 4 1 1.4. Nasal congestion 17 7 1.5. Sore throat 98 20 7 2 1.6. Tiredness 93 72 15 2 1.7. Nauseallomiting 17 4 2 1.8 Fatigue 94 54 13 5 1 9_ Muscle/body pain 83 71 36 12 3 1.10. Diarrhea 14 3 1 1.11. Headache 76 43 7 3 1.12. Appetite 84 53 22 7 3 2 1.13. Taste 53 44 43 28 15 1.14. Smell 61 55 41 38 32 28 1.15. Concentration 32 28 16 7 1.16. Dyspnoea 37 27 13 7 2 1.17. Breath shortness 54 43 26 15 7 2 1.18. Chest pressure 41 28 17 5 1 1.19 Normal breathing 28 37 45 94 98 1.20. Sleep better 29 38 45 51 67 97 121. Sp02 94 95 96 97 2. Record of investigations Days Since Starting Treatment 4 7 14 2.1. CBC 86 14 2.2. CRP +Ve 96 Normal 100 2.3. RFT Normal 2.4. PCR +Ve 100 -ye 100 2.5. Chest-Ray +Ve 100 -ye 100 2.6. CT Scan +Ve 100 From both results shown in Table 3 and Table 4, the respiratory complications were improved after 8 hours of receiving the medicament. Full relief of the COVID-19 symptoms from the patients was achieved after 2 or 3 days of receiving the medicament. No side effects were observed, nor complaints received from the patients. Furthermore, the patients' immune status was significantly improved after 36 hours of taking either the lozenge or the sachet medicament formulations. 95% of the patients' experienced that fevers were significantly and noticeably relieved after 4 hours (i.e. after the first medicament dosage). Overall results showed that both forms of the medicament formulations were found to be significant and have a "Curative Effect" against the COVID-19 infection caused by SARS-COV-2 virus. Furthermore, all patients showed a significant improvement in their immune systems.
Overall, the medicaments proved to be effective with potential efficacy to treat the symptoms associated with the COVID-19 caused by the SARS-CoV-2 virus.
Attention is directed to all papers and documents which are filed concurrently with or previous to this specification in connection with this application and which are open to public inspection with this specification, and the contents of all such papers and documents are incorporated herein by reference.
All of the features disclosed in this specification (including any accompanying claims, and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive.
Each feature disclosed in this specification (including any accompanying claims, abstract and drawings) may be replaced by alternative features serving the same, equivalent or similar purpose, unless expressly stated otherwise. Thus, unless expressly stated otherwise, each feature disclosed is one example only of a generic series of equivalent or similar features.
The invention is not restricted to the details of the foregoing embodiment(s). The invention extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

Claims (14)

  1. Claims 1. A composition comprising: (i) an extract of Aucklandia lappa Decne; (ii) an extract of Punica granatum; and (iii) an extract of one or more of Rhus coriaria L., Rhus glabra and Rhus typhina.
  2. 2. The composition according to claim 1, wherein the extract of Aucklandia lappa Decne and the extract of Punica granatum are provided in a weight ratio of from 4:1 to 1:1.
  3. 3. The composition according to any preceding claim, wherein the extract of Aucklandia lappa Decne is an extract of the root of Aucklandia lappa Decne, preferably an aqueous extract of the root of Aucklandia lappa Decne.
  4. 4. The composition according to any preceding claim, wherein the extract of Punica granatum is an extract of the peel of Punica granatum, preferably an aqueous extract of the peel of Punica granatum.
  5. 5. The composition according to any preceding claim, comprising an extract of Rhus coriaria L., an extract of Rhus glabra and an extract of Rhus typhina.
  6. 6. The composition according to claim 5, wherein the extracts of Rhus coriaria L, Rhus glabra and Rhus typhina are provided in a weight ratio of 1:1:1.
  7. 7 The composition according to any preceding claim consisting essentially of: (i) an extract of Aucklandia lappa Decne; (ii) an extract of Punica granatum; and (iii) an extract of Rhus coriaria L., an extract of Rhus glabra and an extract of Rhus typhina. 30
  8. 8. The composition according to any preceding claim, wherein the composition is for oral administration.
  9. 9. The composition according to any preceding claim for use as a medicament.
  10. 10. The composition according to any of claims 1 to 8 for use in the treatment of a respiratory tract infection, for example an upper and/or lower respiratory tract infection.
  11. 11. The composition according to any of claims 1 to 8 for use in the treatment of a coronavirus infection, such as severe acute respiratory syndrome coronavirus (SARS-CoV) and/or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
  12. 12. The composition for use according to claim 10 0111 which is orally administered once per day.
  13. 13. A method of preparing a lozenge comprising: admixing a therapeutically effective amount of a composition according to any of claims 1 to 7 with a lozenge base; and forming a lozenge.
  14. 14. A kit for providing a medicament (such as for oral administration), the kit comprising packaging containing: (i) an extract of Aucklandia lappa Decne; (H) an extract of Punica granatum; (iii) an extract of one or more of Rhus coriaria L., Rhus glabra and Rhus typhina; and (iv) instructions for administration of the medicament.
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Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
Computers in Biology and Medicine, vol. 136, 2021, Belhassan, A. et al., Camphor, Artemisinin and Sumac: Phytochemicals as inhibitors against COVID-19: Computational approach, p. 1-17, article 104758. *
Journal of Nutrition and Metabolism, vol. 2022, 2022, Banihani, S.A., Possible beneficial effects of fresh pomegranate juice in SARS-CoV-2 infection conditions, p. 1-7. *
Sohag Medical Journal, vol. 24, no. 3, 2020, Saif-Al-Islam, M., Saussurea costus may help in the treatment of COVID-19, p. 6-17. *

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