Composition based on plant extracts for use in the treatment of protozoan parasitic diseases, including leishmaniasis.

Abstract

Composition based on plant extracts for use in the treatment of protozoan parasitic diseases, in particular leishmaniasis. The invention relates to a composition comprising a mixture of plant extracts, for use in the treatment of a human or veterinary disease caused by a pathogenic protozoan, said mixture of plant extracts being composed of (composition in g / L): - 10*n of Angelica archangelica root; - 5*n of Carlina acaulis root; - 10*n of Fraxines ornus; - 5*n of Commiphora myrrha gum resin; - 10*n of Rheum officinalis / palmatum root; - 10*n of Cassia angustifolia leaf; - 10*n of Curcuma zedoaria rhizome; - 10*n of Aloe vera mucilage and leaf; - 2*n of natural Cinnamomum camphora;- 10.21*n of Thériacal mixture consisting of Acorus calamus var. americanus rhizome, Pimpinella anisum fruit, Cinnamomum zeylanicum bark, Citrus limonum bark, Foeniculum dulce seed, Gentiana lutea root, Zingiber officinale rhizome, Cinchona succirubra bark, Glycyrrhiza glabra root, saffron stigmas and Valeriana officinalis root; - Said mixture of plant extracts being diluted in 1L of an alcoholic solution having an alcohol content of approximately 50°; - With n greater than or equal to 0.5 and less than or equal to 2. Figure for the abbreviation: Fig. 1;

Description

Title of the invention: Composition based on plant extracts for use in the treatment of protozoan parasitic pathologies, in particular leishmaniasis.

[0001] The present invention relates to the field of human and veterinary medicine for the treatment of diseases caused by pathogenic protozoa.

[0002] The present invention relates more specifically to a composition comprising a mixture of plant extracts, known under the name of "Swedish elixir" for its use in particular in the treatment of a cutaneous or mucocutaneous pathology due to a pathogenic protozoan, and more specifically in the treatment of leishmaniasis.

[0003] The present invention also relates to a process for preparing such a composition, subsequently intended to be used in the treatment of protozoan parasitic pathologies.

[0004] Protozoa are unicellular eukaryotic organisms without specialized tissues, heterotrophic and mobile, ingesting their food by phagocytosis, and the largest specimens can reach a size of the order of a millimeter.

[0005] Certain protozoa are parasites responsible for pathologies which can be serious, such as malaria, caused by a parasite belonging to the genus Plasmodium following a mosquito bite, or even certain dysenteries, such as amoebiasis, which is linked to the presence in the body of the protozoan Entamoeba histolytica.

[0006] Protozoa belonging to the genus Leishmania are parasites of mammals which are transmitted by the bite of females of a dipterous insect called phlebotomine and these protozoa are responsible for leishmaniasis.

[0007] During the parasitic cycle, infected female sandflies inject, during a blood meal, the parasite in the metacyclic promastigote form, 15 to 25 pm in size and elongated and fusiform in shape, with a kinetoplast (specialized mitochondria) in an anterior position relative to the nucleus, and a flagellum, emerging in the anterior part, which gives significant mobility to the protozoan in this form.

[0008] At the level of the puncture wound, the promastigotes are phagocytosed by the macrophages and transform into amastigotes, smaller than the promastigote form, 2 to 6 pm in long axis and ovoid in shape, and immobile.

[0009] Amastigote parasites multiply in infected cells and reach different tissues, depending on the species of Leishmania involved.

[0010] Sandflies become infected during a blood meal on an infected host, by ingesting macrophages carrying the parasite in its amastigote form. In the intestine of the sandfly, this parasite differentiates to return to the promastigote form before migrating into the sandfly's proboscis.

[0011] Leishmaniasis is a chronic disease with cutaneous and / or mucocutaneous and / or visceral manifestations which can affect humans as well as other mammalian species (dogs, horses, etc.).

[0012] Transmission occurs depending on the species of leishmania either from man to man, this is the anthroponotic form (man is both reservoir and host); or from animal to man, this is the zoonotic route (the wild or domestic animal is the reservoir of contamination).

[0013] Cutaneous leishmaniasis is the most widespread; it causes ulcerative lesions on the body, appearing weeks or even months after a subject is infected. In some cases, they can heal within a few months, but leave particularly unsightly scars. In addition, cutaneous leishmaniasis can become chronic in the form of visceral leishmaniasis, which can lead to splenic involvement. When diffuse, leishmaniasis causes widespread skin lesions resembling those of leprosy, which are particularly difficult to treat.

[0014] There are no preventive treatments for leishmaniasis, apart from protection with repellents and wearing clothing.

[0015] Only curative treatments exist, and the techniques used to treat leishmaniasis vary according to several factors including: the form of the disease, concomitant conditions, the parasitic species involved, the geographical location as well as local recommendations.

[0016] Current treatments are thus based on chemotherapies using drugs called antileishmanials.

[0017] Their dosage generally requires administration in a medical environment, or even in a hospital environment, by intramuscular or intravenous route.

[0018] Thus, as a first-line treatment, certain treatments for cutaneous leishmaniasis use drugs that are difficult to handle, such as drugs belonging to the antimonial family, containing antimony, such as meglumine antimoniate and sodium stibogluconate, and heavy metals which are toxic, and whose side effects are significant.

[0019] Thus, meglumine antimoniate can cause anaphylactic-type stibio-intolerance: chills, fever, arthromyalgia, skin rash, whooping cough, tachycardia, lipothymia, hemorrhages, headache.

[0020] This compound is also responsible for stibio-intoxication by overdose at the end of treatment: fever, myalgia, arthralgia, neuralgia, with cardiac conduction disorders, hepatic and pancreatic cytolysis, hematological damage, acute renal failure (the most serious accident).

[0021] Furthermore, the injection of these compounds is painful, and resistance is reported with increasing frequency.

[0022] Pentamidine, and its synthetic organic derivative pentamidine isethionate, also constitute an antileishmanial drug which can be indicated in the treatment of cutaneous and visceral leishmaniasis, with parenteral, intramuscular or intravenous use. Its mechanism of action is not fully understood. However, it would appear that this drug inhibits the synthesis of the parasite's DNA either by blocking thymidine synthetase or by fixation on transfer RNA.

[0023] Here again, the side effects can be significant, in particular immediate allergic-type reactions, as well as toxic effects depending on the cumulative doses, namely renal, pancreatic (induced diabetes) or hematological damage, or even rhabdomyolosis.

[0024] As a second line of treatment, when treatments with pentamidine or antimony salts fail, different molecules can be used to try to treat infections due to Leishmania, in particular antibiotics (paramomycin or azithromycin), antifungals (amphotericin B desoxycholate or liposomal amphotericin B, fluconazole, ketoconazole or itraconazole), or anticancer drugs (miltefosine).

[0025] However, some induce serious side effects, notably in the case of miltefosine (vomiting, diarrhea in 25% of cases, in rare cases renal failure), amphotericin B desoxycholate (chills, fever and renal toxicity), liposomal amphotericin B (acute renal failure, anaphylaxis) and azithromycin (diarrhea, headache, vomiting, nausea, abdominal pain, abnormal blood count).

[0026] Miltefosine is also potentially embryotoxic and teratogenic, therefore prohibited in pregnant women, while fetal auditory toxicity has been reported for paramomycin.

[0027] The present invention is intended to be able to remedy, at least in part, the drawbacks of what currently exists in the state of the art in terms of treatment of parasitic pathologies, in particular cutaneous and mucocutaneous, due to pathogenic protozoa capable of affecting mammals, and particularly in the treatment of such pathologies due to protozoa belonging to the genus Leishmania.

[0028] In an inventive approach, a composition comprising a mixture of several plant extracts was used, such a composition being known under the name of "Swedish elixir", in order to treat human and veterinary protozoan pathologies.

[0029] To this end, the invention relates to a composition comprising a mixture of plant extracts, for its use in the treatment of a human or veterinary pathology due to a pathogenic protozoan, said mixture of plant extracts being made up of (composition in g / L):

[0030] - 10*n of Angel ica archangelica root;

[0031] - 5*n of Carlina acaulis root;

[0032] - 10*n of Fraxines omus;

[0033] - 5*n of gum resin of Commiphora myrrha;

[0034] - 10*n of Rheum officinalis / palmatum root;

[0035] - 10*n of Cassia angustifolia leaf;

[0036] - 10*n of Curcuma zedoaria rhizome;

[0037] - 10*n of mucilage and Aloe vera leaf;

[0038] - 2*n of natural Cinnamomum camphora;

[0039] - 10.21*n of Theriacal mixture consisting of rhizome of Acorus calamus var americanus, Pimpinella anisum fruit, Cinnamomum zeylanicum bark, Citrus limonum peel, Foeniculum dulce seed, Gentiana lutea root, Zingiber officinale rhizome, Cinchona succirubra bark, Glycyrrhiza glabra root, saffron stigmas and Valeriana officinalis root;

[0040] - Said mixture of plant extracts being diluted in 1L of an alcoholic solution having an alcohol content of around, or equal to, 50°;

[0041] - With n greater than or equal to 0.5 and less than or equal to 2.

[0042] According to particular embodiments of the invention:

[0043] - the Thériacal mixture is made up of 0.40 g of rhizome of Acorus calamus var americanus, 2.18 g of Pimpinella anisum fruit, 2.18 g of Cinnamomum zeylanicum bark, 2.18 g of Citrus limonum bark, 2.18 g of Foeniculum dulce seed, 2.18 g of Gentiana lutea root, 2.18 g of Zingiber officinale rhizome, 2.18 g of Cinchona succirubra bark, 2.18 g of Glycyrrhiza glabra root, 0.40 g of saffron stigmas and 2.18 g of Valeriana officinalis root;

[0044] - the value of n is equal to 2. ;

[0045] - said composition comprising a mixture of plant extracts according to the invention is intended for use in the treatment of leishmaniasis;

[0046] - said composition comprising a mixture of plant extracts according to the invention is intended for use in the treatment of cutaneous leishmaniasis caused by a protozoan belonging to the genus Leishmania and to the species amazonensis or to the species braziliensis or to the species guyanensis.

[0047] - said composition comprising a mixture of plant extracts according to the invention is intended for use in the treatment of equine piroplasmosis caused by protozoa belonging to the species Theileria equi or the species Babesia caballi.

[0048] - said composition comprising a mixture of plant extracts according to the invention is intended for use in the treatment of equine protozoal myoencephalitis due to Sacrocystis neurona.

[0049] The present invention also relates to a process for preparing a composition comprising a mixture of plant extracts, said process being characterized in that it comprises, at least, the following steps:

[0050] - In a container, an alcoholic solution having a alcohol content of the order of, or equal to, 50°, the following quantities of plant extracts, in powder form: 10g*n of Angelica archangelica root, 5g*n of Carlina acaulis root, 10g*n of Fraxines omus, 5g*n of Commiphora myrrha gum resin, 10g*n of Rheum officinalis / palmatum root; 10g*n of Cassia angustifolia leaf, 10g*n of Curcuma zedoaria rhizome, 10g*n of Aloe vera mucilage and leaf, 2g*n of natural Cinnamomum camphora, and 10.21g*n of Theriacal mixture consisting of Acorus calamus var americanus rhizome, Pimpinella anisum fruit, Cinnamomum zeylanicum bark, Citrus limonum peel, Foeniculum dulce seed, Gentiana lutea root, Zingiber officinale rhizome, Cinchona succirubra bark, Glycyrrhiza glabra root, saffron stigmas and Valeriana officinalis root, n being greater than or equal to 0.5 and less than or equal to 2;

[0051] - Mix until homogenized;

[0052] - The mixture is left to macerate at a temperature between 26 and 32°C, for a period of between 15 days and 90 days, with weekly homogenization of the mixture;

[0053] - The mixture is filtered to obtain the composition.

[0054] Other aims and advantages of the present invention will appear during the description which follows relating to embodiments which are given only as indicative and non-limiting examples.

[0055] Understanding of this description will be facilitated by referring to the attached drawings in which:

[0056] [Fig-1] illustrates, through five photographs, the evolution of a wound located at the level of the left forearm of a first subject infested with a protozoan Leishmania guyanensis and treated using the composition in accordance with the invention.

[0057] [Fig.2] illustrates, through two photographs, the development of a wound located on the right forearm of a second subject infested with a protozoan Leishmania guyanensis and treated using the composition in accordance with the invention.

[0058] [Fig.3] illustrates, through four photographs, the evolution of a wound located between the thumb and index finger of the left hand of a third subject infested by a protozoan Leishmania braziliensis and treated using the composition in accordance with the invention.

[0059] [Fig.4] illustrates, through two photographs, the evolution of a wound located on the anterior face of the thorax, right subclavicular part, of a fourth subject infested by a protozoan Leishmania guyanensis and treated using the composition in accordance with the invention.

[0060] The present invention then relates to a therapeutic composition comprising a mixture of a plurality of plant extracts which will be described in detail below.

[0061] The composition according to the present invention is particularly indicated for use as a medicament in the treatment of a cutaneous pathology or a mucocutaneous pathology affecting humans or animals, and due to a pathogenic protozoan.

[0062] In particular, said mixture of plant extracts has the following composition, this being expressed in g / L, considering that said mixture of plant extracts detailed below is intended to be diluted in an alcoholic liquid at 50° alcohol or approximately 50° alcohol:

[0063] - 10 g / L*n of Angelica archangelica (angelica) root;

[0064] - 5 g / L *n of Carlina acaulis (Carline) root;

[0065] - 10 g / L *n of Fraxines ornus (Manna in tear ash);

[0066] - 5 g / L *n of gum resin of Commiphora myrrha (myrrh);

[0067] - 10 g / L *n of Rheum officinalis / palmatum root (rhubarb) ;

[0068] - 10 g / L *n of leaf of Cassia angustifolia (sené);

[0069] - 10 g / L *n of Turmeric rhizome zedoaria (zedoaire);

[0070] - 10 g / L *n of mucilage and leaf of Aloe Vera;

[0071] - 2 g / L *n of Cinnamomum natural camphora (camphre) ;

[0072] - 10.21 g / L *n of Thériacal mixture consisting of rhizome of Acorus calamus var americanus, Pimpinella anisum fruit, Cinnamomum zeylanicum bark, Citrus limonum bark, sweet Foeniculum seed, Gentiana lutea root, Zingiber officinale rhizome, Cinchona sucirubra bark, Glyza stigma glacier root, saffron and root of Valeriana officinalis ;

[0073] The value of the number n is greater than or equal to 0.5 and less than or equal to 2, and preferably n is equal to 2 / 3, 1 or 2.

[0074] When n is equal to 2 / 3 this corresponds to a total concentration of plant extracts, as mentioned above, of 54.81 g / L.

[0075] When n is equal to 1, this corresponds to a total concentration of plant extracts of 82.21 g / L and, most preferably, when n is equal to 2, the total concentration of plant extracts corresponds to 164.42 g / L.

[0076] The plants used in the composition according to the present invention are, most preferably, derived from organic farming, and the camphor is advantageously natural camphor.

[0077] The different plant extracts which are mixed to obtain the present composition are, most preferably, in the form of crushed dry plants, the aloe Vera and the Thériacal mixture are in powder form with a particle size of between 300 and 500 μm.

[0078] Most preferably, the Thériacal mixture is made up of, in percentage by mass (m / m):

[0079] - 1.96% of rhizome of Acorus calamus var americanus,

[0080] - 10.67% of Pimpinella anisum fruit,

[0081] - 10.67% bark of Cinnamomum zeylanicum,

[0082] - 10.67% Citrus limonum peel,

[0083] - 10.67% Foeniculum dulce seed,

[0084] - 10.67% of Gentiana lutea root,

[0085] - 10.67% of Zingiber officinale rhizome,

[0086] - 10.67% Cinchona succirubra bark,

[0087] - 10.67% of Glycyrrhiza glabra root,

[0088] - 1.96% saffron stigmas and

[0089] - 10.67% of Valeriana officinalis root.

[0090] Thus, for example, for a total mass of 20.42 g, the Thériacal mixture consists of 0.40 g of rhizome of Acorus calamus var americanus, 2.18 g of fruit of Pimpinella anisum, 2.18 g of bark of Cinnamomum zeylanicum, 2.18 g of bark of Citrus limonum, 2.18 g of Foeniculum dulce seed, 2.18 g of Gentiana lutea root, 2.18 g of Zingiber officinale rhizome, 2.18 g of Cinchona succirubra bark, 2.18 g of Glycyrrhiza glabra root, 0.40 g of saffron stigmas and 2.18 g of Valeriana officinalis root.

[0091] It has been able to be established, surprisingly, by the applicant, that the composition based on plant extracts in accordance with the present invention was particularly effective in the treatment of cutaneous leishmaniasis.

[0092] The action of the present composition on protozoa belonging to the genus Leishmania will be illustrated in connection with the examples described in detail below, which demonstrate the effectiveness of said composition on skin lesions resulting from the infestation of a human patient or an animal by such parasites.

[0093] Most preferably, the composition comprising a mixture of plant extracts according to the present invention is used in the treatment of leishmaniasis caused by a protozoan belonging to the genus Leishmania and to the species ama-zonensis or to the species braziliensis or to the species guyanensis.

[0094] The present composition can also advantageously be used in the treatment of diseases called equine piroplasmoses, for which are responsible protozoa belonging to either the species Theileria equi or the species Babesia caballi and which can be transmitted to equines via a bite from a tick carrying the pathogen.

[0095] Here again, example 4 below demonstrates the effectiveness of the composition in the treatment of a pathology due to a protozoan of the species Theileria equi affecting an equine.

[0096] The composition based on the above-mentioned plant extracts can also be used in the treatment of another pathology targeting equines, called equine protozoal myoencephalitis, this being due to a protozoan of the species Sacrocystis neurona.

[0097] The present invention also relates to a process for preparing a composition comprising a mixture of plant extracts according to the present invention.

[0098] In a first step of this process, the following quantities of plant extracts are introduced into a suitable container, in the form of ground dry plants, in other words in powder form: - 10 g*n of Angelica archangelica root,

[0099] - 5 g*n of Carlina acaulis root,

[0100] - 10 g*n of Fraxines omus,

[0101] - 5 g*n of gum resin of Commiphora myrrha,

[0102] - 10 g*n of Rheum officinalis / palmatum root;

[0103] - 10 g of Cassia angustifolia leaf,

[0104] - 10 g*n of Curcuma zedoaria rhizome,

[0105] - 10 g*n of mucilage and Aloe vera leaf,

[0106] - 2 g*n of natural Cinnamomum camphora, and

[0107] - 10.21 g *n of Theriacal mixture consisting of rhizome of Acorus calamus var americanus, Pimpinella anisum fruit, Cinnamomum zeylanicum bark, Citrus limonum peel, Foeniculum dulce seed, Gentiana lutea root, Zingiber officinale rhizome, Cinchona succirubra bark, Glycyrrhiza glabra root, saffron stigmas and Valeriana officinalis root.

[0108] As indicated previously, the value of the number n is between 0.5 and 2, most preferably equal to 2 / 3 or equal to 1 or, even more preferably, equal to 2.

[0109] The preferred mass composition of the Thériacal mixture is as mentioned previously, in connection with the detailed description of the composition of the invention.

[0110] The different plant extracts which are mixed in the first step of the process of the invention are, preferably, in the form of ground dry plants, the aloe Vera and the Thériacal mixture being in powder form with a particle size of between 300 and 500 μm.

[0111] In the first step of the process, the crushed dry plants are diluted in a volume equal to 1 L of an alcoholic solution having an alcohol content of the order of or equal to 50°.

[0112] The alcoholic liquid solution used in the process of the present invention can thus preferably consist of 50° sugar cane alcohol.

[0113] Advantageously, the Thériacal mixture is previously mixed alone with a quantity of alcoholic liquid solution approximately equal to 200 mL for homogenization, while the remainder of the solution (qsp IL) is incorporated into the other plant extracts of the mixture.

[0114] In a second step of the process of the invention, the whole is mixed until homogenized, for example by manual application of circular movements.

[0115] Then, in a third step of the process of the invention, the mixture is left to macerate, which is maintained at a temperature of between 26 and 32°C, for a period of between 15 days and 90 days.

[0116] Optionally, this maceration period can be longer, in particular up to 9 months, or even up to 2 years.

[0117] During this maceration stage, the mixture is homogenized regularly, every day for the first fifteen days, then three times a week.

[0118] In a final step of the process of the invention, the mixture obtained after maceration is filtered, in particular by means of a paper filter to obtain the composition based on plant extracts according to the invention, in the form of a liquid composition.

[0119] The filters used preferably have pores having a size of less than 300 pm.

[0120] The liquid composition based on plant extracts thus obtained can thus be packaged in suitable containers, capable of being hermetically sealed, which will preferably be stored at a temperature between 26 and 32°C and away from light.

[0121] Most preferably, said composition based on plant extracts thus obtained can be applied directly to ulcerative lesions caused by a pathogenic protozoan.

[0122] The examples below, in connection with the attached figures, illustrate the effectiveness of the composition of the invention in the treatment of such skin lesions caused by protozoa belonging to the genus Leishmania.

[0123] Example 1: First clinical case and test of the effectiveness of the composition based on plant extracts of the invention on a wound caused by a protozoan of the genus Leishmania guyanensis on a human patient

[0124] The composition that was tested was obtained by implementing the pre-process preparation as described previously, with n=2 for the quantities of each of the plants incorporated into the mixture.

[0125] The patient is male and 27 years old. He was infected in French Guiana, in the place called "Bélison".

[0126] The diagnosis was made by taking a skin sample from the wound by the CHAR Cayenne dermatology department, and it was established that the patient had been contaminated by a protozoan Leishmania guyanensis.

[0127] The dermatological examinations were carried out by the Pasteur Institute in Cayenne.

[0128] As visible in [Fig.l], at the level of the two photographs 1 which were taken before the start of the treatment with the composition of the invention, the wound is located at the level of the left forearm, lower 1 / 3, above the head of the ulna.

[0129] The wound is circular in shape, and has a diameter of around 1.5 cm.

[0130] Treatment with the composition based on plant extracts began approximately 30 days after the bite which caused the contamination and the skin manifestation.

[0131] The composition of the invention was sprayed once a day, for a period equal to 90 days.

[0132] Photograph 2 of [Fig.l] was taken 30 days after the start of treatment, while photographs 3 and 4 were taken, respectively, 60 days and 90 days after the start of treatment with the composition of the invention.

[0133] Lymphatic exudation could be noted from the first application, followed, during the continuation of the treatment, by a marginal closure in a ridge (photographs 2 and 3)

[0134] A definitive closure of the wound, with a fine scar and without hair, was observed by the dermatologists, as well as a definitive cure, after a treatment period using the composition, of 90 days.

[0135] Photograph 4 illustrates the appearance of the patient's forearm after treatment, while the arrow highlights the fine scar.

[0136] To date, no recurrence of the infection has been observed.

[0137] Example 2: Second clinical case and test of the effectiveness of the composition based on plant extracts of the invention on a wound caused by a protozoan of the genus Leishmania guyanensis on a human patient

[0138] The composition which was tested was obtained by implementing the preparation process as described previously, with n=2 for the quantities of each of the plants incorporated into the mixture.

[0139] The patient is male and 16 years old. He was contaminated in French Guiana, at the place called "Bélison". The contamination occurred simultaneously with that of clinical case no. 1 of example 1

[0140] It was established that the patient had been contaminated by a protozoan Leishmania guyanensis.

[0141] As visible in [Fig.2], in the photograph taken before the start of treatment with the composition of the invention, several wounds are located in the middle of the dorsal side of the right forearm.

[0142] The wounds are circular in shape, and have a diameter of the order of a few millimeters.

[0143] Treatment with the composition based on plant extracts began 8 days after the bite which caused the contamination and the skin manifestations.

[0144] The composition of the invention was applied dropper-sized, once a day, for a period equal to 14 days, directly to all wound impacts.

[0145] Photograph 6 of [Fig.2] was taken 14 days after the start of treatment with the composition of the invention.

[0146] Lymphatic exudation could be noted from the first application, then drying of all the impacts for complete healing of the wounds in two weeks without any scarring, as illustrated in photograph 6 of [Fig.2].

[0147] To date, no recurrence of the infection has been observed.

[0148] Example 3: Third clinical case and test of the effectiveness of the composition based on plant extracts of the invention on a wound caused by a protozoan of the genus Leishmania braziliensis on a human patient

[0149] The composition which was tested was obtained by implementing the preparation process as described previously, with n=2 for the quantities of each of the plants incorporated into the mixture.

[0150] The subject tested is female and aged 40, infected in French Guiana, in the place called “Antécumpata”.

[0151] The diagnosis was made by taking a skin sample from the wound by the CHAR Cayenne dermatology department, and it was established that the patient had been contaminated by a protozoan Leishmania braziliensis.

[0152] The dermatological examinations were carried out by the Pasteur Institute in Cayenne.

[0153] As visible in [Fig.3], at the level of photograph 7 which was taken before the start of treatment with the composition of the invention, the wound is located between the thumb and the index finger of the left hand.

[0154] The wound is oval in shape and has a length of around 1 cm.

[0155] The composition of the invention was applied as a second line, after two injections of pentamidine (pentacarinat (registered trademark)).

[0156] Photograph 8 of [Fig.3] was taken 8 days after the start of treatment, while photographs 9 were taken 60 days after the start of treatment.

[0157] The application of the composition of the invention was carried out drop by drop at at a rate of 3 drops per cm2 twice at 1 week intervals, directly on the wound.

[0158] Lymphatic exudation was noted from the first application, then marginal closure in a ridge and finally drying and complete closure of the wound in 30 days.

[0159] Photographs 9 illustrate the appearance of the patient's hand after treatment, while the arrow points to the absence of a scar.

[0160] Example 4: Fourth clinical case and test of the effectiveness of the composition based on plant extracts of the invention on a wound caused by a protozoan of the genus Leishmania guyanensis on a human patient

[0161] The composition which was tested was obtained by implementing the preparation process as described previously, with n=2 for the quantities of each of the plants incorporated into the mixture.

[0162] The subject tested is female and 8 years old, contaminated in French Guiana, commune of Montsinéry-Tonnegrande, place called “risk all west”

[0163] The diagnosis was made by taking a skin sample from the wound by the CHAR Cayenne dermatology department, and it was established that the patient had been contaminated by a protozoan Leishmania guyanensis.

[0164] As visible in [Fig.4], at the level of photograph 10 which was taken before the start of treatment with the composition of the invention, the wound is located at the level of the anterior face of the thorax, right subclavicular part.

[0165] The wound is round in shape, and has a diameter of around 3 cm.

[0166] The composition of the invention was applied as a first-line treatment.

[0167] The application of the composition of the invention was carried out using a dropper at a rate of 3 drops per cm2 once a day, directly onto the wound.

[0168] Lymphatic exudation was noted from the first application, then marginal closure in a ridge and finally drying and complete closure of the wound in 30 days.

[0169] Photograph 11 illustrates the appearance of the anterior face of the thorax, right subclavicular part of the patient after treatment.

[0170] Note that other clinical cases have been tested, without however being detailed here, on human patients infected by protozoa of the genus Leishamnia and belonging to the different species guyanensis and braziliensis.

[0171] In particular, the study was conducted on a total of nine cases of cutaneous leishmaniasis (CL) due to Leishamnia guyanensis strains and cutaneous and muco-mutaneous leishmaniasis, due to Leishamnia braziliensis strains. The first three examples detailed above are part of these nine cases.

[0172] The subjects studied were aged 8 to 62 years, and among them, four were male and five were female.

[0173] Eight dermatological diagnoses were carried out at the CHAR in Cayenne and one in Kourou.

[0174] The biological analyses were carried out at the Pasteur Institute in Cayenne.

[0175] In the nine cases, treatment using the composition based on plant extracts of the invention has proven effective with a definitive cure in first or second intention (after application of a first antimony and pentaminide treatment proving ineffective and / or due to medical contraindications to these treatments), with an efficacy of 100% and definitively.

[0176] More particularly, for all the cases tested, it was possible to observe the obtaining of a fine scar of the wounds, depending on the depth of the wound, and a disappearance of the hairiness, without side effects, and with ease of application of the composition in accordance with the invention.

[0177] It was also possible to note, as a distinctive sign of the onset of the healing process, lymphatic exudation from the first application, then, generally, a marginal closure in a ridge.

[0178] The healing time varies between 15 days and 3 months, up to 100% definitive healing depending on the extent of the lesion.

[0179] Example 5: Clinical case and test of the effectiveness of the composition based on plant extracts of the invention on blood contamination caused by a protozoan of the genus Theileria equi on a horse

[0180] The composition which was tested was obtained by implementing the preparation process as described previously, with n=2 for the quantities of each of the plants incorporated into the mixture.

[0181] The subject tested is a 7-year-old mare contaminated by a protozoan belonging to the species Theileria equi.

[0182] Blood samples, taken by a veterinarian and followed by analyses by a specialized laboratory, made it possible to determine that the animal's serum was contaminated by the protozoan Theileria equi (1 / 640) and negative for the protozoan Babesia caballi. The clinical picture showed symptoms of weight loss, asthenia and apathy.

[0183] The treatment using the composition of the invention was carried out with a view to reducing and / or eliminating the parasites present in the blood of the animal.

[0184] The treatment was carried out by impregnating the liquid composition based on plant extracts of the invention in food (feed) twice a day for a period of 21 days, as follows: - Treatment of the acute phase (for 8 days): 45 ml of the composition of the invention; Purifying treatment (13 days): • D9: 40 ml D10: 35 ml from D11 to D21: 30 ml

[0185] After 21 days of treatment, a blood parasite count was again carried out, under the same conditions as the first analysis mentioned above, and by the same laboratory.

[0186] The results obtained showed a reduction by half in the number of Theileria equi parasites (1 / 320), and, at the clinical level, it was possible to observe, in the mare, a weight gain and an improvement in her vitality in the month after treatment, she having regained tone and appetite, which allowed her to resume riding work.

Claims

Claims

1. Composition comprising a mixture of plant extracts, for use in the treatment of a human or veterinary pathology due to a pathogenic protozoan, chosen from leishmaniasis, equine piroplasmosis due to protozoa belonging to the species Theileria equi or to the species Babesia caballi, and equine protozoan myoencephalitis due to Sacrocystis neurona, said mixture of plant extracts being composed of (composition in g / L): - 10*n of Angel ica archangelica root; - 5*n of Carlina acaulis root; - 10*n of Fraxines omus; - 5*n of Commiphora myrrha gum resin; - 10*n of Rheum officinalis / palmatum root; - 10*n of Cassia angustifolia leaf; - 10*n of Curcuma zedoaria rhizome; - 10*n of mucilage and Aloe vera leaf; - 2*n of natural Cinnamomum camphora;- 10.21*n of Theriacal mixture consisting of rhizome of Acorus calamus var americanus, fruit of Pimpinella anisum, bark of Cinnamomum zeylanicum, peel of Citrus limonum, seed of Foeniculum dulce, root of Gentiana lutea, rhizome of Zingiber officinale, bark of Cinchona succirubra, root of Glycyrrhiza glabra, stigmas of saffron and root of Valeriana officinalis; - Said mixture of plant extracts being diluted in 11 of an alcoholic solution having an alcohol content of the order of, or equal to, 50°; - With n greater than or equal to 0.5 and less than or equal to 2.;

2. Composition comprising a mixture of plant extracts according to claim 1 in which the Theriacal mixture consists of 0.40 g of rhizome of Acorus calamus var americanus, 2.18 g of fruit of Pimpinella anisum, 2.18 g of bark of Cinnamomum zeylanicum, 2.18 g of peel of Citrus limonum, 2.18 g of seed of Foeniculum dulce, 2.18 g of root of Gentiana lutea, 2.18 g of rhizome of Zingiber officinale, 2.18 g of bark of Cinchona succirubra, 2.18 g of root of

3.

4.

5. Glycyrrhiza glabra, 0.40 g of saffron stigmas and 2.18 g of Valeriana officinalis root. Composition comprising a mixture of plant extracts according to claim 1 or claim 2 in which n is equal to 2. Composition comprising a mixture of plant extracts according to any one of claims 1 to 3 for its use in the treatment of cutaneous leishmaniasis caused by a protozoan belonging to the genus Leishmania and to the species amazonensis or to the species braziliensis or to the species guyanensis. Process for preparing a composition comprising a mixture of plant extracts according to any one of the preceding claims, said process being characterized in that it comprises, at least, the following steps: - In a container, the following quantities of plant extracts, in powder form, are introduced into 1L of an alcoholic solution with an alcohol content of around, or equal to, 50°: 10g*n of Angelica archangelica root, 5g*n of Carlina acaulis root, 10g*n of Fraxines omus, 5g*n of Commiphora myrrha gum resin, 10g*n of Rheum officinalis / palmatum root;10g*n of Cassia an-gustifolia leaf, 10g*n of Curcuma zedoaria rhizome, 10g*n of mucilage and Aloe vera leaf, 2 g*n of natural Cinnamomum camphora, and 10.21 g*n of Theriacal mixture consisting of rhizome of Acorus calamus var americanus, Pimpinella fruit anisum, bark of Cinnamomum zeylanicum, bark of Citrus limonum, seed of Foeniculum dulce, root of Gentiana lutea, rhizome of Zingiber officinale, bark of Cinchona succirubra, root of Glycyrrhiza glabra, stigmas of saffron and root of Valeriana officinalis, n being greater than or equal to 0.5 and less than or equal to 2; - Mix until homogenized; - The mixture is left to macerate at a temperature between 26 and 32°C, for a period of between 15 days and 90 days, with weekly homogenization of the mixture; - Filter the mixture to obtain the composition.