COMPOSITION AGAINST ECTOPARASITES

Abstract

A composition including a mixture of extracts of aromatic plants, and in particular extracts of lemon balm, thyme, rosemary, wormwood and lemongrass, veterinary or pharmaceutical compositions including the composition and a food for non-human animals including the composition. Also, a method for preparing the composition and a method for the prevention or treatment of flea infestation that include the administration of the composition to a domestic mammal.

Claims

1-10. (canceled)

11. A composition comprising, an extract of each of the following aromatic plants: aromatic plants of the Lamiaceae family, aromatic plants of the Asteraceae family, and aromatic plants of the Poaceae family.

12. The composition according to claim 11, further comprising an extract of aromatic plants of the Fabaceae family.

13. The composition according to claim 11, wherein the extract of aromatic plants of the Lamiaceae family represents from 5 to 50% by mass, the extract of aromatic plants of the Asteraceae family represents from 1 to 20% by mass, and the extract of aromatic plants of the Poaceae family represents from 1 to 10% by mass, the percentages being expressed by mass relative to the total mass of the composition.

14. The composition according to claim 12, wherein the extract of aromatic plants of the Fabaceae family represents from 5% to 15% by mass, the percentages being expressed by mass relative to the total mass of the composition.

15. The composition according to claim 11, wherein the composition consists of a mixture of a lemon balm extract, a thyme extract, a rosemary extract, a wormwood extract and a lemongrass extract.

16. The composition according to claim 11, wherein the composition consists of a mixture of a lemon balm extract, a thyme extract, a rosemary extract, a wormwood extract and a lemongrass extract, and a fenugreek extract.

17. The composition according to claim 11, wherein the composition consists of: from 5% to 50% lemon balm extract, from 10% to 50% thyme extract, from 10% to 50% rosemary extract, from 1% to 20% wormwood extract, and from 1% to 10% lemongrass extract, the percentages being expressed by mass relative to the total mass of the composition.

18. The composition according to claim 11, wherein the composition consists of: from 5% to 50% lemon balm extract, from 10% to 50% thyme extract, from 10% to 50% rosemary extract, from 1% to 20% wormwood extract, and from 1% to 10% lemongrass extract, from 5% to 15% fenugreek extract the percentages being expressed by mass relative to the total mass of the composition.

19. The composition according to claim 11, further comprising vitamins, or amino acids or minerals, or a mixture thereof.

20. A veterinary or pharmaceutical composition comprising, as an active substance, a composition according to claim 11, in association with an acceptable carrier.

21. A food intended for feeding non-human animals comprising from 0.01% to 100% of a composition according to claim 11, the percentages being expressed by mass relative to the total mass of the food.

22. A method for the prevention or treatment of flea infestation (pulicosis), and the prevention of associated symptoms, the method comprising the administration, to a domestic mammal, of an affective amount of the composition according to claim 11.

23. A method for preparing a composition according to claim 11, wherein: lemon balm, thyme, rosemary, wormwood and lemongrass leaves are compacted in a sufficient volume of water to cover them, to obtain a mixture of compacted leaves, the mixture of compacted leaves is left to macerate for at least two weeks at room temperature, with regular mixing of the mixture of compacted leaves, to obtain a liquid fraction and a macerate, and the macerate is eliminated to preserve the liquid fraction.

24. The method according to claim 23, wherein the liquid fraction is mechanically stirred to obtain a homogeneous composition.

Description

BRIEF DESCRIPTION OF THE FIGURE

[0133] FIG. 1 is a box diagram (boxplot) showing the comparison of the distributions of the number of fleas per animal (y axis) as a function of the food received (batch A in white or batch B in gray) and as a function of time (x axis; 0=start of the study). The horizontal line in the box indicates the median, the box boundaries indicate the 25th and 75th percentiles, and the whiskers indicate the maximum and minimum results values. The cross (x) inside the box represents the average of the data.

EXAMPLES

Example 1: Method for Preparing a Composition According to the Invention

[0134] The method for producing the food supplement comprises the steps of: [0135] Introducing water into a tank. The volume of the mixture corresponds to one third of the volume of the tank. [0136] Introducing the leaves of the aromatic plants, starting with the lowest quantity. [0137] Compacting the plants with a spatula. [0138] If necessary, adding a water mixture to completely cover the plants. [0139] Covering the tank with the cover and leaving it to macerate at room temperature (15 to 27° C.) for at least 2 weeks, while stirring the mixture regularly with a spatula, in particular every 3 days. [0140] Filtering the mixture by clarifying filtration through a sieve. [0141] Optionally adding additional active ingredients (minerals, vitamins, extracts, etc.). [0142] Stirring the extract using a mechanical stirrer set at approx. 100 rpm for 12 hours to obtain a homogeneous composition.

[0143] The composition thus obtained is optionally sprayed into a mixer containing a powdered food carrier (before being packaged, to obtain a food comprising the composition according to the invention.

[0144] The food is thus ready to be distributed to the animals.

[0145] Finally, the constituents of the composition can be sterilized, in particular by heating and/or by passing through a membrane. They can be disinfected, also by heating or by means of a disinfectant.

Example 2: Measurement of the Effectiveness of the Composition According to the Invention

1—Purpose of the Study.

[0146] The aim of this study was to evaluate, in a double-blind, placebo-controlled setting, the effectiveness of the composition according to the invention used alone, in the summer, to limit flea populations in naturally infested dogs living in dirt-floor kennels without environmental treatment.

2—Material and Method.

2.1 Animals.

[0147] Twenty-two healthy adult dogs aged 1 to 11 years were included, and they were housed in 7 semi-open kennels in groups of 1 to 5. Their food consisted exclusively of the food provided by the study sponsor, and was distinguishable only by the letter on the outer packaging (A or B). There was plenty of water available. Throughout the study, accommodation and food conditions remained stable. No anti-parasitic drugs were allowed. No external anti-parasitic treatment had been administered during the past 6 months. The description of each animal appears in Table 1.

TABLE-US-00001 TABLE 1 animal report No. in the Age Weight study Sex (years) Breed Kennel (kg) Group 1 M 8 Bruno Jura Hound 1 27 A 2 M 3 Griffon 1 24 A 3 F 11 Bruno Jura Hound 1 25 A 4 F 11 Bruno Jura Hound 1 27 A 10 F 6 Bleu de Gascogne 3 24 A 11 M 1 Griffon 3 18 A 12 F 2 Bleu de Gascogne 3 20 A 13 F 3 Griffon 3 19 A 19 M 3 Griffon 6 25 A 20 M 7 Griffon 6 35 A 21 M 3 Griffon 6 23 A 22 M 7 Griffon 7 30 A 5 M 6 Bruno Jura Hound 2 27 B 6 M 5 Bleu de Gascogne 2 25 B 7 M 1 Griffon 2 20 B 8 M 3 Griffon 2 31 B 9 M 1 Griffon 2 22 B 14 M 5 Griffon 4 23 B 15 M 7 Griffon 4 30 B 16 M 1 Bleu de Gascogne 4 22 B 17 M 2 Bleu de Gascogne 4 22 B 18 M 5 Griffon 5 31 B

2.2 The Product.

[0148] The active ingredient to be evaluated was incorporated into the food before sending it to the animal keeper. The bags (12 kg each) could only be distinguished by the letter “A” or “B” on the packaging. The bags were stored in a suitable dry place at a temperature below 25° C.

[0149] The food consists of dehydrated chicken meat (43%), dehydrated whole potato, potato pulp, peas, poultry fat, dehydrated shrimp (4%), animal protein hydrolysate, kaolin (2%), minerals, gluten-free flax meal, dehydrated Yucca schidigera extract, dehydrated brewer's yeast, dehydrated chicory pulp, and a premix of flavoring additives with active substances from citrus fruits. This food is constituted by mass relative to the total mass of the food: 34% crude protein, 12% crude fat, 3% crude fiber, 6% mineral material, 0.75% calcium, 0.47% phosphorus, 0.20% omega 3 and 1.10% omega 6, with a Ca/P ratio of 1.55.

[0150] The food was distributed once a day by the owner, and the quantity distributed was based on the manufacturer's recommendations for animals with intense activity of more than two hours of exercise so as to adequately cover the needs. Within the same pen, all dogs were fed the same food.

2.3 Method

2.3.1 Evaluation of the Anti-Parasitic Activity.

[0151] Counting was carried out according to the method recommended by the

[0152] European Medicines Agency (EMEA) for carnivores in field trials (Guideline for the testing and evaluation of the efficacy of antiparasitic substances for the treatment and prevention of tick and flea infestation in dogs and cats EMEA/CVMP/EWP/005/2000-Rev. 3-14 Jul. 2016). The flea population of each dog is assessed by visual counting. Area counts are performed on five body regions of each animal: dorsal line, base of tail, right side, left side and inguinal region. For each area, the counting time is limited to one minute and the counting is carried out by parting the hairs using both hands until the surface of the area is covered. For each area, the maximum number of fleas counted is limited to 50, which brings the maximum number of fleas evaluated per animal to 250.

[0153] The counting was carried out before the start of the study (D0), then 14 days, and 1, 2, 3, 4 and 5 months after the start of the supplementation.

2.3.2 Clinical Evaluation

2.3.2.1 Tolerance.

[0154] Immediate tolerance was assessed at the time of each meal by the owner. At each follow-up visit, local and general clinical examination was used to assess medium-term tolerance.

2.3.2.2 Dermatological Monitoring

[0155] The evaluation took place before the start of the study (D0), then 14 days, and 1, 2, 3, 4 and 5 months after the start of the supplementation. For each animal, the intensity of the following injuries was graded on a scale of 0 to 3 [0: absence; 1: moderate presence; 2: average presence; 3: significant presence]:

[0156] infected area

[0157] pruritus intensity

[0158] erythema

[0159] scales

[0160] secondary injuries (excoriations, scabs, etc.)

[0161] lichenification

[0162] The clinical score corresponds to the sum of the evaluations per injury.

2.4 Analysis of the Results

[0163] The flea counts of the two groups were compared by a test t for two independent samples with a significance level of 5%. The calculations were performed using the XLSTAT software (Addinsoft, v. 19.02 43358).

3 Results

3.1 Tolerance

[0164] No intolerance reaction was detected after distribution of the food. In post-application clinical examinations, no clinical abnormalities were detected.

[0165] Dog 6 was excluded from the study as of D60, having been moved out of the kennel.

[0166] 3.2 Anti-Parasitic Efficacy (Table 2 and FIG. 1).

[0167] On inclusion in the study, the dogs were harboring between 5 and 15 fleas, i.e. on average 7.9±3.3 fleas for batch A (12 dogs) and 9.5±3.6 fleas for batch B (10 dogs).

[0168] The results of the study are shown in FIG. 1, and in Table 2 below.

TABLE-US-00002 30-Jul 14-Aug 28-Aug 25-Sep 26-Oct 20-Nov 18-Dec Batch Dog D 0 D 14 D 30 D 60 D 90 D 120 D 150 A 1 5 5 20 25 25 25 20 2 8 12 20 30 35 28 25 3 5 7 10 12 25 20 15 4 7 10 10 10 13 15 12 10 5 7 15 10 19 20 15 11 10 14 20 30 12 25 20 12 15 14 15 15 17 20 15 13 10 12 12 10 20 20 16 19 5 6 5 4 8 12 7 20 5 6 15 20 30 28 25 21 12 15 17 18 25 20 17 22 8 10 15 30 20 25 18 B 5 10 12 12 15 4 4 4 6 5 7 8 — — — — 7 5 8 4 8 10 5 3 8 8 7 15 6 10 5 3 9 8 9 8 7 5 4 3 14 15 13 10 4 3 2 2 15 15 12 12 12 10 8 7 16 12 14 11 10 4 4 2 17 7 8 7 7 5 4 3 18 10 11 10 10 3 3 1 Avg A 7.9 9.8 14.5 17.8 20.8 21.5 17.1 Avg B 9.5 10.1 9.7 8.8 6.0 4.3 3.1 SD A 3.3 3.6 4.6 9.1 7.7 4.9 5.1 SD B 3.6 2.6 3.1 3.3 3.1 1.7 1.7 Statistics NS S S S S S % reduction B/A / 33.1% 50.8% 71.1% 79.8% 81.8%

[0169] The average flea population hosted by the dogs of group B remained stable during the first month of the study and then gradually decreased to 3.1±1.7 at month 5. At the same time and under the same rearing and maintenance conditions, the average population of fleas in group A increased steadily until month 4 (21.5±4.9) and then decreased significantly in month 5 (17.1±5.1). The reduction percentages of batch B compared to batch A are 33%, 51%, 71%, 80% and 82%, respectively, at one, two, three, four and five months after the start of the study.

[0170] Statistical analysis showed no significant difference on DO. The averages of the two groups are significantly different between D14 and D0+5 months (p<0.05).

3.3 Skin Examination

[0171] Skin examinations generally revealed good skin and coat quality, apart from scales noted at ⅓ for some dogs at the start and during the study:

[0172] D0: dogs 12, 14, 15 and 21

[0173] D14: dogs 12, 14, 15 and 21

[0174] D30: dogs 12, 14, 15 and 21

[0175] D60: dogs 2, 12, 15 and 21

[0176] D90: dogs 2, 12, 15, 20 and 21

[0177] D120: dogs 2, 12, 20 and 21

[0178] D150: dogs 2, 12, 20 and 21

4 Conclusion

[0179] Flea populations in naturally infested dogs, with an average level of infestation at the start of the study (8 to 9.5 fleas on average) and living in dirt-floor kennels without environmental treatment were monitored for 5 months. In the batch provided with food A, the populations increased until they reached an average of greater than 20 fleas per animal; they were significantly higher than those of the dogs provided with food B, which gradually decreased to reach averages of less than 5 fleas per dog. The intake of the food did not cause any adverse event.

[0180] At the end of the study, the veterinarian was informed of the composition of food B, which contained the following composition according to the invention:

[0181] Lemon balm extract: 37%

[0182] Thyme extract: 25%

[0183] Rosemary extract: 20%

[0184] Wormwood extract: 15%

[0185] Lemongrass extract: 1%

[0186] the percentages being expressed by mass relative to the total mass of the composition, and the composition being used at a rate of 1% by mass relative to the mass of the food to which it is added to feed the animals.