FIELD OF INVENTION

The present invention relates to an herbal composition for treating fungal, scaling, foot-crack, eczema and dry skin diseases made from non-toxic ingredients. The herbal composition may also be useful in treating psoriasis, foot com disease and the like.

BACKGROUND OF THE INVENTION

The skin acts as an effective barrier to maintain a dynamic equilibrium between the body and the environment. Skin also prevents invasion of pathogens, chemical and physical assaults, as well as the unregulated loss of water and solute from the body.

Dry skin is a skin condition characterised by a lack of appropriate amount of water in the skin's epidermis. During drying of the skin, the corneous layer prematurely flakes away and cracks and scaling develop on the skin surface.

In foot crack disease, the sensitive skin on the bottom of the feet becomes too dry and may split open, causing painful cracks. These cracks may lead to pain during walking and can lead to serious infections. These cracks can become more severe and may even lead to bleeding. Foot crack disease can occur by cold and low humidity weather, dehydration, taking very hot bath showers etc.

In skin scaling, the outer layer of the epidermis is lost as large, scale-like flakes. The scales can itch and redden, and it may occur in the hands, feet, face etc. affecting the quality of life. Scaling of skin may be a symptom of many medical conditions, including psoriasis, eczema, and fungal skin infections. In severe cases of scaling, the skin may break and may become vulnerable to bacterial, viral, and fungal infections, which can lead to other health complications as well.

Eczema is a disease, which causes the skin to become itchy and red. It is common in children but can arise at any age. Eczema harms the skin barrier function. It also causes the skin to be more sensitive to various infections. Major symptoms of eczema include itching, red rashes, bumps and scaly, leathery patches of skin. The causes of the eczema are not well understood and is thought to be caused by a disorder of the immune system and appears to have an interplay between genetic and environmental factors. Currently there is no cure for eczema. In severe cases of infection, anti-inflammatory corticosteroids like prednisone or cortisone are used and they usually cause stretch marks, eye damage and thinning of skin. Antihistamines are generally prescribed to reduce the itching associated with eczema.

Tinea is a group of skin infections, caused by fungus; examples include tinea corporis (ringworm), tinea pedis. In ringworm infection, no worm is involved and gets its name because of its appearance. Tinea is a superficial skin infection that may affect any part of human body, including the face, hands, feet, scalp, beard etc. It usually appears as a red, itchy, circular rash with clearer skin in the middle. Ringworm is very contagious, and people can get the infection by direct contact and also by indirect contact through an infected person's clothing or even by touching any object that has contacted an infected person's skin. Mild infections may be cured by antifungal medications applied on the skin externally. In severe infections, an infected person may need to take antifungal pills for several weeks. Corticosteroids are used for tinea corporis treatments. However, prolonged use of steroids can lead to persistent and recurrent infections and can have adverse effects on the skin such as skin atrophy, stretch marks and threadlike red lines or patterns on the skin.

Foot coms and calluses are potentially painful conditions that form thickened skin areas. While com occurs in a thick and localized area, that usually has a conical or circular shape. Callus occurs in more diffused and flattened area of the skin. Coms and calluses may occur on any part of the feet and sometimes on the fingers also. Coms are often very painful and may lead to difficulty in walking. Com is caused by repeated mechanical trauma due to pressure forces or fiction. Treatment for coms and calluses usually involves the removal of excess skin by trimming or applying callus-removing medication such as salicylic acid. The conventional method of treating coms involves surgery. However, it is not a permanent solution, as coms recur frequently. Thus, all these treatments give only temporary cure.

Now-a-days consumers increasingly seek natural, non-toxic and eco-friendly ingredients in skin medicine, which does not have any side effects on the skin. Most of the currently available treatment methods for above mentioned skin diseases have many limitations and hence it is very pertinent to develop a skin medicine from non-toxic and environmentally friendly ingredients.

SUMMARY OF THE INVENTION

The present invention relates to a topical herbal composition comprising 1 to 5 parts by weight of a mixture comprising 80 wt% to 99.9 wt% of dried Indigofera tinctoria leaves powder or aqueous extract, 0. lwt% to 20 wt % of a base or a mixture of two or more bases, and 1 to 10 parts by weight of water.

The base(s) may be selected from the group comprising of CaO, MgO, SrO, BaO, Li ₂ O, Na ₂ O, K ₂ O, Rb ₂ O, Cs ₂ O, LiOH, NaOH, KOH, RbOH, CsOH, Li ₂ CO3, Na ₂ CO ₃ , K ₂ CO ₃ , Rb ₂ CO ₃ and Cs ₂ CO ₃ .

The composition can further comprise of 10 wt% to 40 wt% of a pharmaceutically acceptable excipients, 0.01wt%-0.3 wt% of a preservative, 0. 1 wt% to lwt% of a fragrance oil, 3 wt% to 8 wt% of an emulsifying agent.

The pharmaceutically acceptable excipient can be selected from glycerol, petroleum jelly, or beeswax, the preservative can be selected from methyl paraben, butylparaben, ethylparaben, propylparaben, the fragrance oil can selected from be vetiver oil, lavender oil, lemongrass oil, jasmine, or sandalwood oil, the emulsifying agent can selected from triethanol amine, beeswax, borax, lecithin, gum arabic, gelatin, or cholesterol. The topical composition can be an ointment, a paste, or a cream.

The topical herbal composition can comprise of 2.5 parts by weight of the mixture of dried Indigofera tinctoria leaves powder or aqueous extract and CaO powder in a weight ratio of 97.5:2.5, and 5.5 parts by weight of water. The composition can further comprise of 3.0 wt% of glycerol, 1.0 wt% of vetiver oil and 0.1 wt % of methyl paraben.

The topical composition can be for treating skin ailments selected from dry skin, footcracking, eczema, scaling, fungal infections, psoriasis, foot com disease or the like.

The present invention also relates to a method of treating skin ailments selected from dry skin, foot-cracking, eczema, scaling, fungal infections, psoriasis, foot com disease or the like by applying the composition on the affected area for 3 to 5 days. BRIEF DESCRIPTION OF DRAWING

Figure 1 shows the before and after images of applying the herbal topical composition on foot cracking. Fig 1(a) shows the photograph of the cracked foot before application and Fig 1(b) shows the photograph of the foot after the application of the composition for 3 to 4 consecutive days. Fig. 1(b) shows that the dry and thickened skin was found to be completely removed and natural skin was restored.

Figure 2 shows before and after images of applying the herbal topical composition on a patient with Eczema. Fig. 2(a) shows the photograph of an Eczema patient having severe red rashes, bumps, scaly patches at the back of the neck before application of the composition and Fig. 2(b) shows the photograph of the skin after application of the composition for 2-3 consecutive days. Fig 2(b) shows that the itching, red rashes, bumps on the skin and scaly, leathery patches of skin associated with eczema were completely cured and natural skin was restored after applying the composition for 2-3 days.

Figure 3 shows the before and after images of applying the herbal topical composition on a patient with Fungal infection. Fig 3(a) shows photograph of the patient’s skin affected with fungal infection before application and Fig. 3(b) clearly shows the reduction in itching, redness, scaling and the inflammation associated with the tinea infections after application of the composition two times per day for 3-4 days.

DETAILED DESCRIPTION OF INVENTION

The aim of the present invention is to formulate an herbal composition that can be used for treating various skin conditions such as fungal infection, foot-cracking, scaling, eczema and dry skin diseases using non-toxic ingredients. The herbal composition may also be useful in treating psoriasis, foot com disease and the like.

In an embodiment, the present invention provides a topical herbal composition comprising about 1 to 5 parts by weight of a mixture comprising 80wt% to 99.9 wt% of dried Indigofera tinctoria leaves powder and 0.1wt% to 20 wt% of a base or a mixture of two or more bases, and 1 to 10 parts by weight of water.

In an embodiment, the present invention provides a topical herbal composition comprising about 1 to 5 parts by weight of a mixture comprising 80wt% to 99.9 wt% of dried Indigofera tinctoria leaf aqueous extract and 0.1wt% to 20 wt% of a base or a mixture of two or more bases, and 1 to 10 parts by weight of water.

The base(s) in the composition can be selected from the following group comprising of MgO, CaO, SrO, BaO, Li ₂ O, Na ₂ O, K ₂ O, Rb ₂ O, Cs ₂ O, LiOH, NaOH, KOH, RbOH, CsOH, Li ₂ CO ₃ , Na ₂ CO ₃ , K ₂ CO ₃ , Rb ₂ CO ₃ and Cs ₂ CO ₃ or a combination thereof. Preferably, the base can be CaO.

The composition of the present invention comprising dried Indigofera tinctoria and a base can be effective in treating various skin conditions such as foot cracking, scaling, eczema, dry skin disease and fungal infection. Figures 1 to 3 demonstrate the efficacy of the composition in said skin conditions. It was found that Indigofera tinctoria when used alone with water and without the base such as CaO did not provide such a result. Therefore, Indigofera tinctoria and the base synergistically treats the said skin conditions such as dry skin, eczema, foot cracking and scaling. It was observed that the said conditions did not recur even after 6 months of the treatment using the composition of the present invention. Thus, the composition of the present invention synergistically treats more than one skin ailments and obviates the need of using different products. For example, typically, for the treatment of eczema, a patient is required to use a dry skin treatment cream and a corticosteroid. The composition of the present invention synergistically treats eczema with one paste or cream treatment and obviates the need of using steroids such as corticosteroid.

The composition of the present invention also alleviates the symptoms and restore the normal skin in a short period of time. The composition shows effective results in 3 to 6 days for various skin ailments such as eczema, fungal disease, and dry skin.

In another embodiment, the herbal topical composition can be a cream or an ointment. The composition can be used as such without any further pharmaceutical excipient. However, the herbal composition can also be made in cream form by mixing the paste form with desired weight ratio of the composition along with a cream base. The cream base can be formulated with variety of pharmaceutically acceptable excipient, oils, preservatives, fragrance oils and emulsifying agents known in the art.

The composition can optionally further comprise 10 wt% to 40 wt% of a pharmaceutically acceptable excipient, 0.01wt%-0.3 wt% of a preservative, 0. lwt% to lwt% of a fragrance oil, and/or 3wt% to 8 wt% of an emulsifying agent. The pharmaceutically acceptable excipient can be selected from glycerol, petroleum jelly, or beeswax. The preservative can be selected from methyl paraben, butylparaben, ethylparaben, propylparaben, etc. The fragrance oil can be selected from vetiver oil, lavender, lemongrass, jasmine, sandalwood, etc. The emulsifying agent can be selected from triethanol amine, beeswax, borax, lecithin, gum Arabic, gelatin, cholesterol, etc.

The composition of the present invention can be prepared by methods known in the art to form a cream or paste composition.

In another embodiment, the composition in paste form can further be mixed with a 20 wt%- 40 wt% of a pharmaceutically acceptable excipient such as petroleum jelly, a 0.01wt%-0.3 wt% of preservative such as methyl paraben and a 0.1 wt%-lwt% of a fragrance oil such as vetiver oil to form a cream.

In another embodiment, the composition in paste form can further be mixed with 20 wt% - 40 wt% of pharmaceutically acceptable excipients such as glycerol, 2 wt% -6 wt% of a beeswax, 3wt%-8 wt% of an emulsifier such as triethanol amine, 0.01wt%-0.3 wt% of a preservative such as methyl paraben and 0.1wt%-lwt% of a fragrance oil such as vetiver oil to form cream.

In a preferred embodiment, the topical composition comprises 2.5 parts by weight of the mixture of dried Indigofera tinctoria leaves powder or aqueous extract and CaO powder in a weight ratio of 97.5:2.5, and 5.5 parts by weight of water. In an embodiment, the composition can be in the form of a paste. The composition may optionally further comprise of 3.0 wt% of glycerol, 1.0 wt% of vetiver oil and 0.1 wt% of methyl paraben to form a cream.

The present invention also relates to a composition for use in the treatment of skin conditions selected from dry skin, foot-cracking, eczema, scaling, fungal infections, psoriasis, foot com disease or the like.

The present invention also relates to a method of treating skin conditions selected from dry skin, foot-cracking, eczema, scaling, fungal infections, psoriasis, foot com disease or the like by applying the composition of the present invention topically on the affected area. The method includes applying the composition of the present invention topically on the affected area of dry skin 1 or 2 times per day for 3 to 4 days. The dry skin condition was completely cured, and natural and supple skin were found to be restored. Dry skin condition did not recur for at least 6 months.

In another embodiment, a method of treating cracks in the foot comprising cleaning the foot with soap and soaking the cracked foot in lukewarm salt water for about 15 minutes, and allowing the foot to dry. Applying the composition of the present invention on the affected areas of the foot and keeping the foot undisturbed for 30 to 60 minutes. The method is repeated for 3 to 4 consecutive days. The dry and thickened skin was found to be completely removed. Figure 1(a) and 1(b) shows the before and after images of foot cracking respectively upon applying the composition of the present invention.

In a further embodiment, a method of treating scaling of skin comprising applying the composition of the present invention to the affected areas of the foot of the patient 2 times per day for one week. The flakes sticking to the skin were found to be peeled off. Itching and redness were healed and smooth skin appeared within 3-4 days.

In a further embodiment, a method for treating Eczema in a patient with the topical composition of the present invention is disclosed. The method includes applying the composition of the present invention to the affected area of skin of the patient 2 times per day for 2-3 days. The itching, red rashes, bumps on the skin and scaly, leathery patches of skin associated with eczema were completely cured and natural and supple skin was restored. Fig.2(a) shows image of the affected skin of Eczema patient before application of the composition and Fig. 2(b) shows that symptoms associated with eczema were completely cured, and natural skin was restored upon application of the composition for 2-3 consecutive days.

In further embodiment, a method of treating fungal infections in a patient with the topical composition of the present invention is disclosed. The method includes applying the topical composition to the affected area of skin, having characteristics of tinea infections two times per day for 3-4 consecutive days. Fig. 3(a) shows image of the skin affected with fungal infection before the application and Fig.3(b) shows that after application of the composition for 3-4 days, the itching, redness, scaling, inflammation associated with tinea infection were completely healed and smooth skin was restored.

The topical composition of the present invention can be made from non-toxic and herbal ingredients and was found not to have any side effects. The composition was found to be very effective in restoring the normal and supple skin. The composition was found to give permanent/long term cure even within 3-5 times of topical application for the skin problems such as scaling, dry skin, foot cracking, eczema etc. In the case of eczema currently no satisfactory cure currently available and the doctors prescribe several medications to alleviate the symptoms of eczema. These include corticosteroid creams and ointments, antiinflammatory medications to relieve inflammation and itchiness. The corticosteroid creams have potential side effects and are not safe to use. The composition of the present invention can therefore be a safe, effective, natural and cheap alternative for the existing treatments for skin ailments such as scaling, dry skin, foot cracks and eczema.

EXAMPLES

The invention is furth er illustrated herein by mean of examples. The following examples are given by way of illustration only and therefore should not be constructed to limit the scope of the present invention.

The invention is illustrated with the help of following examples.

EXAMPLE 1

97.5 g of dried indigofera tinctoria leaves powder was mixed with 2.5 g of CaO powder (in the weight ratio 97.5:2.5). This mixture was stored in tight and dark vessels to prevent the entry of air and light. To 2.5 g of the above mixture was taken and was mixed with 5.5 g of demineralised water to form a paste. The paste is applied on the affected area of skin.

EXAMPLE 2

2.5 g of the mixture of dried indigofera tinctoria leaves powder and CaO powder (in the weight ratio 97.5:2.5) was mixed with 5.5 g of demineralised water to form a paste. This paste was then mixed with 3.0 g of glycerol to form a cream. Then 1.0 g of vetiver oil was added to give fragrance and 0.1g of methyl paraben was added as preservative. This composition was stored closed vessels and was found to be stable for at least 6 months. The cream was applied on the affected area of the skin.

EXAMPLE 3

95.0 g of dried indigofera tinctoria leaves powder was mixed with 5.0 g of MgO powder (in the weight ratio 95.0:5.0). This mixture was stored in tight and dark vessels to prevent the entry of air and light. 2.5 g of the above mixture was taken and was mixed with 6.0 g of demineralised water to form a paste. The paste was applied on the affected area of the skin.

EXAMPLE 4

2.5 g of the mixture (indigofera tinctoria leaves powder and CaO powder) obtained in example 3 was mixed with 5.5 g of demineralised water to form a paste. To the paste 3.0 g of glycerol was added to form a cream. Then 1.0 g of vetiver oil was added to give fragrance and 0.1g of methyl paraben was added as preservative. This composition was stored closed vessels and was found to be stable for at least 6 months. The cream was applied on the affected area of the skin.

EXAMPLE 5

About 0.1 g NaOH was mixed well with 9.99 g of the dried Indigofera tinctoria leaves powder. This mixture was stored in tight and dark vessels to prevent the entry of air and light. 2.5 g of above mixture was taken and mixed with 5.0 g of demineralised water to form a paste. The paste was applied on the affected area of dry skin.

EXAMPLE 6

The paste obtained in example 5 (8.0 g) was mixed with 3.0 g of glycerol to form a cream. Then 1.0 g of vetiver oil was added to give fragrance and 0. 1 g of methyl paraben was added as preservative. This composition was stored closed vessels and was found to be stable for at least 6 months. The cream was applied on the affected area of skin.

EXAMPLE 7

The paste obtained in example 1 (8.0 g) is mixed with 4.28 g of petroleum jelly, 0.5 g of vetiver oil (to give fragrance) and 0.2 g of methyl paraben (added as preservative). This composition was stored closed vessels and was found to be stable for at least 6 months. The paste was then applied on the affected area of skin. EXAMPLE 8

Paste obtained in example 1 (8.0 g) is mixed with 5.0 g of glycerol, 0.6 g of beeswax and 1.0 g of triethanol amine as emulsifier, 1.0 g of vetiver oil (to give fragrance) and 0.2 g of methyl paraben (added as preservative). This composition was stored closed vessels and was found to be stable for at least 6 months.

EXAMPLE 9

The compositions given in example 1-8 and as a control only Indigofera tinctoria leaf powder was mixed with water were applied to the affected skin areas of various patients suffering from skin ailments such as dry skin, foot-cracking, scaling, eczema and fungal infections. The results, after application of the skin compositions, are summarized below.

EXAMPLE 9A

Treatment of Dry skin: The composition given in examples 1 to 8 was applied 1 or 2 times a day on the affected area of dry skin on patient for 3 to 4 days.

The results are tabulated in Table 1: Table 1 It was observed that the dry skin condition was completely cured and natural and supple skin were found to be restored on treating with the composition of Examples 1 to 8.

Example 9B

Treatment of Foot cracking: The affected foot was thoroughly cleaned with soap and soaked in lukewarm salt water for about 15 minutes and allowed to dry. Then the composition given in example 1 to 8 was applied in the affected areas of the foot and some of the surrounding areas for 3-4 consecutive days. Then the foot was kept undisturbed for 30 to 60 minutes.

The results are tabulated in Table 2: Table 2

It was observed that after the application of the medicine for 3 to 4 consecutive days, the dry and thickened skin was found to be completely removed. The Figure 1 shows the before and after images of foot cracking upon applying the composition. The natural and supple skin was restored and foot crack did not recur at least for one year upon treating with composition of

Example 1-8

EXAMPLE 9C

Treatment of Scaling: The composition given in examples 1-8 were applied to the affected areas of the foot of the patient 2 times per day for one week. The results are tabulated in Table 3:

Table 3

It was observed that the flakes sticking to the skin were peeled off. The itching and redness were completely healed and smooth skin appeared within 3-4 days upon treating with the compositions of Example 1-8. EXAMPLE 9D

Treatment of Eczema: The composition, given in examples 1-8, were applied to the affected area of skin of the patient 2 times per day for 2-3 days.

The results are tabulated in Table 4:

Table 4:

The Figure 2(a) is a photograph of an Eczema patient with severe red rashes, bumps, scales on the back of the neck before applying the composition and Fig 2(b) is the photograph of the skin after applying the composition on the affected area 2 times per day for 2-3 days. It was observed that the itching, red rashes, bumps on the skin and scaly, leathery patches of skin associated with eczema were found to be cured and natural and supple skin was restored upon application of the composition in Examples 1-8.

EXAMPLE 9E

Treatment of Fungal infection: The composition given in examples 1-8 were applied to the affected area of skin, showing the characteristics of tinea infections, two times per day for 3-4 days.

The results are tabulated in Table 5:

Table 5:

It was observed that the compositions of Examples 1-8 were effective in reducing the itching, redness, scaling and the inflammation associated with the tinea infections. The Figure 3(a) and 3(b) shows the photographs before and after applying the composition on a patient with fungal infections respectively.

The paste of dried indogofera leaves with water alone (without bases such as Cao, MgO) was found not found to be effective for treating any of the above skin ailments. Hence combining indigofera leaves powder with water and bases selected from MgO, CaO, SrO, BaO, Li ₂ O, Na ₂ O, K ₂ O, Rb ₂ O, Cs ₂ O, LiOH, NaOH, KOH, RbOH, CsOH, Li ₂ CO ₃ , Na ₂ CO ₃ , K ₂ CO ₃ , Rb ₂ CO ₃ and Cs ₂ CO ₃ provides distinct advantages in treating skin disorders such as fungal, scaling, foot-crack, eczema and dry skin diseases. A very fast and permanent/long term cure was observed. The compositions may also be useful in treating other skin disorders like psoriasis, foot com disease.

The foregoing description of specific embodiments of the present invention has been presented for purposes of illustration and description. They are not intended to be exhaustive or to limit the present invention to the precise forms disclosed, and obviously many modifications and variations are possible in light of the above teaching. The embodiments were chosen and described in order to best explain the principles of the present invention and its practical application, to thereby enable others, skilled in the art to best utilize the present invention and various embodiments with various modifications as are suited to the particular use contemplated.

It is understood that various omission and substitutions of equivalents are contemplated as circumstance may suggest or render expedient, but such are intended to cover the application or implementation without departing from the spirit or scope of the present invention.