FIELD OF INVENTION

[001] This invention relates to a herbal formulation for treatment of obesity and hyperlipidemia, and more particularly to the use of extracts of Pterocarpus marsupium, green coffee bean and Caralluma fimbriata for the treatment of obesity and hyperlipidemia; their uses for controlling body weight and serum lipid levels and a process for preparing the same.

BACKGROUND OF INVENTION
[002] Pterocarpus: it belongs to family Legurninnaceae family and includes a number of species. The species include but is not limited to Pterocarpus acapulcensis, Pterocarpus albopubescens, Pterocarpus amazonum, Pterocarpus angolensis, Pterocarpus antunesii, Pterocarpus brenanii, Pterocarpus claessensii, Pterocarpus dalbergioides, Pterocarpus echinatus, Pterocarpus erinaceus, Pterocarpus gilletii, Pterocarpus hockii, Pterocarpus homblei, Pterocarpus indicus, Pterocarpus lucens, Pterocarpus macrocarpus, Pterocarpus marsupium, Pterocarpus mildbraedii, Pterocarpus mutondo, Pterocarpus officinalis, Pterocarpus orbiculatus, Pterocarpus osun, Pterocarpus rohrii, Pterocarpus rotundifolius, Pterocarpus santalinoides, Pterocarpus santalinus, Pterocarpus soyauxii, Pterocarpus ternatus, Pterocarpus tessmannii, Pterocarpus tinctorius, Pterocarpus velutinus, Pterocarpus villosus, Pterocarpus violaceus, Pterocarpus zehntneri and Pterocarpus zenkeri. Pterocarpus is commonly known as Vijaysar in India. Pterocarpus marsupium is found commonly in hilly regions throughout the Deccan Peninsula, and extending to Gujarat, Madhya Pradesh, Uttar Pradesh, Bihar and Orissa states of India.

[003] In traditional practice, diabetic patients were given water which had been allowed to sit overnight in a goblet made from Pterocarpus marsupium heartwood. It turns the water blue as soon as it comes in contact with water. It is considered magical for diabetes. The heartwood of Pterocarpus marsupium is astringent, bitter acrid, anti inflammatory, anthelmintic and anodyne. Pterocarpus marsupium is useful in treating diabetes and heart problems. It is helpful in controlling skin diseases. It is also beneficial in the treatment of fractures, bruises, leprosy, leucoderma, constipation, depurative, rectalgia, ophthalmopathy, hemorrhages and rheumatoid arthritis. It is also good for elephantiasis, leucoderma, diarrhoea, dysentery, rectalgia, cough and greyness of hair. The bark is used as an astringent and to treat toothache. The bruised leaves are considered useful as an external application for boils, sores and skin diseases.

[004] Green coffee bean extracts (GCBE) contains strong antioxidants that belong to polyphenol family. The primary polyphenol antioxidant in green coffee bean extract is in a family known as chlorogenic acids (CGA).

[005] Chlorogenic acids are responsible for many health benefits. It neutralizes free radicals, and addresses the problem of hydroxyl radicals, both of which can lead to cellular degeneration if left unchecked. Chlorogenic acid also helps regulate metabolism. The chlorogenic acid is thought to boost metabolism by changing the way glucose is taken up by the body. Green coffee bean extract also contains caffeic acids, which give a boost to energy levels like regular coffee does.

[006] Caralluma belongs to the family Asclepiadaceae and comprises a number of species. These species include but are not limited to: Caralluma acutangula, Caralluma adscendens, Caralluma burchardii, Caralluma crenulata, Caralluma edulis, Caralluma europaea, Caralluma fimbriata, Caralluma joannis, Caralluma negevensis, Caralluma somalica, Caralluma speciosa, Caralluma indica, Caralluma attenuata, Caralluma tuberculata, Caralluma stalagmifera, Caralluma umbellata, Caralluma penicillata, Caralluma russeliana, Caralluma retrospiciens, Caralluma arabica and Caralluma lasiantha. Some of the species are distributed throughout various parts of India and also found in the wilds of Africa, the Canary Islands, Arabia, Southern Europe, Ceylon and Afghanistan.

[007] Caralluma fimbriata is the most prevalent of the genus, as it grows wild in urban centers, is planted as a roadside shrub, and is commonly used as a boundary-marker in gardens. The species of Caralluma found in India are edible and form part of the traditional medicine system of the country.

[008] Caralluma fimbriata has been eaten for many centuries in rural India. The plant is consumed in several forms. It is cooked as a regular vegetable in some regions of India. It may be cooked with spices, used in sauce and pickles, and sometimes may be eaten raw.

[009] Indian tribesmen have been using Caralluma fimbriata during their hunting trips as portable food for hunting.

[0010] Obesity is considered as one of the most important nutritional diseases in both developing and developed countries of the world. Key lifestyle parameters like increasing preference for mass-produced food over traditional home cuisine, increased intake of sugar and fatty foods, stress and lack of aerobic activity, all contribute to unhealthy weight gain.

[0011] Excessive body weight is no longer regarded merely as a cosmetic problem rather it is a causal factor in chronic conditions like diabetes, atherosclerosis, hypertension, bone disorder, endocrine dysfunction and other ailments. In addition to physiological ailments, excessive body weight can pose challenges to mental well-being. Such patients are predisposed to lower self-esteem, clinical depression, anxiety neuroses and eating disorders.

[0012] Weight reduction and other related treatments such as regulation of BMI (Body Mass Index), an increase of lean mass, and an increase of BMR (Basal Metabolic Rate), are also being increasingly adopted by people who are not clinically obese but desire to feel and look good for personal or social reasons.

[0013] The known pharmaceutical options for treatment of obesity, that is, for weight reduction are: thermogenesis methods, lipase inhibitors, and compounds that suppress appetite and/or stimulate the central nervous system (CNS).

[0014] The thermogenesis methods involve the increase of the body core temperature slightly. Increase of body core temperature increases the metabolism of the deposited lipids in the body. Thermogenesis drugs act on the brain and the thyroid gland, resulting in the increase of the body core temperature.

[0015] The lipase inhibitors work by reducing absorption of the fat in the intestine system. Thus, when a lipase inhibitor is administered to a subject, the fat portion of the food consumed by the subject passes through his intestinal system unabsorbed and is excreted into stools.

[0016] The appetite suppressants/CNS stimulators modify the levels of neurotransmitters such as catecholamine and serotonin in the blood, leading to a decreased feeling of hunger.

[0017] Therefore, there is a need for a new formulation or food additive that deals with weight reduction and helps in the control of lipid levels in the body.

OBJECT OF INVENTION

[0018] A primary object of the invention is to provide a herbal formulation for obesity and hyperlipidemia.

[0019] Another object of the invention is to use Pterocarpus extract along with green coffee bean extract and Caralluma extract for obesity that provides solutions for weight reduction.

[0020] Another object of the invention is to provide a herbal formulation where extracts of Pterocarpus, green coffee bean extract, Caralluma and additional herbs may also be used to obtain an effective and synergistic formulation that enhances the activity of the Herbal formulation for anti-obesity and hyperlipidemia.

[0021] Another object of the invention is to provide a herbal formulation in a tablet form for treatment of obesity and hyperlipidemia.

[0022] Another object of the invention is the use of aqueous extract of herbs for management of obesity.

[0023] Yet another object of the present invention to provide a process of preparation of the herbal formulation containing Pterocarpus marsupium, green coffee bean extract and Caralluma extract.

[0024] These and other aspects of the embodiments herein will be better appreciated and understood when considered in conjunction with the following description and the accompanying drawings. It should be understood, however, that the following descriptions, while indicating preferred embodiments and numerous specific details thereof, are given by way of illustration and not of limitation. Many changes and modifications may be made within the scope of the embodiments herein without departing from the spirit thereof, and the embodiments herein include all such modifications.

DETAILED DESCRIPTION OF INVENTION

[0025] The embodiments herein and the various features and advantageous details thereof are explained more fully with reference to the non-limiting embodiments that are illustrated in the accompanying drawings and detailed in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein. The examples used herein are intended merely to facilitate an understanding of ways in which the embodiments herein may be practiced and to further enable those of skill in the art to practice the embodiments herein. Accordingly, the examples should not be construed as limiting the scope of the embodiments herein.

[0026] The invention provides a herbal formulation for controlling body weight and serum lipid levels that contains extracts of Pterocarpus plant, Green Coffee Bean and Caralluma plant.

[0027] In another embodiment, the invention provides a herbal formulation including Pterocarpus plant extract, a Green Coffee bean extract, and a Caralluma extract; and at least one pharmaceutically acceptable carrier.

[0028] In another embodiment, the invention provides a method of preventing and/or treating a subject suffering or having predisposition to suffering therefrom, to obesity and/or hyperlipidemia, the method including administering to the subject a therapeutically effective amount of a herbal formulation, the herbal formulation further comprising of a Pterocarpus plant extract, a Green Coffee Bean extract, and a Caralluma plant extract, and at least one pharmaceutically acceptable carrier.

[0029] The Pterocarpus plant is selected from the group consisting of Pterocarpus acapulcensis, Pterocarpus albopubescens, Pterocarpus amazonum, Pterocarpus angolensis, Pterocarpus antunesii, Pterocarpus brenanii, Pterocarpus claessensii, Pterocarpus dalbergioides, Pterocarpus echinatus, Pterocarpus erinaceus, Pterocarpus gilletii, Pterocarpus hockii, Pterocarpus homblei, Pterocarpus indicus, Pterocarpus lucens, Pterocarpus macrocarpus, Pterocarpus marsupium, Pterocarpus mildbraedii, Pterocarpus mutondo, Pterocarpus officinalis, Pterocarpus orbicularis, Pterocarpus osun, Pterocarpus rohrii, Pterocarpus rotundifolius, Pterocarpus santalinoides, Pterocarpus santalinus, Pterocarpus soyauxii, Pterocarpus ternatus, Pterocarpus tessmannii, Pterocarpus tinctorius, Pterocarpus velutinus, Pterocarpus villosus, Pterocarpus violaceus, Pterocarpus zehntneri, Pterocarpus zenkeri and mixtures thereof; and the Caralluma plant is selected from the group consisting of Caralluma acutangula, Caralluma adscendens, Caralluma burchardii, Caralluma crenulata, Caralluma edulis, Caralluma europaea, Caralluma fimbriata, Caralluma joannis, Caralluma negevensis, Caralluma somalica, Caralluma speciosa, Caralluma indica, Caralluma attenuata, Caralluma tuberculata, Caralluma stalagmifera, Caralluma umbellata, Caralluma penicillata, Caralluma russeliana, Caralluma retrospiciens, Carallvima Arabica, Caralluma lasiantha and mixtures thereof.

[0030] In a preferred embodiment, the Pterocarpus plant is Pterocarpus marsupium and the Caralluma plant is Caralluma fimbriata.

[0031] Additional herbs may also be used to enhance the activity of the herbal formulation. In a preferred embodiment of the invention, Pterocarpus marsupium, Green Coffee Bean extract and Caralluma fimbriata may be added in a 2:1:2 ratio in the herbal formulation. Within the scope of the invention, the 1 herbal formulation may comprise of additional components that enhance the performance of the herbal formulation synergistically or otherwise, or that complement extracts in terms of the action or in providing additional effects.

[0032] Typical compositions of the herbal extract of the invention are given below. In an embodiment, the herbal composition may be present in the form of a tablet. In an embodiment, each tablet of 500mg may contain:

[0033] Pterocarpus marsupium: It is a large deciduous tree. It is one of the most highly valued trees of Eastern herbal medicine. Pterocarpus marsupium is an important element of the herbal formulation. It is used in the herbal formulation to lower the lipid and glucose level in body. It is also used for its cholesterol reduction activity. The tree's golden heartwood has been found to contain high concentrations of flavonoids, believed to be the source of the tree's chemical potency. Preferably, bark or heartwood of Pterocarpus marsupium may be used for the formulation.

[0034] Green coffee bean: Green coffee bean is rich in chlorogenic acid and its related compounds. The green coffee bean extract (GCBE) is used in the herbal formulation to act on fat accumulation and body weight and promotes lipolysis. Caffeine present in GCBE promotes glucose consumption with an increase in blood epinephrine and promotes ventilation and enhances lipolysis. Chlorogenic acid, another main constituent of coffee beans, selectively inhibit hepatic glucose-6-phosphatase, which is a rate-limiting enzyme involved in gluconeogenesis. However, roasting of coffee beans has been shown to reduce the content of chlorogenic acid in coffee. Studies carried out on Wistar albino rats suggests that GCBE is possibly effective against weight gain and fat accumulation by inhibition of fat absorption and activation of fat metabolism in the liver. GCBE is used in the herbal formulation for assisting the body to burn a higher proportion of lipids (fats) compared to carbohydrates.

[0035] Extract of Caralluma fimbriata along with Pterocarpus marsupium extract, Green coffee bean extract and the effects thereof in said control and management of weight reduction is established by animal tests. Studies carried out on Wistar albino rats suggest that the herbal formulation was well tolerated.

[0036] Caralluma fimbriata has been used in the herbal formulation as an appetite suppressant to complement the role of Pterocarpus marsupium and Green Coffee Bean Extract.

[0037] In addition to Pterocarpus marsupium extract, Green coffee bean extract and Caralluma extract; the herbal extract may contain additional herbs having similar activity (such as hyperlipidemic, appetitie suppressant, fat burning). The use of additional herbs is to enhance the activity and efficacy of the herbal formulation. Additional herbs within the scope of the invention comprise of:

• Betula bhojapatra;
• Terminalia arjuna
• Pongamia pinnata;
• Acacia catechu;
• Albizzia lebbek;
• Dalbergia latifolia;
• Santalum album;
• Pterocarpus santalinus;
• Berberis aristata;
• Butea monosperma;
• Aquillaria agalocha;
• Acacea Arabica;
• Holarrhena antidysentrica

[0038] Within the scope of the invention, the solvent utilized for the extraction of Pterocarpus, Green Coffee Bean, Caralluma or more specifically Pterocarpus marsupium, Green Coffee bean, Caralluma fimbriata along with additional herbs comprises of water, low molecular weight alcohols, esters, hydrocarbons, ketones, halogen-containing hydrocarbons, and mixtures thereof.

[0039] The present invention also pertains to the process of preparation of the herbal formulation comprising the extracts of Pterocarpus, Green Coffee Bean, Caralluma or more specifically Pterocarpus marsupium, Green Coffee bean, Caralluma fimbriata.

[0040] In one embodiment of the invention, the process of preparation of the herbal formulation involves the sifting of the extracts of Pterocarpus, Caralluma fimbriata, Coffee bean extract, Sodium lauryl Sulphate and starch-1500 (LM). The collected sifted material is then mixed. The material obtained is referred to as the "Mixed Bulk". Povidone (PVPK-30) is added and dissolved in Isopropyl alcohol to obtain a solution referred to as the 'Binder Solution'. The Binder Solution is added and mixed with the Mixed Bulk. Once both the materials have been completely added, the resulting mass is further mixed. The wet mass is then milled using a Multimill to obtain wet granules. The wet granules are then dried to the desired level of moisture content. The granules obtained are then sifted using a sifter. The granules obtained are then collected to check the weight of the granules. Further, the granules are transferred and mixed.

[0041] Crospovidone (Plasdone XL-10), Talc and Colloidal silicon dioxide, Croscarmellose Sodium are sifted using a sifter. The obtained sifted lubricants and the granules are then mixed and compressed under appropriate compression parameters.

Extraction methods: Extraction method of coffee bean extracts

[0042] In an embodiment, the ground coffee bean extract of the invention is extracted with methanol in a soxhlet extractor. Preferably, said ground coffee bean of 50gm is extracted with 500 ml of methanol. Further, methanol is distilled from the extract and the crude product is continuously extracted with dichloromethane. The dichloromethane extract is then discarded. Further, said residue is dissolved in 200ml of aqueous methanol and filtered. Finally, the filtrate is then spray dried to give a pale brown powder. The proportions of said coffee bean therein can have any set values within the scope of the invention.

[0043] Other methods generally known to a person skilled in the art may also be used for extraction of Coffee Bean extract.

Extraction methods: Extraction Method for other ingredients
[0044] The herbal extract of the invention is a suspension. Preferably, 50g of powdered herbs are suspended in 500ml of water and then heated under reflux in a 1L flask for 5 hours. Further, the contents are filtered hot under vacuum and the dark brown filtrate is concentrated to thick syrup on a rotary evaporator. The final volume should be about 50 ml. Finally, the concentrate is
then spray dried or freeze dried to give a brown powder, weighing about 5-6g in different runs. The proportions of said herbs therein can have any set values within the scope of the invention.

[0045] Other methods generally known to a person skilled in the art may also be used for extraction of Pterocarpus, Caralluma and the additional herbs.

[0046] According to the invention, the herbal formulation helps in faster and quicker reduction in body weight and serum lipid levels.

[0047] In an embodiment, the herbal formulation may be composition for oral administration. For oral administration, the extracts may be provided as a tablet, aqueous or oil suspension, dispersible powder or granule, emulsion, hard or soft capsule, syrup, elixir, or beverage. Compositions intended for oral use may be prepared according to any method known in the art for the manufacture of pharmaceutically acceptable compositions and such compositions may contain one or more of the following agents: sweeteners, flavoring agents, coloring agents and preservatives. The sweetening and flavoring agents will increase the palatability of the preparation. Tablets ! containing extracts in admixture with non-toxic pharmaceutically acceptable excipients suitable for tablet manufacture are acceptable. Pharmaceutically acceptable means that the agent should be acceptable in the sense of being compatible with the other ingredients of the formulation (as well as non-injurious to the patient).

[0048] The invention provides for the methods of control and management of obesity and said obesity related symptoms/disorders and for said alteration/improvement/regulation by the administration of effective doses of said herbal formulation) or said mixtures or said extracts. Further, the invention provides for herbal formulation compositions for said uses and methods.

[0049] Various embodiments and variations other than described hereinabove that are within the scope of the invention.

[0050] The uses and methods of this invention may be adopted for control/regulation of one or more Parameters/conditions/functions to be brought in line with the particular/desired values.

[0051] The invention is further illustrated by the following examples, which should not be construed to limit the scope of the invention in anyway.

FORMULA: - (Core)

Coating formula:-

Process for Preparation:

[0052] Extracts of Pterocarpus, Caralluma fimbriata, Coffee bean, Sodium lauryl Sulfate and Starch - 1500 (LM) are sifted through 30 meshes invibratory sifter. The sifted material is collected in polylined containers. The collected sifted material is then transferred into a Rapid Mixer Granulator and the contents mixed for 20 minutes. The material obtained is referred to as the
"Mixed Bulk".

[0053] Povidone (PVPK-30) is added and dissolved into Isopropyl alcohol [IP], with continuous stirring. The solution obtained is referred to as the 'Binder Solution'. The Binder Solution is added and mixed with the Mixed Bulk. Once both the materials have been completely added, the resulting mass is further mixed for 10 minutes. After mixing, sides of the mixer and blades are
scraped and the mixing is continued for another 5 minutes.

[0054] The wet mass is then milled through 8 mm screen using a Multimill (knives forward, slow speed) to obtain wet granules. The wet granules are then loaded in a bowl of Fluid bed dryer and dried at 45°C to the desired level of moisture content (preferable moisture content is 2.0 - 3.0 %).

The drying time generally required to dry the material to the desired level of moisture content is 10 to 15 min.

[0055] The granules obtained are then sifted through 16 meshes using a vibratory sifter. The granules still remaining on the 16 meshes are milled /through a screen of 2 mm using a Multimill (knives forward, slow speed). The granules obtained are then collected in polylined containers to check the weight of the granules. Further, the granules are transferred into an octagonal blender and mixed for 3 minutes. The moisture content is preferably within 2.0-3.0 %.

[0056] Plasdone XL-10, Talc and Colloidal silicon dioxide, CCS. (Croscarmellose Sodium) are sifted through 40 meshes using vibratory sifter. The sifted lubricants obtained and the granules are then transferred into a double cone blender and mixed for 5 minutes. The resulting lubricated granules are then loaded onto a suitable size clean polylined containers.

[0057] Under appropriate compression parameters the granules are further compressed using 16.5 x 8.5 mm punches oblong shaped with break line on upper punches, plain on lower punches and dies.

[0058] Mix the Instamoist shield (IC-MS-6798) in isopropyl alcohol and add dichloromethane with continuous stirring. Mill the slurry through colloid mill, pass through 200 mesh nylon cloth and collect in suitable container. Coat the tablets by spraying the coating solution continuously.

[0059] The invention is further described by reference to the following examples by way of illustration only, and should not be construed to limit the scope of the present invention. It will be apparent to those skilled in the art that many modifications, both to materials and methods, may be practiced without departing from the scope of the present invention.

Efficacy study of the Herbal formulation:
[0060] Hyperlipidaemia was induced in Wistar albino rats by giving a high fat diet (Vanaspati and coconut oil with 3:2 ratio at a dose of lOml/kg body weight) for 28 days. Obesity and hyperlipidaemia was confirmed by comparing the higher values of total cholesterol, triglyceride, high density lipoprotein cholesterol and very low density lipoprotein cholesterol and body weight of control group II, group III, group IV, group V, group VI with normal control group I. Herbal formulation extract was dissolved in distilled water and was given from day 30 to 56. Blood was collected on day 28,42 and 56 for the estimation of serum biochemical parameters such as, total cholesterol, triglyceride, high density lipoprotein cholesterol and very low density lipoprotein cholesterol. There was significant decrease in total cholesterol, triglyceride, high density lipoprotein cholesterol and very low density lipoprotein cholesterol at high dose (90 mg/kg) as compared to other test groups (low dose and medium dose, 15 and 30 mg/kg, respectively). No significant decrease was observed in these parameters when high dose group VI compared with standard control group III (Atorvastatin, 1 mg/kg).

Furthermore, there were also significant decrease in body weight and feed intake in the treatment groups (groups IV, V and VI) as compared to normal control group I. This observation was further substantiated by histo-pathological changes. Therefore, Herbal formulation extract at high dose 90mg/kg was effective in controlling the obesity and hyperlipidaemia.
Toxicity study of the Herbal formulation:

[0061] Apart from efficacy study the sub chronic toxicity study was also carried out for the herbal formulation. Sub chronic toxicity study was carried out in the Wistar albino rats as per the OECD guidelines 408. The herbal formulation was given at the dose rate of 15, 30 and 90 mg/kg for 90 days and compared with the normal control group I. It was observed that there were no significant (P>0.05) alterations found in the body weight, hematological (Hb, PCV, TEC, TLC), biochemical parameters (Serum ALT, AST, BUN and creatinine), gross and histopathological observations compared to normal control group I indicating that the herbal formulation was non toxic for the dose and duration studied.

[0062] In summary, the herbal formulation was effective in controlling the experimentally induced obesity and hyperlipidaemia (significantly reduced total cholesterol, triglycerides, LDL cholesterol and VLDL cholesterol) in rats in the dose of 90mg/kg.

[0063] The herbal formulation was found to be non toxic for all the three doses (15,30 and 90 mg/kg) in the sub-chronic toxicity study.

CLAIMS
We claim,

1. A herbal formulation comprising Pterocarpus plant extract, green coffee bean extract and Caralluma plant extract.

2. The herbal formulation of claim 1, wherein the Pterocarpus plant is selected from the group consisting of Pterocarpus acapulcensis, Pterocarpus albopubescens, Pterocarpus amazonum, Pterocarpus angolensis, Pterocarpus antunesii, Pterocarpus brenanii, Pterocarpus claessensii, Pterocarpus dalbergioides, Pterocarpus echinatus, Pterocarpus erinaceus, Pterocarpus gilletii, Pterocarpus hockii, Pterocarpus homblei, Pterocarpus indicus, Pterocarpus lucens, Pterocarpus macrocarpus, Pterocarpus marsupium, Pterocarpus mildbraedii, Pterocarpus mutondo, Pterocarpus officinalis, Pterocarpus orbiculatus, Pterocarpus osun, Pterocarpus rohrii, Pterocarpus rotundifolius, Pterocarpus santalinoides, Pterocarpus santalinus, Pterocarpus soyauxii, Pterocarpus ternatus, Pterocarpus tessmannii, Pterocarpus tinctorius, Pterocarpus velutinus, Pterocarpus villosus, Pterocarpus violaceus, Pterocarpus zehntneri, Pterocarpus zenkeri and mixtures thereof; and the Caralluma plant is selected from the group consisting of Caralluma acutangula, Caralluma adscendens, Caralluma burchardii, Caralluma crenulata, Caralluma edulis, Caralluma europaea, Caralluma fimbriata, Caralluma joannis, Caralluma negevensis, Caralluma somalica, Caralluma speciosa, Caralluma indica, Caralluma attenuata, Caralluma tuberculata, Caralluma stalagmifera, Caralluma umbellata, Caralluma penicillata, Caralluma russeliana, Caralluma retrospiciens, Caralluma Arabica, Caralluma lasiantha and mixtures thereof.

3. The herbal formulation of claim 1, wherein the Pterocarpus plant is Pterocarpus marsupium and the Caralluma plant is Caralluma fimbriata.

4. The herbal formulation of claim 1, further comprising of at least one ingredient selected from the group consisting of Betula bhojapatra, Terminalia arjuna, Pongamia pinnata, Acacia catechu, Albizzia lebbek, Dalbergia latifolia, Santalum album, Pterocarpus santalinus, Berberis aristata, Butea monosperma, Aquillaria agalocha, Acacea Arabica, Holarrhena antidysentrica and mixtures thereof.

5. The herbal formulation of claim 1 which is obtained using an extraction medium comprising at least one solvent selected from the group consisting of water, low molecular weight alcohols, esters, hydrocarbons, ketones, halogen-containing hydrocarbons, and mixtures thereof.

6. The herbal formulation of claim 1 according to any one of the preceding claims further comprising of one or more pharmaceutically acceptable carrier.

7. A method of preventing and/or treating a subject suffering or having predisposition to suffering therefrom, to obesity and/or hyperlipidemia, the method comprising of administering to the subject a therapeutically effective amount of a herbal formulation, the herbal formulation further comprising of a Pterocarpus plant extract, a Green Coffee Bean extract, and a Caralluma plant extract, and at least one pharmaceutically acceptable carrier.

8. The method of claim 7, wherein the Pterocarpus plant is selected from the group consisting of Pterocarpus acapulcensis, Pterocarpus albopubescens, Pterocarpus amazonum, Pterocarpus angolensis, Pterocarpus antunesii, Pterocarpus brenanii, Pterocarpus claessensii, Pterocarpus dalbergioides, Pterocarpus echinatus, Pterocarpus erinaceus, Pterocarpus gilletii, Pterocarpus hockii, Pterocarpus homblei, Pterocarpus indicus, Pterocarpus lucens, Pterocarpus macrocarpus, Pterocarpus marsupium, Pterocarpus mildbraedii, Pterocarpus mutondo, Pterocarpus officinalis, Pterocarpus orbicularis, Pterocarpus osun, Pterocarpus rohrii, Pterocarpus rotundifolius, Pterocarpus santalinoides, Pterocarpus santalinus, Pterocarpus soyauxii, Pterocarpus ternatus, Pterocarpus tessmannii, Pterocarpus tinctorius, Pterocarpus velutinus, Pterocarpus villosus, Pterocarpus violaceus, Pterocarpus zehntneri and Pterocarpus zenkeri; and the Caralluma plant is selected from the group consisting of Caralluma acutangula, Caralluma adscendens, Caralluma burchardii, Caralluma crenulata, Caralluma edulis, Caralluma europaea, Caralluma fimbriata, Caralluma joannis, Caralluma negevensis, Caralluma somalica, Caralluma speciosa, Caralluma indica, Caralluma attenuata, Caralluma tuberculata, Caralluma stalagmifera, Caralluma umbellata, Caralluma penicillata, Caralluma russeliana, Caralluma retrospiciens, Caralluma Arabica and Caralluma lasiantha.

9. The method of claim 8, wherein the Pterocarpus plant is Pterocarpus marsupium and the Caralluma plant is Caralluma fimbriata.

10. The method of claim 7, further comprising of at least one ingredient selected from the group consisting of Betula bhojapatra, Terminalia arjuna, Pongamia pinnata, Acacia catechu, Albizzia lebbek, Dalbergia latifolia, Santalum album, Pterocarpus santalinus, Berberis aristata, Butea monosperma, Aquillaria agalocha, Acacea Arabica, Holarrhena antidysentrica and mixtures thereof.

11. A process for preparing an extract, the process comprising: (i) providing a Pterocarpus plant, a Green Coffee Bean plant, a Caralluma plant, or mixtures thereof; (ii) providing an extraction medium comprising at least one solvent selected from the group consisting of water, low molecular weight alcohols, esters, hydrocarbons, ketones, halogen-containing hydrocarbons, and mixtures thereof; and (iii) contacting the Pterocarpus plant, a Green Coffee Bean plant, a Caralluma plant, or mixtures thereof with the extraction medium