DESC:FIELD OF THE INVENTION
The present invention is directed to an herbal composition with anti-inflammatory, analgesic, anti-pyretic properties for alleviation of arthritis and gout. More particularly, the invention relates to a composition comprising of extracts of Ixora parviflora, Buchanania lanzan, Ficus benghalensis, Carum carvi, Brassica nigra and Allium sativum herbs as active ingredients and process of preparation thereof.

BACKGROUND OF THE INVENTION
Arthritis is a chronic syndrome characterized by inflammation of the peripheral joints, while gout manifests itself as an inflammation of the lower leg. For brevity, reference to arthritis mentioned herein below should be understood as comprehending gout, since the fundamental difference between arthritis and gout is the location of inflamed joints. Symptoms of arthritis include pain and limited function of joints. Symptoms associated with inflammation of the joints include joint stiffness, swelling, redness, warmth, swelling and tenderness. Advanced stages may result in loss of range of motion and deformity. Certain forms of arthritis can also be associated with pain and inflammation of tendons surrounding joints.

The treatment of arthritis depends on the particular form of arthritis, its location, severity, persistence, and any underlying background medical conditions of the patient. Treatment regimen for the disease can incorporate home remedies, non-prescription and prescription medications, joint injections and surgical operations. Some treatment programs involve weight reduction and avoiding activities that exert excessive stress on the joint. The major goal of treatment is to reduce associated symptoms such as, joint pain and inflammation while preventing damage, improving, and maintaining joint function. Beside, over-the-counter medications can also be used to control pain and inflammation in the joints.

Present treatment of arthritis includes first line drugs for control of pain and inflammation classified as non- steroidal anti-inflammatory drugs (NSAIDs), e.g., aspirin, ibuprofen, naproxen, methotrexate, etc. Secondary treatments include corticosteroids, slow acting anti-rheumatic drugs (SAARDs) or disease modifying drugs (DMs), e.g., penicillin amine, cyclophosphamide, gold salts, azothipprine, levamisole, etc. Besides, Canes, crutches, walkers or splints may help relieve the stress and strain on arthritic joints. Certain exercises and physical therapy may be used to decrease stiffness and to strengthen the weakened muscles around the joint.

TNF-a is an inflammatory mediator and one of the key cytokines involved in the process of chronic joint inflammation and the concomitant erosive changes in cartilage and bone. Reduction in the amount of these cytokines is used as an effective therapy to prevent the development of arthritis. Interleukin 6 (IL-6) is another pleiotropic cytokine with a pivotal role in the pathophysiology of rheumatoid arthritis. It is found in abundance in the synovial fluid and serum of patients with rheumatoid arthritis. Due to implication of IL-6 in promotion of synovitis and joint destruction, blockade of IL-6 using antibodies is a desirable therapeutic option in the treatment of rheumatoid arthritis.

Major limitation associated with the use of foregoing drugs is a variety of side effects and most of these drugs are cytotoxic. Moreover, the effects of synthetic drugs are mainly of short term duration. Usage of these drugs over extended periods of time is harmful due to association with the side effects they produce, e.g., gastric erosion, and adverse effects on the kidneys and liver. Further the drugs used at present are costly and have low benefit-risk ratios. There still remains a need for alternative therapies for the management of arthritis which are moderate in cost, safe, efficacious and which eliminate the need for allopathic drugs and their associated side effects, particularly over prolonged daily use.

Although herbs having anti-inflammatory properties are known, it is continually desirable to provide herbal compositions which have improved anti-inflammatory properties, particularly by reducing the levels of circulating cytokines such as TNF- a and IL-6.

Thus, the dire and perpetual need to develop herbal medication for arthritis and associated pain, inflammation and other complications is for the reasons enumerated below:
i) since arthritis is growing prevalent among both, old age and young age groups, there is a need of medication that is readily available at affordable price for a common man;
ii) Despite the wide spread diseases or conditions, therapeutic options are limited and effectiveness of therapies remains insufficient.
iii) The herbal medications are considered safer than some of the conventional modern synthetic drugs and therapies, which may show severe life-threatening side effects;
The present invention satisfies the existing needs, as well as others, and generally overcomes the deficiencies found in the prior art.

The above-described deficiencies of existing medicaments are merely intended to provide an overview of some of the problems of existing medicines, and are not intended to be exhaustive. Other problems with existing medications and corresponding benefits of the various non-limiting embodiments described herein may become further apparent upon review of the following description.

Groupings of alternative elements or embodiments of the invention disclosed herein are not to be construed as limitations. Each group member can be referred to and claimed individually or in any combination with other members of the group or other elements found herein. One or more members of a group can be included in, or deleted from, a group for reasons of convenience and/or patentability.

Several herbal formulations are available for the treatment of inflammation, but these medications have unpleasant side effects. Therefore, there has been a constant need for developing a herbal alternative for the same. Researches in the field have resulted in various herbal formulations based on plants extracts.

US6391346B1 presents a herbal formulation for relief in skin inflammation and also helps in reducing sleeping disorders and is formulated out of extracts of hops, chamomile, ginger, valerian and Melissa, holy basil, turmeric, scutellaria baicalensis and chamomile. This formulation is claimed for helping in skin inflammation and sleep disorders and not arthritis related problems per se.

US20060263449A1 defines a herbal composition for treatment of the skin inflammation and pain and is formulated out of the extracts of Andrographis paniculata Nees. The extracts so used are for curing skin inflammation and pain and which provides relief to pain and inflammation and no permanent treatment of arthritis.

US6387416B1 defines a herbal composition for reducing skin inflammation and is formulated out of the extracts of holy basil, turmeric, scutellariae baicalensis, rosemary, green tea, huzhang, Chinese goldthread, and barberry. The extracts so used are for reducing skin inflammation only and no permanent relief to arthritis problems.

There is a continuous need for developing new, effective, safe and cheaper herbal formulation for the treatment of arthritis.

Therefore, the innovator has formulated a herbal composition for effectively treating the arthritis. Further, the combination comprises of two herbal ingredients and therefore easy to prepare in comparison to formulations comprising of multiple herbal ingredients.

OBJECTS OF THE INVENTION
The main object of the invention is to provide an anti-inflammatory and anti-arthritic herbal extract comprising solvent extracts from stem bark of Ixora parviflora, stem bark of Buchanania lanzan, stem bark of Ficus benghalensis, seeds of Carum carvi, seeds of Brassica nigra and bulbs of Allium sativum.

Another objective of the present invention is to provide a method of preparation of the herbal extract comprising solvent extracts from stem bark of Ixora parviflora, stem bark of Buchanania lanzan, stem bark of Ficus benghalensis, seeds of Carum carvi, seeds of Brassica nigra and bulbs of Allium sativum.

SUMMARY OF THE INVENTION
The following presents a simplified summary of the invention in order to provide a basic understanding of some aspects of the invention. This summary is not an extensive overview of the present invention. It is not intended to identify the key/critical elements of the invention or to delineate the scope of the invention. Its sole purpose is to present some concept of the invention in a simplified form as a prelude to a more detailed description of the invention presented.

One or more of the problems of the conventional prior art may be overcome by various embodiments of the present invention.

It is a primary object of the invention to provide an anti-inflammatory and anti-arthritic herbal extract comprising;
solvent extracts from stem bark of Ixora parviflora, stem bark of Buchanania lanzan, stem bark of Ficus benghalensis, seeds of Carum carvi, seeds of Brassica nigra and bulbs of Allium sativum,
wherein solvent extract comprises 2-50 w/w of actives from Ixora parviflora,
wherein solvent extract comprises 2-15 w/w of actives from Buchanania lanzan,
wherein solvent extract comprises 2-15 w/w of actives from Ficus benghalensis,
wherein solvent extract comprises 2-8 w/w of actives from Carum carvi,
wherein solvent extract comprises 2-8 w/w of actives from Brassica nigra,
wherein solvent extract comprises 2-6 w/w of actives from Allium sativum.

It is another object of the invention to provide a herbal extract, wherein the solvent can be selected from water, alcohol and a combination thereof.

It is another object of the invention to provide a herbal extract, wherein the solvent is an alcohol selected from the group consisting of methanol, ethanol, iso-propanol, and butanol.

It is yet another object of the invention to provide a method of preparation of herbal extract comprising steps of;
A) washing, drying and grinding of stem bark of Ixora parviflora, stem bark of Buchanania lanzan, stem bark of Ficus benghalensis, seeds of Carum carvi, seeds of Brassica nigra and bulbs of Allium sativum to get the powdered forms of herbs;
B) taking the powdered herbs from step (A) in a solvent to form a solution;
C) evaporating the solution obtained in step (B) by boiling to concentrate the extract to half of its initial volume; and
D) concentrating the herbal extract from step (C) to obtain a concentrate.

It is another object of the invention to provide a method of preparation of herbal extract as, wherein the solvent is selected from water, alcohol and a combination thereof.

It is another object of the invention to provide a method of preparation of herbal extract, wherein the solvent is an alcohol selected from the group consisting of methanol, ethanol, iso-propanol, and butanol.

DETAILED DESCRIPTION OF THE INVENTION
The present invention is thus directed to be a herbal composition for treatment of inflammation, arthritis and associated symptoms comprising of pharmaceutically effective amounts of Ixora parviflora, Buchanania lanzan, Ficus benghalensis, Carum carvi, Brassica nigra and Allium sativum.
The terms and words used in the following description and claims are not limited to the bibliographical meanings, but, are merely used by the inventor to enable a clear and consistent understanding of the invention.

Accordingly, it should be apparent to those skilled in the art that the following description of exemplary embodiments of the present invention are provided for illustration purpose only and not for the purpose of limiting the invention as defined by the appended claims and their equivalents.

It is to be understood that the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise.

It should be emphasized that the term “comprises/comprising” when used in this specification is taken to specify the presence of stated features, integers, steps or components but does not preclude the presence or addition of one or more other features, integers, steps, components or groups thereof.

It is also understood that the terms “washing”, “powdering”, “drying", "extracting", “concentrating” used herein intend to cover all kinds of conventional methods used for the said purpose.

The term “herbal composition” as used herein, intends to cover herbal composition having anti-inflammatory and anti-arthritic activity and useful in treating inflammation, arthritis and associated complications.

The term “Arthritis” as used herein includes arthritis of all types’ mainly osteoarthritis and rheumatoid arthritis and refers to a condition characterized by a pain in the joints.

As used herein, "treatment", “management” and "treating" and the like generally mean obtaining a desired pharmacological and physiological effect. The effect may be prophylactic in terms of preventing or partially preventing a disease or symptom or condition thereof and/or may be therapeutic in terms of a partial or complete cure of a disease, condition, symptom or adverse effect attributed to the same. The term "treatment" as used herein covers any treatment of a disease or condition in a mammal, particularly a human, and includes: (a) preventing the disease or condition from occurring in a subject which may be predisposed to the disease or condition but has not yet been diagnosed as having it; (b) inhibiting the disease or condition, i.e., arresting its development; or relieving the disease or condition, i.e., causing regression of the disease or conditions or its symptoms.

The term “subject” as used herein refers to mammals. For examples, mammals contemplated by the present invention include humans and the like.
In an embodiment of the present invention, the herbal composition of the invention comprises of about 2-50% w/w of at least one part of Ixora parviflora, about 2-15% w/w of at least one part of Buchanania lanzan, about 2-15% w/w of at least one part of Ficus benghalensis, about 2-8% w/w of at least one part of Carum carvi, about 2-8% w/w of at least one part of Brassica nigra and about 2-6% w/w of at least one part of Allium sativum

In a preferred embodiment the parts of Ixora parviflora, Buchanania lanzan, Ficus benghalensis, Carum carvi, Brassica nigra and Allium sativum preferably includes stem bark of Ixora parviflora, stem bark of Buchanania lanzan, stem bark of Ficus benghalensis, seeds of Carum carvi, seeds of Brassica nigra, and bulbs of Allium sativum.

Details of the herbal ingredients of the composition:
Ixora parviflora: Ixora parviflora belongs to the Ixora genus under the Rubiaceae family. It is a small, much branched tree. The leaves of Ixora parviflora vary from ovate-oblong to cuneate-obovate, bluntish or short-pointed, and are about 3-4 inches long. Flowers are small, numerous, white or pink, and distinctly fragrant too. Flower tube is short, hairless, 7.5-10 mm long, with 4 oblong-linear petals with curled margins. The plant generally flowers in the month of March or April. The herb has been traditionally been used for the purpose for curing cough, protecting liver, inhibits viral growth and relieve spasm of smooth muscle.
Buchanania lanzan: Buchanania lanzan belongs to the Buchanania genus under Anacardiaceae family. It is a deciduous tree which produces seeds edible by humans. It is known as charoli. These Almond-flavored seeds are used as a cooking spice primarily in India. Buchanania lanzan is cultivated across India. After the hard shell is cracked, the stubby seed within is as soft as a pine nut. The Buchanania lanzan seed is lentil-sized, is slightly flattened and has an almond-like flavour. Though they can be eaten and used raw they are often toasted or roasted before use.it is useful in curing blood disorders, skin disorders and nasal bleeding, also relieves in constipation.

Ficus benghalensis: Ficus benghalensis belongs to the Ficus genus under Moraceae family. It is commonly known as the banyan, banyan fig and Indian banyan; it is native to the Indian Subcontinent. Ficus benghalensis are large, evergreen to deciduous, up to 20 (-25) m tall, with wide leafy crown and branches spreading up to 100 m or more with pillar-like prop roots and accessory trunks. Trunk is massive, fluted, bark grey, smooth and young softly white puberulous. Leaves are stout, ventrally compressed hairy petiole; lamina coriaceous, lateral nerves 4-7 pairs, intercostal distinct, bulging stipules coriaceous, stout, acute; cystoliths abundant on side. It is useful in treating diarrhea, dysentery, poultice, in case of fever, toothache and also as a pain relief.

Carum carvi: Carum carvi belongs to the Carum genus under the Apiaceae family. It is also known as meridian fennel or Persian cumin and is a biennial plant. The plant is similar in appearance to other members of the family, as they have finely divided, feathery leaves with thread-like divisions, growing on 20–30 cm stems. The main flower stem is 40–60 cm tall, with small white or pink flowers in umbels. Caraway fruits are crescent-shaped achenes, around 2 mm long, with five pale ridges. Carum carvi prefers warm, sunny locations and well-drained soil rich in organic matter. In warmer regions, it is planted in the winter as an annual. In temperate climates, it is planted as a summer annual or biennial. It is used as an antiseptic, antispasmodic, aromatic, carminative, digestive, emmenagogue, expectorant, galactogogue and stimulant.

Brassica nigra: Brassica nigra is commonly known as the black mustard belongs to the Brassica genus and the Brassicaceae family. It is an annual plant cultivated for its black or dark brown seeds, which are commonly used as a spice. It is an upright plant, with large stalked leaves. They are covered with hairs or bristles at the base, but on the stem smoother. It can reach up to 80–90 cm (31–35 in) in height or even up to 2.4 m (8 ft.) in moist fertile soil. The flowers have four yellow petals, which are twice as long as the sepals. Each stem has around four flowers at the top, forming a ring around the stem. Later, the plant forms long seed pods that contain four rounded seeds. It has traditionally been used for the treatment of epilepsy, toothache, headache, digestion supplement and for poultice.
Allium sativum: Allium sativum commonly known as Garlic is a species in the genus Allium and belongs to the family Amaryllidaceae. Allium sativum is a bulbous plant. It grows up to 1.2 m (4 ft.) in height. It produces hermaphrodite flowers. It is pollinated by bees, butterflies, moths, and other insects. Garlic is easy to grow and can be grown year-round in mild climates. While sexual propagation of garlic is possible, nearly all of the garlic in cultivation is propagated asexually, by planting individual cloves in the ground. In colder climates, cloves are planted in the autumn, about six weeks before the soil freezes, and harvested in late spring or early summer. The cloves must be planted deep enough to prevent freeze/thaw, which causes mold or white rot. Garlic plants prefer to grow in a soil with a high organic material content, but are capable of growing in a wide range of soil conditions and pH levels. It has traditionally been used for the purpose of hardening of arteries, helpful in difficult heart condition and also in keeping healthy blood pressure.

In regard to this invention the herbs Ixora parviflora, Buchanania lanzan, Ficus benghalensis were collected from Kasargod district of Kerala, India.

An important aspect of the present invention is that the composition contains extracts of herbs and therefore it is extracted in such a manner that it won’t create any harmful effect on usage and thus healthy and helpful for consumption.

In an embodiment the herbal composition shall include at least one pharmaceutically acceptable excipient suitable for administration.

One skilled in art shall appreciate that the composition are directly dependent on the form of consumption and all such necessary forms are covered by the present invention.

In an embodiment of present invention, the herbal composition for the treatment of inflammation, arthritis and associated symptoms can be made in a delivery system of any form which will include, but not limited to, a liquid, a dry powder, a tablet, and a capsule. And the formulation can be used for in dosage forms mentioned above in a quantity not exceeding 7-8 g/ 100 ml twice a day.

In another embodiment of present invention the herbal composition comprises of at least one pharmaceutically accepted excipient selected from the solubility enhancing agents such as polysorbate, cyclodextrin and their derivative, a sweetening agent such as isomalt, lactitol, maltitol, maltitol syrup, erythritol and hydrogenated starch hydrolysates in a range preferably, 0.03 to 0.7 % by weight, a buffering agent such as citrate , borate, phosphate, citro- phosphate in a range preferably 0.03 % – 0.07% by weight, a preservative such as benzalkonium chloride, sorbic acid ,methyl paraben, propyl paraben in a range preferably 0.05 % - 0.8 % by weight, a bulking agent such as potassium bitartarate, aluminium ammonium sulfate, ammonium hydrogen carbonate in a range preferably 10 % – 25 % by weight, a binder such as sucrose, lactose, starch and others in a range preferably 2 % to 9 % by weight, a dis- integrant such as crosslinked polyvinylpyrrolidone (crospovidone), crosslinked sodium carboxymethyl cellulose in a range preferably 0.5 – 4 % by weight, co-solvents such as water, methanol or ethanol in a range preferably 1 % to 10 % by weight, a glidant in a range preferably 0.1 to 0.5 % by weight, depending upon the form of herbal composition.

In one of the embodiment of the present invention as given in scheme 1, the process (200) of preparation of herbal extract (100) for treatment of inflammation, arthritis and associated symptoms provides the steps of washing (202), drying (204), powdering (206) of stem bark of Ixora parviflora, Buchanania lanzan & Ficus benghalensis, seeds of Carum carvi & Brassica nigra, and bulbs of Allium sativum, and adding the powdered plant parts in a solvent in step (208). This is followed in step (210) by doing hot water extraction of powdered herbs at a temperature of about 90°C - 100?C till the solution gets concentrated to half of its initial volume. Aqueous extract is dried in step (212) in a rotary evaporator at temperature of 50°C - 60°C under reduced pressure, resulting into a concentrate. This is followed in step (214) by adding at least one pharmaceutical excipient to get claimed herbal composition (100).

SCHEME 1: Process flow chart of preparation of herbal extract

EXAMPLE
The present disclosure is further explained in the form of following examples. However, it is to be understood that the foregoing examples are merely illustrative and are not to be taken as limitations upon the scope of the invention. Various changes and modifications to the disclosed embodiments will be apparent to those skilled in the art. Such changes and modifications may be made without departing from the scope of the invention.

Example 1:
The whole plant or part of Ixora parviflora, preferably including stem bark of Ixora parviflora, stem bark of Buchanania lanzan, stem bark of Ficus benghalensis, seeds of Carum carvi, seeds of Brassica nigra and bulb of Allium sativum plant were collected, washed and dried under shade. Dried plants parts were grinded and passed through a sieve in order to obtain a particle size of = 250 µm. The powdered plant parts were mixed to get a mixture containing of 2% - 50% w/v of Ixora parviflora, 2-15% w/w of Buchanania lanzan, about 2-15% w/w of Ficus benghalensis, about 2-8% w/w of Carum carvi, about 2-8% w/w of Brassica nigra and about 2-6% w/w of Allium sativum. The mixture was extracted in a solvent at a temperature of about 90 to 100ºC. The extract obtained was filtered through whatmann filter paper 1 and reconstituted to obtain a herbal composition effective for treatment and management of arthritis, inflammation, pain and associated complications.

Example2:
Efficacy of claimed herbal extract was checked in experimental model of Carrageenan induced inflammation.

Male SD rats aged 7 to 9 weeks and weighing 180-200 gm were chosen and divided into following animal groups.
1) Normal control
2) Vehicle control
3) Treatment with herbal extracts at a dose of 10.4, 20.9 and 5.2 ml/kg of the herbal extract prepared by a process mentioned in Example 1
4) Positive control
Animals were dosed with vehicle (Group 2; QID), herbal extract (10.45 ml/kg, 20.90 ml/kg, 5.22 ml/kg) to group 3, 4 and 5 respectively and positive control animals with Diclofenac on day of experiment. Administration of the extract was done for a period of 15 days.

One hour after treatment animals were injected with carrageenan (1%,100 µl/rat) by intraplantar route. Paw volume of rats was recorded at 1, 3 and 6 hrs post carrageenan injection. Carrageenan induced paw edema model is used to evaluate anti-inflammatory therapeutic agents and to study the contribution of mediators involved in acute inflammation. The edema or swelling is one of the acute inflammation signs, and it is important indicator to be considered when examining agents with potential anti-inflammatory activities. Local neutrophil infiltration and activation contribute to Carrageenan induced inflammatory response by releasing Myeloperoxidase (MPO), superoxide anion and hydroxyl radicals.
At the end of experiment after recording paw volume at 6 hrs post carrageenan injection, carrageenan injected paw was collected from each animal. The levels of MPO, PGE2, COX1 and COX2 in carrageenan injected paw were determined (Table 1).
Table 1 COX-2 Estimation and Paw volume
Groups AVG Paw volume (ml) % inhibition
0 hrs 1 hrs 3 hrs 6 hrs 1 hrs 3hrs 6 hrs
AVG SEM N AVG SEM N AVG SEM N
Normal control 1.32 1.41 1.46 1.31 - - - - - - - - -
Vehicle control 1.38 1.94 2.58 2.33 0 5 8 0 7 8 0 8 8
Herbal extract (0.5x) 1.52 1.88 2.38 2.27 37 9 8 28 10 8 21 9 8
Herbal extract (1x) 1.37 1.88 2.31 2.29 9 10 8 22 6 8 4 8 8
Herbal extract (2x) 1.30 1.75 2.12 2.15 20 10 8 31 8 8 10 9 8
Diclofenac (15mg/kg) 1.42 1.49 1.83 1.91 87 6 8 66 4 8 48 7 8
Treatment with Herbal extracts did not show any effects on body weight of animals. Average basal paw volume before carrageenan injection was 1.38 ml. while after injecting carrageenan average paw volume was 1.94 ml, 2.58 ml and 2.33 ml at 1, 3 and 6 hrs respectively. In saline injected normal control animals, average basal paw volume was 1.32 ml, after injecting saline average paw volume was 1.41 ml, 1.46 ml, 1.31 ml at 1, 3 and 6 hrs respectively.

Treatment with herbal extract at different doses resulted in inhibition of carrageenan induced paw edema. Treatment also resulted in significant inhibition of carrageenan induced enhancement in Prostaglandin E2 levels. No significant changes in the levels of cyclooxygenase enzymes were seen. The data indicates potent anti-inflammatory activity of herbal extracts.

Example 3:
Anti-arthritic efficacy of claimed herbal composition was checked in experimental model of collagen induced arthritis. Male SD rats aged 7 to 9 weeks and weighing 21-32 gm. were chosen and divided into following animal group: Normal control, Vehicle control, Treatment group (herbal extract at a dose of 20.56 ml/Kg, 41.11 ml/Kg and 10.27 ml/Kg b.w.) and positive control group.

Primary immunization was done by using emulsion prepared by emulsifying equal volume of Bovine type II collagen with Complete Freund Adjuvant (CFA). Post primary immunization was done by using emulsion prepared by emulsifying equal volume of Bovine type II collagen with Incomplete Freund adjuvant (IFA). Animals of normal control group did not receive immunization. Remaining animals in study underwent immunization. Animals were randomized according to baseline arthritic score

After randomization on day-31, post immunization, animals were dosed with following regiment. Vehicle (Group 2; BID), Ixora extract (20.56 ml/kg, 41.11 ml/kg, 10.27 ml/kg to group 3, 4, 5 respectively; QID). Positive control animals were dosed with Dexamethasone (0.3 mg/kg, QID) as per study plan for 14 days. At the end of the study various assay parameters including spleen weight, IL-6, IL-10, TNF-a level were measured

Collagen-induced arthritis (CIA) model in mice is the robust and most widely used animal model of rheumatoid arthritis. To induce the disease genetically susceptible mice are immunized with type II collagen in adjuvant. B-lymphocytes and T-lymphocytes play important role in the pathogenesis of CIA model, with T-cell response peaking around the time of diseases onset. Histopathological assessment of the joints in CIA animals exhibits proliferative synovitis with infiltration of polymorphonuclear and mononuclear cells, erosive Pannus formation, cartilage degradation and fibrosis. Similar to human rheumatoid arthritis, pro inflammatory cytokines (TNF-A, IL-1b, IL-6) are elevated in CIA mice.
Treatment with herbal extract resulted in significant reduction in spleen weight in comparison to disease control. Significant reduction in levels of IL-6 was observed with inhibition reaching to the levels of 48% at highest tested doses. The experimental data indicates the remarkable anti-arthritic activity of herbal extract. The herbal extract possesses the capability to bring down the cytokines levels, which get elevated in human rheumatoid arthritis patients. ,CLAIMS:I Claim:
1. An anti-inflammatory and anti-arthritic herbal extract comprising;
solvent extracts from stem bark of Ixora parviflora, stem bark of Buchanania lanzan, stem bark of Ficus benghalensis, seeds of Carum carvi, seeds of Brassica nigra and bulbs of Allium sativum,
wherein solvent extract comprises 2-50 w/w of actives from Ixora parviflora,
wherein solvent extract comprises 2-15 w/w of actives from Buchanania lanzan,
wherein solvent extract comprises 2-15 w/w of actives from Ficus benghalensis,
wherein solvent extract comprises 2-8 w/w of actives from Carum carvi,
wherein solvent extract comprises 2-8 w/w of actives from Brassica nigra,
wherein solvent extract comprises 2-6 w/w of actives from Allium sativum

2. The herbal extract as claimed in claim 1, wherein the solvent can be selected from water, alcohol and a combination thereof.
3. The herbal extract as claimed in claim 1, wherein the solvent is an alcohol selected from the group consisting of methanol, ethanol, iso-propanol, and butanol.

4. A method of preparation of herbal extract comprising steps of;
A) washing, drying and grinding of stem bark of Ixora parviflora, stem bark of Buchanania lanzan, stem bark of Ficus benghalensis, seeds of Carum carvi, seeds of Brassica nigra and bulbs of Allium sativum to get the powdered forms of herbs;
B) taking the powdered herbs from step (A) in a solvent to form a solution;
C) evaporating the solution obtained in step (B) by boiling to concentrate the extract to half of its initial volume; and
D) concentrating the herbal extract from step (C) to obtain a concentrate.

5. The method of preparation of herbal extract as claimed in claim 4, wherein the solvent is selected from water, alcohol and a combination thereof.
6. The method of preparation of herbal extract as claimed in claim 4, wherein the solvent is an alcohol selected from the group consisting of methanol, ethanol, iso-propanol, and butanol.