Field of the Invention:
The present invention relates to an herbal formulation having anti-arthritic effect. The invention further provides the process for the manufacture of herbal formulation having anti-arthritic effect.
Background of the invention:
Arthritis, inflammation of a joint or a state characterized by inflammation of joints, is the leading cause of disability in human beings, affects daily activities and the sufferers endure severe pain and have difficulty performing routine daily chores. More than 10% of Indian population is affected with this painful disease.
Rheumatoid arthritis most often affects the wrist and finger joints closest to the hand, but can also affect joints in the feet and throughout the body. The pain of arthritis may come from different sources. These may include inflammation of the synovial membrane (tissue that lines the joints), the tendons, or the ligaments; muscle strain; and fatigue. A combination of these factors contributes to the intensity of the pain.
The hallmark symptom of rheumatoid arthritis is pain with morning stiffness that lasts for at least an hour. In about 20% of people with RA, inflammation of small blood vessels can cause nodules, or lumps, under the skin.
Osteoarthritis is characterized by erosion of articular cartilage, either primary or secondary to trauma or other conditions, which becomes soft, frayed, and thinned with eburnation of subchondrial bone and outgrowths of marginal osteophytes; pain and loss of function results, mainly affects weight-bearing joints, is more common in older persons.
Medications that treat osteoarthritis and rheumatoid arthritis symptoms but are not used for long-term care include corticosteroids (also known as steroids), and nonsteroidal anti¬inflammatory drugs (NSAIDs).

Medications that slow rheumatoid arthritis are called disease modifying anti-rheumatic drugs (DMARDs). This category includes a wide range of unrelated drugs that affect the body's immune system. They are effective against rheumatoid arthritis, but also cause many serious side effects because they weaken the body's defenses.
Nonsteroidal anti-inflammatory drugs (NSAIDs) are effective in relieving pain in rheumatoid arthritis (Towheed and Hochberg 1997). The side effects of other NSAIDs are potentially severe when taken at the elevated doses that are necessary to control rheumatoid arthritic pain.
Ulcers, bleeding in the stomach, increased blood pressure, retention of salt and water in the body, impaired kidney function, interference with coagulation of blood etc are some of the side effects of NSAIDs.
The common DMARD drug used in the treatment of RA by majority of the doctors is Ibuprofen. It helps control the symptoms but may not cure the disease. Side effects of Ibuprofen include gastric ulceration.
Experts believe that no single drug will ever cure rheumatoid arthritis because of the many factors that affect the disease at various times. The goal of any new drug treatment for rheumatoid arthritis is as follows:
• Reduce inflammation
• Prevent damage to the bones and ligaments of the joint
• Preserve movement and
• To be as inexpensive and as free from side effects as possible over the long-term.
As the modern medicines could only slow the progression of the disease and have several side effects, the need of the hour is natural medications.
Therefore, the object of the invention is to provide a plant based formulation which can slow the progression of the disease and without having any side effects.

Several formulations are listed for rheumatoid arthritis in ayurvedic literature. The plants and their extracts have been carefully chosen to answer several symptoms and root cause of the disease. The dosage and contents in the formulation were finalized after an extensive search on the efficacy and toxicity of the individual plants and a limited efficacy study conducted by the applicant.
Further, object of the present invention is to provide a process for the manufacture of the herbal formulation having anti-arthritic effect.
Summary of the Invention:
In order to obviate the drawbacks of the prior art and achieve the above said objectives the present invention provides an herbal formulation having anti-arthritic effect comprising of:
Salai Guggul tail (Boswellia serrata) 7.5% to 17.5% v/v,
Haridra tail (Curcuma longa) 4% to 9% v/v,
Sonth tail (Zingiber officinale) 4% to 9% v/v,
Til tail (Sesamum indicum) 69.5% to 79.5% v/v
The invention further provides the process for the manufacture of the above said herbal formulation.
Detailed Description of the invention
A unit dosage can comprise of a therapeutically effective amount of each herbal oil for a single daily administration; or it can be formulated into smaller quantities of each ingredient to provide for multiple doses in a day. In either instance, the formulation of this invention can be manufactured into oil.
The essential oils are obtained from steam distillation of the plant part. After the essential oil from each herb is obtained, they are mixed together in a dose that is pharmacologically active. The mixture of essential oils can be formulated with a physiologically acceptable vehicle.

This invention is based upon the discovery of an herbal formulation that, when administered as part of a routine therapeutic regimen to individuals diagnosed with arthritis, has the ability to reduce/alleviate the physical symptoms associated with arthritis and has a disease modifying effect.
For external application, the essential oils of Salai Guggul tail {Boswellia serrate); Haridra tail {Curcuma longa) and Sonth tail {Zingiber officinale) were prepared and then formulated in sesame oil in 0 to 100% each.
The ratio of the ingredients in the composition is as follows:
Salai Guggul tail {Boswellia serrate) 7.5% to 17.5% v/v,
Haridra tail {Curcuma longa) 4% to 9% v/v,
Sonth tail {Zingiber officinale) 4% to 9% v/v,
Til tail {Sesamum indicum) 69.5% to 79.5% v/v
In one of the embodiment the composition has following ratio of the ingredients:
Salai Guggul tail {Boswellia serrate) 11% v/v,
Haridra tail {Curcuma longa) 5.5% v/v,
Sonth tail {Zingiber officinale) 5.5% v/v,
Til tail {Sesamum indicum) 78% v/v
In another embodiment the composition has following ratio of the ingredients:
Salai Guggul tail (Boswellia serrata) 15 % v/v,
Haridra tail (Curcuma longa) 7.5% v/v,
Sonth tail (Zingiber officinale) 7.5% v/v,
Til tail (Sesamum indicum) 70% v/v
In another embodiment the composition has following ratio of the ingredients:

Salai Guggul tail (Boswellia serrata) 12.5% v/v,
Haridra tail (Curcuma longa) 6.5% v/v,
Sonth tail (Zingiber officinale) 6.5% v/v,
Til tail (Sesamum indicum) 74.5% v/v
Boswellia serrata
The part used in Boswellia serrata is the oleo-gum resin of the bark. The gum resin contains a mixure of triterpene acids known as boswellic acids (a, 0, y-boswellic acids) and their derivatives. It also yields a volatile oil (about 0.6%) containing anisaldehyde, a-pinene, a-phellandrene and sesquiterpene alcohols. Boswellia serrata was found to inhibit leukotriene synthesis.
Curcuma lonaa
The rhizome of Curcuma longa is widely used in indigenous medicine. The volatile oil and curcumin obtained from Curcuma longa exhibit potent anti-inflammatory effect. Curcuma longa inhibits Arachidonic Acid metabolism.
Zingiber officinale
The part used in Zingiber officinale is rhizome. The volatile oils (1-3%) consists predominantly hydrocarbons, P-Bisabolene and zingiberine; other sesquiterpenes include zingiberol, zingiberenol, ar-curcumene, 0-sesquiphellandrene, p-sesquiphellandrene, p-sesquiphellandrol (cis and trans); numerous monoterpene hydrocarbons, alcohols, and aldehydes.
Zingiber officinale was found to reduce platelet synthesis of prostaglandins-endoperoxides, thromboxane and prostaglandins. It was postulated that these oils will exhibit synergistic effect on rheumatoid arthritis and osteoarthritis patients since leukotriene is responsible for arthritic pain and inflammation and prostaglandins mediates pain and swelling.

9 Sesasum indicum
The medicinal part of Sesasum indicum is the seed. The oil is pressed or extracted from the ripe seeds and refined. It contains fatty oils (97-98%); chief fatty acids are oleic acid (35-50%), linoleic acid (35-50%), palmitic acid (7-12%), stearic acid (3-6%); lignans (0.8-1.7%) including sesamine and sesamolin; steroids: sterols including beta-sitosterol (0.4%), campesterol.
Essential oils used in the composition penetrate through the stratum comeum, layer of the skin and gets absorbed quickly whereas in the existing technology, the herbs are boiled in oil that have doubtful absorption through the skin layers.
Several different classes of inflammatory mediators control vascular and cellular responses to inflammation. Phospholipids are acted on by enzyme phospholipase A2 to give Arachidonic Acid. Arachidonic Acid is metabolized in two pathways-Lipoxygenase and cycloxygenase. Lipoxygenase produces Leukotriene B4, which is responsible for arthritic pain and inflammation whereas Cycloxygenase pathway produces Prostaglandin E2 that mediates pain and oedema.
Boswellia serrata is valued for its well-documented antiarthritic action, which is attributable to the boswellic acids. These acids inhibited leuktriene synthesis via 5-lipoxygenase but did not affect either 12-lipoxygenasae or cycloxygenase. Boswellic acids did not impair the peroxidation of arachidonic acid by iron and ascorbate, indicating they are specific, non-redox inhibitors of leukotriene synthesis either interacting directly with 5-lipoxygenase or blocking its translocation. The boswellic acids possess varying degrees of activity in dose-related acute and chronic test models.
The anti-inflammatory activity of Curcumin is mainly due to inhibition of Arachidonic Acid metabolism, Cycloxygenase, Lipoxygenase, cytokines (lis and TNF) and NF-kB. Curcumin is reported to stabilize lycosomal membrane and causes uncoupling of oxidative phosphorylation besides having strong oxygen radical scavenging activity.

i
Ginger was found to reduce platelet synthesis of prostaglandin-endoperoxides, thromboxane, and prostaglandins. A good correlation was reported between concentrations of the extract required to inhibit platelet-thromboxane synthesis.
The external use of sesame oil includes removal of scabs and crust formations, for swellings, rheumatism and as massage oil.
The combination of the oils produces a synergistic effect and the oil not only has anti- arthritic activity but it shows anti-inflammatory activity, anti-apoptotic, anti-catabolic activity and free radical scavenging activity.
The process of invention for the preparation of the composiution is under;
1. All the ingredients are weighed accurately.
2. Propyl Gallate and Butylated Hydroxy Toluene, antioxidants to prevent rancidity of oils, dissolved in Sesame oil.
3. Boswellia oil, Turmeric oil and Ginger oil added.
4. Make up the volume with Sesame oil.
5. Filter through nylon cloth.
The composition is in the form of oil / rub / cream / gel / spray formulation.
The specification of the composition is as follows:
Description: Yellow colored clear liquid having characteristic odour. Identification:
(a) The spots of Boswellia serrata oil, Curcuma longa oil and Zingiber officinale oil are detected by Thin Layer Chromatography.
(b) Gives positive test for Curcumin.
Specific Gravity (at 25°C): 0.895 to 0.945, Refractive Index: 1.470 to 1.485,

1 Optical Rotation: -1.00 to 2.50, Acid Value: Not more than 5.00, Saponification Value: 95 to 115, Ester Value: 95 to 115, Iodine Value: 139 to 170.
A clinical trial was conducted on 30 patients to study pain control after administration through the skin in patients having rheumatoid arthritis or osteoarthritis for four weeks. Assessment of effectiveness included a rating of pain control (excellent, good, moderate, poor, very poor), Pain Assessment Questionnaire, Quality of Life Assessment, Health Assessment Questionnaire. The inclusion criteria was patients having rheumatoid arthritis or osteoarthritis of the hip or knee and having moderate or severe pain that is not adequately controlled by other medications like paracetamol, NSAIDs, COX-2 inhibitors, weak opioids. The oil was administered to the patients through the skin on effected parts, two times a day for four weeks. Moderate to excellent results were achieved without any known adverse effects.
Three samples of oil were evaluated for anti-inflammatory activity in acute and chronic models of inflammation in rats. Carrageenan induced rat paw edema and Formalin induced rat paw edema served as acute models whereas Freund's complete adjuvant induced rat paw served as chronic model of inflammation. The percentage protection of carragenen induced paw edema calculated for each sample. The rat paw edema was reduced significantly as compared to placebo.
The invention will now be explained with the help of following examples. However, the scope of the invention should not be limited to these examples as the person skilled in the art can easily vary the proportion of the ingredients and combinations.
Example 1:
Oleo resin is distilled under vacuum at 100-110°C using water as a solvent. Oily layer is separated in conical tanks. The oil is filtered through nutzch filter using filter media.

Example 2:
Boswellia oil, Turmeric oil and Ginger oil are taken in a definite proportion and dissolved in Sesame oil separately and mixed together.

' We claim:
1. A herbal formulation for external application having anti-arthritic effect comprising the
essential oils of herbs in the ratio mentioned below:
Salai Guggul tail (Boswellia serrata) 7.5% to 17.5% v/v,
Haridra tail (Curcuma longa) 4% to 9% v/v,
Sonth tail (Zingiber officinale) 4% to 9% v/v,
Til tail (Sesamum indicum) 69.5% to 79.5% v/v
2. A herbal formulation for external application having anti-arthritic effect as claimed in
claim 1, comprising:
Salai Guggul tail {Boswellia serrata) 11% v/v,
Haridra tail {Curcuma longa) 5.5% v/v,
Sonth tail {Zingiber officinale) 5.5% v/v,
Til tail {Sesamum indicum) 78% v/v
3. A herbal formulation for external application having anti-arthritic effect as claimed in
claim 1, comprising:
Salai Guggul tail (Boswellia serrata) 15 % v/v,
Haridra tail (Curcuma longa) 7.5% v/v,
Sonth tail (Zingiber officinale) 7.5% v/v,
Til tail (Sesamum indicum) 70% v/v
4. A herbal formulation for external application having anti-arthritic effect as claimed in
claim 1, comprising:
Salai Guggul tail (Boswellia serrata) 12.5% v/v,
Haridra tail (Curcuma longa) 6.5% v/v,
Sonth tail (Zingiber officinale) 6.5% v/v,
Til tail (Sesamum indicum) 74.5% v/v

5. The formulation as claimed in claim 1, wherein the formulation is an oil / rub / cream / gel / spray formulation.
6. The process for preparation of the herbal formulation as claimed in claim 1 comprising the steps of mixing of oils.
7. An herbal formulation for external application having anti-arthritis effect substantially as herein described with reference to the forgoing examples.
8. The process for preparation of the herbal formulation substantially as herein described with reference to the forgoing examples.