Title of Invention

A NOVEL HERBAL PRODUCT FOR TREATING ABNORMAL CONDITIONS OF BONES AND A PROCESS FOR MAKING THE SAME

Abstract

A herbal formulation for treatment of fractures and other disorders of bones comprising a dough consisting of (1) macerated bulbs of Allium sativum (Lasuna, Garlic), (2) powdered dried flower buds of Eugenia caryophyllata (Lavangam, Clove), (3) powdered stem/ bark of Cinnamomum zeylanicum (Tvak, Cinnamon), (4) fruits of Piper nigrum Linn (Maricam, Black pepper) and (5) gm of leaves of Premna mucronata Roxb (Agnimantha) in combination with a vegetable oil and a carrier.

Full Text

FORM - 2 THE PATENTS ACT, 1970 (39 of 1970) & THE PATENTS RULES, 2003 COMPLETE Specification (See section 10 and rule 13) A NOVEL HERBAL PRODUCT FOR TREATING ABNORMAL CONDITIONS OF BONES AND A PROCESS FOR MAKING THE SAME (a) KARaANDE TULASHIDAS NAMADEO an Indian National of At-Post-Harapur, Tal-Manglwednu, Dist.Solapur, Maharashtra, India; and (b) KARANDE RAYACHAND BANDU an Indian National of At-Post-Harapur, Tal-Manglwednu, Dist.Solapur, Maharashtra, India THE FOLLOWING SPECIFICATION PARTICULARLY DESCRIBES THE INVENTION AND THE MANNER IN WHICH IT IS TO BE PERFORMED. FIELD OF INVENTION This invention relates to a novel herbal product for treating abnormal conditions of bones and a process for making the same. More particularly, this invention relates to a herbal composition for treating fractures of bones and other conditions such as spondylitis, vertebral disc prolapse; for healing and promoting healthy bone structure and providing relief from pain in such conditions. BACKGROUND OF THE INVENTION For over 3000 years herbal therapies have addressed themselves to the fundamental principles of good health and longevity, based on the inherent ability of the human body to rejuvenate, to heal and to restore its natural balance. The herbal therapies do not have any harmful side effects but they have very effective healing properties. The term 'herb' can broadly be used to refer to the seeds, leaves, stems, flowers, roots, berries, bark, or any other plant parts that are used for healing. It is estimated that approximately 50 percent of the thousands of drugs commonly used and prescribed today are either derived from a plant source or contain chemical imitations of a plant compound. The popularity of herbal or herb based medicines are increasing because of less or no side effects / toxicity associated with them. Herbal medications are available in many forms, including capsules, tablets, or coated tablets, pellets, extracts or tinctures, powders, fresh or dried plants or plant parts, prepared teas, juices, creams and ointments, essential oils or as combinations of any of these forms. Herbal medicines are administered by any one of various methods, including orally, rectally, transdermally, via feeding tubes, inhalation and the like. 2 This invention relates to a novel herbal product and a method of making the same using a combination of potent herbs for the treatment of bone related disorders. The bones of the body form the human frame, or skeleton, which supports and protects the softer parts of the body. Bones are living tissues. They grow rapidly during one's early years, and renew themselves when they are broken. Bones have a center called the marrow, which is softer than the outer part of the bone. Bone marrow has cells that develop into red blood cells that carry oxygen to all parts of the body and into white blood cells that help fight disease. The outer part of the bones is formed of latticework structure comprising the minerals calcium and phosphorus. Because of their unique structure, bones can bear large amounts of weight and forces acting in different directions. However if the force applied on the bones is more than the bearing capacity, the bone or bones will break leading to a fracture. Fractures are very painful and make it difficult if not impossible to use the part of the body that is injured. A medical examination and x-rays are usually necessary to confirm and to ensure proper treatment. In the conventional therapies it is very important to control the movement of a broken bone. Moving a broken or dislocated bone can cause additional damage to the bone, nearby blood vessels, and nerves or other tissues surrounding the bone. Improper healing of a fracture may also lead to permanent deformity. The severity of a fracture usually depends on the force that caused the fracture. If the bone's breaking point has been exceeded only slightly, then the bone may crack rather than breaking all the way through. If the force is extreme, the bone may shatter. If the bone breaks in such a way that bone fragments stick out through the skin or a wound penetrates down to the broken bone, the fracture is called an "open" fracture. This type of fracture is 3 particularly serious because once the skin is broken, infection in both the wound and the bone can occur. Fractures can result because of an accidental injury or due to decrease in the mineral density of the bones, which is called osteoporosis. Bone resorption, when exceeding bone formation, can lead to bone fractures resulting from minimal trauma. Spondylitis (also called ankylosing spondylitis) is a type of arthritis that affects the spine or backbone. Spondylitis may cause back pain and stiffness. The bones of the spine, called vertebrae, may grow or fuse together resulting in a rigid spine. These changes may be mild or severe. Severe disease may lead to poor posture and deformities. Early diagnosis and treatment helps control pain and stiffness, and may reduce or prevent significant deformity. The most common early signs of spondylitis are constant pain and stiffness in the low back, buttocks and hips that continue for more than three months. Spondylitis often starts around the sacroiliac joints where the sacrum (the lowest major part of the spine) joins the ilium of the pelvic bone. Spondylitis can cause an overgrowth of the bones, which may lead to abnormal joining of parts that are normally separate. This is called bony "fusion." Fusion affecting bones of the neck, back or hips may impair a person's ability to perform routine activities. Fusion of the ribs to the spine or breastbone may limit a person's ability to expand his or her chest when taking a deep breath. Spondylitis may also affect some of the ligaments and tendons that attach to bones leading to tendonitis. PRIOR ART The conventional way of treating various types of fractures is by one or more of the following ways: Ø Cast immobilization-A plaster or fiberglass cast is the most common type of fracture treatment, because most broken bones can heal successfully once they have 4 been repositioned and a cast has been applied to keep the broken ends in proper position while they heal. Ø Functional cast or brace-The cast or brace allows limited or "controlled" movement of nearby joints. This treatment is desirable for some but not all fractures. Ø Traction-Traction is usually used to align a bone or bones by a gentle, steady pulling action. The pulling force may be transmitted to the bone through skin tapes or a metal pin through a bone. Traction may be used as a preliminary treatment, before other forms of treatment. Ø Open reduction and internal fixation-In this type of treatment, an orthopedist must perform surgery on the bone. During this operation, the bone fragments are first repositioned (reduced) into their normal alignment, and then held together with special screws or by attaching metal plates to the outer surface of the bone. Inserting rods down through the marrow space in the center of the bone may also hold the fragments together. These methods of treatment can reposition the fracture fragments very exactly. Because of the risks of surgery, however, and possible complications, such as infection, they are used only when the orthopedic surgeon considers such treatment to be the only option to restore the broken bone to normal function. Ø External fixation-In this type of treatment, pins or screws are placed into the broken bone above and below the fracture site. Then the orthopedic surgeon repositions the bone fragments. The pins or screws are connected to a metal bar or bars outside the skin. This device is a stabilizing frame that holds the bones in the proper position so they can heal. After an appropriate period of time, the external fixation device is removed. All trie above methods have shown consistent and good results but they are expensive and time consuming. They are associated with risks of surgery such as problems of anesthesia, infections, excessive bleeding and death. On removal of the cast or metal devices, there is stiffness of movement, which requires physiotherapy for a long time. Many times, the return to normal function is not complete. 5 There are inflammations and topical reactions under the cast or at the site of applications of the external devices. While a cure for spondylitis is not available, certain drugs help provide relief from pain and stiffness and allow patients to perform their exercises with minimal discomfort. Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most commonly used drugs for spondylitis treatment. In severe cases, other medications may be added to the treatment regimen. NSAIDs are however known to have several side effect e.g.: Gastrointestinal side effects such as gastritis or stomach ulcers; anti-clotting effects leading to bleeding or bruising easily. Large doses of NSAIDs can also lead to kidney problems and fluid retention, which can worsen congestive heart failure. NSAIDs can cause liver function test abnormalities, as well as ringing in the ears, headache, dizziness and drowsiness. Mouth sores and skin rashes also can occur while taking NSAIDs. Many herbal formulations have been used and recommended for the treatment of bone disorders such as fractures and inflammations. U.S. Pat. No. 5,595,743 discloses herbal compositions which include licorice extract (Glycyrrhiza) and Siegesbeckia, Sophora, Stemonaa and Tetrandra herbs used for the treatment of various mammalian diseases, including inflammation and rheumatoid arthritis. U.S. Pat. No. 5,683,697 discloses a pharmaceutical composition having anti-inflammatory, anti-pyretic activity wherein the composition includes plant parts from the species Melia, Angepica, Dendrobium, Impatiens, Citrus, Loranthus, Celosia, Cynanchum and Glehnia. U.S. Pat. No. 5,683,698 discloses a herbal formulation comprising extracts of the roots, rhizomes, and/or vegetation of Alphinia, Smilax, Tinospora, Tribulus, Withania and Zingiber has been found to reduce or alleviate the symptoms associated with rheumatoid 6 arthritis, osteoarthritis, reactive arthritis and for reducing the production of proinflammatory cytokines. All the aforesaid herbs are exotic herbs not available in the Indian sub continent easily. Also their method of extraction as suggested are very complicated. Based on the foregoing, there currently exists a need for anti-inflammatory, analgesic herbal composition, which has low toxicity and few side effects. There is also a need for a simple home based, effective and comparatively inexpensive remedy for the treatment of fractures and spondylitis. OBJECT OF THE INVENTION: It is an object of the present invention to provide a herbal composition for healing and accelerating the rate of recovery from bone injuries like fracture and other bone affiliations like spondylitis. It is another object of this invention to provide a herbal composition having bone regenerating, anti-inflammatory, analgesic properties. It is yet another object of the present invention to provide a highly effective herbal formulation which has no toxicity and no side effects. Further object of this invention is to provide a simple home based, patient friendly, comparatively inexpensive remedy for the treatment of bone injuries like fracture and other bone affiliations like spondylitis. The novel compositions of the present invention fulfill these requirements. 7 SUMMARY OF THE INVENTION According to this invention there is provided a herbal formulation for treatment of fractures and other disorders of bones comprising (1) macerated bulbs of Allium sativum (Lasuna, Garlic), (2) powdered dried flower buds of Eugenia caryophyllata (Lavangam, Clove), (3) powdered stem/ bark of Cinnamomum zeylanicum (Tvak, Cinnamon), (4) fruits of Piper nigrum Linn (Maricam, Black pepper) and (5) macerated leaves of Premna mucronata Roxb (Agnimantha) in combination with a vegetable oil and a carrier. The vegetable oil is selected from a group of oils comprising Groundnut Oil from the plant Arachis hypogaea, Sunflower oil from the kernels of the plant Helianthus annu, and Safflower oil from the seeds of the plant Carthamus tinctorius. The carrier is milk, preferably goat's milk. The herbal composition could be an oral medicament or a topical medicament. According to another aspect of the invention there is provide a process for preparing the herbal composition comprising the steps of: 1) peeling bulbs of Garlic and grinding the peeled bulbs to a fine paste; 2) mixing together dried flower buds of Clove, stem bark of Cinnamon and fruits of Black pepper and grinding the mixture to a fine powder; 3) removing the petioles of freshly harvested leaves of Agnimantha, cutting the leaves to small pieces and grinding the same to a paste; 4) mixing the paste of the bulbs of Garlic obtained in step 1 thoroughly with the mixture of the fine powders of Clove, Cinnamon and Black pepper obtained in step 2; 5) adding the paste of finely cut leaves of Agnimantha obtained in step 3 to the mixture obtained in step 4; 8 6) to the mixture from step - 5, mixing sufficient quantity of vegetable oil to prepare a mixture with a paste like consistency; 7) mixing the paste in a carrier, preferably goat's milk to make an oral medicament. The sediment of the oral medicament acts as a topical medicament. The percentage of the ingredients in the dough are as follows: 1) Garlic 12 to 18% 2) Clove 3 to 5 % ; 3) Cinnamon 3 to 5 % 4) Black pepper 3 to 5 % 5) Agnimantha 60 to 80%. For administration of the medicament the paste like mixture obtained is divided into three equal parts; One part of herbal composition so obtained is mixed well with 80-100 ml of Goat's milk and drunk. The sediment remaining at the bottom of the container after drinking is applied topically on the affected area. This is repeated for three consecutive days so that the three parts of the herbal composition prepared are administered to the patient. The formulation can be administered one to four times at an interval of 15-18 days depending on the response of the patient. Prior to administration of the herbal composition, the fractured or dislocated bones should be properly aligned. During the therapy, the patient is advised not to move the affected part. 9 DETAILED DESCRIPTION OF THE INVENTION One dose of the herbal composition according to the present invention comprises: Bulbs of Allium sativum( Lasuna, Garlic)- 8-12 gm Dried flower buds of Eugenia caryophyllata (Lavangam, Clove)- 3-5 gm Stem bark of Cinnamomum. zeylanicum (Tvak, Cinnamon)- 3-5 gm Fruits of Piper nigrum Linn (Maricam, Black pepper)- 3-5 gm Leaves of Premna mucronata Roxb (Agnimantha)- 40-60 gm In combination with a vegetable oil selected from a group of oils comprising Groundnut Oil from the plant Arachis hypogaea, Sunflower oil from the kernels of the plant Helianthus annuu, Safflower oil from the seeds of the plant, Carthamus tinctorius. In a suitable carrier preferably milk and more preferably goat's milk. The botanical references of the plants used for the medicinal preparation are as follows: 1) Botanical name : Allium sativum Sanskrit name : Lasuna, Ugragandha Popular English name : Garlic Habitat : Originally from Central Asia, garlic is cultivated worldwide in good draining soils and is particularly grown all over India. Parts Used : Cloves Constituents : The active component of garlic is sulfur compound called allicin, which is produced when a garlic clove is broken. Allicin, in turn, becomes ajoene, allyl sulfide, and vinyldithiin. Action : Anthelmintic, antispasmodic, carminative, cholagogue, digestive, diuretic, expectorant, febrifuge. It is antibacterial, antifungal, antiviral 10 and anti-inflammatory. Preparations/ Uses : It counters many infections, including those of the nose, throat and chest. Garlic boosts immune function, helps digestion and has also been shown to have anti-cancer properties. Reduces cholesterol, blood pressure, blood clotting and limits free radical damage, lowers blood sugar levels which makes it useful in cases of late-onset diabetes. Garlic is known for improving the voice, intellect, and skin complexion. 2)Botanical name Sanskrit name Popular English name Habitat : Eugenia caryophyllata, Caryophyllus aromaticus : Lavangam, Devakusumam : Clove Parts Used Constituents : Clove trees are original from Indonesia but grow extensively in Southern part of India, particularly the State of Kerala. : The dried flower buds. : The content of essential oil in cloves may be upto 15%. The oil itself is mainly eugenol (70 to 85%>) which is a a strong anesthetic and antiseptic substance, eugenol acetate (15%) and 0-caryophyllene (7%), which together make up 99% of the oil. Cloves contain about 2% of the triterpene oleanolic acid. Action : Antiseptic, mind and body stimulant, analgesic, antibacterial, carminative. Preparations/ Uses : The dried flower buds, clove, are extensively used as spice. The buds, leaves and stems are used for the extractions of clove's oil. Both the oil and 11 the flower buds have been valued as a herbal medicine for a long time. Cloves are also well known for their antispasmodic and stimulative properties. 3)Botanical name Sanskrit name Popular English name Habitat Parts Used Constituents Action Preparations/ Uses : Cinnamomum. zeylanicum/ C. verum : Tvak, Darusita : Cinnamon : Cinnamon is native to Sri Lanka, growing in tropical forest and being extensively cultivated in South India, hills of Burma and throughout the tropical regions of the world. : bark. : The essential oil of cinnamon bark (max. 4%) is dominated by the two phenylpropanoids namely cinnamaldehyde and eugenol. Other phenylpropanoids (safrole, coumarine) mono-and sesquiterpenes, although occurring only in traces, do significantly influence the taste of cinnamon. : Warming stimulant, carminative, antispasmodic, antiseptic, anti-viral. : Cinnamon has a long history of use in India. The infusion or powder is used for stomach pains and cramps. Traditionally, the herb was taken for colds, flu and digestive problems, and it is still used in much the same way today. Cinnamon is useful in anorexia, inflammations, odontalgia. 4) Botanical name : Piper Nigrum Linn. Sanskrit name : Maricam Popular English name : Black pepper, common pepper, pepper. 12 Habitat Parts Used Constituents Action Preparations/ Uses : Grows throughout India, in evergreen forests upto 1,500 m and is also widely cultivated. : Fruits. : The chief constituents of black pepper are a crystalline alkaloid, piperine (5 to 8.25 per cent.), volatile oil (1 to 2.3 per cent), and a pungent resin called chavicin, of which little definite is known. The volatile oil consists almost entirely of terpenes, amongst which 1-phellandrene has been identified. : Black pepper is acrid, Pungent, hot, carminative, and antiperiodic. Externally it is rubefacient and stimulant. Piperin is mild antipyretic and antiperiodic. : Mostly, black pepper is used as a culinary spice. However it is also used widely for therapeutic and medicinal purposes for a variety of ailments from paralysis to toothache. It stimulates the appetite as well as an aids in the relief of nausea, colic, gas, gastric ailments, diarrhea and indigestion. It is also used for fever, sinus congestion, sore throat, cough, phlegm and fever. Used for obesity, hemorrhoids. Also used for chronic rheumatism. 5) Botanical name : Premna mucronata Roxb Ayurvedic/ Sanskrit name : Agnimantha. Takli. Habitat : Throughout India in the plains, specially in Sahyadris and Konkan area. Parts Used : Roots and leaves Action : Astringent, bitter, acrid, thermogenic, anodyne, 13 anti-inflammatory, cardiotonic, expectorant, digestive, antibacterial and tonic. Preparations/ Uses : Inflammations, cardiac disorders, piles rheumatalgia, neuralgia, general debility. Used in boils and colic. It has been observed that the leaves of this plant when growing in the wild, are only eaten by goats and not by other animals such as cows. The references of the vegetable oils used in the medicinal preparation are as follows: Groundnut oil: Groundnut Oil is obtained from the plant Arachis hypogaea . The oil obtained is of pale yellow colour, with odour and taste reminiscent of the seeds. The relatively high content of arachidic, behenic and lignoceric acid (1-6%) is characteristic for Groundnut Oil. Groundnut Oil has high temperature stability and is used as a basic component for margarines. It is also registered in all major pharmacopoeias worldwide and used in many products and formulations of the pharmaceutical and cosmetic industries. Sunflower oil: Sunflower oil is of vegetable origin from the plant Helianthus annum and is obtained from the fatty kernels of sunflowers. Cold-pressed crude oil is light yellow, hot-pressed crude oil has a brown color and refined oil is colorless. Sunflower oil is high-quality edible oil. The best oil is produced from shelled kernels. Sunflower oil is used as an edible oil and in margarine production. It ranks fourth most used vegetable oil in the World. Its pleasant taste and health giving properties have made it very popular in normal kitchens and food industry. It is very stable, light, neutral and has long shelf life without hydrogenation hence it has started getting preference over other vegetable cooking oils. 14 Safflower oil: An oily liquid extracted from the seeds of the safflower, Carthamus tinctorius. The safflower, which is a member of the thistle family, grows to a height of 4 feet and is topped by beautiful yellow, gold, and orange flowers. The seeds of the safflower are used for the production of safflower oil, which has the highest level of polyunsaturated fat of any edible oil. It is low in saturated fat so it is considered to be a healthy all-purpose oil. Uses: cooking, salad dressings, margarine production, used as a dietary supplement in the management of hypercholesterolemia. The reference for the Goat- Milk used in the medicinal preparation are as follows: Goat's milk has a reputation as being a highly digestible dairy product. This is due to the composition and structure of the lipid (fat) portion of goats milk and in part to the way the protein in goats milk reacts in the stomach as it starts to be digested. The food constituents of goat's milk contain excess of calcium and vary only a little from that of human milk. Goat's milk is sweet, cooling, astringent and constipating. It is very invigorating and promotes appetite and digestion. It is useful in, bile disorders, cough, chronic diarrhea and vomiting in children; variety of piles, bronchitis, and chronic cases of enlarged liver and spleen. In combination with barley gruel, it is recommended in dysenteric and diarrhea. Goat's milk is known for its hypo-allergenic properties. It has often been found that infants that are not able to tolerate mother's milk or cow's milk are able to drink goat's milk. Composition: Goat milk contains 4.5 grams of fat, 3.3 grams of protein and 71 Kcal of energy per 100 grams. Method of preparation : 1) 8 to 12 gm of the bulbs of Garlic are peeled and ground to a fine paste. 15 2) 3 to 5 gm of the dried flower buds of Clove, 3 to 5 gm of the stem bark of Cinnamon and 3 to 5 gm of the fruits of Black pepper are mixed together and ground to a fine powder. 3) The petioles of 40-60 gm of freshly harvested leaves of Premna mucronata Roxb (Agnimantha) are removed and the leaves are cut to fine pieces and ground to a paste. 4) The paste of the bulbs of Garlic obtained in step 1 is mixed thoroughly with the mixture of the fine powders of Clove, Cinnamon and Black pepper obtained in step 2. 5) To the mixture obtained in step 4 are added the paste of finely cut leaves of Agnimantha obtained in step 3. 6) The mixture from step - 5 is mixed with sufficient quantity oil selected from a group of oils comprising Groundnut Oil, Sunflower oil and Safflower oil to prepare a mixture with a paste like consistency. 7) The paste like mixture obtained in step 6 is divided into three equal parts. 8) One part of herbal composition so obtained is mixed well with 80-100 ml of Goat's milk and drunk. The sediment remaining at the bottom of the container after drinking is applied topically on the affected area. 9) The step no 8 is repeated for three consecutive days so that the three parts of the herbal composition prepared in step 7 are administered to the patient. The formulation can be administered one to four times at an interval of 15-18 days depending on the response of the patient. Prior to administration of the herbal composition, the fractured or dislocated bones should be properly aligned. During the therapy, the patient is advised not to move the affected part. Anecdotal studies Trials with the herbal product of this invention have been conducted on approximately 10,000 patients, humans as well as animals including roughly 2,000 patients with vertebral 16 disc prolapse, pain in the joints and roughly 8,000 patients with fractures of ribs, jaw, metatarsals, clavicles or long bones of the limbs. Example 1 A 25 years old driver met with a road accident and sustained a fracture of the radius bone of upper limb. There was no wound on the skin but the affected area was swollen. The fracture was reduced by manipulation. The herbal composition as described by this invention was administered to the patient orally as well as applied topically at the fracture site for three consecutive days while keeping the limb immobile. The patient was examined on the twelfth day when he complained of slight pain still persisting at the site of injury. So the three consecutive doses of the herbal composition were freshly prepared and administered to the patient. He was examined again after a week when he was found to be completely free of pain, movement of the limb was normal and x-ray taken of the limb showed complete healing. Example 2 55 years old female patient presented with complain of pain in the lower back area and on examination, was found to have prolapsed intervertebral disc between LI and L2 vertebra. The vertebrae were aligned by topical manipulation. The herbal composition as described by this invention was administered to the patient orally as well as applied topically at the site of pain at the backbone region for three consecutive days. The patient reported on the 15th day with approximately 60% reduction in pain. She was given another course of treatment for three more days. There was complete relief from pain after one month. Example 3 50 year old male tripped over a stone on the road after consuming alcohol and fractured two lower ribs on the right side. The herbal composition as described by this invention was administered to the patient orally as well as applied topically at the fracture site for three consecutive days. The fracture was found healed in 15 days with single course of treatment. 17 Example 4 A 13 year old female teenager fractured ulna bone of fore-limb due to a fall while playing. The herbal composition as described by this invention was administered to the patient orally as well as applied topically at the fracture site for three consecutive days, while keeping the limb immobile. The fracture was found healed in 15 days with single course of treatment. Example 5 35 year old male collided with another cyclist while riding on his bike and sustained injuries along with fracture of the tibia bone of the leg. The bones were aligned manually. The herbal composition as described by this invention was administered to the patient orally. As there was a gaping skin wound over the site of the fracture, topical application was done over the calf region just opposite the fracture site. The fracture was found healed in 32 days with two courses of treatment given at an interval of 15 days. Example 6 A male patient 35 years old developed a highly painful but fracture of the right jaw bone due to a fall. Patient was put on a liquid diet to minimize movement of the jaw bone. Three courses of the herbal treatment as described in this invention were administered at intervals of 15 days each. Patient was examined at the end of 45 days. There was complete reversal of symptoms and x-ray showed union of the bone. Example 7 Treatment was given to a 62 year old man suffering from pain in the left leg. As on examination it was found that the pain was due to slipped vertebral disc, topical application was done at the lower back. Three courses of the treatment were required to give complete relief from pain. Example 8 A 25 year old boy was hit in a quarrel and developed hairline fracture of the left collar bone ( clavicle ). The herbal composition as described by this invention was administered to the 18 patient orally as well as applied topically at the fracture site for three consecutive days, while keeping the limb immobile. The fracture was found healed in 15 days with single course of treatment. Example 9 Treatment with the herbal composition of this invention was given to a horse which had fractured one of the limbs in a fall on a slippery ground. Two courses of treatment, oral and topical, were given on three consecutive days each, at interval of 10 days. The animal was examined on the 21st day. The animal was free from the agony and the fracture site was normal except for slight tenderness. 19 We Claim: 1)A herbal formulation for treatment of fractures and other disorders of bones comprising a dough consisting of (1) macerated bulbs of Allium sativum (Lasuna, Garlic), (2) powdered dried flower buds of Eugenia caryophyllata (Lavangam, Clove), (3) powdered stem/ bark of Cinnamomum zeylanicum (Tvak, Cinnamon), (4) fruits of Piper nigrum Linn (Maricam, Black pepper) and (5) gm of leaves of Premna mucronata Roxb (Agnimantha) in combination with a vegetable oil and a carrier. 2) A herbal composition as claimed in claim 1, in which the percentage of the ingredients in the dough, based on the mass of the dough, are as follows 1) Garlic 12 to 18% 2) Clove 3 to 5 % ; 3) Cinnamon 3 to 5 % 4) Black pepper 3 to 5 % 5) Agnimantha 60 to 80%. 3) A herbal composition according to claim 1 wherein the vegetable oil is selected from a group of oils comprising Groundnut Oil from the plant Arachis hypogaea, Sunflower oil from the kernels of the plant Helianthus annu, and Safflower oil from the seeds of the plant Carthamus tinctorius. 4) A herbal composition according to claim 1 wherein the carrier is milk, preferably goat's milk. 5) A herbal composition according to claim 1 wherein the herbal composition is an oral medicament. 20 6) A herbal composition according to claim 1 wherein the herbal composition is a topical medicament. 7) A process for preparing the herbal composition according to claim 4 comprising the steps of: 1) peeling bulbs of Garlic and grinding the peeled bulbs to a fine paste; 2) mixing together equal quantities of dried flower buds of Clove, the stem bark of Cinnamon and the fruits of Black pepper and grinding the mixture to a fine powder; 3) removing the petioles of freshly harvested leaves of Agnimantha, cutting the leaves to small pieces and grinding the same to a paste; 4) mixing the paste of the bulbs of Garlic obtained in step 1 thoroughly with the mixture of the fine powders of Clove, Cinnamon and Black pepper obtained in step 2; 5) adding the paste of finely cut leaves of Agnimantha obtained in step 3 to the mixture obtained in step 4; 6) to the mixture from step - 5 to form a dough, mixing sufficient quantity of vegetable oil to prepare a mixture with a paste like consistency; 7) mixing the paste in a carrier, preferably goat's milk to make an oral medicament. 8)A process for preparing the herbal composition according to claim 5 comprising the steps of: 1) peeling bulbs of Garlic and grinding the peeled bulbs to a fine paste; 2) mixing together equal quantities of dried flower buds of Clove, the stem bark of Cinnamon and the fruits of Black pepper and grinding the mixture to a fine powder; 3) removing the petioles of freshly harvested leaves of Agnimantha, cutting the leaves to small pieces and grinding the same to a paste; 4) mixing the paste of the bulbs of Garlic obtained in step 1 thoroughly with the mixture of the fine powders of Clove, Cinnamon and Black pepper obtained in step 2; 5) adding the paste of finely cut leaves of Agnimantha obtained in step 3 to the mixture obtained in step 4; 21 6) to the mixture from step - 5 to form a dough, mixing sufficient quantity of vegetable oil to prepare a mixture with a paste like consistency; 7) mixing the paste in a carrier, preferably goat's milk to form a suspension; 8) collecting the sediment formed after removal of the suspension to obtain a topical medicament. 22 ABSTRACT A herbal formulation for treatment of fractures and other disorders of bones comprising a dough consisting of (1) macerated bulbs of Allium sativum (Lasuna, Garlic), (2) powdered dried flower buds of Eugenia caryophyllata (Lavangam, Clove), (3) powdered stem/ bark of Cinnamomum zeylanicum (Tvak, Cinnamon), (4) fruits of Piper nigrum Linn (Maricam, Black pepper) and (5) gm of leaves of Premna mucronata Roxb (Agnimantha) in combination with a vegetable oil and a carrier.

Documents:

699-MUM-2005-ABSTRACT(13-6-2005).pdf

699-MUM-2005-ABSTRACT(5-9-2008).pdf

699-MUM-2005-ABSTRACT(7-10-2008).pdf

699-MUM-2005-ABSTRACT(GRANTED)-(1-5-2009).pdf

699-mum-2005-abstract.doc

699-mum-2005-abstract.pdf

699-MUM-2005-ASSIGNMENT(5-9-2008).pdf

699-MUM-2005-CANCELLED PAGES(5-09-2008).pdf

699-MUM-2005-CANCELLED PAGES(5-9-2008).pdf

699-MUM-2005-CANCELLED PAGES(7-10-2008).pdf

699-MUM-2005-CLAIMS(13-6-2005).pdf

699-MUM-2005-CLAIMS(5-9-2008).pdf

699-MUM-2005-CLAIMS(7-10-2008).pdf

699-MUM-2005-CLAIMS(AMENDED)-(7-10-2008).pdf

699-MUM-2005-CLAIMS(GRANTED)-(1-5-2009).pdf

699-mum-2005-claims.doc

699-mum-2005-claims.pdf

699-MUM-2005-CORRESPONDENCE(5-9-2008).pdf

699-MUM-2005-CORRESPONDENCE(7-10-2008).pdf

699-MUM-2005-CORRESPONDENCE(IPO)-(15-5-2009).pdf

699-mum-2005-description (complete).pdf

699-MUM-2005-DESCRIPTION(COMPLETE)-(13-6-2005).pdf

699-MUM-2005-DESCRIPTION(COMPLETE)-(5-9-2008).pdf

699-MUM-2005-DESCRIPTION(COMPLETE)-(7-10-2008).pdf

699-MUM-2005-DESCRIPTION(GRANTED)-(1-5-2009).pdf

699-MUM-2005-FORM 1(13-06-2005).pdf

699-MUM-2005-FORM 1(5-9-2008).pdf

699-MUM-2005-FORM 18(8-1-2007).pdf

699-MUM-2005-FORM 18(8-11-2007).pdf

699-mum-2005-form 2(5-9-2008).pdf

699-mum-2005-form 2(7-10-2008).pdf

699-MUM-2005-FORM 2(COMPLETE)-(13-6-2005).pdf

699-MUM-2005-FORM 2(GRANTED)-(1-5-2009).pdf

699-MUM-2005-FORM 2(TITLE PAGE)-(13-6-2005).pdf

699-MUM-2005-FORM 2(TITLE PAGE)-(5-9-2008).pdf

699-MUM-2005-FORM 2(TITLE PAGE)-(GRANTED)-(1-5-2009).pdf

699-MUM-2005-FORM 3(5-9-2008).pdf

699-mum-2005-form-1.pdf

699-mum-2005-form-2.doc

699-mum-2005-form-2.pdf

699-mum-2005-form-26.pdf

699-mum-2005-form-3.pdf

699-MUM-2005-SPECIFICATION(AMENDED)-(5-9-2008).pdf