A herbo-mineral metallic composition and a process for preparation thereof

Abstract

ABSTRACT A HERBO-MINERAL METALLIC COMPOSITION AND A PROCESS FOR PREPARATION THEREOF The present disclosure relates to the herbo-mineral metallic composition and a process for preparation thereof. The herbo-mineral metallic composition of the present disclosure can be used for alleviating adverse effects of chemotherapy and radiotherapy such as stomatitis, xerostomia, taste alteration, excessive salivation, trismus, dysphagia, nausea and local pain in oral cavity cancer patients. The herbo-mineral metallic composition comprises predetermined amounts of Suvarna Bhasma, Mouktik Bhasma, Shankha bhasma, Shouktik Bhasma, Kapardika Bhasma, Pravala Bhasma, Shudhha Gairik, Guduchi Sattva and at least one excipient.

Description

DESC:FIELDThe present disclosure relates to a herbo-mineral metallic composition and a process for preparation thereof. Particularly, the present disclosure relates to a herbo-mineral metallic composition for alleviating adverse effects of radiotherapy and chemotherapy for improving quality of life of cancer patients.DEFINITIONSAs used in the present disclosure, the following terms are generally intended to have the meaning as set forth below, except to the extent that the context in which they are used to indicate otherwise.Suvarna bhasma: The term “Suvarna bhasma” refers to “incinerated gold” prepared by incinerating gold in accordance with the present disclosure. The term “Suvarna” refers to 24 carat gold. The term “Suvarna bhasma” as is referred to in the present disclosure is not the same as used in the Ayurveda. Mouktik bhasma: The term “Mouktik bhasma” refers to “incinerated pearl”, natural or cultured, prepared by incinerating pearl in accordance with the present disclosure. The term “Mouktik bhasma” as referred to in the present disclosure is not the same as used in Ayurveda.Shankha bhasma: The term “Shankha bhasma” refers to “incinerated Conch shell”. The term “Shankha bhasma” as is referred to in the present disclosure is not the same as used in Ayurveda. Shouktik bhasma: The term “Shouktik bhasma” refers to “incinerated empty pearl shell”. The term “Shouktik bhasma” as is referred to in the present disclosure is not the same as used in Ayurveda.Kapardika bhasma: The term “Kapardika Bhasma” refers to “incinerated Cowries”. The term “Kapardika Bhasma” as is referred to in the present disclosure is not the same as used in Ayurveda. Pravala bhasma: The “Pravala Bhasma” refers to “incinerated coral”. The term “Pravala Bhasma” as is referred to in the present disclosure is not the same as used in Ayurveda.Guduchi Sattva: The term “Guduchi Sattva” refers to an alcoholic, hydro alcoholic or aqueous extract comprising mainly starch of Tinospora cordifolia or Tinospora sinensis or Tinospora crispa or Tinospora glabra. The term “Guduchi Sattva” as is referred to in the present disclosure is not the same as used in Ayurveda.Shudhha Gairik: The “Gairik” is a natural clay earth pigment which is a mixture of ferric oxide and varying amounts of clay and sand. “Shudhha Gairik” refers to “processed Gairik”, prepared by roasting Gairik in ghee obtained from cow’s milk. The term “Gairik” as is referred to in the present disclosure is not the same as used in Ayurveda.Tulsi: The term “tulsi” refers to Ocimum sanctum belonging to the family Lamiaceae. It is also known as holy basil.Aloe Vera: A gelatinous substance obtained from aloe vera plant.Incinerate: The term “Incinerate” refers to a method of destroying waste material by burning.Cow-dung cakes: The traditionally prepared cakes of cow dung, which are used for generating fire after ignition. Amalgamate: The term “Amalgamate” refers to a method of combining alloy (a metal) with mercury.Granule: The term “Granule” refers to a small compact particle of a substance. Pellet: The term “Pellet” refers to a small, rounded, compressed mass of a substance.WBC: The term “WBC” refers to White blood cells. Karnofsky score: The term “Karnofsky score” refers to the Karnofsky Performance Scale Index, which allows patients to be classified according to their functional impairment.QoL: QoL refers to the general Quality of Life QLQ: QLQ refers to the Quality of Life QuotientQLQ H&N: refers to the Quality of Life Questionnaire for head and neck cancerSymptom score: Symptom score of QLQ is indicative of symptomatology; hence decrease in symptom score represents both decrease in disease related symptoms and adverse effects of conventional treatment.Functional score: Functional score of QLQ signifies status of routine physical activities. Increase in functional score represents improvement in QoL. Global score: Global score of QLQ represents overall well-being of a patient. Increase in global score represents improvement in QoL.Head and Neck Score: Head and Neck score of QLQ is indicative of local head and neck related symptomatology; hence decrease in symptom score represents decrease in disease related local symptoms and adverse effects of conventional treatment.Decoction: Decoction is a method of extraction by boiling herbal or plant material to dissolve the chemicals of the material, which may include stems, stolens, roots, bark and rhizomes.SGOT: Serum glutamic-oxaloacetic transaminase (SGOT), or Aspartate aminotransferase (AST), is an enzyme that is primarily found in the liver and heart. The SGOT is a blood test that helps to determine how well the liver is functioning. Too much of this enzyme can indicate a problem, such as liver damage.SGPT: Serum glutamic-pyruvic transaminase (SGPT), or alanine transaminase (ALT), is an enzyme made in the liver. It is released into the blood when tissues are damaged. The SGPT is a blood test that checks for and measures damage to the liver.BACKGROUNDThe background information herein below relates to the present disclosure but is not necessarily prior art.Chemotherapy is used to reduce the primary tumor load as well as recurrence and metastasis. Chemotherapy induces adverse side effects which are mainly caused by the inability of chemotherapeutic drugs to distinguish between dividing cancer cells and normal cells. Adverse effects can also be caused by an increase in oxidative stress and hampered immune status. The adverse side effects include nausea, vomiting, loss of appetite, diarrhea, constipation, weakness, alopecia (loss of hair) and neurological problems. These adverse side effects interfere with patient compliance and results in poor quality of life of cancer patients. Further, the side effects may include myelo-suppression as well as liver and bladder toxicities, which may require discontinuation of therapy itself.Cancer is defined as the uncontrollable growth of cells that invade and cause damage to surrounding tissue. Oral cancer, which includes cancers of the lips, tongue, cheeks, floor of the mouth, hard and soft palate, sinuses, and pharynx (throat), can be life threatening if not diagnosed and treated early. Oral cancer is a major public health problem in the Indian subcontinent, where it ranks among the top three types of cancer in the country. The first-line of treatment for oral cancer is surgery combined with radiotherapy for the treatment of regionally advanced cancers, and for the treatment of recurrent or metastatic disease in combination with platinum-based chemotherapy. It is well known that both radiotherapy and chemotherapy have adverse side effects often leading to interruption in therapeutic schedule in these patients. Radiation induced side effects in oral cancer patients such as stomatitis, trismus, xerostomia, taste disturbance, fatigue etc are well documented. These symptoms lead to increase in oxidative stress and hampered immune status.Efforts have been made to overcome these side effects by using alternative or adjunct therapies. However, these therapies do not show effective reduction of the side effects. Further, the subjects undergoing chemotherapy and / or radiotherapy need to take several other medicines, in order to avoid the adverse side effects. Multiple administration of various drugs on a daily basis becomes hectic for patients as well as care givers. No efforts have been made to combine drugs and to derive synergistic effects to avoid multiple administration of various drugs. Therefore, there is felt a need to provide a herbo-mineral metallic composition that mitigates the aforestated drawbacks. OBJECTSSome of the objects of the present disclosure, which at least one embodiment herein satisfies, are as follows.An object of the present disclosure is to ameliorate one or more problems of the prior art or to at least provide a useful alternative. Another object of the present disclosure is to provide a herbo-mineral metallic composition.Yet another object of the present disclosure is to provide a process for preparing a herbo-mineral metallic composition.Still another object of the present disclosure is to provide a herbo-mineral metallic composition for alleviating the adverse effects of chemotherapy and radiotherapy.Still another object of the present disclosure is to provide a herbo-mineral metallic composition for improving the quality of life in patients undergoing radiotherapy.Yet another object of the present disclosure is to provide a herbo-mineral metallic composition for improving the immune response in patients undergoing radiotherapy.Another object of the present disclosure is to provide a herbo-mineral metallic composition for reducing oxidative stress in patients undergoing radiotherapy.Other objects and advantages of the present disclosure will be more apparent from the following description, which is not intended to limit the scope of the present disclosure.SUMMARY In one aspect, the present disclosure provides a herbo-mineral metallic composition comprising Suvarna bhasma in an amount ranging from 1.5 wt% to 2.5 wt% of the total weight of the composition; Mouktik bhasma in an amount ranging from 15 wt% to 25 wt% of the total weight of the composition; Shankha bhasma in an amount ranging from 5.0 wt% to 8.0 wt% of the total weight of the composition; Shouktik bhasma in an amount ranging from 5.0 wt% to 8.0 wt% of the total weight of the composition; Kapardika bhasma in an amount ranging from 5.0 wt% to 8.0 wt% of the total weight of the composition; Pravala bhasma in an amount ranging from 5.0 wt% to 8.0 wt% of the total weight of the composition; Guduchi Sattva in an amount ranging from 25.0 wt% to 35.0 wt% of the total weight of the composition; Shudhha Gairik in an amount ranging from 5.0 wt% to 8.0 wt% of the total weight of the composition; and at least one excipient in an amount ranging from 3.0 wt% to 30.0 wt% of the total weight of the composition. In one embodiment, the Suvarna bhasma is obtained by stabilizing Suvarna with Ocimum sanctum.In another aspect, the present disclosure provides a process for preparing a herbo-mineral metallic composition comprising the steps of mixing predetermined amounts of Suvarna bhasma, Mouktik bhasma, Shankha bhasma, Shouktik bhasma, Kapardika bhasma, Pravala bhasma, Guduchi Sattva, Shudhha Gairik and at least one excipient to obtain a mixture; adding water to the mixture to obtain a dough; pelletizing the dough to obtain pellets; drying the pellets at a temperature in the range of 40oC to 50oC to obtain dried pellets; grinding the dried pellets to obtain grinded pellets having powder to granule ratio of 30 : 70; and compressing the grinded pellets to obtain solid dosage form of the herbo-mineral metallic composition.In one embodiment, the Suvarna bhasma is prepared by amalgamating Suvarna with mercury and sulphur to obtain amalgamated Suvarna; sequentially incinerating amalgamated Suvarna at a temperature ranging from 650 °C to 700 °C to obtain powdered Suvarna; triturating said powdered Suvarna with juice of fresh leaves of Ocimum sanctum (Tulsi), for 5 hours to 7 hours, to obtain a triturated mixture; and incinerating said triturated mixture at a temperature ranging from 550°C to 650°C to obtain Suvarna bhasma. The Suvarna bhasma so obtained has particle size ranging from 20nm to 500 nm.BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGThe present disclosure will now be described with the help of the accompanying drawing, in which:Figure 1 depicts the results of clinical investigation for stomatitis, xerostomia, taste alteration and excessive salivation in Study group and Control group; Figure 2 depicts the results of clinical investigation for trismus, dysphagia, nausea, and local pain in Study group and Control group;Figure 3 depicts the results of clinical investigation of Karnofsky score and weight in Study group and Control group;Figure 4 depicts a graphical representation in Functional score, Symptom score, Global score and Head & Neck score in Study group and Control group;Figure 5 depicts a graphical representation showing effect of radiotherapy on hemoglobin (Hb) count of Study group and Control group;Figure 6 depicts a graphical representation showing effect of radiotherapy on white blood cell (WBC) count of Study group and Control group;Figure 7 depicts a graphical representation showing effect of radiotherapy on platelet count of Study group and Control group;Figure 8 depicts a graphical representation showing effect of radiotherapy on Serum Bilirubin level of Study group and Control group;Figure 9 depicts a graphical representation showing effect of radiotherapy on SGOT, SGPT and Alkaline phosphatase level of Study group and Control group;Figure 10 depicts a graphical representation showing effect of radiotherapy on Serum Creatinine and Serum Urea level of Study group and Control group;Figure 11 depicts a graphical representation showing effect of radiotherapy on C - reactive protein (CRP) level of Study group and Control group.DETAILED DESCRIPTIONEmbodiments are provided so as to thoroughly and fully convey the scope of the present disclosure to the person skilled in the art. Numerous details are set forth, relating to specific components, and methods, to provide a complete understanding of embodiments of the present disclosure. It will be apparent to the person skilled in the art that the details provided in the embodiments should not be construed to limit the scope of the present disclosure. In some embodiments, well-known processes, well-known apparatus structures, and well-known techniques are not described in detail. The terminology used, in the present disclosure, is only for the purpose of explaining a particular embodiment and such terminology shall not be considered to limit the scope of the present disclosure. As used in the present disclosure, the forms "a,” "an," and "the" may be intended to include the plural forms as well, unless the context clearly suggests otherwise. The terms "comprises," "comprising," “including,” and “having,” are open ended transitional phrases and therefore specify the presence of stated features, integers, steps, operations, elements, modules, units and / or components, but do not forbid the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof. The particular order of steps disclosed in the method and process of the present disclosure is not to be construed as necessarily requiring their performance as described or illustrated. It is also to be understood that additional or alternative steps may be employed.Oral cancer is a major public health problem worldwide, particularly in the Indian subcontinent. The first-line of treatment for oral cancer is surgery combined with radiotherapy for the treatment of loco regionally advanced cancers, and for the treatment of recurrent or metastatic disease in combination with platinum-based chemotherapy. It is well known that both radiotherapy and chemotherapy have adverse side effects often leading to interruption in therapeutic schedule in these patients. Radiation induced side effects in oral cancer patients such as stomatitis, trismus, xerostomia, taste disturbance, fatigue etc are well documented. These symptoms lead to increase in oxidative stress and hampered immune status.Therefore, the present disclosure provides a herbo-mineral metallic composition for alleviating adverse side effects of chemotherapy and radiotherapy, improving immune response, quality of life and controlling oxidative stress. In one aspect, the present disclosure provides a herbo-mineral metallic composition comprising Suvarna bhasma in an amount ranging from 1.5 wt% to 2.5 wt% of the total weight of the composition; Mouktik bhasma in an amount ranging from 15 wt% to 25 wt% of the total weight of the composition; Shankha bhasma in an amount ranging from 5.0 wt% to 8.0 wt% of the total weight of the composition; Shouktik bhasma in an amount ranging from 5.0 wt% to 8.0 wt% of the total weight of the composition; Kapardika bhasma in an amount ranging from 5.0 wt% to 8.0 wt% of the total weight of the composition; Pravala bhasma in an amount ranging from 5.0 wt% to 8.0 wt% of the total weight of the composition; Guduchi Sattva in an amount ranging from 25.0 wt% to 35.0 wt% of the total weight of the composition; Shudhha Gairik in an amount ranging from 5.0 wt% to 8.0 wt% of the total weight of the composition; and at least one excipient in an amount ranging from 3.0 wt% to 30.0 wt% of the total weight of the composition.All the ingredients of the herbo-mineral metallic composition of present disclosure act synergistically in controlling ROS (Reactive oxygen species) generation, improving anti-inflammatory activity and immunomodulation, and sustaining oral hygiene, thereby reducing the adverse side effects of radiotherapy and improving the quality of life in cancer patients. Therefore, when this composition is administered, it improves immunomodulatory activity and has rejuvenation effect. In one embodiment, Suvarna bhasma, also known as incinerated gold, is obtained by stabilizing Suvarna with Ocimum sanctum. Suvarna bhasma prepared in accordance with the present disclosure has been found to be effective in managing the adverse side effects of radiotherapy. Suvarna bhasma provides nourishment to body as well as to tissues, which are hampered due to this conventional cancer therapy. This conventional anti-cancer therapy like radiotherapy produces local inflammation, and interferes with the process of absorption of micronutrients at cellular level. These malfunctions are effectively corrected by Suvarna bhasma.The quantities of Suvarna bhasma, Mouktik bhasma, and Guduchi Sattva are carefully triturated. Combining Suvarna bhasma with Mouktik bhasma and Guduchi Sattva pacifies the aggressiveness of Suvarna bhasma on the digestive power as well as absorption at tissue level of the patient. Additionally Mouktik Bhasma has an antacid effect whereas Guduchi Sattva has an immunomodulatory effect.Mouktik bhasma, also known as incinerated pearl, alleviates lack of taste and vomiting by improving digestion. Nausea and loss of taste developed during course of radiotherapy are well controlled due to the combined anti-emetic activity and carminative activity of Mouktik bhasma, Pravala bhasma, Shankha bhasma, Shouktik bhasma, Kapardika Bhasma and Shudhha Gairik.Pravala Bhasma is prepared from Coral. Pravala (coral) has rejuvenator effect, anti-pyretic effect and detoxifying effect, which is beneficial in radiotherapy, induced adverse effects like stomatitis, loss of taste and boosting up immunity. In one embodiment, Pravala is triturated in aloe vera pulp, which provides additional cooling effect.Shankha bhasma is prepared from conch shell. Shouktik bhasma is obtained from incinerated pearl shell. Kapardika Bhasma is prepared from Cowries. Guduchi is the common name for Tinospora species. The Tinospora (Guduchi) plant is obtained from Tinospora cordifolia or Tinospora sinensis belonging to the family Menispermaceae. Particularly the stem of the Tinospora (Guduchi) plant is used for making the Sattva. Tinospora cordifolia is indigenous to the tropical areas of India, Myanmar, and Sri Lanka. Tinospora sinensis is found in India, China, Sri Lanka, Nepal, Cambodia, Thailand, Vietnam, and Myanmar. Tinospora sinensis is also known as Malabar Gulbel or Gulvel. In the present disclosure, Tinospora cordifolia and Tinospora sinensis is obtained from Bharatiya Sanskriti Darshan Trust (BSDT), Wagholi, Pune. Shudhha Gairik is Red ochre, a natural clay earth pigment which is a mixture of ferric oxide and varying amounts of clay and sand. In accordance with the present disclosure Shudhha Gairik is prepared by roasting Red ochre in ghee obtained from cow’s milk. The excipient is a binder selected from the group consisting of gum acacia, guar gum, and xanthan gum. In an embodiment of the present disclosure, the binder is gum acacia, obtained from Bharatiya Sanskriti Darshan Trust (BSDT), Wagholi, Pune.The herbo-mineral metallic composition is in solid dosage form selected from tablet, pill, and capsule.The herbo-mineral metallic composition of present disclosure can be administered at a dose of 950 mg - 1200 mg per day by oral administration in solid dosage form. In another aspect, the present disclosure provides a process for preparing a herbo-mineral metallic composition. The process comprises mixing together predetermined amounts, in powdered form, of Suvarna bhasma, Mouktik bhasma, Shankha bhasma, Shouktik bhasma, Kapardika bhasma, Pravala bhasma, Guduchi Sattva, Shudhha Gairik and at least one excipient to obtain a mixture. In one embodiment, all the ingredients are blended in a mixer.The predetermined amounts of Suvarna bhasma ranges from 1.5 wt% to 2.5 wt%, Mouktik bhasma ranges from 15 wt% to 25 wt%, Shankha bhasma ranges from 5.0 wt% to 8.0 wt%, Shouktik bhasma ranges from 5.0 wt% to 8.0 wt%, Kapardika bhasma ranges from 5.0 wt% to 8.0 wt%, Pravala bhasma ranges from 5.0 wt% to 8.0 wt%, Guduchi Sattva ranges from 25.0 wt% to 35.0 wt%, Shudhha Gairik ranges from 5.0 wt% to 8.0 wt%, and at least one excipient ranges from 3.0 wt% to 30.0 wt% of the total weight of the composition.Water is then added to the mixture to form dough. The dough is pelletizing to form pellets. In one embodiment, the pellets have an average weight of 5 gm.These pellets are dried at a temperature in the range of 40oC to 50oC to obtain dried pellets. In one embodiment, the pellets are tray-dried typically at temperatures in the range of 40°C to 45°C, preferably at 45 °C. The dried pellets are then grinded to obtain grinded pellets having powder to granule ratio of 30: 70. In one embodiment, the dried pellets are granulated in a mixer grinder. The grinded pellets are compressed to obtain solid dosage form of herbo-mineral metallic composition.In one embodiment, the solid dosage is in the form of a compressed tablet, obtained by compressing the grinded pellets in a tablet punching machine. In one embodiment, the average weight of the uncoated tablets is 270 mg ± 5%. The typical shelf life of the tablets is 3 years.In one embodiment, Suvarna bhasma is prepared by amalgamating Suvarna with mercury and sulphur to obtain amalgamated Suvarna. The amalgamated Suvarna is sequentially incinerated at a temperature ranging from 650 °C to 700 °C to obtain powdered Suvarna. Powdered Suvarna is triturated with juice of fresh leaves of Ocimum sanctum (Tulsi), for 5 hours to 7 hours, to obtain a triturated mixture. The triturated mixture is incinerated at a temperature ranging from 550°C to 650°C to obtain Suvarna bhasma.The biological name of Tulsi or holy basil is Ocimum sanctum and belongs to the family Lamiaceae. In the present disclosure, Ocimum sanctum is obtained from from Bharatiya Sanskriti Darshan Trust (BSDT), Wagholi, Pune.In one embodiment, the particle size of the prepared Suvarna bhasma is in the range of 20nm to 500 nm. The particle size of Suvarna bhasma can be analysed by using a Particle Size Analyser (90 plus from Brookhave Instruments, USA). In one embodiment, Mouktik bhasma is prepared by boiling Mouktik (pearl) in butter milk having curd to water ratio of 1:2 w / v and pH of 3 to obtain purified Mouktik. The purified Mouktik is powdered and triturated with rose water. The triturated mixture is incinerated using cow-dung cakes at a temperature in the range of 650 °C to 750 °C to obtain Mouktik Bhasma.In one embodiment, the Shankha bhasma is prepared by boiling Shankha (conch) in diluted lemon juice having pH ranging from 3-4 to obtain purified Shankha. The purified Shankha is powdered and triturated with aloe vera pulp. The triturated mixture is incinerated using cow-dung cakes at a temperature in the range of 800 °C to 900 °C to obtain Shankha bhasma.In one embodiment, the Shouktik bhasma is obtained by boiling Shouktik (pearl shell) in diluted lemon juice having pH ranging from 3-3.5 to obtain purified Shouktik. The purified Shouktik is powdered and triturated with aloe vera pulp. The triturated mixture is incinerated using cow-dung cakes at a temperature in the range of 900 °C to 1000 °C to obtain Shouktik Bhasma.In one embodiment, the Kapardika bhasma is obtained by boiling Kapardika (cowry) in diluted lemon juice having pH ranging from 3-3.5 to obtain purified Kapardika. The purified Kapardika is powdered and triturated with aloe vera pulp. The triturated mixture is incinerated using cow-dung cakes at a temperature in the range of 750 °C to 850 °C to obtain Kapardika Bhasma.In one embodiment, the Pravala bhasma is obtained by boiling Pravala (coral) in butter milk having curd to water ratio of 1:2 w / v and pH of 3 to obtain purified Pravala. The purified Pravala is powdered and triturated with Aloe vera pulp. The triturated mixture is incinerated using cow-dung cakes at a temperature in the range of 650 °C to 750 °C to obtain Pravala Bhasma.In one embodiment, the Guduchi Sattva is obtained by extracting starch from the chopped pieces of fresh stems of Tinospora spp. by crushing and soaking the pieces for 12 hours in 4 times (w / v) of water to obtain a mixture. The mixture is macerated and filtered to obtain solution containing aqueous extract of Tinospora spp. The solution containing aqueous extract of Tinospora spp. is kept aside for 12 hours to obtain sediment as smooth starchy substance. The sedimented smooth starchy substance is dried in an oven at a temperature in the range of 40 °C to 50 °C to obtain dry starch of Guduchi Sattva. In one embodiment, the Shudhha Gairik (red ochre) is obtained by roasting the powdered red ochre in 1 / 10th amount of cow’s ghee at a temperature ranging from 150-180 ºC to form free flowing powder. The resulting powder is cooled at optimal temperature to form Shudhha Gairik.The foregoing description of the embodiments has been provided for purposes of illustration and not intended to limit the scope of the present disclosure. Individual components of a particular embodiment are generally not limited to that particular embodiment, but, are interchangeable. Such variations are not to be regarded as a departure from the present disclosure, and all such modifications are considered to be within the scope of the present disclosure.The present disclosure is further described in light of the following experiments which are set forth for illustration purpose only and not to be construed for limiting the scope of the disclosure. The following experiments can be scaled *up to industrial / commercial scale and the results obtained can be extrapolated to industrial scale.EXPERIMENTAL DETAILS: A herbo-mineral metallic composition prepared in accordance with the present disclosure.Example 1: Herbo-mineral metallic composition Three different batches of the herbo-mineral metallic compositions were prepared, by varying the quantity of each of its components, as provided in Table 1 below. Each of these 3 batches was administered to oral cancer patients scheduled for radiotherapy. On administration, it was found that all the three batches are effective in managing the side effects associated with the radiotherapy in oral cancer patients. However, Batch 1 was found to give the best results.Table 1: Herbo-mineral metallic composition Sr.No. Contents Latin name / English Name Batch 1Quantity(2650 g) Batch 2Quantity(2650 g) Batch 3Quantity (2650 g)1 Suvarna Bhasma Incinerated Gold 50.00g(1.88 wt %) 42.50 g(1.60 wt %) 57.50 g(2.16 wt %)2 Mouktik Bhasma Incinerated Pearl 490.00 g(18.49 wt %) 416.50 g(15.71 wt %) 563.50 g(21.24 wt %)3 Shankha bhasma Incinerated Conch 175.00 g(6.60 wt %) 148.75 g(5.61 wt %) 201.25 g(7.59 wt %)4 Shouktik Bhasma Incinerated Pearl Shell 175.00 g(6.60 wt %) 148.75 g(5.61 wt %) 201.25 g(7.59 wt %)5 Kapardika Bhasma Incinerated Cowrie 175.00 g(6.60 wt %) 148.75 g(5.61 wt %) 201.25 g(7.59 wt %)6 Pravala Bhasma Incinerated Coral 175.00 g(6.60 wt %) 148.75 g(5.61 wt %) 201.25 g(7.59 wt %)7 An aqueous extract of Tinospora cordifolia / T. sinensis Starch of Tinospora cordifolia / T.sinensis 800.00 g(30.18 wt %) 680.00 g(25.66 wt %) 920.00 g(34.71 wt %)8 Shudhha Gairik Red ochre roasted in cow ghee 175.00 g(6.60 wt %) 148.75 g(5.61 wt %) 201.25 g(7.59 wt %)9 Excipient Gum Acacia powder 435.00 g(16.41 wt %) 767.25 (28.95 wt %) 102.75 g(3.87 wt %)Example 2: Process for preparing solid dosage form (Tablet) The biological materials used in this example were obtained from Bharatiya Sanskriti Darshan Trust (BSDT), Wagholi, Pune. a) Preparation of Suvarna bhasma: Suvarna was amalgamated with mercury and sulphur to obtain amalgamated Suvarna. The amalgamated Suvarna was sequentially incinerated at temperatures of 650 °C to 700 °C to obtain powdered Suvarna. Powdered Suvarna was triturated with juice of fresh leaves of Ocimum sanctum (Tulsi), for 6 hours to obtain a triturated mixture. The triturated mixture was incinerated at a temperature ranging from 600°C to obtain Suvarna bhasma.b) Preparation of Mouktik bhasma: Mouktik bhasma was prepared by boiling Mouktik (pearl) in butter milk having curd to water ratio of 1:2 w / v and pH of 3 to obtain purified Mouktik. The purified Mouktik was powdered and triturated with rose water. The triturated mixture was incinerated using cow-dung cakes at a temperature of 700 °C to obtain Mouktik Bhasma.c) Preparation of Shankha bhasma: Shankha bhasma was prepared by boiling Shankha (conch) in diluted lemon juice having pH ranging from 3-4 to obtain purified Shankha. The purified Shankha was powdered and triturated with aloe vera pulp. The triturated mixture was incinerated using cow-dung cakes at a temperature of 850 °C to obtain Shankha bhasma.d) Preparation of Shouktik bhasma: Shouktik bhasma was prepared by boiling Shouktik (pearl shell) in diluted lemon juice having pH ranging from 3-3.5 to obtain purified Shouktik. The purified Shouktik was powdered and triturated with aloe vera pulp. The triturated mixture was incinerated using cow-dung cakes at a temperature of 950 °C to obtain Shouktik Bhasma.e) Preparation of Kapardika bhasma: Kapardika bhasma was obtained by boiling Kapardika (cowry) in diluted lemon juice having pH ranging from 3-3.5 to obtain purified Kapardika. The purified Kapardika was powdered and triturated with aloe vera pulp. The triturated mixture was incinerated using cow-dung cakes at a temperature of 800 °C to obtain Kapardika Bhasma.f) Preparation of Pravala bhasma: Pravala bhasma was obtained by boiling Pravala (coral) in butter milk having curd to water ratio of 1:2 w / v and pH of 3 to obtain purified Pravala. The purified Pravala was powdered and triturated with aloe vera pulp. The triturated mixture was incinerated using cow-dung cakes at a temperature of 700 °C to obtain Pravala Bhasma.g) Preparation of Guduchi Sattva: Guduchi Sattva was obtained by extracting starch from the chopped pieces of fresh stems of Tinospora cordifolia by crushing and soaking the pieces for 12 hours in 4 times (w / v) of water to obtain a mixture. The mixture was macerated and filtered to obtain a solution containing aqueous extract of Tinospora cordifolia. The solution containing aqueous extract of Tinospora cordifolia was kept aside for 12 hours to obtain sediment as smooth starchy substance. The sedimented smooth starchy substance was dried in an oven at 45 °C to obtain dry starch of Guduchi Sattva. h) Preparation of Shudhha Gairik: Shudhha Gairik was obtained by roasting powdered red ochre in 1 / 10th amount of cow’s ghee at a temperature of around 160 ºC to form free flowing powder. The free flowing powder was cooled at optimal temperature to form Shudhha Gairik. i) Preparation of solid dosage form of the herbo-mineral metallic composition: In a mixer, Suvarna bhasma, Mouktik bhasma, Shankha bhasma, Kapardika Bhasma, Shouktik Bhasma, Pravala Bhasma, Guduchi Sattva (starch from Tinospora cordifolia), Shudhha Gairik and gum acacia were mixed in a proportion given in Table 1. To this mixture, sufficient amount of water was added to obtain dough. The dough was further pelletized to obtain pellets. The pellets were dried in oven at 45 °C to obtain dried pellets. The dried pellets were grinded to obtain granules having powder to granule ratio of 30:70. The mixture of granules and powder was compressed in tablet punching machine to obtain solid dosage form as compressed tablet of weight 270 mg ± 5 % variation. Specification of the Tablet: Description : Faint brown colored, circular, compressed, biconvex, uncoated tablet, characteristic odourLoss on drying : 3 - 4 %w / wAverage Weight : 0.2698 gmWeight Variation : 0.2650 – 0.2778 gmDiameter : 7.5 - 8 mmThickness : 3 - 3.5 mmHardness : 4.5 - 5 kg / sq.cmDisintegration Time : NMT 30 minFriability : NMT 1 %w / w Gold content : 1.25 – 1.75 %Calcium content : 17 – 18.5 % w / wIron content : 1.25 – 1.75 % w / wExample 3: Efficacy study of the herbo-mineral metallic composition In this study, eight oral cancer patients scheduled for radiotherapy were included. Out of these, four patients (Study group), were given additional herbo-mineral metallic composition mentioned hereinabove, whereas the remaining four patients (Control group) were not provided with any additional herbo-mineral metallic composition of the present disclosure. The stage and grade of the disease were matched for both Study Group and Control Group. Herbo-mineral metallic composition was given from the start of radiotherapy until completion of radiotherapy.Inclusion criteriaOral cavity cancer patients of all stages and grades, scheduled for radiotherapy dose up to 7000 Cgy in 30-35 fractions for 6-7 weeks. Exclusion criteriaPatients taking other Ayurvedic drugs for cancer or any other ailment and patients with oral cavity cancer scheduled for palliative radiotherapy. Outcome measures – Time points for assessment of outcome measures- A - Before radiotherapy B - End of radiotherapy A. Clinical Investigations The patients were followed-up for: - Clinical assessment of adverse effects and its grading using CTCAE 4.03 Version. Stomatitis, dysphagia and nausea recorded on the scale of grade 1-5; excessive salivation and local pain on 1-4;xerostomia and trismus on 1-3 and taste alteration 1-2; while Grade ‘0’ denoting absence of symptom. Lower scale denotes less severity of the symptoms.- Assessment of performance status using Karnofsky score (Grading for well-being on 0 to 100 scale, higher score denotes better performance) and weight.- Assessment of Quality of Life (QoL) using Questionnaire QLQ C30 (designed for all types of cancers) and H&N35 (specially designed for oral cancer patients) of EORTC determined based on patients’ own perspective about wellbeing. - QLQ C30 can be interpreted as – 1. Symptomatology (Symptom score) 2. Ability to perform routine activities (Functional score) 3. Overall well-being (Global score) CTCAE, Karnofsky score and scoring for QoL are internationally accepted means of scoring symptoms and quality of life for cancer patients used in various studies in clinical trials.B. Laboratory investigations: To support the clinical observations, additional studies were conducted using clinical laboratory investigations and basic laboratory investigations as follows: Clinical Laboratory investigations: These investigations were conducted for assessing hemoglobin (Hb) status and various cell types in peripheral blood. Toxicity for liver and kidney was assessed on the basis of corresponding enzyme levels. CRP (C-reactive protein) levels were assessed as an indicator of initiation of inflammatory response. The tests performed were Haemogram, LFT (Liver Function Test), KFT (Kidney Function Test), CRP (C-reactive protein test).Assessment of data: The data for adverse effects, Karnofsky score, weight, QLQ, biochemical investigations and basic laboratory parameters was represented as mean of absolute values at each time point. Experiment 1: Alleviation of adverse effects (symptoms) of radiotherapy in oral cancer patients using herbo-mineral metallic composition of the present disclosureOut of commonly observed adverse effects of radiotherapy in oral cavity cancer, eight significant symptoms were recorded in this study. The mean of gradation of symptom at each time point was recorded for both the groups and histograms were plotted (Figure 1 to Figure 2). Results:Stomatitis, xerostomia, taste alteration and excessive salivation– As shown in Figure 1, Control group shows significant increase in stomatitis, as compared to the Study group at the end of radiotherapy i.e. at time point B. Excessive salivation, xerostomia and taste alteration did not show significant differences in both the groups, however were much pronounced in Control group compared to Study group patients. Trismus, dysphagia, Nausea and local pain – As shown in Figure 2, Control group shows significant increase in trismus, as compared to the Study group at the end of radiotherapy i.e. at time point B. Though nausea did not show significant difference in both, the Control and Study group, but was much pronounced in Control group compared to study group patients. In case of dysphagia and local pain there was no difference noted in any of the groups.Experiment 2: Assessment of quality of life during radiotherapy using herbo-mineral metallic composition of the present disclosure Karnofsky score and weight –Karnofsky score and weight were represented as the mean values at each time point in both the groups. Control group showed significant reduction in the Karnofsky score at time point B compared to the Study group whereas weight did not show any significant change at any of the time points in both the groups (Figure 3).QLQ scores (QLQ C30 and H&N 35) - These scores were calculated as mean values and represented at each time point for both the groups. Quality of life scores did not show significant difference in both the groups at any time point (Figure 4).Experiment 3: Efficacy studies of the herbo-mineral metallic composition of present disclosure using hematological and biochemical parametersThe clinical laboratory parameters studied were Haemogram, LFT (Liver Function Test), KFT (Kidney Function Test) and CRP (C-reactive protein test) and found to be within normal range at both the time points. Given below are the trends of differences between study and control groups. The results are based on mean values at each time point.Result:Hemoglobin – Hemoglobin remains unchanged during radiotherapy in both the groups (Figure 5). WBCs and Platelets – WBCs and platelet count decreased slightly at the end of radiotherapy in both the groups (Figure 6 and Figure 7).S. Bilirubin, SGPT, SGOT and Alkaline phosphatase - S. Bilirubin, SGPT, SGOT and Alkaline phosphatase levels were within normal range in both the groups throughout the study (Figure 8 and Figure 9).Serum Creatinine – S. Creatinine levels and Serum Urea were within normal range in both the groups throughout the study (Figure 10). The above results clearly indicate non-toxicity of the herbo-mineral metallic composition to liver and kidney functions.CRP - CRP level was comparable before commencement of radiotherapy and increased during radiotherapy in both the groups. The increase was higher in Study group than that of Control group but is not significant (Figure 11). TECHNICAL ADVANCEMENTSThe present disclosure described herein above has several technical advantages including, but not limited to, the realization of a herbo-mineral metallic composition:- that alleviates the symptoms of chemotherapy and / or radiotherapy, such as stomatitis, trismus, and taste disturbance; and- that improves quality of life of patients treated with radiotherapy. The embodiments herein and the various features and advantageous details thereof are explained with reference to the non-limiting embodiments 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.The foregoing description of the specific embodiments so fully reveal the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and / or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope of the embodiments as described herein.The use of the expression “at least” or “at least one” suggests the use of one or more elements or ingredients or quantities, as the use may be in the embodiment of the disclosure to achieve one or more of the desired objects or results. Any discussion of documents, acts, materials, devices, articles or the like that has been included in this specification is solely for the purpose of providing a context for the disclosure. It is not to be taken as an admission that any or all of these matters form a part of the prior art base or were common general knowledge in the field relevant to the disclosure as it existed anywhere before the priority date of this application. The numerical values mentioned for the various physical parameters, dimensions or quantities are only approximations and it is envisaged that the values higher / lower than the numerical values assigned to the parameters, dimensions or quantities fall within the scope of the disclosure, unless there is a statement in the specification specific to the contrary.While considerable emphasis has been placed herein on the components and component parts of the preferred embodiments, it will be appreciated that many embodiments can be made and that many changes can be made in the preferred embodiments without departing from the principles of the disclosure. These and other changes in the preferred embodiment as well as other embodiments of the disclosure will be apparent to those skilled in the art from the disclosure herein, whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the disclosure and not as a limitation.

Claims

,CLAIMS:I CLAIM:

1. A herbo-mineral metallic composition, said composition comprising:a) Suvarna bhasma in an amount ranging from 1.5 wt% to 2.5 wt% of the total weight of said composition;b) Mouktik bhasma in an amount ranging from 15.0 wt% to 25.0 wt% of the total weight of said composition; c) Shankha bhasma in an amount ranging from 5.0 wt% to 8.0 wt% of the total weight of said composition;d) Shouktik bhasma in an amount ranging from 5.0 wt% to 8.0 wt% of the total weight of said composition;e) Kapardika bhasma in an amount ranging from 5.0 wt% to 8.0 wt% of the total weight of said composition;f) Pravala bhasma in an amount ranging from 5.0 wt% to 8.0 wt% of the total weight of said composition;g) Guduchi Sattva in an amount ranging from 25.0 wt% to 35.0 wt% of the total weight of said composition;h) Shudhha Gairik in an amount ranging from 5.0 wt% to 8.0 wt% of the total weight of said composition; and i) at least one excipient in an amount ranging from 3.0 wt% to 30.0 wt% of the total weight of said composition.

2. The herbo-mineral metallic composition as claimed in claim 1, wherein said Suvarna bhasma is obtained by stabilizing Suvarna with Ocimum sanctum.

3. The herbo-mineral metallic composition as claimed in claim 1, wherein said excipient is a binder selected from the group consisting of gum acacia, guar gum and xanthan gum.

4. The herbo-mineral metallic composition as claimed in claim 3, wherein said binder is gum acacia.

5. The herbo-mineral metallic composition as claimed in claim 1, wherein said composition is in solid dosage form selected from the group consisting of tablet, pill and capsule.

6. The herbo-mineral metallic composition as claimed in claim 1, wherein said composition is capable of alleviating adverse effects of radiotherapy and chemotherapy for improving quality of life of cancer patients.

7. A process for preparing a herbo-mineral metallic composition, said process comprising the following steps:• mixing predetermined amounts of Suvarna bhasma, Mouktik bhasma, Shankha bhasma, Shouktik bhasma, Kapardika bhasma, Pravala bhasma, Guduchi Sattva, Shudhha Gairik and at least one excipient to obtain a mixture;• adding water to said mixture to obtain a dough;• pelletizing said dough to obtain pellets;• drying said pellets at a temperature in the range of 40oC to 50oC to obtain dried pellets;• grinding said dried pellets to obtain grinded pellets having powder to granule ratio of 30 : 70; and• compressing said grinded pellets to obtain solid dosage form of said herbo-mineral metallic composition.

8. The process as claimed in claim 7, wherein said Suvarna bhasma is prepared by the following steps:• amalgamating Suvarna with mercury and sulphur to obtain amalgamated Suvarna;• sequentially incinerating amalgamated Suvarna at a temperature ranging from 650 °C to 700 °C to obtain powdered Suvarna;• triturating said powdered Suvarna with juice of fresh leaves of Ocimum sanctum (Tulsi), for 5 hours to 7 hours, to obtain a triturated mixture; and • incinerating said triturated mixture at a temperature ranging from 550°C to 650°C to obtain said Suvarna bhasma;wherein, said Suvarna bhasma has particle size ranging from 20nm to 500 nm.

9. The process as claimed in claim 7, wherein said Mouktik bhasma is prepared by the following steps:• boiling Mouktik in butter milk having curd to water ratio of 1:2 w / v and pH of 3 to obtain purified Mouktik; • powdering and triturating said purified Mouktik with rose water to obtain a triturated mixture; and• incinerating said triturated mixture using cow-dung cakes at a temperature in the range of 650 °C to 750 °C to obtain said Mouktik bhasma.

10. The process as claimed in claim 7, wherein said Shankha bhasma is prepared by the following steps:• boiling Shankha in diluted lemon juice having pH ranging from 3-4 to obtain purified Shankha; • powdering and triturating said purified Shankha with aloe vera pulp to obtain a triturated mixture; and• incinerating said triturated mixture using cow-dung cakes at a temperature in the range of 800 °C to 900 °C to obtain said Shankha bhasma.

11. The process as claimed in claim 7, wherein said Shouktik bhasma is prepared by the following steps:• boiling Shouktik in diluted lemon juice having pH ranging from 3 to 3.5 to obtain purified Shouktik; • powdering and triturating said purified Shouktik with aloe vera pulp to obtain a triturated mixture; and• incinerating said triturated mixture using cow-dung cakes at a temperature in the range of 900 °C to 1000 °C to obtain said Shouktik bhasma.

12. The process as claimed in claim 7, wherein said Kapardika bhasma is prepared by the following steps:• boiling Kapardika in diluted lemon juice having pH ranging from 3 to 3.5 to obtain purified Kapardika; • powdering and triturating said purified Kapardika with aloe vera pulp to obtain a triturated mixture; and• incinerating said triturated mixture using cow-dung cakes at a temperature in the range of 750 °C to 850 °C to obtain said Kapardika bhasma.

13. The process as claimed in claim 7, wherein said Pravala bhasma is prepared by the following steps:• boiling Pravala in butter milk having curd to water ratio of 1:2 w / v and pH of 3 to obtain purified Pravala; • powdering and triturating said purified Pravala with Aloe vera pulp to obtain a triturated mixture; and• incinerating said triturated mixture using cow-dung cakes at a temperature in the range of 650 °C to 750 °C to obtain said Pravala bhasma.

14. The process as claimed in claim 7, wherein said Guduchi Sattva is prepared by the following steps:• crushing fresh stem of Tinospora spp. and soaking the crushed stem in 4 times (w / v) of water for 12 hours to obtain a mixture;• macerating and filtering said mixture to obtain a solution containing aqueous extract of Tinospora spp.;• keeping aside said solution containing aqueous extract of Tinospora spp. for 12 hours to obtain a sediment; and• drying said sediment at a temperature in the range of 40 °C to 50 °C to obtain said Guduchi Sattva.

15. The process as claimed in claim 7, wherein said Shudhha Gairik is prepared by the following steps:• roasting powdered red ochre in cow’s ghee at a temperature ranging from 150 to 180 ºC to form free flowing powder; and• cooling said free flowing powder to form said Shudhha Gairik.

16. The process as claimed in claim 7, wherein said predetermined amounts of said Suvarna bhasma ranges from 1.5 wt% to 2.5 wt%, said Mouktik bhasma ranges from 15.0 wt% to 25.0 wt%, said Shankha bhasma ranges from 5.0 wt% to 8.0 wt%, said Shouktik bhasma ranges from 5.0 wt% to 8.0 wt%, said Kapardika bhasma ranges from 5.0 wt% to 8.0 wt%, said Pravala bhasma ranges from 5.0 wt% to 8.0 wt%, said Guduchi Sattva ranges from 25.0 wt% to 35.0 wt%, said Shudhha Gairik ranges from 5.0 wt% to 8.0 wt%, and said at least one excipient ranges from 3.0 wt% to 30.0 wt%, of the total weight of said composition.