JP2020517751A - Hervomineral preparation for prevention, treatment and management of renal disorders and method for preparing the same - Google Patents

Abstract

Disclosed herein are herbomineral formulations for the prevention and treatment of renal disorders. The formulation comprises a combination of herbal and mineral elements for treating renal disorders. Renal disorders include conditions associated with renal function, such as chronic renal failure.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application is based on and benefit from Indian Provisional Application No. 20171014513 filed April 24, 2017, the contents of which are incorporated herein by reference.
Embodiments disclosed herein relate to herbo-mineral formulations that are effective in the treatment, management and prevention of renal disorders, and more specifically to formulations that act as nephron protective agents. Embodiments also relate to methods of preparing such formulations.

Renal disorders are diseases associated with renal function. Due to its ability to purify blood, maintain a water-salt balance, and regulate the volume and composition of body fluids, the kidney is one of the most important organs in the human body. Impairment of this ability of the kidney can have serious consequences. Therefore, maintaining a well-functioning kidney is important for good health.

Renal disorders can be due to a number of reasons, such as in the case of acute kidney injury (AKI), where renal insufficiency results from blood loss, dehydration, or the use of medication. AKI is usually a more sudden and reversible state. On the other hand, chronic renal failure (CRF) is an irreversible condition with progressive loss of renal function. One of the major causes of CRF includes diabetes causing diabetic nephropathy. Other major indications for impaired renal function include hypertension, glomerulonephritis, infections and the like.

Various methods are known for treating renal disorders. Appropriate treatment lines can be selected based on the cause of renal damage. In some cases, medications may be directed to the treatment of major complications affecting renal function. Such medicines may include medicines for treating diabetes mellitus, high blood pressure, high cholesterol, anemia and the like. In addition, in the case of end-stage renal disease, treatment would include dialysis and kidney transplant. The symptomatic regimes often practiced in the practice of allopathic medicine can help temporarily alleviate symptoms, but these usually do not focus on improving the overall health of the kidneys.

The core principle of Ayurvedic medicine is to achieve/maintain the harmony of the system, so that approach addresses improving physical health rather than treating symptoms. Ayurvedic intervention is also known for the treatment of renal disorders. Many herbal formulations have been developed based on knowledge of the healing properties of various herbs. Formulations containing herbs such as Tinospora cordifolia, Terminalia chebula and Boerhavia diffusa have been developed. However, the efficacy of such formulations is controversial. There is a need for effective methods of treating/managing renal disorders.

The main purpose of the embodiments disclosed herein is to provide compositions and methods for treating renal disorders.

A second object of the embodiments disclosed herein is to provide compositions and methods for managing renal damage.

Another object of the embodiments disclosed herein is to provide compositions and methods for preventing renal damage.

Another object of the embodiments disclosed herein is to provide herbomineral formulations and methods for their preparation.

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

The embodiments disclosed herein are illustrated in the accompanying drawings, wherein like reference characters refer to corresponding parts of the various views throughout. Embodiments of the present specification will be better understood from the following description with reference to the drawings.

FIG. 1 shows a flow chart for preparing Swarna Maksika Bhasma.

FIG. 6 shows a flow chart for preparing Mandura Bhasma.

FIG. 3 shows a flow chart for preparing Loha Bhasma.

FIG. 6 shows a flow chart for preparing a fortified tablet.

It is a figure which shows the histopathological findings of the kidneys of group I (normal control) and group II (positive control).

FIG. 6 shows histopathological findings of Group III and Group IV kidneys treated with the embodiments disclosed herein.

FIG. 6 shows histopathological findings of the livers of groups I, II, III and IV according to embodiments herein.

The embodiments herein and various features and advantageous details thereof are more fully described with reference to the non-limiting embodiments illustrated in the accompanying drawings and detailed in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein. The examples used herein are merely intended to facilitate an understanding of how the embodiments herein may be practiced and to enable any person skilled in the art to practice the embodiments herein. doing. Therefore, the examples should not be construed as limiting the scope of the embodiments herein.

Embodiments herein achieve therapeutically valuable herbomineral formulations and methods of preparing the formulations. The herbomineral formulations disclosed herein are useful in the treatment, prevention and management of renal disorders. In various embodiments herein, nephropathy can include any condition associated with the kidney, such as nephritis, nephrosis, chronic renal failure, and the like. It is also recognized that embodiments of the disclosed formulations may help prevent complications of renal disease such as anemia, electrolyte imbalance, hypertension, proteinuria, hyperkalemia and the like.

In addition, the disclosed formulations find use in increasing the resistance of renal parenchyma to various types of nephrotoxicity. Various embodiments of the formulation also include supplements for use as a renal protective agent. The formulation may be used as a monotherapy or as an adjunct to other pharmaceuticals used in the treatment of renal disease. Thus, the embodiments disclosed herein achieve a method of treating/managing/preventing renal disorders.

Formulations The embodiments disclosed herein provide herbomineral formulations with selected herbal and mineral combinations. In one embodiment, the herbomineral formulation comprises herbal and mineral elements. In another embodiment, the herbomineral formulation comprises a herbal constituent, a mineral constituent and at least one alkali. In yet another embodiment, the herbal formulation comprises a herbal component, a mineral component, at least one alkali and at least one salt. In one embodiment, the herbomineral formulation may further include one or more suitable excipients.

Herbal elements In one embodiment, the herbal elements are camphora (Cinnamomum camphora), ginger (Acorus calamus), mokko (Saussurea lapapa), sengren (Andrographis panicorata), and Tinospora cod. , Turmeric (Curcuma longa), Aconitum heterophyllum, Berberis aristata, Piper a languum, Plumbago rozua (Plumbergo, Plumbago, Plumbago rosea) Milobaran (Terminalia chebula), Terminia bellelica (Embelia ribes), Piper chaphum (Piper chaucharum), Piper chugaum (Piper longacum), Piper linguum (Piper longaum), Piper linguum (Piper longaum) ) And ginger (Zingiber officinalis), or an extract thereof, or an active ingredient extracted from these herbs. In another embodiment, the herbaceous elements are: Dermatophagoides vulgaris (Operculina turpethum), Baliospermum montanum, Cinnamorum umum tumaeum, Cynamoum zeumonica, Cinnaumum zeumonica. Manna (Bamboo manna), Boerhavia diffusa, Cyperus rotundas, Firisoshinka (Bauhinia varieenta or these), and Horallena antidicentrica (or these). It further comprises at least one of the active ingredients extracted from the herbs.

Herbal elements may include specific parts of herbs (also called herbal constituents) such as roots, flowers, fruits, stems, bark, resins, rhizomes, whole plants, extracts and the like. In one embodiment, the herb components are ginger (Acorus calamus), mokko (Saussurea lappa), Aconitum heterophyllum, Berberis aripata chapa (Per), hibernata (Per), hibernation. ), Plumbago rosea, Plumbago rosea, Operculina turpethum, Baliospermum otanuha cultivated from Baliospermum a tum humorum and sardine Roots of medicinal plants to be used; Coriander (Coriandrum sativum), Amla (Emblica officinalis), Myrobalan (Terminalia cherubula), Terminia pierumeria (Periperia buleria), Hihatsu (Piper vulia) Fruits of medicinal plants selected from the group; crystals of camphor (Cinnamomum camphora); heartwood of cedar (Cedrus deodara); leaves of Cinnamomum tamala; whole plant of Andrographis moth (Andrographis); And turmeric (Curcuma longa) rhizome; Tinospora cordifolia, sugarcane (Saccharum officinarum) and piper chaba liga cinna huma yanae umina zynaica (Circuma zynaica). -The stem bark of anti-discentrica (Holarrhena antidysenterica); or these extracts may be included.

The herbal component may also include any form of secretions, resins or excretions that may be exuded by the herb or any part of the herb. In one embodiment, the herbal constituents may include Bamboo manna secretions and Commiphora mukul oleo-gum resin. However, it is also within the scope of the claims provided herein that the herbomineral formulation includes other herbal ingredients such as leaves, flowers, etc. without interfering with the intended function of the herbomineral formulation.

The herbal component may be included in the formulation in any form commonly known in the art. For example, herbal ingredients may be dried, powdered and processed to form concentrates, extracts and the like. In one preferred embodiment, the herbal ingredients are dried, powdered and further incorporated into the formulation. In another embodiment, the herbal component comprises a stem that can be ground to obtain an extract and further used in the formulation (eg, Saccharum officinarum stem).

In one embodiment, the herbaceous element comprises herbaceous camphor trees (Cinnamomum camphora), ginseng (Acorus calamus), mokko (Saussurea lapapa), sengren (Andrographis panicola), and herbaceous elements in an amount ranging from 1 to 4% by weight. cordifolia), cedar (Cedrus deodara), turmeric (Curcuma longa), Aconitum heterophyllum, Berberis arugosa (Berberis aprita), Berberis aprista (Perbia rosta), hibernation. sativum), Amla (Emblica officinalis), Myrobalan (Terminalia chebula), Terminia bellelica (Terminalia belligerica), Piper chapba (Piper chopaba), Embelia (Ebellia, Embellia) (Zingiber officinalis);; Guggul (Commiphora mukul) in an amount ranging from 6 to 10% by weight; and Sugarcane (Saccharum officinarum) in an amount ranging from 2 to 6% by weight. Further, in another embodiment, the herb components are in amounts ranging up to 2% by weight, such as Opperculina turpethum, Baliospermum montanum, Cinnamomum tamalum, cinnamoum, and cinnamoum. zeylanica), cardamom (Elettaria cardamomum), bamboo manna (Bamboo manna), Nahakanokosou (Boerhavia diffusa), purple nutsedge (Cyperus rotundas), at least one of Fuirisoshinka (Bauhinia variegate) and Horarurena anti di first move Rika (Holarrhena antidysenterica) including.

Mineral Element In one embodiment, the mineral element comprises basma or a baked preparation, such as Swarna maxica basma, mandura basma and roja basma. Alternatively, the mineral elements may be selected from the group consisting of iron rust, iron and at least one of chalcopyrite. In a disclosed embodiment, Basma forms a bioavailable herbomineral complex useful with herbal components to treat, prevent and manage kidney-related complications. In one embodiment, the mineral element further comprises Shilajit. However, it is also provided that the herbomineral formulation comprises other similar baked preparations or minerals, as an alternative or in addition, without interfering with the intended function of the hervomineral formulation. Within.

In one embodiment, the mineral element comprises Shilajit in the range of 6-10% by weight. In another embodiment, the mineral elements are Swarna maxica basma in an amount of 1-4% by weight, Mandura basma in an amount of 2-6% by weight, and Roja Basuma in an amount of 1-4% by weight. including.

Alkali In addition, in one embodiment, the alkali comprises at least one alkali selected from the group consisting of Yavakshara and Sarjakshara. The yavakshala disclosed in embodiments herein includes barley (Hordeum vulgare) alkali, and the saljakshala includes valilla. In one embodiment, the herbomineral formulation disclosed herein comprises alkali in an amount in the range of 2% by weight or less.

Salt In one embodiment, the salt comprises at least one salt selected from the group consisting of rock salt, Sonchal salt and black salt. In one embodiment, the herbomineral formulation disclosed herein comprises salt in an amount ranging from 1 to 4% by weight.

The disclosed formulations, in various embodiments herein, may further comprise suitable excipients. Suitable excipients include solvents, binders, lubricants, herbal carriers, oils and salts commonly known in the art. In a preferred embodiment, the excipient comprises acacia gum.

Further, the amounts of herbal and mineral elements that can be included in various embodiments of the disclosed formulations can range from 0-10% by weight. In one embodiment, the formulation is camphora (Cinnamomum camphora) (1-4% by weight), ginger (Acorus calamus) (1-4% by weight), Mokko (Saussurea lappa) (1-4% by weight), Senshinren (Andrographis). paniculata) (1 to 4% by weight), Tinospora cordifolia (1 to 4% by weight), cedar (Cedrus deodara) (1 to 4% by weight), turmeric (Curcuma longa) (1 to 4% by weight) %), Aconitum heterophyllum (1 to 4% by weight), Berberis aristata (1 to 4% by weight), Piper longum (1 to 4% by weight), Plumbago rosea (Plumbagosea) (1 to 4% by weight), Coriander (Coriandrum sativum) (1 to 4% by weight), Amla (Emblica officinalis) (1 to 4% by weight), and Milobaran (Terminalia chebula) (1 to 4% by weight). , Terminalia bellerica (1-4% by weight), Piper chaba (1-4% by weight), Embelia ribes (1-4% by weight), Piper chaba (Piper chaba) ) (1 to 4% by weight), Hihatu (Piper longum) (1 to 4% by weight), Pepper (Piger nigrum) (1 to 4% by weight), Ginger (Zingiber officinalis) (1 to 4% by weight), Guggle ( Commiphora mukul (6 to 10% by weight), Shilajit (6 to 10% by weight), Sugarcane (Saccharum officinarum) (2 to 6% by weight), Swarna maxica basma (1 to 4% by weight), Mandura basma ( 2 to 6% by weight) and Roja Basma (1 to 4% by weight).

In one embodiment, the formulation is camphora (Cinnamomum camphora) (1-4% by weight), ginger (Acorus calamus) (1-4% by weight), Mokko (Saussurea lappa) (1-4% by weight), Senshinren (Andrographis). paniculate) (1 to 4% by weight), Tinospora cordifolia (1 to 4% by weight), cedar (Cedrus deodara) (1 to 4% by weight), turmeric (Curcuma longa) (1 to 4% by weight) %), Aconitum heterophyllum (1 to 4% by weight), Berberis aristata (1 to 4% by weight), Piper longum (1 to 4% by weight), Plumbago rosea (Plumbagosea) (1 to 4% by weight), Coriander (Coriandrum sativum) (1 to 4% by weight), Amla (Emblica officinalis) (1 to 4% by weight), Myrobalan (Terminalia chebula) (1 to 4% by weight) , Terminalia bellerica (1-4% by weight), Piper chaba (1-4% by weight), Embelia ribes (1-4% by weight), Piper chaba (Piper chaba) ) (1 to 4% by weight), Hihatu (Piper longum) (1 to 4% by weight), Pepper (Piper night) (1 to 4% by weight), Ginger (Zingiber officinalis) (1 to 4% by weight), Guggle ( Commiphora mukul (6 to 10% by weight), Shilajit (6 to 10% by weight), Sugarcane (Saccharum officinarum) (2 to 6% by weight), Yavaksala (1 to 4% by weight), Sarjakshala (1 to 4% by weight) %), Swarna maxica basma (1 to 4% by weight), Mandura basma (2 to 6% by weight) and Roja Basma (1 to 4% by weight).

In yet another embodiment, the formulation is a camphor tree (Cinnamomum camphora) (1-4% by weight), ginger (Acorus calamus) (1-4% by weight), a moth (Saussurea lappa) (1-4% by weight). , Andrographis paniculate (1 to 4% by weight), Tinospora cordifolia (1 to 4% by weight), Cedar deodara (1 to 4% by weight), and turmeric (Curcuma). 1 to 4% by weight), Aconitum heterophyllum (1 to 4% by weight), Berberis aristata (1 to 4% by weight), Piper longum (1 to 4% by weight) , Plumbago rosea (1 to 4% by weight), Coriander (Coriandrum sativum) (1 to 4% by weight), Amla (Emblica officinalis) (1 to 4% by weight), Myrobalan (Terminalia chebula) (1 to 4% by weight) 4% by weight), Terminalia berelica (1-4% by weight), Piper chaba (1-4% by weight), Embelia ribes (1-4% by weight), Piper Ciaba (Piper chaba) (1 to 4 wt%), Hihatu (Piper longum) (1 to 4 wt%), Pepper (Piger nigrum) (1 to 4 wt%), Ginger (Zingiber officinalis) (1 to 4 wt%) ), Guggul (Commiphora mukul) (6 to 10% by weight), Shilajit (6 to 10% by weight), Sugarcane (Saccharum officinarum) (2 to 6% by weight), Yavakshala (1 to 4% by weight), Sarjakshala (6). 1-4% by weight), rock salt (1-4% by weight), Sonchal salt (1-4% by weight), black salt (1-4% by weight), Swarna maxica basma (1-4% by weight), mandura Includes Basma (2-6% by weight) and Roja Basma (1-4% by weight).

In another embodiment, the formulation is in an amount in the range of 2% or less by weight, Opperculina turpethum, Baliospermum montanum, Cinnamamium tamala, cinnamoum zeum. Owl (Elettaria cardamomum), Bamboo manna (Bamboo manna), Boerhavia diffusa (Berhavia dentate), Cyperus rotida (Berhavia dentaria) ..

Further, the amount of acacia gum can be any amount suitable to carry out the activity of the excipient. In one embodiment, the formulation may comprise acacia gum in the range of 0-50 mg/500 mg formulation, preferably 10% by weight.

However, it is clear that slight variations in the amounts of the components can be carried out without disturbing the intended function of the Herbomineral formulation.

The herbomineral formulations disclosed herein can be formulated into various dosage forms suitable for oral administration. Herbomineral formulations may be tablets, pellets, lozenges, granules, capsules, solutions, emulsions, suspensions or any other form suitable for use. In one embodiment, the herbomineral formulation is formulated in the form of tablets, preferably 500 mg tablets. For example, Table 1A shows the amount of each ingredient in a 500 mg tablet.

Further disclosed herein are tablets for treating/preventing/controlling renal disorders. In one embodiment, the tablet is a 500 mg tablet having the herbal elements, mineral elements and excipients shown in Table 1A.

Embodiments of the disclosed formulations in tablet form were analyzed for parameters including physicochemical properties such as tablet hardness, loss on drying, assay, disintegration time, ash value, etc. and the results recorded. Table 2 shows the results of the analyzes performed to determine the physicochemical properties of embodiments of the disclosed formulations. In one embodiment, the disclosed pharmaceutical tablets have the characteristics shown in Table 2. It will be apparent to those skilled in the art that many modifications can be made to both materials and methods without departing from the scope of the invention.

Methods Disclosed herein are embodiments of methods of preparing herbomineral formulations. In one embodiment, the method comprises
Crushing basma, guggul and shilajit with a crusher,
Adding herbs, alkalis and salts to the grinder,
Adding the ground decoction, fresh herb juice and gomutra while continuing to grind to obtain a ground mass.

Basma includes at least one of Roja Basma, Mandura Basma, and Swarna Maxima Basma. The mixture of basma, guggul and shilajit can be in semi-solid form. In one embodiment, the grinding can be done for about 3 hours.

In addition, the herbs are ginger (Acorus calamus), mokko (Saussurea lappa), Aconitum heterophyllum, Berberis aristata (Berberis apata), hihatsu (Piper, piper, pihaper). Rosea (Plumbago rosea), Fusarium morning glory (Operculina turpethum), Baliospermum montanum (Baliospermum montanum), eucalyptus (Elettaria cardamom), Naha-no-hao (Bleo sperum ayu) Coriandrum sativum, Amla (Emblica officinalis), Myrobalan (Terminalia cherubula), Terminalia berelica (finely dried fruit), Pepper longium (Piper longum) and Pemella vulgaris (Piper longium) and Emberia (Ebelia) Crystals of Cinnamomum camphora; finely powdered dried heartwood of Cedrus deodara; finely powdered dried leaves of Cinnamomum tamala; dried powder of cincinurene (Andrographis paniculate); And finely powdered dried rhizomes of turmeric (Curcuma longa); Tinospora cordifolia, sugarcane (Saccharum officinarum) and piper chaba (Piper chaba) finely powdered dry roots and cinnamo; Of finely pulverized dried stem bark of Bauhinia variegata and Hollarhena antidiscentica; Secretion of Bamboo manna And the oleo gum resin of Commiphora mukul. In one embodiment, the micronised herb/herbal component can be obtained by pulverizing and sieving the herbal component through a 80 mesh screen.

Ground decoctions are herbal decoctions that can facilitate grinding. In one embodiment, the milled decoction comprises at least one herbal decoction selected from the list consisting of: Cyperus rotundas, Piper longum, Asparagus racemosus, Firiohsinka. variegate), Oldenburg Randy a-Unberata (Oldenlandia umbelata), Hemidesumusu indicus (Hemidesmus indicus), vetiver (Vetiveria zizanioides), amla (Emblica officinalis), Mirobaran (Terminalia chebula), Teruminaria-Bererika (Terminalia bellerica) and Nahakanokosou ( Boerhavia diffusa). The decoction can be obtained by any decoction method commonly known in the art. In one embodiment, a method of preparing a ground decoction comprises grinding ground herbs: powdered dry roots of Cyperus rotundas, dried fruits of Piper longum, dry roots of Asparagus racemosus, irisocinca. (Bauhinia variegata) dried stem bark, whole dried plants of Oldenlandia umbelata, dried roots of Hemidesmus indicus, dried roots of Vetiveria idelasia, vetiver, vetiver Further comprising the steps of dipping the fruits, dried fruits of Terminalia chebula, dried fruits of Terminalia bellerica and dried roots of Boerhavia diffusa, and concentrating by boiling.

In another embodiment, the soaking can be performed by soaking the ground herbs in 16 parts water overnight. In a further embodiment, the concentration can be carried out by boiling at an elevated temperature, preferably about 80-85°C, until 1/8 of the liquid remains. The concentration can be confirmed with the help of a Brix meter.

Furthermore, once the ground decoction has been added, the grinding is continued while adding fresh juice of the herb. Fresh juices of herbs include at least one fresh juice of the herbs selected from the list consisting of Aloe vera, Punica granatum, Cynodon dactylon and Pineapple. Fresh juice of the herbs obtained by any method commonly known in the art can be added. In one embodiment, fresh juices can be obtained by grinding the herbs together or separately. In addition, once fresh juice of the medicinal herb has been added, continue to grind while adding rubber tiger (cow urine). In one embodiment, milling is continued for about 72 hours, preferably 120 rpm, to obtain a milled mass. In one embodiment, the method of preparation may further comprise the step of adding an excipient to the ground mass, wherein the acacia gum is added to the ground mass by dissolving in the ground decoction while milling is continued for 3 hours. A solid mass can be obtained. The preparation method may further comprise the steps of drying at 50° C., preferably in a hot air oven, wet granulating and punching to obtain 500 mg tablets. FIG. 2 shows a flow chart for preparing a fortified tablet. Table 1B shows the herbal components (milled herbs) required for milling in one of the preferred embodiments.

The basma used in the various embodiments of the disclosed herbomineral formulations can be prepared by methods generally known in the art. Basma selects pure standard minerals as starting materials such as iron rust, iron, chalcopyrite, etc.; dry in a hot air oven; refine minerals by grinding, quenching, boiling, etc.; grinding with herbal decoction It may be prepared by preparing into a disc; preparing a shharabasam puta, subjecting the shharabasam puta to a gaja puta, and pulverizing the cooled disc. In one embodiment, this method is repeated 30 times until a basma is obtained.

The starting materials used to prepare the basma may include standard minerals commonly used in the art. In one embodiment, the preparation of Swarna maxica basma comprises Swarna maxica as a starting material. FIG. 1(a) shows a flow chart for preparing Swarna maxica basma using Swarna maxica as a starting material. In another embodiment, the Mandura basma preparation comprises iron rust as a starting material. FIG. 1(b) shows a flow chart for preparing Mandura basma using iron rust as a starting material. In one embodiment, the Roja Basma preparation comprises steel as a starting material. Figure 1(c) shows a flow chart for preparing Roja Basma using steel as the starting material.

Mineral purification, or shodhana, can be performed by methods commonly known in the art. In one embodiment, the purification can be by mixing the starting material with rock salt and lemon juice, which is further used in the preparation of Swarna maxica basma. In one embodiment, the refining heats the minerals to a red glow and includes five types of sesame oil, buttermilk, cow urine, Kanji (sour medicinal porridge), and Horse gram decoction. It may be by immersion in a different liquid medium, which is further used in the preparation of Mandura basma. In another embodiment, the purification is obtained by quenching the minerals with a Triphala decoction, which is further used in the preparation of Roja Basma.

The herbal decoction/juice used for grinding may be the herbal decoction/juice commonly used in grinding in the preparation of basma. For example, herbal decoctions/juices may include Trifara, lemon juice, gum tiger (cow urine), and the like. In one embodiment, the herbal decoction comprises bovine urine and Trifara decoction, which is useful in preparing Mandura basma. In another embodiment, the herbal decoctions include Trifala Kashaya (Terminalia chebula, Terminalia bellerica, and Emblica officinalis), in particular. Is useful for the preparation of In yet another embodiment, the trituration can be performed with lemon juice, which is useful in preparing Swarna maxica basma.

Treatment Embodiments of methods of treating/preventing/managing renal disorders and related complications are disclosed herein. The embodiments disclosed herein may also help prevent complications associated with renal disease such as anemia, electrolyte imbalance, hypertension, proteinuria, hyperkalemia, and the like.

In one embodiment, the method comprises administering to the patient a composition described in any of the embodiments disclosed herein. In one embodiment, a patient can include any individual in need of such treatment, including an individual having/suspected of having or having a renal disorder. In addition, a patient may also include any individual who has/is suspected of having complications related to renal disorders such as anemia, electrolyte imbalance, hypertension, proteinuria, etc.

In a preferred embodiment, the method comprises the step of administering to the patient a composition having a herbal constituent, a mineral constituent, at least one alkali, at least one salt and a suitable excipient, wherein the herbal constituent is Cinnamomum camphora. ) (1 to 4% by weight), shovel (Acorus calamus) (1 to 4% by weight), mokko (Saussurea lappa) (1 to 4% by weight), senshinren (Andrographis paniculate) (1 to 4% by weight), Tinospora Codyfolia (Tinospora cordifolia) (1 to 4% by weight), cedar (Cedrus deodara) (1 to 4% by weight), turmeric (Curcuma longa) (1 to 4% by weight), Aconitum heterophyll 1 to 4% by weight), Berberis aristata (1 to 4% by weight), Pigeon longum (1 to 4% by weight), Plumbago rosea (1 to 4% by weight), Coriander (Coriandrum sativum) (1 to 4% by weight), Amla (Emblica officinalis) (1 to 4% by weight), Myrobalan (Terminalia chebula) (1 to 4% by weight), Terminalia berelica (Terminalia bellerica) (1 to 4% by weight) % By weight), Piper chaba (1 to 4% by weight), Embelia ribes (1 to 4% by weight), Piper chaba (1 to 4% by weight), Hihatu (Piper) longum) (1 to 4% by weight), pepper (Piper nigrum) (1 to 4% by weight), ginger (Zingiber officinalis) (1 to 4% by weight), guggul (Commiphora mukul) (6 to 10% by weight), sugarcane (Saccharum officinarum) (2 to 6% by weight) and/or Fusarium morning glory (Operculina turpethum), Baliospermum montanum, Tamarina keimu (Cinnamomum taramaze), (Cinnamomum zeylanica), cardamom (Elettaria cardamomum), Bamboo-manna (Bamboo manna), selected from Nahakanokosou (Boerhavia diffusa), purple nutsedge (Cyperus rotundas), Fuirisoshinka (Bauhinia variegate) and Horarurena Anti-di first move Rika (Holarrhena antidysenterica) At least one (2% by weight or less) of the medicinal herbs; mineral elements selected from Shilajit (6-10% by weight) and Mandura basma (2-6%) and Roja Basma (1-4%) At least one alkali is selected from the group consisting of Yavakshala (up to 2% by weight) and Sarjakshala (up to 2% by weight); and at least one salt is rock salt (1 to 4% by weight). ), Sonchal salt (1-4% by weight) and black salt (1-4% by weight).

In one embodiment, the disclosed formulations can be used to act as at least one of an anti-lipid, a free radical scavenger, a hypolipidemic agent and a renal protective agent.

The disclosed methods of treatment can be used as the main treatment line or as an adjunct to other treatment methods for renal disorders.

A patient can be administered a therapeutically effective amount of an embodiment of the disclosed formulation. A therapeutically effective amount can vary from patient to patient. In one embodiment, the therapeutically effective amount is 500-1000 mg administered 1-3 times daily.

Embodiments of the disclosed formulations have been subjected to acute oral toxicity studies and to confirm their effects on behavior and nervous system. Studies have shown that the formulation embodiments are not toxic even at the maximum possible dose of 6000 mg/kg body weight. It was also found to have no detrimental effects on behavior and nervous system.

Embodiments of the disclosed formulations (also referred to as test products or test drugs) were further evaluated by preclinical and clinical trials for efficacy of nephron protective activity, as described below by way of example. Embodiments are further described, by way of example only, by reference to the following examples, and should not be construed as limiting the claims provided herein. It will be apparent to those skilled in the art that many modifications can be made to both materials and methods without departing from the scope of the claims.

Example 1: Preclinical study The purpose of this study was to analyze the effect of test drug on gentamicin-induced nephrotoxicity in male Sprague Dawley rats.

Experiment details:
Twenty-four Sprague Dawley rats ranging from 200-300 g were selected and acclimated to laboratory conditions for 5 days. After acclimatization, animals were randomized into 4 groups (groups I-IV), with 6 animals per group. Animals in groups I and II received vehicle (0.5% CMC) for 14 days each; groups III and IV at 100 and 200 mg/kg b. wt. , P. o. Received the test drug at. One hour after the drug administration, all experimental animals except the normal control group animals were intraperitoneally administered gentamicin (100 mg/kg; ip) once a day for 14 days. Weekly drug doses were adjusted based on the respective weekly body weight of the animals.

Clinical signs of toxicity, morbidity and mortality were observed daily until the day of necropsy. Body weights were recorded once before dosing and on days 7 and 14. Urine volume and urinary biochemistry were analyzed on days 7 and 14 by individually housing the animals in metabolic cages. Biochemistry and electrolytes in serum were also analyzed at the end of treatment and necropsy. Changes in kidney weight and macroscopic pathology of liver and kidney tissues were observed.

There were no clinical signs of treatment-related death or toxicity among experimental animals. A significant decrease in body weight was observed on day 14 in group II. Animals in groups III and IV prevented weight loss compared to group II.

No change in urine color, pH and specific gravity, excretion of blood, nitrite, bilirubin and ketone was observed between animals of groups I, II, III and IV. Traces of glucose, trace albumin, proteins, albumin, urobilinogen and white blood cells were observed on day 14 in the urine of groups II, III and IV.

Animals in group II also showed a significant increase in urea, creatinine, uric acid, alkaline phosphatase, gamma glutamyl transferase in urine and blood at day 14 compared to group I. Groups III and IV (test drug, 100 and 200 mg/kg) significantly attenuate these levels in a dose-dependent manner.

No significant changes in serum electrolytes such as potassium, pH, sodium, etc. were observed between treatment groups compared to group I. A significant increase in calcium was observed in group II, which was significantly attenuated in group IV in the normal range.

In Group II, lipid peroxidation was significantly (p<0.05) increased by gentamicin administration with concomitant reduction of antioxidants, reduction of superoxide dismutase, reduction of glutathione and glutathione peroxidase. Animals in groups III and IV reverse these changes in a dose-dependent manner.

Gentamicin did not show macroscopic pathological changes between groups. However, histopathology of renal tissue reveals mild to moderate lesions such as tubular degeneration and tubular cell necrosis in group II animals that confirm the induction of rat nephrotoxicity. A significant reduction in renal tissue severity and incidence of lesions was observed in group IV animals (test drug treated at 200 mg/kg b.wt) when compared to gentamicin treated groups and concurrent control animals.

100 and 200 mg/kg b. Histology of livers of animals treated with the test drug treated with wt reveals a reduction in the severity of inflammation in Group II animals.

Overall, this study reports the potential nephrotoxicity caused by gentamicin in rats through urinary glucose, protein, microalbumin, leukocyte, and urobilinogen excretion. Test drug treatment was enhanced by antioxidant protection to neutralize these responses at both dose levels. The results of this test demonstrated that the test drug has a strong nephroprotective effect against gentamicin-induced renal damage in rats, and has anti-lipid peroxidative activity and free radical scavenging activity.

Experiment details:
material:

Chemicals used:

the expendables

Equipment/equipment used:
The following equipment was calibrated periodically as needed;

Experimental conditions:

procedure:
Grouping and administration: The animals were grouped in the following manner with 6 animals per cage. Table 3 shows the grouping and dosing of animals.

Induction: All experimental animals were given gentamicin (100 mg/kg; ip) except for the normal control for 1 day after drug treatment for 14 days.

Dosage Formulation: The test and reference drugs were freshly prepared with the appropriate amount of 0.5% CMC prior to dosing.

Administration:
The dose was 10 ml/kg. The dose of the test substance was adjusted based on the weekly body weight.
Test drug, reference drug, vehicle formulation was orally administered to each animal via intragastric tube for 14 days.

Urine collection:
• On days 7 and 14, animals are housed in metabolic cages for 24 hours for urine collection.
-Urine volume was measured and used for analysis using urine strips.

Blood sampling:
• On day 15, animals were anesthetized using isofluorene for blood collection. Blood was collected in Eppendorf vials and kept in the incline at room temperature for 15-30 minutes for serum separation.
-The vials were centrifuged for 10 minutes at 3500 rpm for separation and used for biochemical analysis.

Histopathology:
Collecting organ kidneys and livers for histopathological processes

Data analysis: All values are mean±S. E. M. As individually expressed. Statistical analysis was performed under various conditions using a one-way analysis of variance (F value) followed by post hoc analysis (Tukey multiple comparison test). p<0.05 and p<0.01 are considered statistically significant.

Observation:
Mortality and morbidity: Animal mortality and morbidity was checked daily.

Clinical signs: Laboratory animals were observed for clinical signs throughout the study.

Body weight: Body weight was recorded on days 0, 7, and 14.

Urine parameters: urine pH, specific gravity, bilirubin, blood, nitrite, glucose, microalbuminuria (MALB), albumin, proteins, ketones and white blood cells were quantified using a urine analyzer via a urine dip strip. .. Urine, creatinine, uric acid and albumin contents and the activities of enzymes such as alkaline phosphatase (ALP), gamma glutamyl transferase (GGT) and acid phosphatase (ACP) were analyzed by Bio-Systems Diagnostics Pvt equipped with a semi-automatic biochemical analyzer. ． Analyzed using Ltd.

Blood parameters: Serum electrolytes (calcium, potassium, pH, sodium) were analyzed using a Cornley Acculyte 5P electrolyte analyzer. Blood urea nitrogen (BUN), creatinine, uric acid, total protein, albumin, globulin, alkaline phosphatase (ALP), gamma glutamyl transferase (GGT) and acid phosphatase (ACP) activities were determined by Bio-Systems Diagnostics Pvt. Analyzed using Ltd.

Oxidative stress marker: About 500 mg of renal tissue was homogenized with 5 mL KCl [10 mM] phosphate buffer solution (1.15%) containing ethylenediaminetetraacetic acid (EDTA, pH 7.4) and centrifuged at 5000 rpm for 60 minutes. Supernatant is used and oxidative stress such as superoxide dismutase (SOD), catalase (CAT), reduced glutathione (GSH), lipid peroxide (TBARS) and total protein (TP) using a multi-plate reader The marker was measured.

Tissue lipid peroxide (LPO, TBARS) levels: Tissue lipid peroxide (LPO) levels were determined as TBA-reactive substances according to the method of Ohkawa et al. (1979). To 1.0 ml of the homogenate was added 3.0 ml of 0.8% TBA HCl reagent and 0.5 ml of 0.05% butylated hydroxyl toluene (BHT) in methanol and mixed thoroughly. The mixture was kept in a boiling water bath for 15 minutes. After cooling, the tube was centrifuged at 1000 g for 10 minutes, and the supernatant was collected for measurement. Standard solutions of different concentrations of malondialdehyde were treated similarly. The absorbance of the pink chromophore was read at 535 nm against the reagent blank. Values were expressed as μg/gm tissue.

Total protein: Tissue protein content was measured by Lowry et al., 1951. To 0.025 ml of homogenate, 0.5 ml of Lowry reagent was added and mixed thoroughly. The mixture was kept at room temperature for 15 minutes. Standard solutions of various concentrations of BSA were treated similarly. The absorbance of the blue chromophore was read at 540 nm against the reagent blank. The value was used to express the enzyme activity

Enzymatic and non-enzymatic antioxidants Superoxide dismutase: Superoxide dismutase activity was assayed by the method of Kakkar et al., 1984. 0.05 ml of homogenate was taken, followed by 0.3 ml of sodium pyrophosphate buffer, 0.025 ml of phenazonium methosulfate (PMS; 186 μM) and 0.075 ml of nitroblue tetrazolium chloride (NBT, 300 μM). Superoxide dismutase was assayed by addition. The reaction was started by adding 0.075 ml NADH (780 μM). After incubation at 300C for 90 seconds, the reaction was stopped by adding 0.25 ml glacial acetic acid. The reaction mixture was then stirred vigorously and shaken with 2.0 ml n-butanol. The mixture was left for 10 minutes and centrifuged. Only 1.5 ml of n-butanol served as a blank. The color intensity of the chromogen was read at 560 nm.

Calculation: Enzyme activity (1 unit) = 50% inhibition/min.
Glutathione peroxidase: Glutathione peroxidase activity was estimated by the method of Rotruck et al. (1973). 200 μl of 0.4 mM Tris Hcl buffer (pH 7.2), 200 μl of K. Glutathione peroxidase (GPx) activity was assayed by combining EDTA (0.4 mM) with 100 μl sodium azide (10 mM) and 200 μl enzyme preparation and mixing well. Then, 200 μl of reduced glutathione solution (2 mM) was added, followed by 0.1 ml of H 2 O 2. The whole reaction was stopped by adding 0.5 ml of 10% TCA. Non-enzymatic kinetics were correspondingly evaluated by replacing the enzyme samples with buffer. The precipitate was removed by centrifugation at 4000 rpm for 10 minutes. The residual reduced glutathione in the supernatant was determined by adding 1.0 ml of 0.6 mM dithiodinitrobenzoic acid (DTNB) in 0.2 M phosphate buffer (pH 8.0). Absorbance was read at 412 nm using a UV/visible spectrophotometer. The GSH content was calculated using the GSH standard graph. Results are expressed as μg GSH consumed per minute per mg protein.

Catalase: Catalase activity was estimated by the method of Sinha AK 1972. Two sets of tubes were placed and labeled as test and control. For the "test", the reaction was started by adding 0.1 ml homogenate and 0.5 ml phosphate buffer and 0.4 ml H2O2. For controls, 0.6 ml phosphate buffer and 0.4 ml H2O2 were added. The reaction mixture was incubated at room temperature for 5 minutes. After the incubation, 2 ml of dichroic acetic acid was added and boiled for 10 minutes. 0.1 ml of homogenate was added to control tubes. The chromium acetate thus produced is measured colorimetrically at 570 nm. The activity of CAT was expressed as units/mg protein. One unit of CAT activity represents the amount of enzyme that destroys 1 μmol H2O2/min.

Reduced glutathione (GSH): Reduced glutathione content was measured by the method of Moren et al., 1979. 0.25 ml of homogenate was added to an equal volume of ice-cold 5% TCA to precipitate the proteins present in the tissue. The precipitate was removed by centrifugation at 4000 rpm for 10 minutes. To a 1 ml aliquot of supernatant was added 0.25 ml phosphate buffer, pH 8.0 and 0.6 mM dithiodinitrobenzoic acid (DTNB) in 0.5 ml 0.2 M phosphate buffer (pH 8.0). , Well mixed. Absorbance was read at 412 nm using a UV/visible spectrophotometer. The GSH content was calculated using the GSH standard graph. Results are expressed in micromoles of GSH per gram of tissue.

Necropsy: At the end of the study, all surviving animals are euthanized by CO2 asphyxiation and all animals are inspected visually including external surfaces of the body and external openings, skull, chest and abdominal cavity and their contents. It was subjected to a detailed gross necropsy.

Histopathology: A sufficient amount of kidney and liver tissue was placed in a formalin-filled container (1:10 ratio) for fixation from the collected organ, and a tissue having a thickness of about 3 to 5 mm was cut out and treated with alcohol and xylene. And impregnated with paraffin. The treated tissues were embedded in paraffin blocks, cut at 3-5 microns and stained with H&E for histopathological examination.

The following rating system was used for the histopathological evaluation of the study:
1-Minimum 2-Mild 3-Moderate 4-Notable 5-Severe

Results and Discussion:
Mortality and morbidity: No morbidity or mortality was observed in experimental animals throughout the study.

Clinical signs: No abnormal clinical signs were observed in experimental animals throughout the study. All animals were found to be normal.

Body weight: No significant weight change was observed on day 7 between control and treated groups. However, when compared to group I, a significant (p<0.05) reduction in body weight was observed in group II on day 14. A slight increase in body weight was observed in study drug treated rats (Groups III and IV), but was not significant and not comparable to normal controls (Group I). Table 4 shows the effect of the test drugs on the weight change of nephrotoxicity-induced rats.

Urine parameters: Urinalysis (UA) is used as a screening tool to detect urinary or cellular substances associated with renal dysfunction or urinary tract infection (UTI). A significant increase in urine volume was observed on Days 7 and 14 of Group II animals when compared to Group I. However, when compared to the II group, no significant change in urine volume was observed on the 7th and 14th days of the IV group. Table 5 shows the effect of test drug treatment on urine output in nephrotoxicity-induced rats.

There was no change in color, pH and specific gravity between control and treated animals. No excretion of blood, nitrite, bilirubin and ketone was observed in control and treated animals.

Traces of glucose (5.6 mmol/L), trace albumin, proteins, significant (p<0.01) levels of albumin, urobilinogen and leukocytes were observed on day 14 in group II, group III and group IV urine. However, such discharge was not observed in Group I. The results show that gentamicin induction causes slight damage to renal tissue, which in turn reflects glucose, protein, microalbumin, leukocyte and urobilinogen excretion. This may be due to increased renal tubular secretion, increased glomerular filtration, urinary tract obstruction and decreased glucose reabsorption in renal tubular disease. Test drug treatment neutralized these reactions, which was insignificant. Table 6 shows the effect of test drug treatment on urine parameters in nephrotoxicity-induced rats.

On the other hand, when compared with Group I, a significant increase in urea, creatinine, uric acid, alkaline phosphatase (ALP) and gamma glutamyl transferase (GGT) was observed in Group II on day 14. Two dose levels of the test drug significantly attenuated these levels when compared to Group II. Table 7 shows the effect of test drug treatment on urinary biochemistry of nephrotoxicity-induced rats. Table 8 shows the effect of test drug treatment on organ weight in nephrotoxicity-induced rats.

Blood parameters: A significant increase in blood urea nitrogen (BUN), creatinine, uric acid, alkaline phosphatase (ALP), gamma glutamyl transferase (GGT) was observed in animals of group II when compared to group I. Groups III and IV (two dose levels of study drug) significantly attenuated GGT and uric acid levels compared to group II, also decreased urea and creatinine, and levels were negligible. Table 9 shows the effect of test drug treatment on blood biochemistry of nephrotoxicity-induced rats.

No significant changes in serum electrolytes such as potassium, pH, sodium were observed between treatment groups. A significant elevation of calcium was observed in Group II, which was normally significantly attenuated by high dose treatment of study drug. Calcium was associated with gentamicin, as previously reported. It impairs calcium transport in renal tubules (Arphitha et al. 2008) and increases serum calcium levels. Table 10 shows the effect of test drug treatment on serum electrolytes of nephrotoxicity-induced rats.

Oxidative stress marker: Renal tissue lipid peroxidation was assessed by MDA accumulation, which was significantly (p<0.05) by gentamicin administration with a decrease in antioxidants, superoxide dismutase, reduced glutathione and glutathione peroxidase. Increased. Test drug treatment significantly maintained lipid peroxidation (p<0.05) and glutathione (p<0.01) in gentamicin-induced rats, closer to normal. Similarly, the dose-dependent manner of study drug treatment amplified superoxide dismutase and glutathione peroxidase levels that were not significant. Table 11 shows the effect of test drug treatment on renal stress markers in nephrotoxicity-induced rats.

Gross pathological condition: During necropsy, macroscopic lesions such as discoloration, pale, perforated surface, and bilaterality were observed in the kidneys of Group II animals. No gross lesions were found in other organs in any of the test animals.

Histopathology: The kidneys of control animals treated with vehicle alone revealed tubular degeneration and/or regeneration, tubular dilation, and inflammatory cell infiltration, but within normal to minimal severity .. The kidneys of gentamicin (100 mg/kg body weight)-induced animals have classical nephrotoxicity-induced histopathological lesions, namely tubular degeneration and/or regeneration, tubular dilation, tubular cell vacuolization, tubular cell necrosis, And revealed mild to moderately higher severity of inflammatory cell infiltration. Table 12 shows the histopathological findings of individual animals.

Both groups of animals treated with the test drug showed a protective effect against gentamicin-induced toxicity. However, the significant effect, namely the reduction in the severity and incidence of lesions in the kidneys of the animals, was 200 mg/kg b.p. compared to animals treated with the test drug (100 mg/kg b.wt.). wt. Observed with study drug treated with. Table 13 outlines a rating system for renal histopathology evaluation.

Histopathology of the liver was not prominent but revealed minimal severity of inflammatory cell infiltration in 3/6 animals of the gentamicin treatment group, which was 200 mg/kg b. It also appeared to be reduced in 1/6 animals treated with wt study drug. Table 14 outlines a rating system for liver histopathology evaluation.

FIG. 3 shows the histopathological findings of the kidneys of Group I and Group II. FIG. 4 shows the histopathological findings of the kidneys of groups III and IV. FIG. 5 shows the histopathological findings of the livers of groups I, II, III and IV.

All other histopathological findings were spontaneous and/or background changes associated with dying changes that are routinely observed in this age rat.

The table of results is as follows:

Results are expressed as individual values as well as mean±SEM (n=6); Statistical analysis was performed using Graphpad Prism 5.0 version and Tukey post hoc tests were performed.

Results are expressed as individual values as well as mean±SEM (n=6); Statistical analysis was performed using Graphpad Prism 5.0 version and Tukey post hoc tests were performed. #P<0.05, ##p<0.01 compared to normal control: gentamicin (100 mg/kg) i. p<0.05 (*) and 0.01 (**) compared to p.

Results are expressed as individual as well as mean±SEM (n=6); statistical analysis was performed using Graphpad Prism 5.0 version and Tukey post hoc tests were performed. #P<0.05, ##p<0.01 compared to normal control: gentamicin (100 mg/kg) i. p<0.05 (*) and 0.01 (**) compared to p.

Results are expressed as individual as well as mean±SEM (n=6); statistical analysis was performed using Graphpad Prism 5.0 version and Tukey post hoc tests were performed. #P<0.05, ##p<0.01 compared to normal control: gentamicin (100 mg/kg) i. p<0.05 (*) and 0.01 (**) compared to p


Results are expressed as individual as well as mean±SEM (n=6); statistical analysis was performed using Graphpad Prism 5.0 version and Tukey post hoc tests were performed. #P<0.05, ##p<0.01 compared to normal control: gentamicin (100 mg/kg) i. p<0.05 (*) and 0.01 (**) compared to p.

Results are expressed as individual as well as mean±SEM (n=6); statistical analysis was performed using Graphpad Prism 5.0 version and Tukey post hoc tests were performed. #P<0.05, ##p<0.01 compared to normal control: gentamicin (100 mg/kg) i. p<0.05 (*) and 0.01 (**) compared to p.

Results are expressed as individual as well as mean±SEM (n=6); statistical analysis was performed using Graphpad Prism 5.0 version and Tukey post hoc tests were performed. #P<0.05, ##p<0.01 compared to normal control: gentamicin (100 mg/kg) i. p<0.05 (*) and 0.01 (**) compared to p.

Conclusion:
The results demonstrate that the test drug has a strong nephroprotective effect against gentamicin-induced renal damage in rats, and has anti-lipid peroxidative activity and free radical scavenging activity. Furthermore, it has been demonstrated that treatment with 200 mg/kg of the test drug can prevent functional as well as histological renal changes induced by gentamicin in rats.

Example 2: Clinical Trials Aim and Objective: To demonstrate the efficacy of a study drug in the management of chronic renal failure (CRF). Scientifically establish the finding that the test drug significantly corrects albuminuria and serum creatinine levels, which are the key features of CRF, and improves renal function, which is trivial by lowering serum creatinine and blood urea levels thing.

Materials and Methods: All patients were selected from the Unipal Ayurveda Hospital and Research Center Manipal OPDs and IPDs.

Inclusion criteria: Patients with a clinically positive history of CRF with clinical features of CRF such as albuminuria, elevated serum creatinine and blood urea were included.

Exclusion Criteria: Patients with diabetic nephropathy were excluded from this study. Patients who received dialysis therapy. Patients with other additional complications.

Study and Management Plan: A total of 100 patients with CRF were enrolled for the study. Patients received 2 tablets (2x500 mg) of the study drug tablet twice daily. The patient continued on a normal, healthy diet. The patient's continued administration of antihypertensive drugs was not prevented. The treatment duration was 1 month.

Evaluation of results: All patients were clinically evaluated before and after treatment. Changes in symptoms, albuminuria, serum creatinine, blood urea and hemoglobin were observed. Observations were evaluated statistically.

Results and observations: The main causative factor for CRF in this study was hypertension; 86% of patients were found in this group. 7% of patients had chronic nephritis and 5% had polycystic kidney disease. Obstructive nephropathy was found in only 2% of patients. Serum creatinine was reduced by 20.71%, which was statistically very significant.

Blood urea was reduced by 32.15%, which was also statistically very significant. Albuminuria was reduced by 36.70%, which was statistically very significant. Hemoglobin increased by 4.65%, which was statistically very significant. None of the patients showed new abnormal features. Urine volume increased by 56.54%, which was statistically very significant. Edema was reported in 58 of the 100 patients, a decrease of 71.56%. Nausea was reported in 46 patients, which was reduced by 68.75%. Twenty-four patients were found to have vomiting, which was reduced by 82.35%. Weakness was seen in 85 patients, which was reduced by 55.61%. Fifty-three patients had anorexia, which increased appetite by 59.29%. Lower extremity spasms were seen in 17 patients, which was reduced by 72%. Shortness of breath was seen in 27 patients, which was reduced by 64.29%. Hiccups were seen in only one patient, which was completely alleviated. Nineteen patients reported pruritus, which was reduced by 66.66%. The reduction of all these symptoms was statistically very significant.

Discussion and Interpretation: As mentioned above, CRF is a specific form of renal disease. According to Ayurveda, CRF is a disease of Mutravaha Srotas. All three Doshas and all Dushyas are involved in this disease, while Kaphas are responsible for the blockage of microvessels and the development of microangiopathy. Vata is responsible for the degeneration of the kidney structure. According to the Ayurvedic principle of disease management, tissue damage can be prevented and repaired by Rasayana drugs due to its ability to improve tissue quality and thereby increase tissue tolerance. On the other hand, the blockage can be removed by a Lekhana drug, which has the effect of scraping off the occluded channels.

In this study, treatment was found to reduce serum creatinine by 20.71%. This beneficial effect is highly statistically significant, encouraging and indicates an improvement in renal function. Blood urea was reduced by 36.15% with treatment, which was also statistically very significant. Treatment reduced albuminuria by 36.70% and hemoglobin by 4.65%, which were statistically highly significant. Edema, weakness, decreased leg cramps, increased appetite, and reduced nausea, shortness of breath and pruritus were statistically highly significant.

Conclusions: With the help of clinical observations and considerations made, it can be concluded that 86% of patients with CRF have hypertension as their underlying underlying cause. The results obtained may be due to the disease-modifying effect of the trial therapy due to Rasayana and anti-Vata-Kapa properties. Trial therapy is an ideal drug as a safe and effective alternative to CRF.

Serum creatinine, blood urea and albuminuria were reduced by 20.71%, 32.15% and 36.70%, respectively. Hemoglobin levels and urine output increased by 4.38% and 56.54%, respectively. These were statistically very significant. All patients showed >50% relief in all signs and symptoms.

The foregoing description of specific embodiments sufficiently elucidates the general nature of the embodiments herein, and by applying the present knowledge, without departing from the general concept, Such adaptations and modifications are to be understood within the meaning and scope of equivalents of the disclosed embodiments, as modifications and/or adaptations to various applications, such as particular embodiments, can be made easily. Yes, and is intended to be so understood. It is to be understood that the phraseology or terminology used herein is for the purpose of description and not limitation. Thus, while the embodiments herein have been described with respect to preferred embodiments, those skilled in the art will appreciate that embodiments of the specification can be modified within the spirit and scope of the embodiments described herein. You will recognize that it can be done.

Claims (27)

Camphora (Cinnamomum camphora), ginger (Acorus calamus), mokko (Saussurea lapupa), senshinren (Andrographis paniculata Cuiphora), Tinospora cordifolia (Cinophora) (Aconitum heterophyllum), Berberis aristata, Piper longum, Plumbago rosa terina (Plumbago rosa terina), Coriandrum (Coliandum ulium), Coriandrum (Coriandrum sativaum) bellerica), Piper chaba, Embelia ribes, Hihatu (Piper longum), pepper (Piper nigrum), guggle (Comiphora mukul) and sugar cane (Saccharum and shochu). Medicinal herbs including things,
A formulation for the treatment and management of renal disorders and related complications, comprising mineral elements including shilajit and bhasma. The herb elements are, for example, Opperculina turpethum, Baliospermum montanum, Cinnamomam tamtamuma numatanum, cinnamom zeumonica, and cinnamo zeumonica. , Boerhavia diffusa, Cyperus rotundas, Firisosinka (Bauhinia variegate) and at least one of the herbal extracts selected from Hora Rena anti-Dentielica (Holarrhena antidica) The formulation according to claim 1. The formulation according to claim 1, wherein the mineral component comprises at least one basma selected from the group consisting of Mandura bhasma and Loha bhasma. The formulation of claim 3, wherein Mandura basma is present in an amount in the range of 2-6% by weight. The formulation of claim 3, wherein Roja Basma is present in an amount ranging from 1 to 4% by weight. Camphora (Cinnamomum camphora) is present in an amount ranging from 1 to 4% by weight, ginger (Acorus calamus) is present in an amount ranging from 1 to 4% by weight, and Mokko (Saussurea lappa) is present in an amount ranging from 1 to 4% by weight. Is present in an amount ranging from 1 to 4% by weight, Sensinlen (Andrographis paniculata) is present in an amount ranging from 1 to 4% by weight, Tinospora cordifolia is present in an amount ranging from 1 to 4% by weight, and cedar (Cedrus deodora) is present in an amount in the range of 1 to 4% by weight, turmeric (Curcuma longa) is present in an amount in the range of 1 to 4% by weight, and Aconitum heterophyllum is 1 to 4% by weight. %, Berberis aristata is present in an amount in the range of 1 to 4% by weight, Hihatu (Piper longum) is present in an amount in the range of 1 to 4% by weight, and Plumbago is present. -Rosea (Plumbagosea) is present in an amount in the range of 1 to 4% by weight, coriander (Coriandrum sativum) is present in an amount in the range of 1 to 4% by weight, and Amla (Emblica officinalis) is 1 to 4% by weight. Is present in an amount in the range of 1 to 4% by weight, Myrovaran (Terminalia chebula) is present in an amount in the range of 1 to 4% by weight, and Terminalia berelica is present in an amount in the range of 1 to 4% by weight, Ciaba (Piper chaba) is present in an amount in the range of 1 to 4 wt%, Embelia ribes is present in an amount in the range of 1 to 4 wt%, and Piper chaba is 1 to 4 wt%. % In an amount in the range of 1 to 4% by weight, pepper (Piper longum) in an amount in the range of 1 to 4% by weight, pepper (Piper nitrogen) in an amount in the range of 1 to 4% by weight, and Zingiber (Zingiber). officinalis) is present in an amount in the range of 1 to 4% by weight, Guggul (Commiphora mukul) is present in an amount in the range of 6 to 10% by weight, and sugarcane (Saccharum officinarum) is in an amount in the range of 2 to 6% by weight. The formulation of claim 1, which is present in The formulation of claim 1, wherein the shilajit is present in an amount ranging from 6 to 10% by weight. The formulation of claim 1, further comprising at least one alkali selected from the group consisting of Yavakshara and Sarjakshara. The formulation of claim 8, wherein the alkali is present in an amount of 2% by weight or less. The formulation of claim 1, further comprising at least one salt selected from the group consisting of rock salt, Sonchal salt and black salt. The formulation of claim 10, wherein the salt is present in an amount ranging from 1 to 4% by weight. Formulation according to claim 1, further comprising suitable excipients, preferably gum acacia. The formulation according to claim 1, further comprising at least one additive selected from the group consisting of flavoring agents, coloring agents, preservatives and pH adjusting agents. The formulation according to claim 1, which is administered in a form selected from the group consisting of powders, emulsions, tablets, capsules, troches and pills. The formulation according to claim 1, which is in the form of a tablet. The formulation of claim 15, wherein the tablet is in the form of a 500 mg tablet. Claims for the preparation of a medicament for treating a condition selected from the group consisting of renal disorders, nephritis, nephrosis, chronic renal failure, anemia, electrolyte imbalance, hypertension, proteinuria, hyperkalemia and related complications. Use of the formulation according to 1. Mashing Basma, Guggul and Shilajit,
Adding herbs, alkalis and salts,
Adding ground decoction, fresh juice and gomutra while continuing to grind to obtain a ground mass. 19. The method of preparing a formulation according to claim 18, wherein the basma is selected from the group consisting of Madura Bhasma and Roja Basma. The herbs are ginger (Acorus calamus), mokko (Saussurea lappa), Aconitium heterophyllum, Berberis aristata (Berberis aripata), Hihatu (Piperlo), and Pihalo (Piper). (Plumbago rosea), Liquidambar formosana Sen morning glory (Operculina turpethum), Barrios Permian-time Montanumu (Baliospermum montanum), cardamom (Elettaria cardamomum), Nahakanokosou (Boerhavia diffusa) and dried roots of purple nutsedge (Cyperus rotundas); coriander (Coriandrum sativum), Amura (Emblica officinalis), Myrobalan (Terminalia chebula), Terminalia berelica (Terminalia bellerica), Hihatu (Piper longum); Crystals; Finely powdered dried heartwood of Cedrus deodara; Finely powdered dried leaves of Cinnamomum tamala; Finely powdered and dried plants of Andrographis paniculata; Whole ginger (Zingivar cornifera) dry powdered rhizome of Longa); finely ground dry stems of Tinospora cordifolia, Saccharum officinarum and Piper chaba (Piper chaba ehina cinnaum); variegate) and finely powdered dried stem bark of Hollarhena antidiscentrica; Bamboo manna secretion and gu 19. A method of preparing a formulation according to claim 18 comprising at least one micronised form of a herb selected from the group consisting of Commiphora muku oleo gum resins. 19. The method of preparing a formulation according to claim 18, wherein the alkali comprises at least one alkali selected from the group consisting of Yavakshala and Sarjakshala. 19. The method of preparing a formulation according to claim 18, wherein the salt comprises at least one salt selected from the group consisting of rock salt, Sonchal salt and black salt. The ground decoction includes dried roots of Cyperus rotundas, dried fruits of Piper longum, dried roots of Asparagus racemosus, dried bahihinia varieun ora trunk, and dried bark of Bauhinia varienda or trunk. Old dried plants of Oldenlandia umbelata, dried roots of Hemidesmus indicus, dried roots of vetiver (Vetiveria zizanioides), dried roots of Amla (Emblica officinalis), dried fruits of Amar (Emblica officinalis), dried fruit of milan (Emblica officinalis), miro 19. A method for preparing a formulation according to claim 18, which is a decoction of at least one herb selected from the group consisting of dried fruits of (Terminalia bellerica) and dried roots of Boerhavia diffusa. 19. The juice of at least one medicinal herb selected from the group consisting of Aloe vera, Punica granatum, Cynodon dactylon, and Pineapple (Ananas comosus). Method for preparing the formulation of. A method of treating renal disorders and related complications, comprising the step of administering a therapeutically effective amount of the formulation of claim 1. 26. The method of treating renal disorders and related complications of claim 25, wherein the therapeutically effective amount is 500-1000 mg administered 1-3 times daily. 26. The method of treating renal disorders and related complications of claim 25, wherein the formulation is administered with the administration of at least one other pharmaceutical agent prescribed for the treatment of renal disorders and related complications.