A polyherbal formulation for vital effect on the pathogenesis of pathogenesis of hemorrhoids

Abstract

The herbal formulation for vital effect on the pathogenesis of hemorrhoids comprises a combination of Bio-methanol, ethyl-acetate, bio-ethanol, and water extracts from kutki (Picrorhiza kurroa), Atibala (Abutilon Indicum), Patha (Cissampelos pareira), Daruharidra (Berberis aristate), Kalinga (Kalinga ornata), Chitraka (Plumbago zeylanica), Herda (Terminalia Chebula) and excipients are selected from DCP, Gelatin, Starch, CMC, Magnesium Stearate, Talc and sufficient quantity of purified water.

Description

[0001] A POLYHERBAL FORMULATION FOR VITAL EFFECT ON THE PATHOGENESIS OF

[0002] HEMORRHOIDS

[0003] FIELD OF THE INVENTION

[0004] This invention relates to the polyherbal formulation and a process for the preparation thereof. More particularly, the present invention relates to a method for preparing a polyherbal formulation consisting of a multitude of ingredients extracted from a multitude of herbs used for lowering the effect of grade I and grade II Hemorrhoids.

[0005] BACKGROUND OF THE INVENTION

[0006] Hemorrhoids are a common condition in which there is an abnormal dilatation and distortion of veins in the anorectal region leading to obstruction of feces leading to constipation.

[0007] According to Ayurveda hemorrhoids are caused due to excessive vatha and pitha, which causes bloating of veins, and we have identified the mechanism.

[0008] A study shows that the development of hemorrhoids could be due to failure of the vascular plexus both morphologically and functionally causing non-coordinated filling and drainage

[0009] Another hypothesis of the hemorrhoidal pathophysiology is that hepatic portal hypertension and varices have Current medical management based on the intensity of the disease, such as oral flavonoids, topical treatment like suppositories and creams

[0010] Lifestyle modifications are recommended. Dietary changes for preventive measures are suggested such as - decreasing fatty food, and oral fluids, increased consumption of foods with high fiber content

[0011] The prevalence of hemorrhoids is considered to increase with age, people in the age group of 45- 65 years are more prone to hemorrhoids. About 4.4% of the general population has symptomatic hemorrhoids. In the United States, up to one-third of 10 million people seek medical treatment.

[0012] Imbalance between endothelium-derived relaxing factors (such as nitric oxide, prostacyclin, and endothelium-derived hyperpolarizing factor) and endothelium-derived vasoconstricting factors (such as reactive oxygen radicals and endothelin) causes several vascular disorders. Hence, there is a need to provide an herbal formulation that can be used for lowering the effect of grade I and grade II Hemorrhoids.

[0013] OBJECT OF THE INVENTION

[0014] The primary objective of the present invention is to provide a polyherbal formulation used for lowering the effect of grade I and grade II Hemorrhoids.

[0015] Another objective of the present invention is to provide a process for the preparation of polyherbal formulation used for lowering the effect of grade I and grade II Hemorrhoids.

[0016] SUMMARY OF THE INVENTION

[0017] The polyherbal formulation comprises 5 to 6% w / w of kutki (Picrorhiza kurrod), 2 to 3 % w / w of Atibala (Abutilon Indicum), 5 to 6 % w / w of Patha (Cissampelos pareira), 5 to 6 % w / w of Daruharidra (Herberts aristate), 1 to 2 % w / w of Kalinga (Kalinga ornatci), 5 to 6 % by weight Chitraka (Plumbago zeylanica). 5 to 6 % by weight Herda erminalia Chebula)' mixed in a proportion of 25-65% w / w along with suitable excipients used for minimizing the effect caused due to grade I and grade II Hemorrhoids.

[0018] Another aspect of the present invention provides a method for preparing the polyherbal formulation that is used for minimizing the effect caused due to grade I and grade II Hemorrhoids.

[0019] BRIEF DESCRIPTION OF THE DRAWINGS

[0020] FIG. 1 illustrates a flow a process flow chart depicting the step-by-step process of the preparation of the herbal formulation according to the present invention.

[0021] DETAILED DESCRIPTION OF THE INVENTION

[0022] A Polyherbal formulation and a process for the preparation thereof is herein described with numerous specific details to provide a complete understanding of the invention.

[0023] However, these specific details are exemplary details and should not be treated as a limitation to the scope of the invention.

[0024] Throughout this specification the word “comprise” or variations such as “comprises or comprising”, will be understood to imply the inclusions of a stated element, integer or step, or group of elements, integers or steps, but not the exclusions of any other element, integer or step or group of elements, integers or steps.

[0025] According to the present invention, the polyherbal formulation comprises of 5 to 6% by weight kutki (Picrorhiza kurroa), 2 to 3 % by weight Atibala (Abutilon Indicum), 5 to 6 % by weight Patha (Cissampelos pareira), 5 to 6 % by weight Daruharidra (Berberis aristate), 1 to 2 % by weight Kalinga (Kalinga omata), 5 to 6 % by weight Chitraka (Plumbago zeylanica), 5 to 6 % by weight Herda ( erminalia Chebula) along with suitable excipients selected from dicalcium phosphate (DCP) in an amount of 40 to 45% by weight of the composition, gelatin in an amount of 7 to 8% by weight of the composition, starch in an amount of 7 to 8% by weight of the composition, carboxymethyl cellulose (CMC) in an amount of 1 to 2% by weight of the composition, magnesium stearate in an amount of the 2 to 4% by weight of the composition, talc in an amount of the 2 to 4% by weight of the composition.

[0026] The carriers are selected from a group comprising of diluent, binder, glidant, and lubricant. The formulation may additionally comprise auxiliary, stabilizing, thickening, flavoring, fragrance, and coloring agents.

[0027] According to another aspect of the present invention, the formulation is used in a dosage of 2 mg - 16 mg / body weight for average body weight in single or divided doses per day.

[0028] According to another aspect of the present invention, the polyherbal composition comprises Picorrhiza kurroa commonly known as “Kutki”. It is well known herbs, in traditional medicine, particularly in Ayurveda, due to its wide range of therapeutic properties. The herb's medicinal value is primarily attributed to a range of active compounds. Kutkin, represented by Picroside I and Picroside II, stands out as a key player among these compounds, functioning as iridoid glycosides responsible for numerous therapeutic effects such as hepatoprotection, antiinflammatory actions, and immunomodulation. Additionally, kutkoside, apocynin, and androsin, all belonging to distinct chemical classes, contribute to Kutki's medicinal profile. Noteworthy are the cucurbitacin glycosides, renowned for their potent anti-inflammatory and anticancer properties. D-Mannitol, a sugar alcohol, and vanillic acid, a phenolic acid with antioxidant properties, further enrich the herb's composition. The overall presence of various phenolic compounds, including phenolic acids and flavonoids, accentuates Kutki's antioxidant and anti-inflammatory characteristics. The culmination of these bioactive constituents underscores Kutki's pharmacological versatility, encompassing its role as a liver tonic, digestive enhancer, and treatment for respiratory conditions. However, it is imperative to acknowledge that while promising results have been observed in research studies, comprehensive investigation, particularly in human clinical settings, is essential to establish the efficacy and safety of Kutki, warranting further exploration such as VPK fingerprinting.

[0029] The active ingredients found in Kutki (Picrorhiza kurroci) can be classified according to their effects on the Ayurvedic doshas: Vata, Pitta, and Kapha. These dosha-specific alignments provide insights into the herb's potential in maintaining balance within the body according to Ayurvedic principles.

[0030] For Vata-pacifying effects, D-Mannitol, a sugar alcohol, is noted for its nourishing and stabilizing properties. Additionally, Androsin is believed to have soothing characteristics, contributing to its potential in calming Vata.

[0031] In the context of Pitta pacification, compounds such as Kutkin (Picroside I and II) exhibit antiinflammatory and liver-protective effects, aligning with the goal of balancing Pitta. Apocynin, known for its anti-inflammatory properties, and Vanillic Acid, functioning as an antioxidant, both contribute to soothing Pitta.

[0032] For Kapha-pacifying effects, Cucurbitacin Glycosides, recognized for their anti-inflammatory properties, may assist in reducing Kapha's heaviness and congestion. Phenolic Compounds, with their antioxidant and anti-inflammatory nature, are also deemed beneficial in balancing Kapha.

[0033] In Ayurveda, the selection of substances is based on their qualities and their impact on the doshas. Kutki, characterized by its bitter and pungent taste and cooling properties, is generally considered to be balancing for Pitta and Kapha. However, it's important to note that it may increase Vata due to its drying nature. Individual constitution and health conditions play a significant role in determining the efficacy and impact of Kutki on the doshas.

[0034] According to another embodiment of the present invention, Abutilon indicum commonly known as “Atibala”. It is a plant widely used in traditional medicine systems like Ayurveda. It contains various active ingredients that contribute to its medicinal properties. Notably, it contains flavonoids such as quercetin and vitexin, recognized for their antioxidant, anti-inflammatory, and antihistamine properties. Alkaloids, saponins, tannins, terpenoids, and phenolic compounds further enhance its pharmacological profile, offering potential benefits ranging from immune-boosting and cholesterol-lowering effects to anti-inflammatory and antimicrobial actions. Atibala's inclusion of mucilage, fatty acids, sterols, proteins, and amino acids adds to its nutritive value and therapeutic potential. This plant is reputed for its versatility, exhibiting anti-inflammatory, analgesic, diuretic, antipyretic, digestive, and wound-healing properties. Traditional medicinal applications of Atibala encompass the treatment of various conditions, including colds, fever, diabetes, and gastrointestinal disorders. Despite promising outcomes in studies, the need for VPK 42 Fingerprinting-based applications underscores the importance of comprehensive research to determine the efficacy and safety of Atibala, especially in human clinical settings.

[0035] In Ayurveda, the realm of Ayurveda, boasting a diverse array of active ingredients that align with the Ayurvedic doshas — Vata, Pitta, and Kapha. In addressing Vata, Atibala's mucilage provides a soothing and nourishing influence, complemented by the nourishing properties of fatty acids and the stabilizing effects of proteins and amino acids, countering Vata's inherent dry and light qualities. For Pitta, the herb's flavonoids, tannins, and sterols contribute anti-inflammatory, antioxidant, and cooling properties, effectively mitigating Pitta's heat. To balance Kapha, Atibala's alkaloids stimulate metabolic processes, while terpenoids and saponins, with their antimicrobial and anti-inflammatory effects, help alleviate congestion and aid digestion. As Ayurveda underscores the importance of harmonizing Vata, Pitta, and Kapha for overall well-being, Abutilon indicum's multifaceted properties position it as a valuable herb capable of addressing the diverse needs of each dosha.

[0036] According to another aspect of the present invention, the polyherbal formulation comprises Cissampelos pareirci commonly known as “Patha”, is a medicinal plant deeply entrenched in traditional medicine systems such as Ayurveda, showcasing a rich array of active compounds that underpin its therapeutic properties. Patha exhibits a diverse array of active compounds, each contributing to its extensive pharmacological profde and traditional medicinal applications. Alkaloids, such as Hayatin, Hayatidin, and Bebeerine (Pelosine), stand out for their antispasmodic and anti-inflammatory properties, marking them as key contributors to the herb's medicinal prowess. The presence of flavonoids, including Quercetin, Kampferol, and Catechins, adds antioxidant capabilities to Patha, enhancing its potential to counter oxidative stress. Tannins, although not extensively detailed for this specific plant, generally provide astringent, antioxidant, and anti-inflammatory properties, supporting the management of conditions like diarrhea and aiding in wound healing. Terpenoids, steroids (including -sito sterol), and saponins contribute to the biological diversity of Patha, showcasing activities ranging from anti-inflammatory effects to immune-boosting and cholesterol-lowering properties. Phenolic acids like Ferulic acid, Vanillic acid, and P-coumaric acid contribute to the herb's antioxidant activity. Fatty acids and trace amounts of essential oils found in Patha further complement its anti-inflammatory properties and aromatic qualities. Collectively, these active compounds synergize to confer Patha with a broad spectrum of pharmacological activities, encompassing anti-inflammatory, antimicrobial, antipyretic, antispasmodic, and diuretic properties. Embraced by traditional medicine, Patha has been historically utilized for treating a variety of ailments, including fever, diarrhea, skin diseases, and menstrual disorders, showcasing its significance in herbal therapeutics. According to Ayurveda, the patha comprises a spectrum of active compounds that harmonize with the doshic principles of Vata, Pitta, and Kapha. Alkaloids such as hayatin and hayatidin contribute to Vata balance by stabilizing the nervous system and alleviating spasms, while saponins bring their soothing properties to calm Vata's dry and erratic nature. For Pitta, flavonoids like quercetin and kampferol, along with tannins and terpenoids, showcase cooling, anti-inflammatory, and astringent qualities, harmonizing with Pitta's heat and oiliness. Alkaloids, terpenoids, and tannins collectively play a role in invigorating Kapha, addressing sluggishness, reducing congestion, and countering the moist and heavy attributes of this dosha. In Ayurveda, where balance among Vata, Pitta, and Kapha is pivotal for health, Patha stands out with its diverse array of active ingredients, positioning itself as a potential regulator for various doshic imbalances. Particularly renowned for managing conditions related to inflammation, infection, and digestive disorders, Patha embodies the principles of Ayurveda in promoting holistic well-being.

[0037] According to another aspect of the present invention, the polyherbal composition further comprises Berberis aristata commonly known as “Daruharidra”. Berberine takes the spotlight, showcasing its versatility with antimicrobial, antidiabetic, cardioprotective, anti-inflammatory, and anticancer activities. The dosha impact of berberine extends to pacifying Pitta primarily through its cooling and detoxifying effects and Kapha through its metabolic regulatory actions. Other constituents like palmatine, jatrorrhizine, columbamine, magnoflorine, berbamine, oxyacanthine, and tannins each contribute unique therapeutic qualities. From antimicrobial and antioxidant effects to diuretic actions, anti-inflammatory properties, immunomodulatory benefits, and sedative or cardiac impacts, these compounds collectively form the pharmacological essence of Daruharidra. The dosha impact of individual components spans across Vata, Pitta, and Kapha, offering a balanced approach to Ayurvedic wellness. However, the efficacy and safety of these compounds in humans necessitate further exploration through methodologies like VPK42 Fingerprinting. The holistic actions of Daruharidra align with its traditional use in treating infections, metabolic disorders, inflammatory conditions, and certain types of cancers, making it a subject of considerable interest in herbal medicine. The Ayurvedic dosha classification of Daruharidra's active compounds provides valuable insights into the herb's potential impact on the three doshas — Vata, Pitta, and Kapha. Oxyacanthine, with its sedative and calming effects, is identified as Vata-pacifying, offering a balancing influence on the nervous system. The Pitta dosha finds pacification in a multitude of compounds, including Berberine, Palmatine, Jatrorrhizine, Columbamine, and Tannins, known for their cooling, anti-inflammatory, and antioxidant properties. These constituents collectively contribute to mitigating excess heat and inflammation associated with Pitta imbalance. Berberine, besides its Pitta-pacifying attributes, takes on a role in Kapha pacification through its metabolic regulatory actions. Magnoflorine, with its diuretic effect, aligns with Kapha-pacifying qualities by promoting fluid balance. Berbamine, with its immunomodulatory effects, further contributes to Kapha balance by enhancing the immune system. Tannins, in addition to their Pitta-pacifying nature, display astringent properties, supporting Kapha equilibrium.

[0038] According to another embodiment of the present invention, the polyherbal composition comprises Kalinga omata, scientifically identified as Holarrhena pubescens, encompasses a rich array of active ingredients, each wielding distinct mechanisms of action. Conessine takes center stage with its renowned antiamoebic and antiprotozoal properties, disrupting the membrane function of protozoan cells and exhibiting antibacterial activity by disrupting cellular processes in bacteria. Isoquinoline alkaloids, including conessine, often showcase antimicrobial prowess, potentially interfering with microbial DNA replication or protein synthesis. Some isoquinoline alkaloids also reveal antispasmodic properties, relaxing smooth muscles. Steroidal alkaloids emerge with potential anti-inflammatory and immunomodulatory effects, inhibiting the synthesis of pro- inflammatory mediators and modulating immune responses. Tannins, celebrated for their astringent and antioxidant properties, form protective layers on mucous membranes, reducing inflammation and irritation. Their antioxidant action neutralizes free radicals, guarding cells against oxidative damage. Flavonoids contribute versatile benefits, exhibiting antioxidant, antiinflammatory, and potential antiviral activities. They scavenge harmful free radicals and may inhibit enzymes involved in inflammation. Saponins display immune-boosting and antimicrobial effects, potentially contributing to the herb's antidiarrheal properties by affecting the intestinal mucosa. Glycosides, diverse in their actions, often influence cardiovascular parameters, impacting heart rate and blood pressure. Holarrhena pubescens, traditionally employed for its antidiarrheal and antiprotozoal properties, draws its therapeutic efficacy from this intricate interplay of bioactive constituents. While these potential active ingredients exhibit promise in various studies, further research is essential to ascertain their efficacy and safety in human clinical settings. The use of Holarrhena pubescens should be approached with caution, and consulting healthcare professionals is advisable, particularly considering potential side effects and interactions with medications.

[0039] According to another embodiment of the present invention, the polyherbal composition further comprises a Plumbago zeylanica commonly known as Chitraka, is a medicinal plant with various active ingredients that contribute to its wide range of therapeutic effects. The active compounds in Plumbago zeylanica, or Chitraka, exert distinct influences on the Vata, Pitta, and Kapha doshas, aligning with Ayurvedic principles of balancing these elemental forces. Plumbagin, the primary active ingredient, exhibits a predominantly Pitta and Kapha pacifying nature, contributing heat and moisture -drying qualities. However, caution is advised to prevent Pitta aggravation when used excessively due to its intense heat. Naphthoquinones, akin to Plumbagin, maintain a Pitta and Kapha pacifying profile, with the potential to elevate Pitta due to their warming attributes. Tannins, recognized for their astringency and cooling effects, play a pivotal role in pacifying Kapha and Pitta. However, their drying nature may aggravate Vata. Organic acids, such as citric acid and plumbagic acid, exhibit a general Pitta-pacifying quality owing to their sour taste, while simultaneously offering Vata-balancing moisture. Alkaloids may provide a balancing effect on Vata, leveraging potential nervine properties. Saponins, with expectorant properties, primarily pacify Kapha, but their moisture -providing quality can extend Vata balance. Flavonoids, predominantly Pitta-pacifying due to their cooling effects, also contribute to Kapha balance through their drying properties.

[0040] In Ayurveda, Chitraka's renowned capacity to kindle the digestive fire (Agni) aligns with its utility in addressing conditions of digestive weakness associated with Kapha imbalance. Its inherent heating properties establish it as an effective remedy for reducing excess Kapha and Vata. However, practitioners must exercise prudence, as the potent heat of Chitraka may escalate Pitta, emphasizing the importance of personalized herbal formulations through VPK (Vata, Pitta, Kapha) Fingerprinting. This nuanced approach recognizes individual constitutions and ensures the optimization of therapeutic benefits while minimizing the risk of dosha imbalances.

[0041] According to the process of the present invention, the above herbal ingredients are mixed and then the mixture is blended into a fine herbal powder, the fine herbal powder is macerated with 20 to 60% bio-methanol (in the proportion of 1:4) for 2-5 days and the mixture is allowed to settle down, then the bio-methanol fraction is separated from the settled down mixture and then subject the bio-methanol fraction to evaporation at 65° C to 70° C for obtaining the bio-methanol soluble extract, the first phase of the final extract is obtained.

[0042] A sufficient quantity of Ethyl acetate is added to the settled-down mixture and then heated at a temperature ranging from 40° C to 80° C for 0.5 hours to 3 hours for extraction of ethyl acetate soluble components from the herbal ingredients, after separation of the ethyl acetate fraction from the settled down the mixture, ethyl acetate is evaporated at 75 to 80° C to obtain the ethyl acetate soluble extract, the second phase of the final extract is obtained.

[0043] The process is continued by washing out the above-obtained mixture with a sufficient quantity of water and then 20 to 60% bio-ethanol is added to the mixture and the mixture is heated at a temperature ranging from 40 °C to 80 °C for 0.5 to 2 hours, after separation of the Bio-ethanol fraction from the mixture, the bio-ethanol fraction is subjected to evaporation point 78 °C to obtain a bio-methanol soluble extract, the third phase of the final extract is obtained.

[0044] After washing out the settled-down mixture obtained above, the mixture is heated with water at a suitable temperature of 100° C to obtain water-soluble extract, fourth phase of the final extract is obtained.

[0045] The final extract is obtained by mixing phases 1, 2, 3, and 4 in the proportion of 21.25% to 28.75% of phase I, 21.25% to 28.75% of phase II, 21.25% to 28.75% of phase III, 21.25% to 28.75% of phase IV, along with the excipients, which are blended together for an acceptable form of oral administration.

[0046] The step by step process involves a series of extractions from a herbal mixture using different solvents. Each solvent has specific characteristics that determine the type of active ingredients it can extract from the plant material. Here's an overview of the types of active ingredients likely to be extracted in each part of the extraction process: b. Grinding the Herbal Ingredients

[0047] • Result: This mechanical process breaks down the plant material, releasing a wide array of compounds, including essential oils, flavonoids, tannins, saponins, alkaloids, and others. It doesn't selectively extract based on solubility but makes all types of compounds more available for subsequent solvent extraction. c. Macerating in 60% Bio-Methanol

[0048] • Bio-Methanol Soluble Extract (Part I): Methanol, being a polar solvent, is effective at extracting polar compounds. This includes most flavonoids, certain alkaloids, glycosides, and some saponins. Methanol may not efficiently extract highly non-polar compounds like some essential oils. e. Adding Ethyl Acetate and Heating

[0049] • Ethyl Acetate Soluble Extract (Part II): Ethyl acetate is a moderately polar solvent. It is good at extracting compounds less polar than those extracted by methanol, which might include certain terpenoids, some flavonoids, and a different fraction of saponins. It may also extract some essential oils. i. Adding 60% Bio-Ethanol and Heating • Bio-Ethanol Soluble Extract (Part III): Ethanol is a versatile solvent that can dissolve a broad range of compounds. It can extract both polar and non-polar substances, including remaining flavonoids, alkaloids, terpenoids, and saponins. l. Heating with Water

[0050] • Water Soluble Extract (Part IV): Water is a highly polar solvent and will predominantly extract the most polar compounds. This includes certain glycosides, polar flavonoids, and polar alkaloids. m. Mixing the Extracts

[0051] • Combined Extract: This final mixture will contain a comprehensive range of compounds, representing the full spectrum of soluble active ingredients extracted by bio-methanol, ethyl acetate, bio-ethanol, and water.

[0052] The present invention is explained in the form of exemplary illustrations. However, it is to be understood that the example is merely illustrative and is not to be taken as a limitation upon the scope of the invention. The disclosed embodiments with various changes and modifications will be apparent to those skilled in the art and are made without departing from the scope of the invention.

[0053] Additionally, to address the treatment of piles (hemorrhoids) using the herbal formulation described in your extraction process, we need to consider how the active ingredients extracted at each stage might collectively contribute to alleviating this condition. Piles are essentially swollen veins in the anal canal, often aggravated by factors like straining during bowel movements, weakening of anal canal structures, persistent cough, heavy lifting, and increased abdominal pressure during pregnancy.

[0054] The potential cumulative effects of the active ingredients based on the extraction method is described herein below:

[0055] 1. Bio-Methanol Soluble Extract (Part I)

[0056] Polar Compounds: Alkaloids, certain flavonoids, glycosides, and saponins are likely extracted here. These compounds can have anti-inflammatory, analgesic, and venotonic effects, which can reduce swelling and discomfort associated with piles. They may also aid in regularizing bowel movements, reducing the need for straining.

[0057] 2. Ethyl Acetate Soluble Extract (Part II) Moderately Polar Compounds: Some terpenoids, additional flavonoids, and other alkaloids could be extracted. Terpenoids might help reduce inflammation and pain, while certain flavonoids can strengthen blood vessels, potentially reducing the tendency for veins to swell.

[0058] 3. Bio-Ethanol Soluble Extract (Part III)

[0059] Wide Range of Compounds: Including both polar and non-polar substances like remaining flavonoids, alkaloids, and phenolic compounds. Phenolic compounds are known for their antioxidant properties, which can aid in tissue repair and healing. Alkaloids may further contribute to pain relief and reducing inflammation.

[0060] 4. Water Soluble Extract (Part IV)

[0061] Highly Polar Compounds: Such as glycosides and tannins. Tannins have astringent properties that can help shrink swollen tissues and form a protective barrier, which is beneficial in the treatment of piles. Glycosides might aid in bowel regulation.

[0062] Cumulative Effect on Piles

[0063] Anti-inflammatory Action: Reduces swelling and irritation in the affected area.

[0064] Pain Relief: Alleviates discomfort associated with piles.

[0065] Venotonic Effect: Strengthens veins and reduces the tendency of venous swelling.

[0066] Astringent Properties: Helps shrink hemorrhoidal tissue and provides relief from symptoms.

[0067] Bowel Regulation: Aids in regularizing bowel movements, reducing constipation, and minimizing straining.

[0068] Tissue Repair and Healing: Antioxidants and other compounds can promote the healing of damaged tissues in the anal area.

[0069] Reduced Straining: By regulating bowel movements, the formulation can decrease the need to strain during defecation, which is a key factor in the formation and aggravation of piles.

[0070] This holistic approach addresses various aspects of hemorrhoid pathology - inflammation, pain, vascular health, tissue integrity, and bowel function. However, it's important to note that while these ingredients can have beneficial effects, the effectiveness of such a herbal formulation would depend on the specific compounds present and their concentrations. Additionally, individuals with piles should consult healthcare professionals for proper diagnosis and treatment, as herbal treatments can complement but not replace standard medical care, especially in severe cases.

[0071] The process of the present invention is now illustrated herein below with the help of the following example: EXAMPLE - 1

[0072] For 1000 mg formulation

[0073] Ingredients like 52.1 gms of kutki (Picrorhiza kurroa), 26 gms of Atibala (Abutilon Indicum), 52.1 gms of Patha (Cissampelos pareira), 52.1 gms of Daruharidra (Berberis aristate), 13 gms of Kalinga (Kalinga omata), 52.1gms of Chitraka (Plumbago zeylanica), 52.1 gms of, Herda (Terminalia Chebula) were combined to make a powder mix.

[0074] All the above active ingredients are mixed with each other one by one and then the mixture is blended into a fine herbal powder, the fine herbal powder is macerated with 60% bio-methanol (in the proportion of 1:4) at room temperature for 5 days and the mixture is allowed to settle down, then the bio-methanol fraction is separated from the settled down the mixture and then subject the bio-methanol fraction to evaporation at 68° C for obtaining the bio-methanol soluble extract. This is the first ingredient for the formulation of the final extract.

[0075] Ethyl acetate is added to the settled-down mixture and then heated at a temperature of 40° C for 2 hours, 50° C for 1 hour, 60° C for 0.5 hours, and 750C - 780C for 0.5 hours for extraction of ethyl acetate soluble components from the herbal ingredients. After the separation of the ethyl acetate fraction from the settled down mixture, ethyl acetate is evaporated at 78° C for obtaining the ethyl acetate soluble extract. This is the second ingredient for the formulation of the final extract.

[0076] After washing out the above obtained settled down mixture with water, 60% bio-ethanol is added to the mixture and then heated at a temperature of 40° C for 2 hours, 50° C for 1 hour, 60° C for 0.5 hours, and 750C - 780C for 0.5 hours. Separate the Bio-ethanol fraction from the mixture and subject the bio-ethanol fraction to 78° C (Evaporation point) to obtain bio-ethanol soluble extract. This is the third ingredient for the final extract to be obtained. Now wash out the settled-down mixture obtained in the above step and heat the mixture with water at a temperature of 100° C for 2 hours for obtaining water-soluble extract. This is the fourth ingredient for the final extract to be obtained.

[0077] The final extract is obtained by mixing phases 1, 2, 3, and 4 in the proportion of 21.25% to 28.75% of phase I, 21.25% to 28.75% of phase II, 21.25% to 28.75% of phase III, 21.25% to 28.75% of phase IV, along with the excipients, which are blended for an acceptable form of oral administration.

Claims

CLAIMSI / we claim,1. A polyherbal formulation comprising: kutki (Picrorhiza kurroa), Atibala Abutilon Indicum), a Patha (Cissampelos pareira), Daruharidra (Berberis aristate), Kalinga (Kalinga ornata . Chitraka (Plumbago zeylanica . Herda (Terminalia Chebula) mixed in a proportion of 25-65% w / w along with suitable excipients used for minimizing the effect caused due to grade I and grade II Hemorrhoids.

2. The polyherbal formulation as claimed in claim 1, wherein the preferred formulation comprises Kutki (Picrorhiza kurroa) in the range of 5 to 6% by weight; Atibala (Abutilon Indicum) in the range of 2 to 3% by weight; Patha (Cissampelos pareira) in the range of 5 to 6% by weight; Daruharidra (Berberis aristate) in the range of 5 to 6% by weight; Kalinga (Kalinga ornata) in the range of 1 to 2% by weight; Chitraka (Plumbago zeylanica) in the range of 5 to 6% by weight; Herda (Terminalia Chebula) in the range of 5 to 6% by weight, along with excipients selected from dicalcium phosphate (DCP), gelatin, starch, carboxymethyl cellulose (CMC), magnesium stearate, and talc, each within specified weight percentages.

3. The polyherbal formulation as claimed in claim 1, wherein the carrier includes diluent, binder, glidant, and lubricant.

4. The polyherbal formulation as claimed in claim 1, wherein formulation further comprising auxiliary, stabilizing, thickening, flavoring, fragrance, and coloring agents.

5. The polyherbal formulation is claimed in claim 1, wherein the formulation is used in a dosage of 2 mg - 16 mg / body weight for average body weight in single or divided doses per day.

6. A process of preparation of an herbal formulation for lowering the effect of grade I and grade II Hemorrhoids comprising the steps of; a. mixing of kutki (Picrorhiza kurroa) in an amount of 5.2% by weight of the composition, Atibala (Abutilon Indicum) in an amount of 2.6% by weight of the composition, a Patha (Cissampelos pareira) in an amount of 5.2 % by weight of the composition, Daruharidra (Berberis aristate) in an amount of 5.2 % by weight of the composition, Kalinga (Kalinga ornata) in an amount of 1.3 % by weight of the composition, Chitraka (Plumbago zeylanica) in an amount of 5.2 % by weight of thecomposition, Herda (Terminalia Chebula) in an amount of 5.2 % by weight of the composition into a fine herbal powder. b. grinding the herbal ingredients of (a); c. macerating the fine herbal powder obtained in step (b) into 60% bio-methanol for 5 days and allowing the mixture to settle down; d. separating the bio-methanol fraction from the settled down the mixture and subjecting the bio-methanol fraction to evaporation at 68° C for obtaining the bio-methanol soluble extract to make Part I; e. taking the mixture obtained in step (d) and adding ethyl acetate into the mixture; f. heating the ethyl acetate and macerated mixture at 40° C for 2 hours, 50° C for 1 hour, and 60° C for 0.5 hours for extracting ethyl acetate soluble components from the herbal ingredients; g. separating the ethyl acetate fraction from the settled-down mixture; h. heating the ethyl acetate fraction of (g) at 78° C for evaporating the ethyl acetate and obtaining the ethyl acetate soluble extract to make Part II; i. washing out the settled-down mixture obtained in step (g) and adding 60% bio-ethanol to the mixture; j. heating the mixture obtained at (i) at 40° C for 2 hours, 50° C for 1 hour, and 60° C for0.5 hours followed by separating the Bio-ethanol fraction from the mixture; k. subjecting the bio-ethanol fraction to 78° C (Evaporation point) for obtaining the bio- ethanol soluble extract to make Part III; l. washing out the settled-down mixture obtained in step (j) and heating the mixture with water at 100° C for 2 hours for obtaining water-soluble extract to make Part IV; m. mixing the part I obtain in (d ), part II obtain in ( h ), part III obtain in ( k ), and part IV obtain in ( 1 )7. The process of preparing an herbal formulation as claimed in claim 6, wherein the formulation is made by combining 21.25% to 28.75% of part I, 21.25% to 28.75% of part II, 21.25% to 28.75% of part III, 21.25% to 28.75% of part IV, excipients, carriers, and solvents.

8. The process of preparing an herbal formulation as claimed in claim 6, wherein the excipients of the formulation can be selected from the group of dicalcium phosphate, gelatin, starch, carboxymethyl cellulose (CMC), magnesium stearate, talc, or a combination thereof.

9. The process of preparing an herbal formulation as claimed in claim 6, wherein the said composition is formulated for oral administration.

10. The process of preparing an herbal composition as claimed in claim 6, wherein the solvents may be selected from methanol, ethanol, ethyl acetate, acetone, hexane, etc.

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