FIELD OF INVENTION

[001] The present invention generally relates to health care products, more particularly, the invention relates to an herbal composition for controlling gastric and ulcers related to gastrointestinal tract (GIT).

BACKGROUND

[002] The stomach is an organ of the digestive system. It has a saccular shape and is located between the esophagus and intestines. The human stomach changes size and shape according to its position within the body and the amount of food inside. The wall of the stomach is lined with millions of gastric glands, which together secrete 400-800 ml of gastric juice at each meal. Three types of cells are found in the gastric glands. These cells are parietal cells, “main” cells, and mucus- secreting cells. Parietal cells contain an enzyme known as H + / K + adenosine triphosphatase. H + / K + adenosine triphosphatase is also called an “acid pump” or “proton pump”. This transmembrane protein secretes H + ions (protons) via active transport using ATP energy. The concentration of H + in gastric juice can be as high as 0.15 M, providing gastric juice with a pH of less than 1.

[003] Stomach ulcers (gastric ulcers) are open sores that develop on the lining of the stomach. Ulcers can also occur in a part of the intestine just beyond the stomach. These are called duodenal ulcers. Stomach and duodenal ulcers are sometimes called peptic ulcers. A peptic ulcer is a sore or break in the lining of any part within the digestive tract that contains concentrated gastric juice. The main components of gastric juice are water, mucus, hydrochloric acid, enzymes, and electrolytes. Ulcers most commonly occur in the first part of the small intestine below the stomach (duodenum) and can also occur at the lower end of the esophagus or in the stomach.

[004] Stomach ulcers occur when the layer protecting the stomach lining from stomach acid breaks down. This allows the stomach lining to become damaged. This is usually caused by: an infection with Helicobacter pylori (H. pylori) bacteria, taking non-steroidal antiinflammatory drugs (NSAIDs), such as ibuprofen or aspirin - particularly if they're taken for a long time or at high doses.

[005] Disorders of the intestine, disorders of the colon, and disorders associated with or suspected of being associated with a dysfunctional intestine and/or dysfunctional colon are unmet medical needs.

[006] So, there exists a need for a solution that would control the gastric, ulcers related to GIT in a simpler and effective manner. The solution needs to be through oral medication with minimal to zero side effects. The present disclosure provides a simple and effective way of preparation of an herbal-based composition that is produced using natural and synthetic ingredients.

STATEMENT OF THE INVENTION

[007] The present invention discloses an herbal composition wherein the composition comprises a first heterogeneous mixture, wherein the first heterogeneous mixture is prepared based on soaked rhizome of Asafetida for a time period. The composition further comprises a second heterogeneous mixture, wherein the second homogenous mixture is prepared based on combination of fruit extracts of Noni and the first heterogeneous mixture, and a primary composition, wherein the primary composition is prepared based on boiling the second heterogeneous mixture for at least one of a specific duration, a specific temperature, and a specific pressure.

[008] The first heterogeneous mixture of the composition further includes soaked of extracts of at least one of Licorice, Turmeric, and Cutch tree. And, the second heterogenous mixture further includes fruit extracts of Cumin, Fennel, Grapes, Pomegranate, Dates, Embelia, Red Mango, Long Pepper, and Ajamoda. Additionally, the second heterogenous mixture further includes plant extracts of mint leaves and Cloves. The primary composition is further filtered based on a filtration technique.

[009] The filtration technique includes at least one of vacuum filtration, centrifugal filtration, gravity filtration, cold filtration, hot filtration, and multi-layer filtration. The primary composition is heated at a boiling temperature and the composition further comprising at least one excipient.

[0010] The present invention includes a method of preparation of an herbal composition, wherein the method comprises soaking of rhizome of Asafetida for a time perioda to obetain a first heterogeneous mixture, combining fruit extracts of Noni with the first heterogeneous mixture to obtain a second heterogeneous mixture, and boiling the second heterogeneous mixture for at least one of a specific duration, a specific temperature, and a specific pressure to obtain a primary composition.

OBJECT OF THE INVENTION

[0011] The principal object of the invention is to provide an herbal composition for the control of gastric, ulcers related to GIT. [0012] Another object of the invention is to repair the stomach inner line, without side effects.

[0013] Yet another object of the invention is to increase the secretion of digestive juices in the stomach.

[0014] Yet another object of the invention is to provide relief from various digestive issues like bloating and acidity.

[0015] Yet another object of the invention is to address the root cause of acidity.

[0016] Yet another object of the invention is to help in gastritis, Mukhavarna, mukhashodaka, amlapitta, parinamashula

[0017] These and other objects and characteristics of the present invention will become apparent from the further disclosure to be made in the detailed description given below.

BRIEF DESCRIPTION OF DRAWINGS

[0018] This invention is illustrated in the accompanying drawings, throughout which, like reference letters indicate corresponding parts in the various figures.

[0019] The embodiments herein will be better understood from the following description with reference to the drawings, in which:

[0020] FIG. 1 illustrates a sequence flow diagram representation of the preparation of an herbal composition, in accordance with an example embodiment of the present disclosure.

[0021] FIG. 2 shows a simplified block diagram representation of an herbal composition, in accordance with an example embodiment of the present disclosure.

[0022] FIG. 3 shows a tabular representation of an herbal composition, in accordance with an example embodiment of the present disclosure. DETAILED DESCRIPTION OF INVENTION

[0023] The embodiments herein and the various features and advantageous details thereof are explained more fully with reference to the non-limiting embodiments that are illustrated in the accompanying drawings and / or 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 intended merely to facilitate an understanding of ways in which the embodiments herein may be practised and to further enable those of skill in the art to practice the embodiments herein. Accordingly, the examples should not be construed as limiting the scope of the embodiments herein.

[0024] Reference in this specification to “one embodiment” or “an embodiment” means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present disclosure. The appearance of the phrase “in an embodiment” in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments mutually exclusive of other embodiments. Moreover, various features are described which may be exhibited by some embodiments and not by others. Similarly, various requirements are described which may be requirements for some embodiments but not for other embodiments.

[0025] Moreover, although the following description contains many specifics for the purposes of illustration, anyone skilled in the art will appreciate that many variations and/or alterations to said details are within the scope of the present disclosure. Similarly, although many of the features of the present disclosure are described in terms of each other, or in conjunction with each other, one skilled in the art will appreciate that many of these features can be provided independently of other features. Accordingly, this description of the present disclosure is set forth without any loss of generality to, and without imposing limitations upon the present disclosure.

[0026] Various embodiments of the present disclosure provide an herbal composition and the method of preparation of the herbal composition. The composition may be consumed by a human being in order to control gastric, ulcers related to GIT. The present disclosure describes a method of preparation of the herbal composition.

[0027] In one embodiment, the composition may control gastric, ulcers related to GIT. The composition may further be used to repair the stomach inner line and increase the secretion of digestive juices in the stomach.

[0028] Referring now to the drawings, where similar reference characters denote corresponding features consistently throughout FIG.l, FIG.2, and FIG. 3, there are shown preferred embodiments.

[0029] FIG. 1 illustrates a sequence flow diagram 100 representation of preparation of the herbal composition, in accordance with an example embodiment of the present disclosure. As per Fig. 1, the sequence flow diagram 100 includes series of steps from step 101 to step 113 representing the preparation of the herbal composition. At step 101, procuring a specific quantity of roots associated with an herb such as Asafetida or Devil's dung (locally referred as Hinghu) is carried out. In another embodiment, the roots of Asafetida or Devil's dung may be combined with the roots of herbs such as Licorice (which is locally referred as Yashtimadhu).

[0030] In some example embodiments, among the roots associated with herbs, one of the root-based herbs, Asafetida may also be called with a scientific name Ferula asafetida. In an alternative embodiment, the Rhizome of the Asafetida may be used in the herbal composition. Further, the roots of Asafetida are amazing spice for treating stomach ailments. Asafetida is antispasmodic and may be used to cure abdominal pain, intestinal problems, flatulence, upset stomach, worm infestation, and irritable bowel syndrome.

[0031] In some example embodiments, among the root associated with herbs, another root-based herbs Licorice, may also be called with a scientific name Glycyrrhizaglabra. In some example embodiments, Licorice may be used in colon treatment, Flatulence treatment of respiratory and digestive disorders. Licorice may be considered to be a "Rasayana". Mulethi uses specifically include treatment of chronic acidity, ulcers, and chronic bronchial conditions. Investigations observed that licorice activates ulcer healing.

[0032] In some example embodiments, among the stem associated with herbs another stem-based herb Turmeric (also referred as Haridra), may also be called with a scientific name Curcuma longifolia. Turmeric extracts are extensively used in the traditional system of medicine. Turmeric is used as an antioxidant and possesses various beneficial properties such as anti-inflammatory, anti- allergic, antiseptic, blood cleansing etc. It is widely prescribed Ayurvedic drug and is used in various diseases.

[0033] In some example embodiments, among the stem associated with herbs another stem of Cutch Tree (locally referred as Khadira), may also be called with a scientific name Acacia catechu. Cutch stem is an effective herb that promotes blood clotting and controls bleeding disorders such as bleeding gums, piles, and other skin injuries. Taking this herb orally aids to control bleeding due to its potent astringent, cold properties, and Gastrointestinal disorders.

[0034] Further, with respect to Fig. 1, the roots and stems associated with respective herbs may be procured in their raw forms. In some example embodiments, the roots and stems associated with respective herbs may be in their processed form. The processed forms may include power, paste etc. In some example embodiments, the specific quality in which each of the respect herbs is procured may change based on one or more requirements such as quality of preparation (i.e., scale of manufacture), purpose, etc.

[0035] In some example embodiments, the roots and the stems of the respective herbs thus obtained may be cleaned thoroughly. In some example embodiment, cleaning may include removal of unwanted elements attached to the herbs such as mud, dirt, and other plant elements. In some example embodiments, the roots and the stems of the respective herbs thus obtained may be cleaned thoroughly using clean water.

[0036] At step 103, the method may further include preparing a first heterogeneous mixture by soaking the respective herbs for a specific duration. In one example, the roots and the stems of the respective herbs which are obtained at step 101, maybe soaked for 6-20 hours in water. However, the duration of soaking may vary based on types of roots, types of stems, or different environmental conditions. In some example embodiments, the water may be De- Mineralised water (DM) or Reverse Osmosis water (RO). Thereby, the soaked herbs form a heterogeneous mixture by the end of six to twenty hours in the RO or DM water, where the respective herbs have been soaked. Hereinafter, for illustrative purposes, the heterogeneous mixture obtained at step 103 is also referred as a first heterogeneous mixture.

[0037] At step 105, the method may further include preparing, a second heterogeneous mixture based on, combining a specific quantity of fruits of Noni with the first heterogeneous mixture.

[0038] In one example, the fruits of Noni may be combined with the fruits of Cumin, Fennel, Grapes, Pomegranate, Dates, Embelia, Red Mango, Long Pepper, and Ajamoda.

[0039] Here, the above-mentioned fruits in any form may be combined with the first heterogeneous mixture to form the second heterogeneous mixture. Further, the fruit may be in any form but not limited to fruits with peel and/or seed. The fruits may be in smashed form or paste form. In some example embodiment, a specific quantity of each fruit may be procured based on the requirement. In some example embodiments, the respective fruits may be presoaked in RO or DM water for 6 to 20 hours before combining with the first heterogeneous mixture.

[0040] In some example embodiment, among the procured fruits, one of the fruit may include Noni. This fruit may also be called with a scientific name Morinda citrifolia. Noni contains many substances, including potassium.

[0041] In some example embodiment, among the procured fruits, one of the fruit may include Cumin (or locally referred as Shweta Jeeraka). The Cumin fruit may also be called with a scientific name Cuminum cyminum. Cumin may be used along with jaggery to improve appetite, cleans the bowel and relieving burning sensation, prevent diarrhea.

[0042] In some example embodiments, among the procured fruits, another fruit may include Fennel or Mishreya. This fruit may also be called with a scientific name Foeniculum vulgare. Fennel is good for constipation, worm infestation and weak digestive fire.

[0043] In some example embodiments, among the procured fruits, another fruit may include Grapes. The Grapes may also be called with a scientific name Vitis vinafera. Draksha helps in easy bowel movement, avoid stomach burning sensations, Raisins are also used to treat intestinal disorders. Dry grapes or raisins help to ease bowel movement and to cool eyes.

• In some example embodiments, among the procured fruits, another fruit may include Pomegranate. This fruit may also be called with a scientific name Punica granatum. Pomegranate is used in diseases like acidosis, dysentery, microbial infections, diarrhea, helminth infection, hemorrhage, respiratory complaints, colic, colitis, menorrhagia, headache, acne, piles, allergic dermatitis, oral diseases etc.

[0044] In some example embodiments, among the procured fruits, another fruit may include Dates. This fruit may also be called with a scientific name Phoenix dactylofera. Decoction prepared from leaves of phoenix sylvetris is used for dysuria, diarrhea, and intestinal worms.

[0045] In some example embodiments, among the procured fruits, another extract may include Embelia or Vidanga fruits. This fruit may also be called with a scientific name Embelia ribes. Vidanga is a useful herb to manage worm infestation that includes threadworms, roundworms, and types of worms due to its Krimighna property. Vidanga controls vomiting, nausea, indigestion, and flatulence due to its hot potency. It also helps manage constipation due to its Rechana (laxative) property.

[0046] In some example embodiments, among the procured fruits, another fruit may include Red Mango or Vrikshamla. This fruit may also be called with a scientific name Garcinia cambogia. Vrikshamla helps reduce unhealthy triglycerides and naturally lower high cholesterol levels. Vrikshamla helps in fat loss by improving fat and carbohydrate metabolism. It reduces the storage of fat and glycogen. Vrikshamla promotes healthy serotonin levels which helps reducing appetite thus prevents overeating.

[0047] In some example embodiments, among the procured fruits, another fruit may include Long Pepper. This fruit may also be called with a scientific name Piper longum. Long Pepper increases Digestion, reduces Gas and bloating, Detoxifies Body, useful in respiratory problems, benefits Anaemia, reduces Nervous system disorders (Anxiety, fear and worry), helps in weight management, benefits Insomnia, useful In Arthritis beneficial in liver, gall bladder and spleen problems. Pippali has Anti-microbial, Anti-inflammatory activity. Consumption of pippali is said to exhibit anti spasmodic action and hypoglycaemic effect which is believed to lower blood sugar level. It is also reported to be antagonist in respiratory depression. Also due to its cooling post-digestive effect consumption of pippali is considered a safe and effective option to avoid all sorts of digestive disorders.

[0048] In some example embodiments, among the procured fruits, another fruit may include Ajamoda. This fruit may also be called with a scientific name Apium leptophyllum. According to Ayurveda, Ajamoda Arka is useful in Agnimandya (Loss of appetite), Ajirna (Indigestion), Bastiroga (Urinary bladder disorder), Vata-kapha-roga (Diseases due to Vata & Kapha disorders), and Aruchi (Anorexia). Loss of appetite.

[0049] In some example embodiments, among the procured herbs, another aerial part may include Pudina or mint leaves. Mint leaves may also be called with a scientific name Mentha piperata. The aromatic ayurvedic herb is a natural coolant, with a sweet and a pungent aftertaste. Mint has the quality to pacify all the three doshas and chiefly manages the Pitta dosha. Mint leaves owing to its carminative properties helps in digestion and assimilation of food and treats colic pain. The extract of Mint leaves is used to treat intestinal worms.

[0050] In some example embodiments, among the procured herbs, another flower bud may include Cloves. Cloves may also be called with a scientific name Syzygium aromaticum. Clove is a known effective herb to resolve digestive problems like intestinal gas, bloating, nausea, stomach upset, distention, and dyspepsia. It also helps to provide relief in heartbum, acidity, and stomach ache. Antihelmenthic properties of Lavanga are good to clear intestinal worms from the body treat the GIT infection caused by bacteria, virus, protozoans, and other pathogens.

[0051] Furthermore, at step 107 the method may further include extracting, a primary composition by, boiling the second heterogeneous mixture for a specific duration at a specific temperature and pressure. In one example, the second heterogeneous mixture comprising the roots, the fruits, the stems, and the plant of respective herbs as illustrated above which are soaked in RO or DM water for 6 to 20 hours, maybe steam boiled for 1-2 hours at 80-100 degree Celsius at 1-2 atmospheric pressure. By doing so, it is possible to obtain a primary composition, which has a synergistic effect based on extracted nutrients from respective herbs and the first composition shows an increased efficacy than original herbs.

[0052] Furthermore, at step 109, the method may further include filtering, the extracted primary composition based on any suitable filtration technique. Based on filtration, the solid particles from the extracted primary composition may be removed from the mixture containing both solids and liquids. The filtration technique may include, but is not limited to, vacuum filtration, centrifugal filtration, gravity filtration, cold filtration, hot filtration, multi-layer filtration, and the like

[0053] Furthermore, at step 111, the method may further include heating, the filtered composition which is obtained at step 109 at a boiling temperature, and add at least one excipient. An excipient is a substance formulated alongside the active ingredient of a composition, included for the purpose of long-term stabilization, bulking up solid formulations. In one example, at least one excipient may be added as preservatives. In some example embodiment, excipient may include, but not limited to sodium benzoate, guargum, and the like.

[0054] Furthermore, at step 113, the method may further include a fine filtration of the composition obtained at step 111 followed by subjecting the composition obtained after the fine filtration to cool down to room temperature. During cooling, the composition obtained after the fine filtration may observe some precipitation. The composition obtained after cooling is a brown-colored solution with a higher viscosity and comprises a pH value in a range of 3-6 ph. The composition obtained from step 101 to step 113 is the herbal composition for controlling gastric, ulcers related to GIT.

[0055] In the present embodiment, the pungent smell and bitter taste of the fruit Noni may be removed based on any suitable masking technique. The masking technique includes mixing of the fruit Noni, with the rest of the herbs (i.e., respective fruits other than Noni, respective roots, respective stems, and the plant). The masking technique retains nutrients present in the noni.

[0056] In some example embodiments, the process of soaking the respective herbs may be eliminated. In some other embodiments, the specific quantity of respective herbs may vary based on the quantity of required composition.

[0057] An example embodiment of the invention illustrating the quantity of each of herbs for preparing 10 ml of the herbal composition is explained in FIG. 2 of the disclosure. In one embodiment, the quantities of the herbs may be varied as per the similar ratios of quantities as mentioned below. In an alternative embodiment, the quantities of the herbs may be varied that is different from the ratios of quantities as mentioned below.

[0058] FIG. 2 shows a simplified block diagram representation illustrating an example of the quantity of herbs for preparing an herbal composition of 10ml, in accordance with a preferred embodiment of the present disclosure.

[0059] In some example embodiments, the herbal composition may comprise rootbased herbs, stem-based herbs, fruit-based herbs, plant-based herbs, and excipients as shown in FIG. 2. In a preferred embodiment, powdered form of roots of Asafetida of about 125 mg and 500 mg of Licorice are procured. Further, in the preferred embodiment, 150 mg of the stem of Turmeric and 150 mg of Cutch leaves are procured. [0060] In some example embodiments, the respective roots and stem of the herbs are soaked in RO or DM water for 6-20 hours to prepare a heterogeneous mixture. In some example embodiments, the duration of soaking and mode of soaking may vary based on types of herbs and other environmental conditions.

[0061] In a preferred embodiment, a specific set of fruits are added to the heterogeneous mixture. In an example, 8.5g of fresh Noni fruits, 150mg of Cumin, 250 mg of Fennel, 200mg of Draksha, 150 mg of Dates, 125 mg of Vidanga, 150 mg of Vrikshamla, 200 mg of Pippali, lOOmg of Ajamod, and Pomegranate fruit. In an alternative embodiment, the fruits may be soaked in RO or DM water for 6 to 20 hours.

[0062] Further, a specific amount of plant-based herbs that are procured and added with the heterogeneous mixture may include 150 mg of Mint leave extract and 20 mg of Cloves. In an example embodiment, the whole plant, including but not limited to leaves, roots, and stems may be used. In some other example embodiments, the plant may be pre-soaked in RO or DM water for 6 to 20 hours before combining with the heterogeneous mixture.

[0063] In some example embodiments, each of the herbs of the heterogeneous mixture may be soaked in the same RO or DM waster for 6 to 20 hours or any combination of thereof is also possible. In some example embodiments, the herbal composition may comprise at least one herb or fruit with complementary characteristics, other than the herbs and fruits mentioned in the disclosure, in any specific quantity. Throughout the disclosure, a mixture of at least two types of herbs, in any form may be considered as a composition.

[0064] Further, the heterogeneous mixture is subjected to boiling, filtering and heating. After boiling, filtering, and heating the heterogeneous mixture is further subjected to addition excipients, fine filtration, and cooling. Throughout the disclosure, the composition obtained after cooling may be called as herbal composition. The herbal composition maybe a brown coloured solution with a higher viscosity and comprise a pH value in a range of 3-6 ph., as explained in FIG. 1.

[0065] FIG. 3 shows a tabular representation of an herbal composition, in accordance with an example embodiment of the present disclosure. The technology used in the production may be known as masking technology where the pungent smell and the bitter taste of noni fruit may be masked by the addition of other herbs. The main advantage of this technology is the nutrients present in the noni are completely retained thus resulting in better results for the end customer. In another example embodiment, the alternative method of debittering may be used where the bitterness and the foul smell of noni are removed. In this process, some of the nutrients required for the human body may be lost along with bitterness.

[0066] The herbal composition obtained from step 101 to 113, is prepared from naturally available components (i.e., herbs and fruits), hence they may not have side effects on the human body. The composition helps in gastritis, Mukhavarna, mukhashodaka, amlapitta, parinamashula. Further, due to synergistic effect of extracted nutrients from respective herbs and addition of excipients make the composition obtained from step 101 to 113 show a higher efficacy than original herbs. Therefore, the compositions obtained from step 101 to 113 composition have properties to control gastric, ulcers related to GIT. The herbal composition may also help the human being to repair the stomach inner line, without side effects, increases the secretion of digestive juices in the stomach, provide relief from various digestive issues like bloating and acidity, and addresses the root cause of acidity.

[0067] The foregoing description of the specific embodiments will so fully reveal the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practised with modification within the spirit and scope of the embodiments as described herein.