FIELD OF THE INVENTION
[0001] The present disclosure relates generally to a herbal composition. Particularly, the present disclosure provides the herbal composition including therapeutically effective amount of Rubia cordifolia (Manjishtha), therapeutically effective amount of Alum and therapeutically effective amount of Saltpeter (Kalmi shora) for the treatment of moles and haemorrhoids.

BACKGROUND OF THE INVENTION
[0002] Background description includes information that may be useful in understanding the present invention. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed invention, or that any publication specifically or implicitly referenced is prior art.
[0003] Haemorrhoids, also known as piles, are lumps that occur inside and around the anal passage and are one of the most common gastrointestinal disorders. Haemorrhoids are known to occur in any age and can affect both sexes. The natural evolution of haemorrhoids is benign in nature, but they tend to get worse over time. Haemorrhoids can be caused by a variety of factors such as increased pressure in the blood vessels in and around anus, hormones, genes, inflammation, infection, constipation, chronic diarrhea, heavy manual labour, vascular stasis, diet, strain, sitting down for long periods of time, physical stance in defecation, age etc.
[0004] The haemorrhoids are three different types and include, internal haemorrhoids (found inside the rectum and they are painless but tend to bleed), prolapsed haemorrhoids (a more severe and painful form of internal haemorrhoids) and external haemorrhoids (small haemorrhages (bleeds) under the skin around the anus).
[0005] Haemorrhoids are very common, affecting as many as 1 in 4 of the population chronically and regularly. It is estimated that almost 50 % of the population over the age of 50 years suffers from piles and nearly half will experience at least one haemorrhoidal episode at some point during their lives. Owing to the ambiguity in the cause associated with piles, it becomes very difficult to treat them effectively.
[0006] The Chinese patent applications, CN102727528 and CN102579892 disclose medicines for the treatment of haemorrhoids. Many over the counter topical treatment products are available for haemorrhoids, which include ointments, creams, gels, lotions, and suppositories. Nevertheless, these compositions provide only temporary relief due to limited local application and cannot be used for systemic use or oral administration.
[0007] Surgeries have been used to treat severe haemorrhoids, for example, haemorrhoidectomy, doppler guided transanal haemorrhoidal dearterialization, and stapled haemorrhoidectomy. However, all surgical treatments are associated with some degree of complications, including bleeding, infection, anal strictures, and urinary retention due to the close proximity to the rectum of the nerves that supply the bladder.
[0008] Therefore, there remains an unmet need to have a safe and effective herbal composition devoid of side effects for the treatment of moles and haemorrhoids. The present invention satisfies the existing needs, as well as others, and generally overcomes the deficiencies found in the prior art.

OBJECTS OF THE INVENTION
[0009] Primary object of the present invention is to provide a herbal composition that finds utility in treatment of moles and haemorrhoids.
[00010] Another object of the invention is to provide a herbal composition for the treatment of moles and haemorrhoids that is substantially devoid of any side effects.
[00011] Another object of the invention is to provide a herbal composition for the treatment of moles and haemorrhoids that is easy to prepare.
[00012] Another object of the invention is to provide a herbal composition for the treatment of moles and haemorrhoids that is cost effective.
[00013] Other objects of the present invention will be apparent from the description of the invention herein below.

SUMMARY OF THE INVENTION
[00014] The present disclosure relates generally to a herbal composition. Particularly, the present disclosure provides a herbal composition including therapeutically effective amount of Rubia cordifolia (Manjishtha), therapeutically effective amount of Alum, and therapeutically effective amount of Saltpeter (Kalmi shora) for the treatment of moles and haemorrhoids.
[00015] An aspect of the present disclosure relates to a herbal composition including: a therapeutically effective amount of Rubia cordifolia (Manjishtha); a therapeutically effective amount of Alum; a therapeutically effective amount of Saltpeter (Kalmi shora); and optionally at least one pharmaceutically acceptable excipients(s). In an embodiment, the composition includes Rubia cordifolia (Manjishtha) in an amount ranging from about 10% to about 90% by weight of the composition. In an embodiment, the composition includes Alum in an amount ranging from about 5% to about 85% by weight of the composition, and wherein Alum comprises any or a combination of potassium aluminium sulphate, sodium aluminium sulphate and ammonium aluminium sulphate. In an embodiment, Alum is in a form of bhasma. In an embodiment, the composition includes Saltpeter (Kalmi shora) in an amount ranging from about 5% to about 85% by weight of the composition.
[00016] In an embodiment, the herbal composition includes Rubia cordifolia (Manjishtha) in an amount of about 30% by weight of the composition; Alum in an amount of about 30% by weight of the composition; Saltpeter (Kalmi shora) in an amount of about 30% by weight of the composition; and the rest being at least one pharmaceutically acceptable excipient(s).
[00017] In an embodiment, the herbal composition includes Rubia cordifolia (Manjishtha) in an amount of about 20% by weight of the composition; Alum in an amount of about 10% by weight of the composition; Saltpeter (Kalmi shora) in an amount of about 5% by weight of the composition; and the rest being at least one pharmaceutically acceptable excipient(s).
[00018] In an embodiment, the composition is formulated in any of a solid dosage form, a liquid dosage form and a semi-solid dosage form. In an embodiment, the composition is formulated as any of an oral dosage form or a topical dosage form.
[00019] In an embodiment, the composition exhibits any or a combination of preventive and ameliorative effect against any or a combination of moles and haemorrhoids.
[00020] Other aspects, advantages, and salient features of the invention will become apparent to those skilled in the art from the following detailed description, which, taken in conjunction with the exemplary embodiments of the invention.

DETAILED DESCRIPTION OF THE INVENTION
[00021] The embodiments herein and the various features and advantageous details thereof are explained more comprehensively with reference to the non-limiting embodiments that are 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 the ways in which the embodiments herein may be practiced and to further enable those of skill in the art to practice the embodiments herein. Accordingly, the examples should not be construed as limiting the scope of the embodiments herein.
[00022] Unless otherwise specified, all terms used in disclosing the invention, including technical and scientific terms, have the meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. By means of further guidance, term definitions may be included to better appreciate the teaching of the present invention.
[00023] As used in the description herein, the meaning of “a,” “an,” and “the” includes plural reference unless the context clearly dictates otherwise. Also, as used in the description herein, the meaning of “in” includes “in” and “on” unless the context clearly dictates otherwise.
[00024] As used herein, the terms “comprise”, “comprises”, “comprising”, “include”, “includes”, and “including” are meant to be non- limiting, i.e., other steps and other ingredients which do not affect the end of result can be added. The above terms encompass the terms “consisting of” and “consisting essentially of”.
[00025] As used herein, the terms “composition”, “blend”, or “mixture” are all intended to be used interchangeably.
[00026] The terms “weight percent”, “vol-%”, “percent by weight”, “% by weight”, and variations thereof, as used herein, refer to the concentration of a substance as the weight of that substance divided by the total weight of the composition and multiplied by 100. It is understood that, as used here, “percent”, “%”, and the like are intended to be synonymous with “weight percent”, “vol-%”, etc.
[00027] In some embodiments, the numbers expressing quantities of ingredients, properties such as concentration, reaction conditions, and so forth, used to describe and claim certain embodiments of the invention are to be understood as being modified in some instances by the term “about”. Accordingly, in some embodiments, the numerical parameters set forth in the written description are approximations that can vary depending upon the desired properties sought to be obtained by a particular embodiment. In some embodiments, the numerical parameters should be construed in light of the number of reported significant digits and by applying ordinary rounding techniques. Notwithstanding that the numerical ranges and parameters setting forth the broad scope of some embodiments of the invention are approximations, the numerical values set forth in the specific examples are reported as precisely as practicable.
[00028] The recitation of ranges of values herein is merely intended to serve as a shorthand method of referring individually to each separate value falling within the range. Unless otherwise indicated herein, each individual value is incorporated into the specification as if it were individually recited herein.
[00029] The headings and abstract of the invention provided herein are for convenience only and do not interpret the scope or meaning of the embodiments.
[00030] The following discussion provides many example embodiments of the inventive subject matter. Although each embodiment represents a single combination of inventive elements, the inventive subject matter is considered to include all possible combinations of the disclosed elements. Thus if one embodiment comprises elements A, B, and C, and a second embodiment comprises elements B and D, then the inventive subject matter is also considered to include other remaining combinations of A, B, C, or D, even if not explicitly disclosed.
[00031] The present disclosure relates generally to a herbal composition. Particularly, the present disclosure provides a herbal composition including therapeutically effective amount of Rubia cordifolia (Manjishtha), therapeutically effective amount of Alum and therapeutically effective amount of Saltpeter (Kalmi shora) for the treatment of moles and haemorrhoids.
[00032] Rubia cordifolia (Manjishtha) commonly known as “madder or Indian madder or Manjishtha” and belongs to the family of “Rubiaceae”. This plant is available across India. Rubia cordifolia is reported to be used to manage dropsy, paralysis, amenorrhea, and jaundice in Indian Ayurvedic system.
[00033] Alum is a type of chemical compound and the most important available alums are potassium alum (Potassium aluminium sulfate), sodium alum (Sodium aluminium sulfate) and ammonium alum (ammonium aluminium sulfate). Alum is reported to be used for various treatments due to its astringent, analgesic, haemostatic, desiccative, expulsive for foetus and placenta, antipyretic, detergent, corrosive, expectorant, emetic and irritant property.
[00034] Saltpeter (Kalmi shora) is commonly known as “Potassium nitrate” and Kalmi shora. Kalmi shora is available in the form of colourless crystals or a white, crystalline powder. It is used in dentifrices to help reduce the pain of hypersensitive teeth. Kalmi shora is alkaline in taste and cooling in nature. It is beneficial in disorders of the urinary tract. Kalmi shora is reported to be used for headache, stomach upset and kidney problems.
[00035] An aspect of the present disclosure relates to a herbal composition including: a therapeutically effective amount of Rubia cordifolia (Manjishtha), a therapeutically effective amount of Alum, a therapeutically effective amount of Saltpeter (Kalmi shora) and optionally at least one pharmaceutically acceptable excipients(s).
[00036] In an embodiment, the composition includes Rubia cordifolia (Manjishtha) in an amount ranging from about 10% to about 90% by weight of the composition. In an embodiment, the composition includes Rubia cordifolia (Manjishtha) in an amount of about 10 % to about 20 % by weight, about 20 % to about 30 % by weight, about 40 % to about 50 % by weight or about 60 % to about 90 % by weight of the composition. In an embodiment, the composition includes Rubia cordifolia (Manjishtha) in an amount of about 10 %, about 20 %, about 30 %, about 40 %, about 50 %, about 60 %, about 70 %, about 80 or about 90 % by weight of the composition.
[00037] In an embodiment, the composition includes Alum in an amount ranging from about 5% to about 85% by weight of the composition. In an embodiment, the composition includes Alum in an amount of about 5 % to about 15 % by weight, about 20 % to about 35 % by weight, about 40 % to about 55 % by weight or about 60 % to about 85 % by weight of the composition. In an embodiment, the composition includes Alum in an amount of about 5 %, about 10 %, about 15 %, about 20 %, about 25 %, about 30 %, about 35 %, about 40 %, about 45 %, about 50 %, about 55 %, about 60 %, about 65 %, about 70 %, about 75 or about 85 % by weight of the composition.
[00038] In an embodiment, Alum includes any or a combination of potassium aluminium sulphate, sodium aluminium sulphate and ammonium aluminium sulphate. In an embodiment, Alum is in a form of bhasma.
[00039] In an embodiment, the composition includes Saltpeter (Kalmi shora) in an amount ranging from about 5% to about 85% by weight of the composition. In an embodiment, the composition includes Saltpeter (Kalmi shora) in an amount of about 5 % to about 15 % by weight, about 20 % to about 35 % by weight, about 40 % to about 55 % by weight or about 60 % to about 85 % by weight of the composition. In an embodiment, the composition includes Saltpeter (Kalmi shora) in an amount of about 5 %, about 10 %, about 15 %, about 20 %, about 25 %, about 30 %, about 35 %, about 40 %, about 45 %, about 50 %, about 55 %, about 60 %, about 65 %, about 70 %, about 75 or about 85 % by weight of the composition.
[00040] In an embodiment, the composition includes Rubia cordifolia (Manjishtha) in an amount of about 30% by weight of the composition; Alum in an amount of about 30% by weight of the composition; Saltpeter (Kalmi shora) in an amount of about 30% by weight of the composition; and the rest being at least one pharmaceutically acceptable excipient(s).
[00041] In an embodiment, the composition includes Rubia cordifolia (Manjishtha) in an amount of about 20% by weight of the composition; Alum in an amount of about 10% by weight of the composition; Saltpeter (Kalmi shora) in an amount of about 5% by weight of the composition; and the rest being at least one pharmaceutically acceptable excipient(s).
[00042] In an embodiment, the composition is formulated in any of a solid dosage form, a liquid dosage form and a semi-solid dosage form. In an embodiment, the composition is formulated as any of an oral dosage form or a topical dosage form.
[00043] In an embodiment, the composition exhibits any or a combination of preventive and ameliorative effect against any or a combination of moles and haemorrhoids.
[00044] Another aspect of the present disclosure relates to a method for preparation of a herbal composition including Rubia cordifolia (Manjishtha), Alum, and Saltpeter (Kalmi shora). In another embodiment, the method of preparation of the herbal composition includes the steps of: (i) taking a therapeutically effective amount of each of Rubia cordifolia (Manjishtha) uniformly with bhasma of alum and saltpeter and (ii) mixing the mixture obtained from step (i), optionally, with at least one pharmaceutically acceptable excipients(s) to prepare a herbal composition that exhibits any or a combination of preventive and ameliorative effect against any or a combination of moles and haemorrhoids.
[00045] The present invention also provides a method of prevention, management or treatment of moles and haemorrhoids utilizing the herbal composition of the present invention, wherein the herbal composition includes a therapeutically effective amount of Rubia cordifolia (Manjishtha), a therapeutically effective amount of Alum, and a therapeutically effective amount of Saltpeter (Kalmi shora) and optionally at least one pharmaceutically acceptable excipients(s).
[00046] In an embodiment, the herbal composition of the present invention is useful in the treatment of any or a combination of moles and haemorrhoids.
[00047] In an embodiment, the herbal composition of the present invention can be useful in the treatment of ano-rectal diseases, including haemorrhoids, anal fissures, fistula etc. In an embodiment, the present invention provides a herbal composition for the treatment of internal haemorrhoids.
[00048] The herbal composition detailed herein can be manufactured in any of the dosage forms as known to a person skilled in the art. In an embodiment, the dosage form is selected from any or a combination of tablets, including suspension tablets, chewable tablets, effervescent tablets or caplets; pills; powders such as a sterile packaged powder, a dispensable powder, and an effervescent powder; capsules including both soft or hard gelatin capsules such as HPMC capsules, lozenges, a sachet, a sprinkle, a reconstitutable powder or shake, a troche, pellets such as sublingual or buccal pellets, granules, liquids for oral or parenteral administration, suspensions, emulsions, semisolids, or gels. In an embodiment, the dosage form can be selected from any or a combination of ointments, creams, mouthwash, skin patches, toothpaste, gels, and lotions. However, any or a combination of dosage form(s), as known to or appreciated by a person skilled in the art, can be utilized to serve its intended purpose, as laid in the present disclosure, without departing from the scope and spirit of the present invention.
[00049] In an embodiment, the herbal composition is formulated in a solid oral dosage form.
[00050] In an embodiment, the herbal composition includes therapeutically effective amount of extract of Rubia cordifolia (Manjishtha), a therapeutically effective amount of Alum, a therapeutically effective amount of Saltpeter (Kalmi shora) and optionally at least one pharmaceutically acceptable excipients(s).
[00051] In an embodiment, the herbal composition includes extract of Rubia cordifolia (Manjishtha) in an amount ranging from about 10% to about 90% by weight of the composition. In an embodiment, the extract of Rubia cordifolia (Manjishtha) can be prepared from the roots or leaves or whole parts of the plant.
[00052] The extract of the herbal composition of the present invention is obtained by any extraction techniques as known to or appreciated by a person skilled in the art, for example utilization of soxhlate apparatus or by simple maceration. Any extraction techniques can be utilized to serve its intended purpose as laid down in the present invention without departing from the scope and spirit of the present invention.
[00053] The powder of the herbs of the present invention is obtained by any techniques as known to or appreciated by a person skilled in the art, for example by subjecting the plant part to the drying process followed by size reduction thereof. Preferably, the one or more plant parts can be subjected to drying such that the active ingredients thereof are not lost during the drying process, for example, the plant parts can be dried in shade, avoiding exposure to direct sun light and the likes. The dried plant part can then be subjected to size reduction as to prepare the powder thereof. However, a person skilled in the art would appreciate that any other method can be used to effect conversion of desired plant part(s) to the powdered form thereof without departing from the scope and spirit of the present disclosure.
[00054] The composition(s) of the present disclosure can be formulated into a solid oral dosage form following the formulation techniques as known to or appreciated by a person skilled in the pertinent art. In a preferred embodiment, the composition can be formulated into a tablet using one or more conventional pharmaceutically acceptable excipients, as known to or appreciated by a person skilled in the pertinent art without departing from the scope and spirit of the present disclosure. Alternatively, the powdered plant parts or the extracts thereof can be enclosed in a soft or hard capsule. However, a person skilled in the art would appreciated that the composition of the present disclosure can be any formulated into any other formulation using the conventionally known excipients and by following any of the conventional techniques without departing from the scope and spirit of the present disclosure.
[00055] In an embodiment, herbal composition includes Alum in the form of bhasma. In an embodiment, the bhasma of alum is prepared by heating the alum in a pan, till moisture is completely removed. The powder is collected at the end and used for the preparation of herbal composition.
[00056] The present invention may be more fully understood by reference to the following example. The following examples illustrate the methods and embodiments in accordance with the invention. The examples provided below are merely illustrative and are not to be taken as limitations upon the scope of the invention. Various changes and modifications to the disclosed embodiments will be apparent to those skilled in the art. Such changes and modifications may be made without departing from the scope of the invention.
EXAMPLE
[00057] Example 1:
Ingredients Amount (g)
Rubia cordifolia (Manjishtha) 34
Bhasma of Alum 33
Saltpeter (Kalmi shora) 33

[00058] Extract of the herb was taken and uniformly mixed with bhasma of alum and Saltpeter (Kalmi shora) in amount as defined hereinabove in example 1 to prepare the 100 grams of the composition.
[00059] Evaluation of herbal composition (example 1) for its ability to treat haemorrhoid
[00060] The herbal composition prepared in example 1 was evaluated for its ability to treat haemorrhoid. The Patients and/or subjects suffering from unmanageable hemorrhoids with age group ranging from about 30 years to 40 years were treated with 5g/day herbal composition, as prepared in Example 1, for a period of 15 days (Table 1 and Table 2).

[00061] Table 1 illustrates the effect of the herbal composition (prepared in example 1) on size of the haemorrhoid
Sr. No. Dosage
(per day) Size of the haemorrhoid (in mm)
0 day 3 day 5 day 10 day 15 days
Subject 1 5g 10 7 5 3 1
Subject 2 5 g 15 10 8 7 3
Subject 3 5 g 14 9 8 5 2
Subject 4 5 g 12 8 7 4 2

[00062] Table 2 illustrates the effect of the herbal composition (prepared in example 1) on volume of blood oozing out from the anus
Sr. No. Dosage
(per day) Volume of blood (in ml)
0 day 3 day 5 day 10 day 15 days
Subject 1 5g 10±1 5±1 2±1 0 0
Subject 2 5 g 9±1 7±1 4±1 ~1 0
Subject 3 5 g 7±1 5±1 2±1 0 0
Subject 4 5 g 8±1 4±1 2±1 ~1 0

[00063] Table 1 and Table 2 clearly indicate that the herbal composition of the present invention can effect significant reduction in haemorrhoid size as well as volume of the blood that oozes out from the anus.
[00064] 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 practiced with modification within the spirit and scope of the embodiments as described herein.

ADVANTAGES OF THE INVENTION
[00065] The present invention provides a herbal composition that finds utility in treatment of moles and haemorrhoids.
[00066] The present invention provides a herbal composition for the treatment of moles and haemorrhoids that is substantially devoid of any side effects.
[00067] The present invention provides a herbal composition for the treatment of moles and haemorrhoids that is easy to prepare.
[00068] The present invention provides a herbal composition for the treatment of moles and haemorrhoids that is cost effective.

Claims:
1. A herbal composition comprising:
a therapeutically effective amount of Rubia cordifolia (Manjishtha);
a therapeutically effective amount of Alum;
a therapeutically effective amount of Saltpeter (Kalmi shora); and
optionally at least one pharmaceutically acceptable excipient(s).
2. The herbal composition as claimed in claim 1, wherein the composition comprises Rubia cordifolia (Manjishtha) in an amount ranging from about 10% to about 90% by weight of the composition.
3. The herbal composition as claimed in claim 1, wherein the composition comprises Alum in an amount ranging from about 5% to about 85% by weight of the composition, and wherein Alum comprises any or a combination of potassium aluminium sulphate, sodium aluminium sulphate and ammonium aluminium sulphate.
4. The herbal composition as claimed in claim 1, wherein Alum is in a form of bhasma.
5. The herbal composition as claimed in claim 1, wherein the composition comprises Saltpeter (Kalmi shora) in an amount ranging from about 5% to about 85% by weight of the composition.
6. The herbal composition as claimed in claim 1, wherein the composition comprises
Rubia cordifolia (Manjishtha) in an amount of about 30% by weight of the composition;
Alum in an amount of about 30% by weight of the composition;
Saltpeter (Kalmi shora) in an amount of about 30% by weight of the composition; and
the rest being at least one pharmaceutically acceptable excipient(s).
7. The herbal composition as claimed in claim 1, wherein the composition comprises Rubia cordifolia (Manjishtha) in an amount of about 20% by weight of the composition;
Alum in an amount of about 10% by weight of the composition;
Saltpeter (Kalmi shora) in an amount of about 5% by weight of the composition; and
the rest being at least one pharmaceutically acceptable excipient(s).
8. The herbal composition as claimed in any of the claims 1 through 8, wherein said composition is formulated in any of a solid dosage form, a liquid dosage form and a semi-solid dosage form.
9. The herbal composition as claimed in any one of the claims 1 through 8, wherein the composition is formulated as any of an oral dosage form or a topical dosage form.
10. The herbal composition as claimed in any of the claims 1 through 9, wherein the composition exhibits any or a combination of preventive and ameliorative effect against any or a combination of moles and haemorrhoids.