COMPLETE DESCRIPTION
FIELD OF THE INVENTION
The present invention relates to a novel synergistic herbal composition for the treatment of Human beings to ease constipation, add bulk to stool, corrects bowel movement and maintains intestinal bacterial flora. The present invention includes herbs Plantago ovata, Foeniculum vulgare, Glycyrrhiza glabra, Emblica officinalis, Rosa sps. Terminalia sps. and non-herbal sweetener having prebiotic property.
BACKGROUND OF THE INVENTION
Constipation also known as costiveness, dyschezia, and dyssynergic defaecation is a symptom of infrequent hard to pass bowel movements. Defecation may be painful, and in severe cases (fecal impaction) may lead to symptoms of bowel obstruction.
Constipation is caused by a number of factors including Irritable Bowel Syndrome (IBS), lack of dietary fiber, inadequate water intake, eating disorders, some medications, psychiatric disorders, haemorrhoids, hormonal disturbances, diseases of the colon such as bowel cancer and other factors.
Laxatives are the most commonly used medicines to help relieve constipation. There are several types of laxatives available on the market: bulk- forming laxatives such as bran and ispaghula husk; osmotic laxatives such as lactulose; and stimulant laxatives like senna. The mechanisms of action of all the above laxatives are different in treating constipation. Each of these laxatives has certain side effects and may even sometimes worsen the constipation and after prolonged use effects peristalsis, thus causes disturb muscle contraction throughout the digestive tract.
Bulk-forming laxatives on their own cannot be used for the longer treatment as they does not produce the stimulating effect on the bowel. For the
desired effect, the daily intake amount is to be increased frequently and subsequently becomes a routine habit or such laxatives termed as habit-forming laxative. Because of that bulk- forming laxatives can cause wind and swelling in the abdomen. They can also block up the bowel.
Osmotic laxatives work by drawing more water into the bowel. The over usage of the osmotic laxative can cause the water imbalance as well as ionic imbalance in the body that can leads to various side effects like Cramps, muscle fatigue etc.
Stimulant laxatives are usually comprised of herbal ingredients such as senna, aloe, cascara or other laxative plants which work by speeding up bowel movement. Senna is most widely used laxative herb and has become a primary ingredient in the wide range of laxative medicines available on the market.
Major problem with senna laxative is that if used in high doses or for prolonged periods of time, it can reduce the level of colonic potassium ions (K+) in the colonic mucus which results in electrolyte disturbances and fluid imbalances. This is one of the primary factors leading to 'lazy-bowel syndrome' - a dependency on laxatives to have any bowel movements as the muscles of the stomach and intestines gradually lose the ability to contract without being stimulated by the laxative. Considerable potassium depletion can be very dangerous for those with heart rhythm irregularities. The issue of nutrients depletion and bowel dependency becomes even more serious when it comes to administration of senna by children. This assumes that senna is safe and poses no health risk to those aged 10 to 18. The truth is that taking senna at this age may course far more serious health damage than in adult because till the age of 21 our body is still growing and developing. Depletion of essential nutrients and vitamins (e.g.-potassium) caused by senna herb at the early age may result in irreversible dysfunction of the intestinal tract.
Other disadvantage of senna laxatives is that they contain none or little amount of natural fiber and moisture therefore they do not add sufficient
amount of bulk and water to the stool. As a result, the laxative properties of senna medicines are limited only by stimulation action of sennosides and that leads to negative side-effects such as stomach cramps, wind, diarrhoea and other adverse reactions.
Some of the senna laxatives available today have been improved by adding active ingredients that are very high in fiber content such as 'bran'.
Bran is the hard outer layer of cereal grains. Although raw bran is very rich is dietary fiber and contains some vitamins, it is quite unpalatable. It doesn't provide the other nutrients found in fiber-rich foods such as wholemeal bread, wholegrain cereals, dried fruits, etc. Moreover, bran can reduce your body's ability to absorb calcium, magnesium, iron and zinc. Phytate (phytic acid) found in cereal fiber (bran) also binds with calcium, iron and zinc making them indigestible, which in turn causes malabsorption. Bran has also been shown to cause faecal losses of calcium, iron, zinc, phosphorus, nitrogen, fats, fatty acids and sterols, thus depleting the body of these materials.
Thus, despite being rich source of dietary fiber, both bran and husk are not entirely safe as laxative because of potential health risk and adverse side-effects. Generally, its administration must be limited to a certain period of time and treatment for children and elderly people should be supervised by health specialist.
The formulations which are available in the dosage form of capsules or tablets are ineffective in producing the desired therapeutic effects due to their very small contents. Furthermore, if the size of the dosage form is increased to increase the contents, the risk of chocking emerges.
The regular use of the laxatives is also been forbidden by the unpalatable taste of the currently available laxatives in the market, especially in children. As a result of all these problems, there remains a strong need for a safer laxative that is free from all the above mentioned problems.
BRIEF SUMMARY
The present invention encompasses a synergistic herbal combination, comprising of seven ingredients that together act for the treatment of human beings to ease constipation, add bulk to stool, corrects bowel movement and maintains intestinal bacterial flora. The seven ingredients are commercially available for the health benefits for the last several years, but they never been used in combination with each other in such a way where the combination comprising Plantago ovata, Foeniculum vulgare, Glycyrrhiza glabra, Emblica officinalis, Rosa centifolia, Terminalia chebula as laxative and cooling from plant origin and a non-herbal sweetener having prebiotic property which improves gut health. The formulation is proportionate blend of bulk laxative, Osmotic laxative, cooling agents and prebiotic, which synergistically cures constipation and improves gut health without depletion of vital nutrients. It is considered that one may use commercially herbal produces th e presently disclosed synergistic herbal combination.
OBJECTIVES OF THE INVENTION
The objective of the invention is to treat constipation and improves gut health with no side effects.
Yet another objective of the invention is to provide a palatable novel herbal composition to treat constipation and maintaining intestinal bacterial flora. Yet another objective is to provide a formulation which is safer in children. Another objective of the present invention is to provide a non-habit forming formulation to treat constipation and maintaining intestinal bacterial flora. Another objective of the present invention is to provide the diabetic patients, a sugar-free formulation to treat constipation and maintaining intestinal bacterial flora.
DETAILED DESCRIPTION
The detailed description set forth below is intended as a description of the presently preferred embodiment of the invention, and is not intended to represent the only form in which the present invention may be constructed or utilized. The description sets forth the functions and sequences of steps for constructing and operating the invention. It is to be understood, however, that the same or equivalent functions and sequences may be accomplished by different embodiments and that they are also intended to be encompassed within the scope of the invention.
Although true psyllium comes from the plant Plantago psyllium, the husk and seed of Plantago ovata (Plantaginaceae) is commonly referred to as psyllium. Psyllium is widely used as a fiber supplement for the treatment of constipation. Psyllium husk is obtained by milling the seed of P. ovata to remove the husk. In some studies the seed has been used instead of the husk, and is also commercially available.
Active Constituents Psyllium husk contains a high proportion of hemicellulose, composed of a xylan backbone linked with arabinose, rhamnose, and galacturonic acid units (arabinoxylans). The seed consists of 35-percent soluble and 65-percent insoluble polysaccharides (cellulose, hemicellulose, and lignin). Psyllium is classified as a mucilaginous fiber due to its powerful ability to form a gel in water. This ability comes from its role as the endosperm of the P. ovata seed, where it functions to retain water in order to prevent the seed from drying out.
The effectiveness of fiber and psyllium in particular, on constipation depends on the main cause of the constipation. In a study of 149 patients with chronic constipation, the consumption of 15-30 grams daily of a psyllium seed preparation provided bowel relief in 85 percent of participants who had no known pathological cause for their constipation. Only 20 percent of individuals with slow transit responded to psyllium. A slightly greater percentage (37%) of those with disorders of defecation - including
rectocele, internal prolapse, anismus, and rectal hyposensitivity found improvement.
Fennel, classified as Foeniculum vulgare (Umbelliferae), is popular as an alternative to standard Western allopathic medicine for a variety of problems, including digestion, over-weight, boosting metabolism as well as for stomach cramps.
Glycyrrhiza glabra (Leguminosae) is used as mild laxative and antacid properties. It has a well-documented reputation for healing ulcers. It can lower stomach acid levels, relieve heartburn and indigestion and acts as a mild laxative. It can also be used for irritation, inflammation and spasm in the digestive tract. Through its beneficial action on the liver, it increases bile flow and lowers cholesterol levels.
Emblica officinalis (Euphorbiaceae), Amla, or holy mother earth, is the most important Rasayana in Ayurveda, most likely because of its high Vit.C content. It is known to defeat all illnesses. Cooling, nourishing, protecting and harmonizing, amla is rightly called the queen of medicinal plants and antioxidants.
The Rosa centifolia (Rosaceae), adds cooling and mild laxative effect. It is regarded as a mild sedative and anti-depressant. It is increasingly used in treatments for conditions of stress: nervous tension, peptic ulcers, heart disease, among others. There is indication that rose essence may also positively influence digestion, bile secretion, womb disorders and circulation.
Terminalia Chebula (Combretaceae) is called the "king of medicines" in Tibet and is always listed first in the Ayurvedic meteria medica because of its extraordinary powers of healing. In Ayurveda it is considered to destroy all diseases and eliminate all waste from the body. At the same time, it is known to promote tissue growth and health.
Terminalia Chebula is used to treat digestive diseases, urinary diseases, diabetes, skin diseases, parasitic infections, heart diseases, irregular fevers, flatulence, constipation, ulcers, vomiting, colic pain and hemorrhoids. If taken after meals it prevents imbalance of any of the humors due to bad food or drink. It promotes wisdom, intellect and eyesight. The ingredients used in the invention are all of Indian origin (indigenous), and the therapeutic properties or Ayurvedic karmas are mentioned in Ayurvedic texts like Charak Samhita, Bhavprakash Nighantu, Dravyagunvigyan etc.
The present invention can be formulated, but not limited to, in the following manners. Example 1
a) The plant parts of all the components were obtained from their respective natural sources.
b) The plants parts are crushed to obtain a fine powder.
c) The quantities of the components are taken as under-
(Table Removed )
d) The quantities taken in step (c) were mixed.
e) 12.6 gm of lactitol monohydrate was taken and mixed with the composition
obtained in (d)
f) 4.5 mg of pan masala flavor was taken to the combination obtained in (e).
Example 2
a) The plant parts of all the components were obtained from their respective natural sources.
b) The plants parts are crushed to obtain a fine powder.
c) The quantities of the components are taken as under-

(Table Removed )

d) The quantities taken in step (c) were mixed.
e) 22.2 gm of lactitol monohydrate was taken and mixed with the composition obtained in (d)
f) 3 mg of pan masala flavor was taken to the combination obtained in
(e).
Example 3
a) The plant parts of all the components were obtained from their respective natural sources.
b) The plants parts are crushed to obtain a fine powder.
c) The quantities of the components are taken as under-
(Table Removed )

d) The quantities taken in step (c) were mixed.
e) 27.6 gm of lactitol monohydrate was taken and mixed with the composition obtained in (d)
f) 4 mg of pan masala flavor was taken to the combination obtained in (e).
Example 4
a) The plant parts of all the components were obtained from their respective natural sources.
b) The plants parts are crushed to obtain a fine powder.
c) The quantities of the components are taken as under-
(Table Removed )
d) The quantities taken in step (c) were mixed.
e) 35 gm of lactitol monohydrate was taken and mixed with the composition obtained in (d)
f) 5 mg of pan masala flavor was taken to the combination obtained in (e).

CLAIMS
1) A herbal laxative preparation comprising husk of Plantago ovata, fruit of Foeniculum vulgare, Root of Glycyrrhiza glabra, Fruit of Emblica officinalis, Flower petals of Rosa centifolia, Fruit of Terminalia chebula and added excipients.
2) The herbs as claimed in 1, wherein Plantago ovata is 15-30%w/w, fruit of Foeniculum vulgare is 7.5-15%w/w, Root of Glycyrrhiza glabra is 8-12%w/w, Fruit of Emblica officinalis is 4-12%w/w, Flower petals of Rosa centifolia is 7.5-15%w/w, and Fruit of Terminalia chebula is 7.5-15% w/w.
3) The herbs as claimed in 2, wherein the preferable percentage of Plantago ovata is 20%w/w, fruit of Foeniculum vulgare is 10%w/w, Root of Glycyrrhiza glabra is 10%w/w, Fruit of Emblica officinalis is 12%w/w, Flower petals of Rosa centifolia is 12%w/w, and Fruit of Terminalia chebula is 12% w/w.
4) The excipients claimed in claim 1 may be sweetener and flavoring agent.
5) The sweetener as claimed in 4 may be lactitol monohydrate, comprising 20% relative to the herbal contents.
6) The flavoring agent as claimed in 4 may be Pan Masala flavor having the concentration 1.8%.
7) A process for preparing herbal composition claimed in 1 having laxative, antacid, stool softening and mild purgative properties the said process comprising the steps of: (a) obtaining plant parts of Plantago ovata,Foeniculum vulgare,Emblica officinalis,Glycyrrhiza glabra, Terminalia chebula and Rosa centifolia (b) crushing the plant parts and mixing them to obtain a powdered mixture; (c) adding sweetening agent to the powdered mixture of step (b); (d)adding lubricating agent to the powdered mixture of step (c); (e) adding flavoring agent to the powdered mixture of step (d) to prepare herbal laxative powder.