Field of the Invention

The present invention relates to a novel herbal composition remedy for weight loss comprising tinctures and/or diluted extracts. More particularly, there is provided a composition which contains a synergistic combination of extracts from different species of Cinnamon species, Foeniculum vulgare and other species of fennel, Zingiber officinale and other species of ginger, Solanum lycopersicum and other species of Tomato, Momordica charantia and any other species of Karela/ bitter gourd. The present invention relates to plant based nutraceutical formulations to tackle health with respect to weight related ailments. The nutraceuticals are non-toxic, natural herbal plant products, easy to digest.

Background of the invention

The nutraceutical food or parts of food may provide medical health benefits including the prevention and or treatment of diseases. Nutraceuticals, are foods or bioactive ingredients in foods that protect or promote health whether delivered in raw agricultural commodities, processed foods, dietary supplements, extracts, beverages or other products and occurs at the intersection of food and pharmaceutical industries.

The word Nutraceuticals combine ‘nutrition’ and ‘pharmaceuticals’ to mean that they can be used as food supplements. The entire concept is based on the disease preventing/treating phytonutrients present in foodstuffs of the diet in combating diseases.

Obesity is a complex disease involving an excessive amount of body fat. Obesity is not just a cosmetic concern. It's a medical problem that increases the risk of other diseases and health problems, such as heart disease, diabetes, high blood pressure, metabolic disorders and certain cancers.

Obesity is a condition in which excess body fat has accumulated to such an extent that it may have a negative effect on health. People are classified as obese when their body mass index (BMI) — a measurement obtained by dividing a person's weight by the square of the person's height (despite known allometric inaccuracies) — is over 30 kg/m; the range 25-30 kg/m is defined as overweight. Some East Asian countries use lower values to calculate obesity.

More than 1 billion people worldwide are obese - 650 million adults, 340 million adolescents and 39 million children. This number is still increasing. WHO estimates that by 2025, approximately 167 million people - adults and children - will become less healthy because they are overweight or obese- WHO. Common Side Effects of Weight Loss Drugs are increased blood pressure and heart rate, insomnia, nervousness, restlessness, dependence, abuse or withdrawal may occur with long-term use.

Herbal medicine, also called botanical medicine or phytomedicine, refers to using a plant's seeds, berries, roots, leaves, bark, or flowers for medicinal purposes. Herbalism has a long tradition of use outside conventional medicine. Herbal medicines are generally considered to be safe and effective agents. Therefore, people more and more turn to herbal medicine.

The first written record of medicinal plants was created on clay tablets over 5000 years ago by the Sumerians, in ancient Mesopotamia (Iraq). Around 1500 BCE the Ancient Egyptians wrote the Ebers Papyrus which listed over 850 herbal medicines. This compilation includes many herbs that we recognize and use today.

Ayurveda is a medical system primarily practiced in India that has been known for nearly 5000 years. Plants and their secondary metabolite constituents have a long history of use in modem ‘western’ medicine and in certain systems of traditional medicine, and are the sources of important drugs such as atropine, codeine, digoxin, morphine, quinine and vincristine.

The medicines are prepared as per the standard prescribed in the official Pharmacopeia’s. Pharmacopoeia is the book of standard, contains authoritative information on drugs and preparations, their description, formulation, analytic composition, physical constants, main chemical properties used in identification, standards for strength, purity and dosage, chemical tests for determining identity and purity etc. Pharmacopeias are usually published by the governmental or government agencies. They differ from formularies, which contain list of drugs or collections of formulas for the compounding of medicinal preparations. However, sometimes the terms "pharmacopoeia" and "formulary" are used interchangeably.

Phytochemicals are natural chemicals produced by plants. They have different biological activities like anti-oxidants, anti-inflammatories and so on. Consumption of vegetables has been linked to a reduction in the risk of many diseases, such as cancer and cardiovascular diseases.

Medicinal plant refers to a plant comprising active ingredients or secondary metabolites that possess biological activity. A whole plant may be medicinally active or plant parts.

Herbal medicine are medicinal preparations comprising active ingredients obtained from the herbal plant. The product can be made from the whole plant or any part. Preparations from by-product herbal plants such as oils, gums, and other secretions are also considered as herbal medicine.

W02006020091 discloses a method for promoting weight loss and/or lowering blood glucose comprises and active material which may be cinnamon, an extract of cinnamon, or a derivative of a cinnamon extract. The active material may be utilized in combination with further active ingredients.

W02006034463 discloses herbal supplement to support weight loss. Herein herbal and chemical combinations for promoting weight loss are disclosed. The herbs in the composition can include, among others, green tea, ginger, cocoa, and yerba mate. Other chemicals in the composition can include, among others, caffeine and a pharmaceutically acceptable salt of calcium.

IN202221027442 relates to an ayurvedic and herbal dietary supplement, composition, nutraceutical, pharmaceutical and system for inducing or treating biological and life-style diseases (Diabetes, Blood Pressure and Cholesterol) and responses or conditions which utilize ultra-low dosage amounts of proteins, vitamins, minerals, amino acids, co-enzymes, stimulants, and/or similar ingredients in a highly bio-active delivery system with extended release. The said composition comprising of the following combination of ingredients: tulsi, withania Somnifera, guggul, garlic, Sepentina, ginger, holy basil, pantothenic acid, grape seed extract, momordica charantia, and garcinia indica.

There is an unmet need for alternative herbal supplements that promote weight loss and increase energy. The present invention relates to a new herbal composition prepared by using dilute concentrations and/or extracts of substances that modify the frequency of the diluent and produce a corresponding response in the human or animal.

In consideration of the need as indicated above, the inventors of the present invention have done extensive research and conducted several experiments to develop a novel synergistic composition of herbal extracts with lesser associated side effects thereby rendering the composition according to the present invention as an easy-to-use composition with optimum oral effects. Further, being devoid of lesser associated side effects, the composition of the present invention has more patient compliance even if it has repeated continuous long term usage.

SUMMARY OF THE INVENTION

According to an aspect of the present invention there is provided a combination of herbal extracts comprising Cinnamon verum, Foeniculum vulgare, Zingiber officinale, Solanum lycopersicum and Momordica charantia.

According to an aspect of the present invention there is provided a herbal composition comprising: i. herbal extracts comprising Cinnamon species- (Cinnamomum verum), Foeniculum vulgare, Zingiberofficinale, Solanum lycopersicum and Momordica charantia; and ii. pharmaceutically acceptable vehicle or carrier medium to form an oral composition.

DETAILED DESCRIPTION OF THE INVENTION

Those skilled in the art will be aware that the present invention is subject to variations and modifications other than those specifically described. It is to be understood that the present invention includes all such variations and modifications. The disclosure also includes all such steps, features, compositions and compounds referred to or indicated in this specification, individually or collectively, and any and all combinations of any or more of such steps or features.

The articles “a”, “an” and “the” are used to refer to one or to more than one (i.e., to at least one) of the grammatical object of the article.

The terms “comprise” and “comprising” are used in the inclusive, open sense, meaning that additional elements may be included. It is not intended to be construed as “consists of only”.

Throughout this specification, unless the context requires otherwise the word “comprise”, and variations such as “comprises” and “comprising”, will be understood to imply the inclusion of a stated element or step or group of element or steps but not the exclusion of any other element or steps. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood to one of ordinary skill in the art to which this disclosure belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of the disclosure, the preferred methods, and materials are now described. All publications mentioned herein are incorporated herein by reference.

The formulation, composition, or substance of this invention may be prepared in a number of ways, including as a bar with taste enhancers, dry powder, as a capsule, as a ready to drink juice or as a food additive. Alternatively, the formulation may also be brewed, fermented, boiled to create a compote, prepared as an alcohol or water extract.

According to one exemplary embodiment the enhancers and preservatives added are of natural origin.

According to one exemplary embodiment, the powders or extracts or concentrates of extracts or pulps are combined using equal amounts from each herb or plant.

Alternative embodiments, utilize various quantities of each powder or extracts or concentrates of extracts or pulps. According to one exemplary embodiment, the quantity of one powder or extracts or concentrates of extracts or pulps may be substantially greater than the quantity of another powder. The amount of each powdered plant or extracts or concentrates of extracts or pulps used to create the final composition may be tailored specifically for a particular use. For example, for a high content of a specific anti-oxidant or vitamin, more of one plant may be used than another.

It will be appreciated by those skilled in the art that while the herbal oral composition has been described in detail herein, the invention is not necessarily so limited and other examples, embodiments, uses, modifications, and departures from the embodiments, examples, uses, and modifications may be made without departing from the process and all such embodiments are intended to be within the scope and spirit of the appended claims.

The formulation disclosed herein provides several benefits. Coconut sugar is beneficial because it has a very low glycemic index, but provides good flavor. The same is true for cocoa powder, which has no sugar included and provides beneficial antioxidants.

In another embodiment, other flavors and natural preservatives can are envisioned. It can be incorporated in cocoa or soft shelled crispy wafers. It can be made savory or sweet. The wafer, preferably is in the form of a shell which can be stacked one over the other so as to be easily accommodated in suitably packaging. In an embodiment of the present invention the composition of herbal extracts are mixed in the following ratio: Cinnamon: Fennel: Ginger: Tomato: Bitter gourd at 1 :1 :1 :1 :1 ; 1 :2:1 :2:2 ;1 :2:1 :2:1 ; or 1 :2:1 :2:2. Preferably at ratio of 1 :1 :1 :1 :1 .

Each active is present in about 50 to 100 g.

For the extraction. Following steps are followed: Collected plant materials is washed with tap water to remove soil debris and then with distilled water. Drying is done at room temperature and material is grinded to make coarse or fine powder as per requirement and ease. Water is used for extraction. Heat is provided externally on controlled temperature,

In one aspect, the invention provides a herbal oral composition having weight loss properties, comprising:

(i) tinctures and/or herbal and/or Ayurveda plant extract composition preparations of herbal extracts comprising but not limited to Cinnamon species (Cinnamomum verum), Foeniculum vulgare and other species of fennel, Zingiber officinale and other species of ginger, Solanum lycopersicum and other species of Tomato, Momordica charantia and any other species of Karela or bitter gourd;

(ii) pharmaceutically acceptable vehicle or carrier medium to form an oral composition (iii) Natural preservatives and/or naturals carriers in the form of oats rice flakes, or seeds can be added to the formulation

In another aspect, the herbal composition comprises:

(i) tinctures/extracts/elutes and/or preparations of herbal extracts comprising of but not limited to Cinnamon species, Foeniculum vulgare and other species of fennel, Zingiber officinale and other species of ginger, Solanum lycopersicum and other species of Tomato, Momordica charantia and any other species of bitter gourd

(ii) pharmaceutically acceptable vehicle or carrier medium to form a oral formulation selected from menthol, glycerin, water or mixtures thereof.

In another aspect, the present invention provides a method of preparation of the herbal oral composition; comprising the steps of:

(i) water is used as a solvent

(ii) All plant materials are measured to 50 gm individually. Water is added to the apparatus and heat is provided

(iii) Heat is provided till the bubbles start appearing. The composition is allowed to reach room temperature before filtration. (iv) Elute is filtered. All elutes are then mixed in set proportions and natural preservatives are added. The resultant elute is dried and powdered.

(v) Filtration is done after cooling. Example 1 :

In another aspect, the present invention provides a method of preparation of the herbal oral composition; comprising the steps of:

(i) water is used as a solvent (ii) All plant materials are measured to individually as per specific measurements. Water is added to the apparatus and heat is provided (iii) Heat is provided till the bubbles start appearing. The composition is allowed to reach room temperature before filtration.

(iv) Elute is filtered, dried and powdered. All elutes are then mixed in set proportions and natural preservatives are added.

(v) Filtration is done after cooling.

Example 2:

In another aspect, the present invention provides a method of preparation of the herbal oral composition; comprising the steps of:

(i) water is used as a solvent

(ii) All plant materials are measured to individually as per specific measurements. Water is added to the apparatus and heat is provided

(iii) Heat is provided till the bubbles start appearing. The composition is allowed to reach room temperature before filtration. (iv) Elute is filtered, dried and powdered. All elutes are then mixed in set proportions and natural preservatives are added.

(v) Filtration is done after cooling. Example 3:

In another aspect, the present invention provides a method of preparation of the herbal oral composition; comprising the steps of:

(i) water is used as a solvent (ii) All plant materials are measured to individually as per specific measurements. Water is added to the apparatus and heat is provided

(iii) Heat is provided till the bubbles start appearing. The composition is allowed to reach room temperature before filtration.

(iv) Elute is filtered, dried and powdered. All elutes are then mixed in set proportions and natural preservatives are added. (V) Filtration is done after cooling.

Example 4:

Example 5:

The method is similar to example 3. The dried and powdered elute is mixed with oats or rice flakes, and put in suitable rectangular mould to provide bar composition of the present invention. Example 6: Weight loss Bar composition of the present invention for oral consumption:

The method is similar to example 3. The dried and powdered elute is mixed with Coconut sugar or cocoa powder and put in suitable rectangular mould to provide bar composition of the present invention.

Example 7 Once combined, the final composition may be packaged and sold as a powder. The composition may then be reconstituted with water or blended with foods and thereby be ingested for medicinal, preventive, nutritional, or otherwise health related purposes. Alternatively the composition may be encapsulated. The composition in capsule may then be swallowed, or broken open to be used as the powder described above. Finally, the composition can be formed into a solid pill. The solid pill can be dissolved in water for intake, crushed into a powder as described above, or it can be swallowed.

Weight loss study data:

This foregoing example disclose the composition and method of the present invention to promote/initiate weight loss in human subjects. In this study the exemplary composition of the present invention (in the form of a ‘bar’) was given to seven human subjects for a period of 7 days. Weights of the subject were recorded before and after 7 days of intake of the weight loss composition of the present invention (one bar per day). Weight of the subjects prior to initiation of the trail was considered as ‘baseline.’

Weights of the subjects before and after the 7-day period were measured and data are shown in table-1 below. [Table 1] work out means cardio workout on treadmill for 30 minutes

Conclusion: As indicated above five of the subjects with once a day intake of the composition with ‘no work’ out lost between 0.6 to 2.7 kg in 7 days. Subjects with once a day intake of the composition with thrice a week workout lost between 0.7 to 0.8 kg in 7 days.

It was observed that the weight loss composition of the present invention yielded good results in subject with no work out. Without wishing to be bound by any theory, the unique composition of the present invention helps curb satiety and hunger pangs. At the same time provides energy so that subject does not feel drained or fatigue. Subject No. 8 and 9 as shown below consumed the weight loss composition of the present invention for 30 days with ‘thrice a week work out’ and ‘no work out’ respectively. Table 2: Details as follows:

The subjects under this category (table 2) weighing more than 100 kg demonstrated appreciable weight loss, with and without work out.

With daily intake of the weight loss composition of present invention changes, diet and workout for 30 days, an appreciable change was seen at weight loss of about 8.35 kg.

Subject no 9 with no work out lost around 5.2 kg of weight in 30 days.

Moderately obese and obese who are at threat of various diseases and need to lose weight but cannot control their eating habits are benefitted by composition of the present invention as its fibre load makes subject feel full, cocoa takes care of taste buds. The composition of the present invention with combination of cocoa, coffee and herbs gives holistic approach at feeling full and losing weight due to hunger management control. It can be seen that while there was weight loss seen in 7 days’ time, the results were better at one-month’s daily intake of the weight loss composition of present invention.

With the existing weight of the given subject as baseline value, significant weight loss was achieved in weight loss composition of the present invention.

The weight loss composition of the present invention was well received by the subjects and found to be acceptable.

Therefore, the inventors have successfully developed herbal composition that is successfully able to initiate weight loss in subjects and tackle weight-related ailments.

The actives of herbal composition of the present invention exhibits synergistic activity which works on satiety, acidity regulation and metabolism boosting.

It is to be understood that the present invention is susceptible to modifications, changes and adaptations by those skilled in the art. Such modifications, changes, adaptations are intended to be within the scope of the present invention.

It should be understood that these are for illustration purposes only and should not be taken as limiting the scope of the subject technology.