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Title:
CARDIAC AND ANTILIPIDIMIC BEVERAGE AND METHOD THEREOF
Document Type and Number:
WIPO Patent Application WO/2018/142419
Kind Code:
A1
Abstract:
The present invention discloses a cardiac and antilipidimic beverage. The same is prepared by boiling a mixture of water and milk with herbal mixture or by addition of extract of herbal mixture to the mixture of water and milk. The herbal mixture consists of a synergistic combination of 13 specific herbs- Five herbs viz. Terminalia arjuna, Inula racemose, Boerhavia diffusa, Cinnamomum zeylanicum and Foeniculum vulgare are essential herbs with therapeutic benefits and remaining eight viz. Glycyrrhiza glabra, Cinnamomum tamala, Elettaria cardamomum, Amomum subulatum, Alpinia galanga, Ocimum sanctum, Cyperus scariosus and Rosa centifolia impart color, taste and fragrance to the beverage so that it closely resembles 'Indian tea'. The beverage when consumed regularly for 3-6 months, in optimal quantity of 2-2.5 grams of herbal mixture or 200-250 mg of extract of herbal mixture, twice a day offers therapeutic benefits of controlling enhanced plasma lipid levels and clearing clogged arteries.

Inventors:
MALHOTRA MOHIT (IN)
MALHOTRA RUPIKA (IN)
Application Number:
PCT/IN2018/050042
Publication Date:
August 09, 2018
Filing Date:
January 27, 2018
Export Citation:
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Assignee:
MALHOTRA MOHIT (IN)
International Classes:
A61K36/00; A23L33/105; A61K36/18
Domestic Patent References:
WO2012094636A22012-07-12
Foreign References:
IN2719DEL2013A
Other References:
S C JOSHI ET AL.: "A review on hypolipidaemic and antioxidant potential of some medicinal plants", WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES, vol. 3, 20 October 2014 (2014-10-20)
RNS YADAV ET AL.: "Phytochemical analysis of some medicinal plants", JOURNAL OF PHYTOLOGY, vol. 3, 2011, pages 10 - 14, XP055530275
SANJUKTA KUNDU ET AL.: "Health benefits of various Indian culinary herbs and comparative statistical analysis for organoleptic properties of Indian teas by using analysis of variance", INTERNATIONAL JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES, vol. 6, no. 4, 1 April 2014 (2014-04-01), pages 621 - 625, XP055530284
Attorney, Agent or Firm:
KOMPAL BANSAL (IN)
Download PDF:
Claims:
I claim

1. A cardiac and anti-lipidimic beverage WHEREIN the said beverage consists of a mixture of water and milk to which a powdered mixture of herbs is added and boiled and WHEREIN the powdered mixture of herbs consists of specific herbs combined in optimal quantities as given in Table below:

2. A cardiac and anti-lipidimic beverage WHEREIN the said beverage consists of a mixture of water and milk to which an extract of mixture of herbs is added and WHEREIN the extract is prepared from a mixture of herbs consisting of specific herbs combined in optimal quantities as given in Table below:

S.No. Latin name Part used Optimal %

1 Terminalia arjuna Bark 22.5%

2 Inula racemosa Root 10% 3 Boerhavia diffusa Root 20%

4 Cinnamomum zeylanicum Bark 5%

5 Foeniculum vulgare Fruit 20%

6 Glycyrrhiza Glabra Root 5%

7 Cinnamomum tamala Leaves 2.5%

8 Elettaria cardamomum Fruit 3.75%

9 Amomum subulatum Fruit 1.25%

10 Alpinia galanga Wild Linn Root 2.5%

11 Ocimum sanctum Leaves 2.5%

12 Cyperus scariosus Dried rhizomes 2.5%

13 Rosa centifolia Petals 2.5%

3. A method to prepare the extract of mixture of herbs as claimed in claim 2 WHEREIN the method comprises of the following steps:

i. Extraction with water- Taking the specific powdered mixture of herbs as given in Table as claimed in Claim 2 and boiling the mixture with water in optimal ratio of 1 :5 parts (w/v) for 5 hours

ii. Filtration: The mixture is filtered to separate the powder.

iii. Drying- The extract obtained is dried under vacuum to obtain aqueous extract powder (Extract A).

iv. Extraction with alcohol- Thereafter, the remaining powder (which is the leftover after aqueous extraction) is extracted with ethanol.

v. Filtration- The extract is filtered to remove the powdered herbs.

vi. Drying- The alcoholic extract is then dried to give alcoholic extract powder (Extract B).

vii. Combining aqueous and alcoholic extracts- Both the extracts viz. Extract A (aqueous extract) and Extract B (alcoholic extract) are then combined in equal ratios to give the unique extract of present invention. A method to prepare a cardiac and anti-lipidemic beverage using the mixture of herbs as claimed in claim 1 WHEREIN the method comprises of the following steps:

i. Preparing a mixture of water and milk: 2 parts of water are added to 1 part of milk e.g. 200 ml of water is added to 100 ml milk.

ii. Addition of herbal mixture to mixture of water and milk: Herbal mixture is added to the water-milk mixture at an optimal concentration of 0.6 to 0.8% e.g. 2- 2.5 grams in a cup of 300 ml water-milk mixture.

iii. Boiling- The mixture is boiled for about 10 minutes, so that both water soluble and fat soluble ingredients of the herbs get extracted into the beverage and the beverage attains a color, texture and flavor which closely resembles the typical light brown color of 'Indian tea' or 'masala chai'.

A method to prepare a cardiac and anti-lipidemic beverage using extract of the herbal mixture as claimed in claim 2 WHEREIN the method comprises of the following steps: i) Preparing a mixture of water and milk: Water and milk are mixed in appropriate ratio e.g. 200 ml water and 100 ml milk and mixture kept cold or at room temperature or heated as per desire of consumer to make cold, warm or hot beverage.

ii) Addition of extract of herbal mixture to water and milk mixture: Extract of herbal mixture is added to the water-milk mixture at a concentration of 0.06-0.08% e.g. 200-250 mg in a cup of 300 ml water-milk mixture and stirred to dissolve the extract and result in formation of beverage.

Description:
CARDIAC AND ANTILIPIDIMIC BEVERAGE AND METHOD THEREOF FIELD OF INVENTION

The invention generally relates to the field of therapeutic beverages and natural products. More specifically it relates to a cardiac and antilipidimic beverage and method thereof.

BACKGROUND OF THE INVENTION

Modern lifestyle associated with stress, lack of exercise and high intake of junk food has led to an increase in cardiac diseases and people suffering from enhanced lipid levels. Blocked arteries need cardiac bypass or open heart surgery. This has serious health and economic implications for healthcare systems worldwide, especially developing countries where trained cardiac surgeons and advanced surgical facilities may be lacking. Cardiovascular disease is the leading cause of death among high-income countries and is projected to be the leading cause of death worldwide by 2030 (Ref: Kreatsoulas C, Anand SS. The impact of social determinants on cardiovascular disease. The Canadian Journal of Cardiology. 2010; 26 (Suppl.) p.8-13; weblink- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2949987/)

The present invention provides a very simple and economic solution to the problem of cardiac diseases and enhanced lipid levels. It consists of a synergistic combination of specific herbs. The beverage of the invention is very easily prepared by boiling a powdered mixture consisting of a synergistic combination of specific herbs in water, adding milk to extract the lipid soluble ingredients and then drinking the beverage on regular basis for few weeks to clear clogged arteries in a natural and effective manner and also bring down lipid levels to normal.

The beverage when boiled in water followed by addition of milk gives a flavor, texture and color which very closely resembles that of common "Indian Tea" (also called 'masala chai') which is peculiar to India in the sense that milk is added to beverage to give a light brown colored beverage which is happily consumed by large sections of population throughout India. Since the beverage of present invention resembles Indian Tea (though it is actually not Tea at all!), its acceptance and compliance amongst consumers is high, since they do not get a feeling that they are taking any medicine, but are only drinking beverage. Tea is made from the dried leaves of Camellia sinensis whereas the present herbal mixture does not contain the leaves of Camellia at all. Terms and Definitions as used in the context of present invention

Herbs: Any plant or plant derived part used for food, flavoring, medicine or fragrance.

Cardiac disorders: Cardiovascular disease (CVD) is a class of disease that involve the heart or blood vessels. It includes coronary artery diseases (CAD) in which the coronary arteries which supply blood to the heart, get blocked and lead to heart attack.

Anti-lipidimic: Any substance which is used to bring to normal elevated blood lipids, such as cholesterol, triglycerides, and phospholipids, in patients.

Problems in the existing approaches for treating cardiovascular disease or enhanced lipid levels:

Existing approaches include surgical intervention (cardiac bypass surgery) or use of medicines. Surgical approaches are costly and required advanced medical facilities and trained surgeons, which may not be available at grass-root level, in developing countries. Drugs may be herbal or synthetic. Synthetic drugs e.g. Statins are associated with undesirable side effects. Doctors often prescribe statins for people with high cholesterol to lower their total cholesterol and reduce their risk of a heart attack or stroke. While statins are highly effective, they have been linked to muscle pain, digestive problems and mental fuzziness in some people and may rarely cause liver damage. Statins include atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Altoprev), pitavastatin (Livalo), pravastatin (Pravachol), rosuvastatin (Crestor) and simvastatin (Zocor). (Reft http://www.mayoclinic.org/diseases-conditions/high-blood-cho lesterol/in-deptW

effects/art-20046013).

Use of herbal drugs in treatment of cardiovascular disease has been reviewed by Mashour et al. (1998). However, many of the herbal remedies used have not undergone careful scientific assessment, and some have the potential to cause serious toxic effects and major drug-to-drug interactions. Continuing research is necessary to elucidate the pharmacological activities of the many herbal remedies now being used to treat cardiovascular diseases. (Reft http://jamanetwork.eom/journals/jamainternalmedicine/fullart icle/210378).

In contrast, the beverage of the present invention consists of herbs which fall in the GRAS category (Generally Regarded as Safe). Secondly, the efficacy of the beverage has been evaluated by the inventors, who are themselves practicing clinicians in the field of natural Indian system of medicine (Ayurveda). No untoward effect was observed in any of the patients over a period of nearly three years and the acceptance of the beverage and dosage compliance was very good. More than 200 patients consumed the beverage, with excellent therapeutic benefits and without any undesirable side-effects.

Introduction to the present invention

The present invention discloses a cardiac antilipidimic beverage made up of a synergistic combination of 13 specific herbs. 5 herbs viz. Terminalia arjuna, Inula racemose, Boerhavia diffusa, Cinnamomum zeylanicum and Foeniculum vulgare are the essential herbs with therapeutic benefits and the remaining 8 viz. Glycyrrhiza glabra, Cinnamomum tamala, Elettaria cardamomum, Amomum subulatum, Alpinia galanga, Ocimum sanctum, Cyperus scariosus and Rosa centifolia are those imparting color, taste and fragrance to the beverage so that it closely resembles 'Indian tea'. The beverage has water soluble and lipid soluble components. It offers therapeutic benefits of controlling enhanced plasma lipid levels and clearing clogged arteries when consumed on regular basis, 2-3 cups/day for about 2-3 months. Prior art is reviewed below:

PRIOR ART

US 20140295049 Al discloses herbal compositions comprising at least one Urtica species, one Artemisia species and one Morus species and extract thereof also it discloses a beverage bag, made from said fruits, herbs, medicinal plants, beverage, vegetable and/or spices. CN 103099896 B discloses pharmaceutical formulations of herbal Tea by using following components viz. Chrysanthemum, Mespilus germanica, Salvia divinorum, worm back) for the treatment of cardiovascular diseases.

The ingredients disclosed in the above two patents are entirely different from the ingredients of the present invention viz. Terminalia arjuna, Inula racemose, Boerhavia diffusa, Cinnamomum zeylanicum, Foeniculum vulgare, Glycyrrhiza Glabra, Cinnamomum tamala, Elettaria cardamomum, Amomum subulatum, Alpinia galanga, Ocimum sanctum, Cyperus scariosus and Rosa centifolia.

No such beverage consisting of a synergistic combination of specific herbs, having color, texture and flavor resembling 'Indian Tea' and having therapeutic benefits of lipid control and cardiac benefits, has been disclosed in prior art, as revealed by search of Indian and International patent databases.

Publications relating to anti-lipidimic effects of herbs are available but do not disclose the specific beverage of present invention which is free from side effects, efficacious, easy to take and also has well-defined dosage and composition. Some of the prior art publications are as below:

1. Rajesh Asija (2014): Anti-hyperlipidemic activity of various herbal plants and various experimental animal models. Vol. 2, 20.

2. Hojjat Rouhi-Boroujeni et al (2015): Herbs with anti-lipid effects and their interactions with statins as a chemical anti- hyperlipidemia group drugs. Jul; 11(4): 244—251.

3. Kanakavalli K et al (2014). Anti-hyperlipidemic herbs in siddha system of medicine. Vol.

4, No. 3: 541-545

None of the above articles anticipates the beverage of present invention and there is no disclosure of any beverage with dual therapeutic benefits of clearing clogged arteries and also lowering enhanced lipid levels in humans. OBJECTS OF THE PRESENT INVENTION

The primary object of the present invention is to disclose a cardiac and antilipidimic beverage consisting of synergistic combination of 5 essential herbs with therapeutic benefits viz. Terminalia arjuna, Inula racemose, Boerhavia diffusa, Cinnamomum zeylanicum, Foeniculum vulgare and 8 herbs to give flavor, texture and color to the beverage so that it resembles tea viz. Glycyrrhiza Glabra, Cinnamomum tamala, Elettaria cardamomum, Amomum subulatum, Alpinia galanga, Ocimum sanctum, Cyperus scariosus and Rosa centifolia..

One more object is to disclose the specific ratios in which the herbs are present.

A further object is to disclose the mode of production of the beverage viz. the specific parts, ratios and the method of mixing. Another object is to disclose the method of use for the treatment of cardiovascular disorders, heart diseases and hyperlipidemia. SUMMARY OF THE INVENTION

The present invention discloses a cardiac and antilipidimic beverage. The same is prepared by boiling a mixture of water and milk with herbal mixture or by addition of extract of herbal mixture to the mixture of water and milk. The herbal mixture consists of a synergistic combination of 13 specific herbs- Five herbs viz. Terminalia arjuna, Inula racemose, Boerhavia diffusa, Cinnamomum zeylanicum and Foeniculum vulgare are essential herbs with therapeutic benefits and remaining eight viz. Glycyrrhiza glabra, Cinnamomum tamala, Elettaria cardamomum, Amomum subulatum, Alpinia galanga, Ocimum sanctum, Cyperus scariosus and Rosa centifolia impart color, taste and fragrance to the beverage so that it closely resembles 'Indian tea'. The beverage when consumed regularly for 3-6 months, in optimal quantity of 2-2.5 grams of herbal mixture or 200-250 mg of extract of herbal mixture, twice a day offers therapeutic benefits of controlling enhanced plasma lipid levels and clearing clogged arteries.

DETAILED DESCRIPTION OF THE INVENTION

The present invention discloses a herbal beverage which provides a very simple and economic solution to the problem of cardiac diseases and enhanced lipid levels. Drinking the beverage on regular basis for few weeks helps to clear clogged arteries in a natural and effective manner and also brings down lipid levels to normal. The beverage is very easily prepared by boiling a powdered mixture consisting of a synergistic combination of specific herbs in water, adding milk to extract the lipid soluble ingredients and then drinking the beverage on regular basis.

The composition of the powdered mixture of herbs used to prepare the beverage is given in Table 1 below:

Table 1: Composition of the powdered mixture of herbs used to prepare the beverage

S.No. Common Latin name Part Optimal %

Name used

1 Arjuna Terminalia arjuna Bark 22.5%

2 Pushkarmool Inula racemosa Root 10%

3 Punarnava Boerhavia diffusa Root 20%

4 Dalchini Cinnamomum zeylanicum Bark 5%

5 Saunf Foeniculum vulgare Fruit 20% 6 Mulethi Glycyrrhiza Glabra Root 5%

7 Tejpatra Cinnamomum tamala Leaves 2.5%

8 Choti elaichi Elettaria cardamomum Fruit 3.75%

9 Badi Elaichi Amomum subulatum Fruit 1.25%

10 Kulanjan Alpinia galanga Wild Linn Root 2.5%

11 Tulsi Ocimum sanctum Leaves 2.5%

12 Nagarmotha Cyperus scariosus Dried 2.5%

rhizomes

13 Gulab Rosa centifolia Petals 2.5%

Properties of the herbs used are as below:

1. Terminalia arjuna: The bark of the tree appears to have medicinal properties, mostly touted to be a cardio-protective agent. It has been used in Ayurveda under the names of Arjuna, Dhavala, Kakubha, Kumbuk, Nadisarja, Veeravriksha, Partha, and Indradru. Usually l-3g of the bark is used per day.

(Reference https://examine.com/supplements/terminalia-arjuna/)

2. Inula racemose: One of the most common uses of this herb is in treating blood sugar metabolism in diabetics. Other uses include the treatment of asthma, bronchitis, cough, heart disease and general cardiovascular health.

(Reference: http://easyayurveda.com/2013/09/18/pushkarmool-inula-racemos a-benefits- usage-dose-side-effects/)

3. Boerhavia diffusa: used for its anti-diabetic, anti-oxidant properties and diuretic properties.

(Reference: https://examine.com/supplements/boerhaavia-diffusa/)

4. Cinnamomum zeylanicum: used for joint pain, heart palpitations, and dysmenorrhea.

(Reference: http://www. herbco. com/t-Medicinal- Uses-of- Cinnamon, aspx )

5. Foeniculum vulgare: positive influence on the digestive system, improves lactation, relaxes muscle spasms and reduces inflammation. It has carminative, expectorant and aromatic properties. (Reference: http://www.alwaysayurveda.com/foeniculum-vulgare/)

6. Glycyrrhiza Glabra: The root known as licorice, has anti-inflammatory properties, helps calm hepatitis-associated liver inflammation and other benefits. (Reference:http://www .livestrong.com/article/447197-what-are-the-health-benefits- of- glycyrrhiza- glabra/)

7. Cinnamomum tamala: used to treat stomach-ache and treatment of colic and diarrhea.

(Reference: http: //tropical, theferns. info/viewtropical.php ?id= Cinnamomum+ tamala ) 8. Elettaria cardamomum: used as a flavoring agent in food preparations, confectioneries and cosmetics, cardamom is used both in ancient and modem medicines.

(Reference:https://www.researchgate.net/publication/26730714 5_Medicinal _properties_ of_Elettaria_cardamomum )

9. Amomum subulatum: It has antihypertensive effect and other beneficial effects on digestive and respiratory systems.

(Reference: http://eijppr.com/api/uploads/2014/January/article/215%20201 3%20Manu- 25.pdf)

10. Alpinia galangal: It has antifungal activity and antiulcer activity. (Reference: https://www. drugs, com/npp/ galangal. html)

11. Ocimum sanctum: The Ocimum sanctum L. has been suggested to possess antifertihty, anticancer, antidiabetic, antifungal, antimicrobial and hepatoprotective activity. (Reference: https://www.ncbi.nlm.nih.gov/pubmed/16170979)

12. Cyperus scariosus: improves lactation, relieves fever, burning sensation, excessive thirst.

Commonly known as nut grass, it is also used in treating diarrhea, dyspepsia, herpes and more. (Reference: http://easyayurveda.com/2015/01/07/musta-cyperus-rotundus-us es- research-side-effects/)

13. Rosa centifolia: Rose petal beverage is efficient in cleansing the gall bladder and liver, and it helps improve bile secretion. Rose petals are dried and crushed to make beverage. (Reference: http: //www. diethealthclub. com/health-food/rose-health-benefits. html ) Method of preparation of beverage herbal mixture

This involves taking respective dried parts of the herbs in % (w/w) as given in Table 1 above and grinding them together, followed by filtering through mesh 8 to get a granular mixture of uniform texture. Method of preparation of beverage herbal mixture extract

This involves the following steps: i. Extraction with water- Taking the specific powdered mixture of herbs as given in Table 1 and boiling the mixture with water in optimal ratio of 1 :5 parts (w/v) for 5 hours

ii. Filtration: The mixture is filtered using muslin cloth to separate the powder. Cloth is folded in 2-3 layers to ensure efficiency and quick filtration.

iii. Drying- The extract obtained is dried under vacuum to obtain aqueous extract powder (Extract A).

iv. Extraction with alcohol- Thereafter, the remaining powder (which is the leftover after aqueous extraction) is extracted with ethanol in optimal ratio of 1:2, 3 times. v. Filtration- The extract is filtered to remove the powdered herbs.

vi. Drying- The alcoholic extract is then dried under vacuum to give alcoholic extract powder (Extract B).

vii. Combining aqueous and alcoholic extracts- Both the extracts viz. Extract A (aqueous extract) and Extract B (alcoholic extract) are then combined in equal ratios as the yield are approximately equal, to give the unique extract of present invention.

Method of preparation of beverage using herbal mixture

This involves the following steps: i. Preparing a mixture of water and milk: 2 parts of water are added to 1 part of milk e.g. 200 ml of water is added to 100 ml milk.

ii. Addition of herbal mixture to mixture of water and milk: Herbal mixture is added to the water-milk mixture at an optimal concentration of 0.6 to 0.8% (e.g. 2-2.5 grams in a cup of 300 ml water-milk mixture).

iii. Boiling- The mixture is boiled for about 10 minutes, so that both water soluble and fat soluble ingredients of the herbs get extracted into the beverage and the beverage attains a color, texture and flavor which closely resembles the typical light brown color of 'Indian tea' or 'masala chai'. Method of preparation of beverage using extract of the herbal mixture

Instead of using the herbal mixture as such, water and alcoholic extract powder can be used. It is more convenient to use, since boiling is not required. The method of preparation of beverage using extract of herbal mixture involves the following steps: i. Preparing a mixture of water and milk: Water and milk are mixed in appropriate ratio e.g. e.g. 200 ml water and 100 ml milk and mixture kept cold or at room temperature or heated as per desire of consumer to make cold, warm or hot beverage.

ii. Addition of extract of herbal mixture to water and milk mixture: Extract of herbal mixture is added to the water-milk mixture at a concentration of 0.06-0.08% e.g. 200-250 mg in a cup of 300 ml water-milk mixture and stirred to dissolve the extract and result in formation of beverage.

Powdered extract can be added to water-milk mixture directly to give refreshing beverage. Since there is no need for boiling to extract the useful phytochemicals, the preparation of beverage is quick and easy, as the powdered extract is simply added to hot or cold water or water and milk mixture as per taste. Optimum dose is very less- about 200 to 250 mg per cup which contains about 200 to 300 ml of water and milk mixture.

Owing to very less quantity of the extract of herbal mixture needed i.e. just 200-250 mg, small sachets or tablets can be prepared, to regulate the therapeutically effective dosage in an easy and convenient manner. However, there is no harm if a user makes 'strong beverage' by adding more quantity of extract, as per taste.

Optimal quantities for therapeutic benefits

Powdered herbal mixture- The optimal quantity of powdered mixture was about 2-2.5 grams in 200 ml (1 teacup of water-milk-sugar mixture) consumed twice a day after meals, just like one takes tea or coffee after meals.

Extract of powdered herbal mixture- The optimal quantity of powdered mixture was about 200 -250 mg in 300 ml (1 teacup of water-milk-sugar mixture) consumed twice a day after meals, just like one takes tea or coffee after meals. Use of extract offered the benefit of quick and easy preparation of the beverage, since no boiling was required at all and beverage could be prepared instantly.

Clinical Data

The herbal mixture (consumed either in raw mixture form or extract form) was particularly beneficial for cardiac patients (heart patients) and hyperlipidemic patients when taken continuously for 3-6 months at optimal dosage viz. 2-2.5 grams twice a day of the herbal mixture or 200-250 mg twice a day of the extract of herbal mixture. No undesirable effects were observed. Further in case of patients suffering from high lipid levels, regular consumption of the beverage of present invention for 3-6 months led to lipid levels coming within normal limits, eliminating the need for prolonged medication or lifelong medication.