Synergistic herbal compositions for immune boosting and respiratory health

1 . An herbal composition for stimulating an immune response in a patient in need thereof, comprising:

10% to 90% by weight of a first ingredient comprising a Terminalia chebula extract containing a metal salt, a metal complex, or a metal chelate of a phytochemical selected from the group consisting of chebulagic acid, chebulinic acid, gallic acid, and a mixture thereof; and

10% to 90% by weight of a second ingredient comprising an extract of an herb selected from the group consisting of Withania somnifera, Tinospora cordifolia, Andrographis paniculata , and mixtures thereof;

wherein percentages of the first ingredient and the second ingredient are based on the combined weight of the first ingredient and the second ingredient; and

wherein the first ingredient and the second ingredient act synergistically in the patient to cause at least one of the following:

an increase in IL-2 production;

a decrease in IL-6 production;

an increase in interferon-γ production;

an increase in lymphocyte proliferation;

an increase in immune cell populations; and

an increase in IgG production.

2 . The herbal composition as claimed in claim 1 , wherein the Terminalia chebula extract contains:

the metal salt, wherein the metal salt is a salt of zinc, magnesium, calcium, or potassium;

the metal complex, wherein the metal complex is a complex of zinc, magnesium, calcium, or potassium; or

the metal chelate, wherein the metal chelate is a chelate of zinc, magnesium, calcium, or potassium.

3 . The herbal composition as claimed in claim 1 , wherein the herbal composition comprises 33% to 75% by weight of the first ingredient and 25% to 67% by weight of the second ingredient, based on the combined weight of the first ingredient and the second ingredient.

4 . The herbal composition as claimed in claim 1 , wherein the first ingredient comprises:

1.0% to 40% by weight of chebulagic acid;

1.0% to 30% by weight of chebulinic acid;

1.0% to 10% by weight of gallic acid; and

0.5-5.0% by weight of a metal ion present in the metal salt, the metal complex, or the metal chelate;

based on the weight of the first ingredient.

5 . The herbal composition as claimed in claim 1 , wherein the second ingredient comprises an extract of Withania somnifera , and

the extract of Withania somnifera comprises 0.01% to 10% by weight of total withanolides, 0.01% to 5% of 8-hydroxytinosporide, and 1.00% to 40% by weight of andrographolides.

6 . The herbal composition as claimed in claim 1 , wherein the first ingredient and the second ingredient are obtained from a plant part selected from the group consisting of a leaf, a stem, a twig, aerial parts, a whole fruit, a fruit peel rind, a seed, a flower head, a root, a bark, hardwood, a rhizome, a whole plant, and a mixture thereof.

7 . The herbal composition as claimed in claim 6 , wherein the first ingredient and the second ingredient are obtained from the plant part by extraction with a solvent selected from the group consisting of C1-C5 alcohols, ketones, chlorinated solvents, water, C1-C7 hydrocarbons, esters, and a mixture thereof.

8 . The herbal composition as claimed in claim 6 , wherein the first ingredient and the second ingredient are obtained from the plant part by extraction with a solvent selected from the group consisting of ethanol, methanol, n-propanol, isopropyl alcohol, acetone, methylisobutyl ketone, methylene dichloride, chloroform, water, hexane; ethyl acetate, and mixtures thereof.

9 . The herbal composition as claimed in claim 1 , further comprising a pharmaceutically, nutraceutically, or dietically acceptable excipient, carrier, or diluent.

10 . The herbal composition as claimed in claim 9 , wherein the excipient, carrier, or diluent is selected from the group consisting of monosaccharides, disaccharides, polycarbohydrates, dextrins, polyhydric alcohols, sugar alcohols, cellulose derivatives, silicates, metallic stearates, organic acids, fatty acid esters, esters of polysorbate, natural gums, B group vitamins, nicotinamide, calcium pantothenate, amino acids, proteins, organic metal salts, natural pigments, flavors, class I & class II preservatives, and a mixture thereof.

11 . The herbal composition as claimed in claim 9 , wherein the excipient, carrier, or diluent is selected from the group consisting of glucose, dextrose, fructose, galactose, sucrose, maltose, lactose, lactulose, trehalose, cellobiose, chitobiose, starch, modified starch, sodium starch glycolate, pre-gelatinized starch, soluble starch, yellow dextrin, white dextrin, maltodextrin, sorbitol, mannitol, inositol, xylitol, isomalt, microcrystalline cellulose, hydroxypropyl methyl cellulose, hydroxyethyl cellulose, veegum, talc, colloidal silicon dioxide, calcium stearate, magnesium stearate, zinc stearate, citric acid, tartaric acid, malic acid, succinic acid, lactic acid, L-ascorbic acid, fatty acid esters, polysorbate esters, acacia gum, carrageenan gum, guar gum, xanthan gum, nicotinamide, calcium pantothenate, amino acids, casein, gelatin, pectin, agar, sodium chloride, calcium chloride, dicalcium phosphate, zinc sulphate, zinc chloride, natural pigments, flavors, class I & class II preservatives, aqueous, alcoholic, hydro-alcoholic, or organic solutions thereof; and mixtures thereof.

12 . The herbal composition as claimed in claim 1 , wherein the herbal composition is formulated into a dosage form selected from the group consisting of a dry powder form, a liquid form, a beverage, a food product, a dietary supplement, a tablet, a capsule, a soft chewable tablet, and a gummy bear.

13 . The herbal composition as claimed in claim 1 , wherein the herbal composition is formulated into a tablet comprising a controlled release coating.

14 . A process for preparing the herbal composition according to claim 1 , wherein the process comprises the following steps of;

(i) extracting dried Terminalia chebula fruit powder with a solvent to obtain a solution;

(ii) treating the solution with a compound of zinc, magnesium, calcium, or potassium;

(iii) filtering the solution;

(iv) evaporating the solution and drying the residue to obtain the first ingredient;

(v) blending the first ingredient with the second ingredient; and

(vi) drying the product of step (v) under vacuum to get the herbal composition.

15 . The process as claimed in claim 14 , wherein the solvent is selected from the group consisting of C1-C5 alcohols, water, and a mixture thereof.

16 . The process as claimed in claim 14 , wherein the compound of zinc, magnesium, calcium, or potassium is selected from the group consisting of zinc oxide, zinc carbonate, zinc hydroxide, magnesium oxide, magnesium carbonate, magnesium hydroxide, calcium hydroxide, calcium carbonate, potassium hydroxide, and potassium carbonate.

17 . A method of stimulating an immune response in a patient in need thereof, wherein the method comprises administering the herbal composition of claim 1 to the patient.

18 . A method of stimulating an immune response in a patient in need thereof, wherein the method comprises administering the herbal composition of claim 1 to the patient, wherein stimulating an immune response comprises at least one of:

eliciting an immune response in the patient;

improving innate immunity in the patient;

improving adaptive immunity in the patient;

improving cellular immunity in the patient;

improving humoral immunity in the patient;

improving protection from airway inflammation in the patient;

improving protection from microbial infection in the patient;

treating viral respiratory infections in the patient; and

improving respiratory health in the patient.

19 . An herbal composition comprising:

33% to 75% by weight of a first ingredient comprising a reaction product of:

a Terminalia chebula extract comprising a phytochemical selected from the group consisting of chebulagic acid, chebulinic acid, gallic acid, and a mixture thereof; and

a compound of a metal selected from the group consisting of zinc, magnesium, calcium, and potassium;

wherein the reaction product comprises a salt, complex, or chelate of the phytochemical and the metal; and

25% to 67% by weight of a second ingredient comprising an extract of an herb selected from the group consisting of Withania somnifera, Tinospora cordifolia and Andrographis paniculata,

wherein percentages of the first ingredient and the second ingredient are based on the combined weight of the first ingredient and the second ingredient; and

wherein the first ingredient and the second ingredient act synergistically in a patient in need thereof to cause at least one of the following:

an increase in IL-2 production;

a decrease in IL-6 production;

an increase in interferon-γ production;

an increase in lymphocyte proliferation;

an increase in immune cell populations; and

an increase in IgG production.

20 . The herbal composition as claimed in claim 19 , wherein:

the reaction product has a solubility of 1 gram in 10 to 20 mL water; and

a 1% solution of the reaction product in water has a pH of 5.5 to 5.9.