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CARDIO CALM DROPS

MONOGRAPH CARDIO CALM DROPS

NPN: 80056684

1 mL of Oral Tincture contains:

Hawthorn (317.7 mg DHE* – Crataegus laevigata fruit),
Skullcap (43.1 mg DHE* – Scutellaria lateriflora aerial parts),
Indian Sarsaparilla (38.6 mg DHE* – Hemidesmus indicus
root),
Peppermint (35.2 mg DHE* – Mentha x piperita leaf),
Hawthorn (31.8 mg DHE* – Crataegus laevigata flower/leaf),
European Mistletoe (31.8 mg DHE* – Viscum album leaf),
Cayenne (2.0 mg DHE* – Capsicum annuum fruit).

Non- medicinal ingredients: purified water, ethanol USP,
glycerin, spearmint flavour.

*DHE = Dry Herb Equivalent.

Directions of Use: Adults, take 1-3 ml, 3 times daily. Use for
at least 2 months to see beneficial results.

Indication: Used in Herbal Medicine to help maintain
cardiovascular health in adults.

Detailed Information: Cardio Calm Drops is an hydroethanolic extract of seven (7) herb ingredients, mainly hawthorn fruit, with hawthorn leaf & flower contributing additively to the recommended use of the product to maintain cardiovascular health in adults. The lesser amounts of skullcap, Indian sarsaparilla, peppermint, European mistletoe, and cayenne provide supportive and complementary effects when Cardio Calm Drops is taken as recommended.

Hawthorn preparations have long been considered among the most valuable tonic remedies for the cardiovascular system(1) .They are used Traditionally to strengthen and invigorate the heart and circulatory function(2), based on their mildly sedative, analgesic, antispasmodic, antiarrhythmic, diuretic, hypotensive, hypothermic, vasodilatory, and cardiotonic actions(3). Hawthorn has been indicated for the the refractory period(8) .Randomized, placebo-controlled, double-blind clinical studies have demonstrated hawthorn fruit extracts to be effective in improving exercise tolerance and quality of life in patients with congestive heart failure (NYHA Stage II)(9). Hawthorn leaf & flower preparations have also been clinically shown to increase exercise capacity in patients with congestive heart failure (NYHA Stage II)(10) and with heart failure-related signs and symptoms(11), as well as to increase maximum workload and reduce blood pressure/heart rate product concomitant with improving dyspnea and fatigue(12), and to significantly reduce resting diastolic blood pressure and reduce anxiety(13). Hawthorn preparations are cost-effective alternatives/adjuncts to chemical-synthetic drugs for mild forms of arrhythmia and tachycardia, and for early treatment of cardiac insufficiency(14). On the basis of available evidence, there are no known risks associated with the long-term use of hawthorn(4,5).

Skullcap is Traditionally used in Herbal Medicine as a mild sedative and sleep aid(15) . It is among the best anxiolytic agents available to herbalists to help strengthen, support and calm the nervous system(16). One of its main active constituents, the flavone baicalein, has demonstrated cardioprotective effects in numerous in vitro and in vivo animal studies(17), supporting the Traditional use of skullcap also for functional cardiac disorders attributable to nervous causes, and that are associated with an intermittent pulse(18). It is considered to be one of the four main ingredients of Traditional herbal formulations for weakness of the heart(16). Clinical trials are lacking for Indian sarsaparilla root, but it has a long history of use in Ayurvedic Medicine as an alterative tonic and “blood purifier”(19). While having similar properties to American sarsaparilla (Smilax spp.), including as an anti- inflammatory, its higher content of coumarin may at least partially contribute to its broader use and its “blood purifying” properties.

Hawthorn has been indicated for the treatment of NYHA Stage I & II cardiac insufficiency, hypertonic heart, arrhythmia, cerebral insufficiency, mild hypertension, and for support of patients with a history of myocardial infarction(4). Hawthorn fruit when taken at a dry weight equivalent of 0.6-3.5 g/day, and dried hawthorn leaf & flower at a crude equivalent dosage of 0.5-5 g/day, is used in Herbal Medicine to help maintain and/or support cardiovascular health in adults(5). Hawthorn preparations have been shown to help dissolve deposits in thickened and sclerotic arteries(6). Results from preclinical trials have demonstrated hawthorn preparations to also have positive inotropic effects on human heart muscle, to reduce stimulus threshold, and to increase coronary vasodilation(7). Hawthorn leaf & flower preparations act on the heart by increasing the force of contraction and lengthening

the refractory period(8). Randomized, placebo-controlled, double-blind clinical studies have demonstrated hawthorn fruit extracts to be effective in improving exercise tolerance and quality of life in patients with congestive heart failure (NYHA Stage II)(9). Hawthorn leaf & flower preparations have also been clinically shown to increase exercise capacity in patients with congestive heart failure (NYHA Stage II)(10) and with heart failure-related signs and symptoms(11), as well as to increase maximum workload and reduce blood pressure/heart rate product concomitant with improving dyspnea and fatigue(12), and to significantly reduce resting diastolic blood pressure and reduce anxiety(13).
Hawthorn preparations are cost-effective alternatives/adjuncts to chemical-synthetic drugs for mild forms of arrhythmia and tachycardia, and for early treatment of cardiac insufficiency(14). On the basis of available evidence, there are no known risks associated with the long-term use of hawthorn(4,5).

Skullcap is Traditionally used in Herbal Medicine as a mild sedative and sleep aid(15). It is among the best anxiolytic agents available to herbalists to help strengthen, support and calm the nervous system(16). One of its main active constituents, the flavone baicalein, has demonstrated cardioprotective effects in numerous in vitro and in vivo animal studies(17), supporting the Traditional use of skullcap also for functional cardiac disorders attributable to nervous causes, and that are associated with an intermittent pulse(18). It is considered to be one of the four main ingredients of Traditional herbal formulations for weakness of the heart16. Clinical trials are lacking for Indian sarsaparilla root, but it has a long history of use in Ayurvedic Medicine as an alterative tonic and “blood purifier”(19). While having similar properties to American sarsaparilla (Smilax spp.), including as an anti- inflammatory, its higher content of coumarin may at least partially contribute to its broader use and its “blood purifying” properties.

Peppermint is well known for its use in the treatment of various digestive complaints(20), including to reduce the tone of the gastroesophageal sphincter(21), making it useful to help reduce or alleviate sympathetic spasms that can manifest as palpitations(1,3). Peppermint leaf, itself, is a common folk remedy for heart palpitations(22), circulatory problems, heart muscle weakness, and heart disturbances attributable to intestinal gas, dyspepsia and/or indigestion(3).

European mistletoe leaf preparations are used orally in Traditional Herbal Medicine as cardiotonic and cardioprotective agents with mild hypotensive action(23). They have been described as particularly helpful in the relief of subjective symptoms associated with cardiovascular
deficiencies, for which there is early clinical support(24).

Cayenne is well known for its stimulant and counterirritant effects and has long been recognised as one of the most powerful and persistent of cardio-stimulants known, with a primary influence on circulation(25), even when only very small amounts are consumed(26). It is used Traditionally in Herbal Medicine to help support peripheral circulation when taken at a dry weight equivalent dosage of 15-650 mg/day(27). It’s main active constituent, capsaicin, has also been shown to increase the permeability of epithelial cells of the gastrointestinal tract to ions and macromolecules(28), thereby facilitating the absorption of medicinal agents with which it is co-administered.

The specific combination of herbal extract ingredients making up the Cardio Calm Drops formulation is unique, and provides a safe, gentle and effective product for its licensed use as a Natural and Non-prescription Health Product to help maintain cardiovascular health in adults.

Cautions and Warnings: Consult a health care practitioner prior to use if you have heart disease, high blood pressure, high cholesterol, anemia, bleeding/clotting disorders, stomach ulcer or gallstones, or if you are taking other medications and/or supplements. Consult a health care
practitioner if symptoms persist or worsen.

Contra-Indications: Do not take if you are pregnant or breastfeeding. Consumption with alcohol, other drugs and/or natural health products with sedative properties is not recommended.

Known Adverse Reactions: Some people may experience drowsiness. Exercise caution if operating heavy machinery, driving a motor vehicle or involved in activities requiring mental alertness. Hypersensitivity/allergic reactions are known to occur; headaches, dizziness, and light-
headedness, and thirst may occur, in which case discontinue use.

1 Ellingwood F. The American Materia Medica, Therapeutics and Pharmacognosy. 11th Edition. Chicago, IL: Bennett Medical College; 1919.
2 Blumenthal et al. (eds.) The Complete German Commission E Monographs—Therapeutic Guide to Herbal Medicines. Austin, TX: American Botanical Council; 1998. 3 Mills & Bone. Principles and Practice of Phytotherapy: Modern Herbal Medicine. Edinburgh, UK: Churchill Livingstone; 2000; Bradley PR. (ed.). British Herbal Compendium, Vol. II. Bournemouth, UK: British Herbal Medical Association; 2006. 4 Upton & Petrone (eds.) Hawthorn Berry. Santa Cruz, CA: American Herbal Pharmacopoeia1; 1999a; Upton & Petrone (eds.) Hawthorn Leaf with Flower. Santa Cruz, CA: American Herbal Pharmacopoeia; 1999b. 5 Health Canada. Hawthorn-Crataegus laevigata monograph. July 2013. 6 Wegrowski et al. The effect of procyanidolic oligomers on the composition of normal and hypercholesterolemic rabbit aortas. Biochem. Pharmacol. 1984; 33(21): 3491-3497. 7 Ammon & Händel. Crataegus, toxicology and pharmacology. Part II: Pharmacodynamics. Planta Med. 1981; 43: 209-239. 8 Schwinger et al. Crataegus special extract WS 1442 increases force of contraction in human myocardium cAMP-independently. J. Cardiovasc. Pharmacol. 2000; 35(5): 700-707. 9 Rietbrock et al. [Efficacy of a standardized extract of fresh Crataegus berries on exercise tolerance and quality of life in patients with congestive heart failure (NYHA II)]. Arzneimittelforsch. 2001; 51(10): 793-798; Degenring et al. A randomised double-blind placebo controlled clinical trial of a standardised extract of fresh Crataegus berries (Crataegisan) in the treatment of patients with congestive heart failure NYHA II. Phytomed. 2003; 10(5): 363-369. Walker et al. 2002; 10 Zapfe G. Clinical efficacy of Crataegus extract WS1442 in congestive heart failure NYHA class II. Phytomedicine 2001; 8(4): 262-266. 11 Tauchert M. Efficacy and safety of Crataegus extract WS 1442 in comparison with placebo in patients with chronic stable New York Heart Association class-II heart failure. Am. Heart J. 2002; 143(5): 910-915. 12 Pittler et al. Hawthorn extract for treating chronic heart failure: meta-analysis of randomized trials. Am. J. Med. 2003; 114: 665-674. 13 Walker et al. Promising hypotensive effect of hawthorn extract: a randomized double-lind pilot study of mild, essential hypertension. Phytother. Res. 2002; 16(1): 48-54. 14 Habs M. Prospective, comparative cohort studies and their contribution to the benefit assessments of therapeutic options: heart failure treatment with and without Hawthorn special extract WS1442. Forsch. Komplementarmed Klass Naturheilkd. 2004; 11(Suppl.1): 36-39. 15 Health Canada. Skullcap monograph. 2008. 16 Willard. Textbook of Modern Herbology, 2 nd Revised Ed. Calgary, AB: Wild Rose College of Natural Healing Ltd.; 1993; Kuhn & Winston. Winston & uhn’s Herbal Therapy & Supplements. A Scientific and Traditional Approach, 2 nd Ed. Philadelphia, PA: Wolters Kluwer Health | Lippincott Williams & Wilkins; 2008. 17 Zhao et al. Cardioprotective effects of baicalein on heart failure via modulation of Ca(2+) handling proteins in vivo and in vitro. Life Sci. 2016; 145: 213-223; Zong et al. Baicalein protects against cardiac hypertrophy through blocking MEK- ERK1/2 signaling. J. Cell. Biochem. 2013; 114(5): 1058-1065. 18 Felter & Lloyd. King’s American Dispensary. Cincinnati, OH: The Ohio Valley Co.; 1898. 19 Nadkarni AK. Indian Materia Medica, Vol.1, 3 rd Ed. Reprint. Bombay, India: Popular Prakasham Private Ltd.; 1976; Bone K. Clinical Applications of Ayurvedic and Chinese Herbs. Monographs for the Western Herbal Practitioner. Warwick, Australia: Phytotherapy Press; 1996. 20 Health Canada. Peppermint monograph. 2008 21 Bradley PR (ed). British Herbal Compendium. Volume 1. A Handbook of Scientific Information On Widely Used Plant Drugs. Bournemouth, UK: British Herbal Medical Association; 1992. 22 Grieve M. A Modern Herbal. New York, NY: Dover Publications Inc.; 1971. 23 Bowman IA. The everlasting mistletoe and the cardiovascular system. Tex. Heart Inst. J. 1990; 17(4): 310-314; Weiss RF, Fintelmann V. Herbal Medicine, Second edition, revised and expanded. New York, NY: Thieme; 2000; Willfort R. Gesundheit durch Heilkräuter. Linz: Rudolf Trauner Verlag, 14 Auflage; 1975. 24 O’Hare JP, Hoyt LH. Mistletoe in the treatment of hypertension. New Eng. J. Med. 1928; 199: 1207-1213; O’Hare JP. Treatment of hypertension. New Eng. J. Med. 1931; 204: 603; Danzer CS. The use of a dialysate of Viscum album in the treatment of arteriosclerotic and hypertensive disorders. Med. Rec. 1934; 140: 483-484. 25 Lyle TJ. Physio-Medical Therapeutics, Materia Medica and Pharmacy. Ohio: Chicago Physio-Medical College; 1897. 26 Blumenthal M. (ed.) Cayenne. In: The ABC Clinical Guide to Herbs. Austin, TX: The American Botanical Council; 2003. 27 Health Canada. Cayenne-Capsicum annuum L. monograph. September 2013. 28 Bouraoui A, Toumi A, Ben Mustapha H, Brazier JL. Effects of capsicum fruit on theophylline absorption and bioavailability in rabbits. Drug Nutr. Interact. 1988; 5(4): 345-350; Jensen-Jarolim E, Gajdzik L, Haberl I, Kraft D, Scheiner O, Graf J. Hot spices influence permeability of human intestinal epithelial monolayers. J. Nutr. 1998; 128(3): 577-581.

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