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MONOGRAPHS

Strauss Heartdrops® | Arterial Support Kit™ (ASK™) MONOGRAPH

NPN: 80030089

1 mL (32 Drops) of Oral Tincture contains:
Aged Garlic (435.5 mg DHE*).
GCMS verified and S-Allyl cysteine 142 ppm avg.
Cayenne (2.4 mg DHE* – Capsicum annuum fruit),
Hawthorn (35.8 mg DHE* – Crataegus laevigata fruit),
Hawthorn (2.1 mg DHE* – Crataegus laevigata flower/leaf),
Motherwort (3.1 mg DHE* – Leonurus cardiaca herb top),
White Willow (1.3 mg DHE* – Salix alba stem bark),
Bilberry (1.9 mg DHE* – Vaccinium myrtillus leaf),
European Mistletoe (17.9 mg DHE* – Viscum album leaf).

Non-medicinal ingredients: purified water, ethanol USP, natural cinnamon flavour (Cinnamon Heartdrops® | ASK™).

*DHE = Dry Herb Equivalent.

Dosage: Adults, 1 mL (32 drops) – 2.5 mL (80 drops), 3 times daily.
May be taken diluted in a small amount of water.

Indication: Used in Herbal Medicine to help maintain cardiovascular health and reduce elevated blood lipid levels/ hyperlipidemia in adults.

Detailed Information: Heartdrops® | ASK™, an alcohol-based extract of aged garlic, hawthorn fruit, hawthorn leaf & flower, cayenne, European mistletoe leaf and bilberry leaf in combination with motherwort and trace amounts of white willow bark, has been marketed for over 35 years.

In a double-blinded, placebo-controlled, randomised parallel group study to  determine if in patients with chronic stable angina Heartdrops® | ASK™ at a dosage below the current minimum dose (15 drops, three times/day, placed under the tongue and held for a minute) for 12 weeks could reduce selected markers of cardiovascular risk (vascular compliance, exercise tolerance, blood lipid profile, inflammatory markers, blood pressure) and improve quality of life, the reduction in symptom frequency was statistically significant (p<0.05) from the 6th to 11th week compared to baseline, while the reduction in symptom severity was significant in weeks 7-8 and 10-12  compared to baseline. The results of this study suggest that supplementation with Heartdrops® | ASK™ improved quality of life by reducing the frequency and severity of heart disease symptoms, and without adverse effects or changes in
blood chemistry despite patients  concurrently taking other heart medications(1).

In a one-year observational study to determine safety and efficacy, fourteen volunteer subjects ingested label- recommended dosages of Heartdrops® | ASK™ three times per day while maintaining their usual life-style and habits. Blood pressure was monitored monthly throughout the entire study period, and all ‘at risk’ blood lipids, including total cholesterol, LDL cholesterol, triglycerides and the total cholesterol/HDL ratio were calculated using the CardioChek device. Over the one-year study period, the blood lipid values that indicated increased risk to coronary heart disease in the  treatment group improved to values that were ‘normal’ or indicative of reduced risk. The reductions in blood lipid values and diastolicblood pressure were statistically (P<0.05) significant. The results of this study supported the safe and efficacious use of Heartdrops® | ASK™ as a supplement for people at increased risk of heart disease(2). Additional actions of Heartdrops® | ASK™ suggested by this study included improvement of lipid profiles, as well as in endothelial function and exercise tolerance.

In a single-blind, placebo-controlled study, 150 hyperlipidemic participants were divided randomly into three equal groups and were given either enteric-coated garlic powder tablets (equal to 400 mg garlic, 1 mg allicin) twice daily, anethum graveolens tablets (650 mg) twice daily, or placebo tablets twice daily for 6 weeks. While anethum had no significant effect on lipid profiles, garlic had a statistically (P<0.001) significant favourable effect, decreasing total cholesterol and LDL-cholesterol and increasing HDL-cholesterol(3).

Individuals with heart disease often have impaired endothelial function. As a result, vasodilation becomes limited and is worsened by oxidant stress and increased systemic inflammation. In a randomized, placebo-controlled, cross-over study involving 15 men with angiographically-proven coronary artery disease that was being treated with aspirin and a statin, 2-week supplementation (with washout periods) with aged garlic extract (AGE) led to a significant (P = 0.04) increase (44%) in brachial artery flow mediated endothelium-dependent dilation (FMD), although circulating markers of oxidative stress (plasma oxidized low density lipoprotein and peroxides), systemic inflammation (plasma C-reactive protein and interleukin-6) and endothelial activation (VCAM-1) did not change significantly during this study(4). In a randomized, double-blind, placebo-controlled clinical trial involving 152 participants, the plaque volumes in both carotid and femoral arteries in the group taking 900 mg/day of garlic powder over a 4-year period significantly reduced the normal increase in arteriosclerotic plaque volume by 5–18%, or even effected a slight regression within the study period. The age-dependent representation of the plaque volume that increased between 50 and 80 years in the placebo group was diminished under garlic treatment by 6–13% over 4 years. In fact, within the age-span of 50–80 years, plaque volume remained practically constant within the garlic treatment group. From these results, the authors concluded that garlic not only decreased therosclerotic plaque progression, but could be useful in arteriosclerosis therapy, by helping to effect plaque regression(5). AGE has demonstrated similar anti-atherosclerotic and anti- therogenic effects which, on the basis of human, animal and in vitro studies, are attributable to multiple actions, including reduction of oxidative stress, reduction in platelet aggregation, vasodilation and inhibition of abnormal angiogenesis(6,7). While previous studies have demonstrated that AGE inhibits the progression of  coronary artery calcification(7,8), the effect of AGE on noncalcified plaque (NCP) has been unclear.

However, a recent study investigated whether AGE reduces coronary plaque volume measured by cardiac  computed tomography angiography (CCTA) in patients with metabolic syndrome (MetS). Fifty-five patients with MetS (mean ± SD age: 58.7 ± 6.7 y; 71% men) were prospectively assigned to consume 2,400 mg AGE/day (27 patients) or placebo (28 patients). Both groups underwent CCTA at baseline and follow-up 354 ± 41 days apart. Coronary plaque volume, including total plaque volume (TPV), dense calcium (DC), NCP, and low-attenuation plaque (LAP), were measured based upon predefined intensity cut-off values. Results of multivariable linear regression analysis, adjusting for age, gender, number of risk factors, hyperlipidemia medications, history of coronary artery disease, scan interval time, and baseline %TPV, revealed that the %LAP reduction in the AGE group compared with the lack of change in the placebo group was significant (-1.5% ± 2.3% compared with 0.2% ± 2.0%; P = 0.0049). In contrast, no difference was observed in %TPV change (0.3% ± 3.3% compared with 1.6% ± 3.0%, P = 0.13), %NCP change (0.2% ± 3.3% compared with 1.4% ± 2.9%, P = 0.14), or %DC change (0.2% ± 1.4%, compared with 0.2% ± 1.7%, P = 0.99) compared to placebo 9. Thus, in addition to multiple risk reduction based upon its pleiotropic action profile6 and a specific anti-arterioscleroticeffect at the molecular level suggested by the garlic-mediated hindrance of membrane calcification (7,8) and/or docking of deleterious lipoproteins to their scavenger receptor (5,9), the use of garlic helps to maintain cardiovascular health and reduce the riskof cardiovascular incidents(5).

Garlic bulb at 0.5-12 g/day is Traditionally used in Herbal Medicine to help relieve the symptoms associated with upper respiratory tract infections and catarrhal conditions, as well as to help reduce elevated blood lipid levels/hyperlipidemia and maintain cardiovascular health in adults(10).

Cayenne fruit is Traditionally used in Herbal Medicine to help support peripheral circulation when taken at a dry weight equivalent dosage of 15-650 mg/day(11). Cayenne has long been recognised as one of the most powerful and persistent of cardio- stimulants known, with a primary influence on circulation(12), even when only very small amounts are consumed(13).

Hawthorn fruit when taken at 0.6-3.5 g/day, and hawthorn leaf & flower at 0.5-5 g/day, is used in Herbal Medicine to help maintain and/or support cardiovascular health in adults(14). Hawthorn has a long-standing reputation as one of the most valuable tonic remedies for the cardiovascular system(15). While hawthorn fruit has Traditionally been used to strengthen and invigorate the heart and circulatory function(16), leaf & flower preparations have been most studied and shown to possess cardiotonic and coronary vasodilator properties(17). When taken in recommended dosages, both types of hawthorn preparation have been indicated for early or mild functional cardiac insufficiency, i.e. Stages I and II  according to New York Health Association’s classification, as well as for mild forms of arrhythmia and tachycardia(17,18). The  available evidence supports the combination of hawthorn with garlic in Heartdrops® | ASK™ for maintenance of cardiovascular health in adults.

Motherwort is described in Traditional Herbal Medicine sources as an excellent cardiac tonic, being particularly useful for heart palpitations and cardiac insufficiency associated with anxiety and/or nervous conditions(16,19), especially when combined with hawthorn15, and when taken at a dosage of 2.4-6 g/day(20).

European mistletoe leaf preparations are used orally in Traditional Herbal Medicine as cardiotonic and cardioprotective agents with mild hypotensive action(19, 21). They have been described as particularly helpful in the relief of subjective symptoms associated with cardiovascular deficiencies(19,21), supporting use of the herb as a complimentary and supportive ingredient of Heartdrops® | ASK™.

Similarly, bilberry leaf preparations are used Traditionally in Herbal Medicine for, among other things, poor circulation and circulatory disorders, functional heart problems, and metabolic stimulation and blood purification(16,19). Use of bilberry leaf in Traditional Chinese Medicine to raise Central Qi and thereby help in venous insufficiency, capillary fragility, and atherosclerosis(22), also supports its use as a complimentary and supportive ingredient of Heartdrops® | ASK™.

White willow bark, best known as a natural remedy for relief of fever and pain(16), may mildly potentiate the effects of anticoagulants(23) and may therefore contribute, as a minor ingredient of Heartdrops® | ASK™, to improving blood flow properties helpful in the support and/or maintenance of cardiovascular health.

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, diabetes, or if you are taking other medications and/or supplements. Consult with a health care practitioner if symptoms persist or worsen.

Contra-Indications: Do not use if you are pregnant or breastfeeding or within 24 hours of surgery.

Known Adverse Reactions: Hypersensitivity/allergic reactions are known to occur; headaches, dizziness, and light-headedness, and thirst may occur, in which case reduce dosage or discontinue use.

1. Petrella R, et al. Effect of Herbal Strauss Heartdrops in Patients with Chronic Stable Angina. Study Report. KGK Synergize Inc.; 2005. 2. Hornby P. A One-Year Observational Study to Determine the Efficacy and Safety of Strauss Heartdrops in Reducing Risk to Coronary Heart Disease. Study Report. Hedron Analytical Inc.; 2006. 3. Kojuri J, Vosoughi AR, Akrami M. Effects of anethum graveolens and garlic on lipid profile in hyperlipidemic patients. Lipids Health Dis. 2007; 6: 5. 4. Williams MJA, Sutherland WH, McCormick MP, Yeoman DJ, de Jong SA. Aged garlic extract improves endothelial function in men with coronary artery disease. Phytother. Res. 2005; 19: 314-319. 5. Koscielny J, Klüssendorf D, Latza R, Schmitt R, Radtke H, Siegel G, Kiesewetter H. The antiatherosclerotic effect of Allium sativum. Atherosclerosis 1999; 144(1): 237-249. 6. Siegel G, Walter A, Engel S, Walper A, Michel F. Pleiotropic effects of garlic. Wien Med Wochenschr. 1999; 149(8-10): 217-224. Siegel G, Malmsten M, Pietzsch J, Schmidt A, Buddecke E, Michel F, et al. The effect of garlic on arteriosclerotic nanoplaque formation and size. Phytomedicine 2004; 11(1): 24-35. 7. Budoff M. Aged garlic extract retards progression of coronary artery calcification. J Nutr. 2006; 136(3 Suppl): 741S-744S. 8. Hom C, Luo Y, Budoff MJ. The effects of aged garlic extract on coronary artery calcification progression. J. Nutr. Food Sci. 2015; S5: 005. 9. Matsumoto S, Nakanishi R, Li D, Alani A, Rezaeian P, Prabhu S, et al. 2016. Aged garlic extract reduces low attenuation plaque in coronary arteries of patients with meta bolic syndrome in a prospective randomized double-blind study. J Nutr. 2016;13. pii: jn202424. [Epub ahead of print].

10. NNHPD Monograph on Garlic. May 2008. 11. NNHPD Monograph Cayenne-Capsicum annuum L. September 2013. 12. Lyle TJ. Physio-Medical Therapeutics, Materia Medica and Pharmacy. Ohio: Chicago Physio-Medical College; 1897. 13. Blumenthal M. (ed.) Cayenne. In: The ABC Clinical Guide to Herbs. Austin, TX: The American Botanical Council; 2003. 14. NNHPD Monograph Hawthorn-Crataegus laevigata. July 2013. 15. Ellingwood F. The American Materia Medica, Therapeutics and Pharmacognosy. 11th Edition. Chicago, IL: Bennett Medical College; 1919. 16. Blumenthal M, Busse WR, Goldberg A, Gruenwald J, Hall T, Riggins CW, et al. (eds.) The Complete German Commission E Monographs—Therapeutic Guide to Herbal Medicines. Austin, TX: American Botanical Council; 1998. 17. Upton R, Petrone C. (eds.) Hawthorn Leaf with Flower. Santa Cruz, CA: American Herbal Pharmacopoeia; 1999a. 18. Upton R, Petrone C. (eds.) Hawthorn Berry. Santa Cruz, CA: American Herbal Phar macopoeia; 1999b. 19. Weiss RF. Weiss’s Herbal Medicine, Classic Edition. New York, NY: Thieme; 2001. 20. Bradley PR. (ed.) British Herbal Compendium, Vol.1. Bournemouth, UK: British Herbal Medicine Association; 1992. 21. BHP (British Herbal Pharmacopoeia). Bournemouth, UK: British Herbal Medicine Association; 1983. 22. Holmes P. The Energetics of Western Herbs. Treatment Strategies Integrating Western and Oriental Herbal Medicine, Revised Third Edition, Vol.2. Boulder, CO: Snow Lotus Press; 1998. 23. Mills S, Bone K. The Essential Guide to Herbal Safety. St. Louis, MI: Elsevier Churchill Livingstone; 2005.

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