A randomized, double-blind, parallel, placebo-controlled study to evaluate efficacy and safety of a synergistic multi-herbal extract blend KaraHeart™ in supporting healthy cholesterol levels

Krishna Rajendran; Rajendran Ramaswamy; Sucharitha L.; Ravikumar Rajendran; Ramachandra Bharadwaja; Latha K.; Dheeraj Kumar Deep

doi:10.18203/2319-2003.ijbcp20220737

Authors

Krishna Rajendran Karallief Inc, Cambridge, MA, USA http://orcid.org/0000-0002-4556-7030
Rajendran Ramaswamy Green Chem, Bangalore, Karnataka, India
Sucharitha L. Shetty’s Hospital, Bangalore, Karnataka, India
Ravikumar Rajendran Green Chem, Bangalore, Karnataka, India
Ramachandra Bharadwaja Ganga Polyclinic & Research Centre, Bangalore, Karnataka, India
Latha K. ISHAYU, Bangalore, Karnataka,
Dheeraj Kumar Deep D2L Clinical Solutions, Bangalore, Karnataka, India

DOI:

https://doi.org/10.18203/2319-2003.ijbcp20220737

Keywords:

Healthy cholesterol, Hyperlipidemia, Herbal supplement, Natural treatment, Randomized Clinical trial, Lipid profile

Abstract

Background: Hyperlipidemia is a condition involving abnormally high levels of lipids in the blood. Hyperlipidemia is a major risk factor for cardiovascular diseases and refers to either high levels of triglycerides (TGL) or cholesterol. Herbal supplements have been used in the management of cholesterol levels in Ayurveda, a complete medical system originating in India. KaraHeart^™ is a multi-herbal extract synergistic blend that may help in the management of healthy cholesterol levels. The current study tested the efficacy, tolerability, and safety of KaraHeart^™ versus a placebo in the management of cholesterol levels of patients with mild hyperlipidemia.

Methods: This was a randomized, double-blind, parallel, and placebo-controlled study. A total of 100 patients were divided into two groups. One group was given KaraHeart^™ and the other group was given a placebo for 120 days. Treatment results were assessed by checking the lipid profile parameters such as total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL), very-low-density lipoprotein (VLDL), and TGL.

Results: The study found that the herbal supplement KaraHeart^™ significantly reduced levels of LDL, VLDL, TGL, and total cholesterol, while increasing the levels of HDL in the blood. Additionally, the study concluded that KaraHeart^™was safe to use.

Conclusions: KaraHeart^™ was shown to be safe and effective in the management of cholesterol levels.

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References

World Health Organization. Global Health Observatory data: Cholesterol, 2021. Available at: http://www.who.int/gho/ncd/risk_factors/cholesterol_prevalence/en/. Accessed on 24 June 2021.

Moor VJ, Amougou S, Ombotto S, Ntone F, Wouamba DE, Nonga B. Dyslipidemia in Patients with a Cardiovascular Risk and Disease at the University Teaching Hospital of Yaoundé, Cameroon. Int J Vasc Med. 2017;2017:6061306.

Cox RA, García-Palmieri MR. Cholesterol, Triglycerides, and Associated Lipoproteins. In: Walker HK, Hall WD, Hurst JW, eds. Clinical Methods: The History, Physical, and Laboratory Examinations. 3rd ed. Boston, MA: Butterworths. 1990;31.

Centres for Disease Control and Prevention. LDL and HDL Cholesterol:“Bad” and “Good” Cholestrol, 2020. Available at: https://www.cdc.gov/cholesterol/ldl_ hdl.htm#:~:text=LDL%20and%20HDL%20Cholesterol%3A%20%22Bad%22%20and%20%22Good%22%20Cholesterol&text=Cholesterol%20travels%20through%20the%20blood,most%20of%20your%20body’s%20cholesterol. Accessed on 20 May 2021.

Lee Y, Siddiqui WJ. Cholesterol levels. StarPearls Publishing. 2019.

Yanai H, Yoshida H. Secondary dyslipidemia: its treatments and association with atherosclerosis. Glob Health Med 2021;3(1):15-23.

Nelson RH. Hyperlipidemia as a risk factor for cardiovascular disease. Prim Care. 2013;40(1):195-211.

Verma SK, Bordia A. Effect of Commiphora mukul (gum guggulu) in patients of hyperlipidemia with special reference to HDL-cholesterol. Indian J Med Res. 1988;87:356-60.

Singh RB, Niaz MA, Ghosh S. Hypolipidemic and antioxidant effects of Commiphora mukul as an adjunct to dietary therapy in patients with hypercholesterolemia. Cardiovasc Drugs Ther. 1994;8(4):659-64.

Hasani-Ranjbar S, Nayebi N, Moradi L, Mehri A, Larijani B, Abdollahi M. The efficacy and safety of herbal medicines used in the treatment of hyperlipidemia; a systematic review. Curr Pharm Des. 2010;16(26):2935-47.

Urizar NL, Liverman AB, Dodds DT, Silva FV, Ordentlich P, Yan Y, et al. A natural product that lowers cholesterol as an antagonist ligand for FXR. Science. 2002;296(5573):1703-6.

Yu BZ, Kaimal R, Bai S, El Sayed KA, Tatulian SA, Apitz RJ, et al. Effect of guggulsterone and cembranoids of Commiphora mukul on pancreatic phospholipase A(2): role in hypocholesterolemia. J Nat Prod. 2009;72(1):24-8.

Singh S, Parmar N, Patel B. Management of Hridroga (Cardiovascular Disease) with Simple Ayurvedic Drugs. A Review. Research & Reviews: A Journal of Ayurvedic Science, Yoga and Naturopathy. 2016;3(1):12-6.

Jalali MT, Honomaror AM, Rekabi A, Latifi M. Reference ranges for serum total cholesterol, HDL-cholesterol, LDL-cholesterol, and VLDL-cholesterol and triglycerides in healthy ranian ahvaz population. Indian Journal of Clinical Biochemistry. 2013;28(3):277-82.

Luc G, Bard JM, Ferrieres J, Evans A, Amouyel P, Arvelier D, et al. Value of HDL cholesterol, apolipoprotein A1, lipoprotein A1, and lipoprotein A-1/A-II in prediction of coronary heart disease. Arterioscler Thromb Vasc Biol. 2002;22:1155-61.

Rahim S, Abdullah HM, Ali Y, Khan UI, Ullah W, Shahzad MA, et al. Serum Apo A-1 and its role as a biomarker of coronary artery disease. Cureus. 2016;8(12).

Cavero-Redondo I, Peleteiro B, Álvarez-Bueno C, Rodriguez-Artalejo F, Martínez-Vizcaíno V. Glycated haemoglobin A1c as a risk factor of cardiovascular outcomes and all-cause mortality in diabetic and non-diabetic populations: a systematic review and meta-analysis. BMJ open. 2017;7(7):e015949.

Lowe GD, Pepys MB. C-reactive protein and cardiovascular disease: weighing the evidence. Curr atherosclero rep 2006;8(5):421-8.

University of Rochester Medical Centre. Health Encyclopedia-Apolipoprotein A. Available at: https://www.urmc.rochester.edu/encyclopedia/content.aspx?contenttypeid=167&contentid=apolipoprotein_a. Accessed on 7 May 2021.

Azemawah V, Movahed MR, Centuori P, Penaflor R, Riel PL, Situ S et al. State of the art comprehensive review of individual statins, their differences, pharmacology, and clinical implications. Cardiovascular drugs and therapy. 2019;33(5):625-39.

Nelson AJ, Pagidipati NJ, Granger CB. The SAMSON trial: using a placebo to improve medication tolerability. European Heart Journal-Cardiovascular Pharmacotherapy. 2021;21:12-9.

Okopień B, Bułdak Ł, Bołdys A. Benefits and risks of the treatment with fibrates––a comprehensive summary. Expert review of clinical pharmacology. 2018;11(11):1099-112.

Riva A, Petrangolini G, Allegrini P, Perna S, Giacosa A, Peroni G et al. Artichoke and Bergamot Phytosome Alliance: A Randomized Double Blind Clinical Trial in Mild Hypercholesterolemia. Nutrients. 2022;14(1):108.

Cicero AF, Colletti A, Bajraktari G, Descamps O, Djuric DM, Ezhov M et al. Lipid-lowering nutraceuticals in clinical practice: Position paper from an International Lipid Expert Panel. Nutr Rev. 2017;75:731-67.