Efficacy and tolerability of the dietary supplement “Altsinara” in subjects with hypercholesterolemia: a laboratory component of the clinical study

Authors

DOI:

https://doi.org/10.24959/cphj.18.1479

Keywords:

dietary supplement “Altsinara”, hypercholesterolemia, efficiency, tolerability, laboratory studies

Abstract

The importance of dyslipidemia as one of the main risk factors of cardiovascular disease is currently undoubted. Medicines of plant origin with the anti-atherogenic potential are of particular relevance for prevention of the dyslipidemia development of borderline states.

Aim. To study the laboratory component of the efficacy and tolerability of the dietary supplement “Altsinara”, produced by PJSC SIC “Borshchahivskiy CPP” compared to placebo in subjects with hypercholesterolemia in the framework of the clinical study “Randomized, simple blind, placebo-controlled study of the efficacy and tolerability of dietary supplement “Altsinara” produced by PJSC SIC “Borshchahivskiy CPP” with the participation of volunteers with hypercholesterolemia”.

Materials and methods. The study was conducted with the participation of 60 volunteers with hypercholesterolemia, whose average age was 48.83 ± 1.17 years. To assess the laboratory component of the effectiveness and tolerability of the dietary supplement “Altsinara” the indicators of the clinical and biochemical blood test were used for 1 (screening), 3 (day 45) and 4 (final day 90) visit.

Results. The prevailing efficacy and good tolerability of long-term use (within 90 days) of a dietary supplement “Altsinara”, tablets produced by PJSC SIC “Borshchahivskiy CPP”, Ukraine, have been proven. Based on the results of the test a dietary supplement “Altsinara”, tablets produced by PJSC SIC “Borshchahivskiy CPP”, Ukraine, can be recommended as a special food product for long-term use in persons with hypercholesterolemia and/or persons with a tendency to hypercholesterolemia (aggravated family history, overweight, inappropriate nutrition, etc.).

Conclusions. Based on the results of a randomized, simple blind, placebo-controlled study on the effectiveness and tolerability of the dietary supplement “Altsinara” produced by PJSC SIC “Borshchahivskiy CPP” with the participation of volunteers with hypercholesterolemia its prevailing efficacy and good tolerability in long-term use (within 90 days) have been proven.

Author Biographies

I. A. Zupanets, National University of Pharmacy

Doctor of Medicine (Dr. habil.), professor, head of the Clinical Pharmacology and Clinical Pharmacy Department

A. S. Shalamay, PJSC SIC “Borshchahivskiy CPP”

Candidate of Chemistry (Ph.D.), deputy director of research

I. A. Otrishko, National University of Pharmacy

Candidate of Pharmacy (PhD), associate professor of the Clinical Pharmacology and Clinical Pharmacy Department

A. I. Fedosov, National University of Pharmacy

Candidate of Pharmacy (PhD), associate professor, Chief Vice-Rector on educational work

S. V. Mіsiurova, National University of Pharmacy

Candidate of Pharmacy (PhD), associate professor of the Clinical Pharmacology and Clinical Pharmacy Department

References

Serhyenko, O. M., Zhyhunova, A. K. (2013). Ukrainskyi medychnyi chasopys, 1, 77–80.

Harnyk, T. P., Tumanov, V. A., Pokanevych, V. V., Frolov, V. M., Peresadin, M. O. (2012). Fitoterapiia. Chasopys, 1, 4–11.

WHO guidelines for assessing quality of herbal medicines with reference to contaminants and residues. (2017). World Health Organization, 118.

Kunle, O. F., Egharevba, H. O., Ahmadu, P. O. (2012). Standardization of herbal medicines - A review. International Journal of Biodiversity and Conservation, 4(3), 101–112. https://doi.org/10.5897/ijbc11.163

Tattis, A., Zupanets, I. A., Otrishko, I. A., & Grintsov, I. F. (2015). The study of the safety profile of “Altsinara” drug under the conditions of acute toxicity modeling. Klìnìčna farmacìâ, 19(3), 44–47. https://doi.org/10.24959/cphj.15.1350

Tattis, A., Zupanets, I. A., Shebeko, S. K., Otrishko, I. A., Hrintsov, Ye. F. (2015). Odeskyi medychnyi zhurnal,6 (152), 37–42.

Tattis, A., Zupanets, I. A., Shebeko, S. K., Otrishko, I. A., Grintsov, Ie. F. (2015). Study of lipid-lowering activity of the drug «Altsinarа» in the experiment. The Pharma Innovation Journal, 4 (8), 77–80.

Zupanets, I. A., Tattis, A., Shebeko, S. K., Otrishko, I. A., Hrintsov, Ye. F., Dobrovolnyi, O. O., Fesenko, S. O., Shalamai, A. S., Shylkina, O. O. (2016). Rozrobka efektyvnykh zasobiv hipolipidemichnoi ta antyaterohennoi dii na osnovi ekstraktu artyshoku ta poroshku chasnyku. Informatsiinyi lyst pro novovvedennia v sferi okhorony zdorovia № 194-2016. Ukrmedpatentinform MOZ Ukrainy. Vypusk z problemy «Klinichna farmakolohiia i klinichna farmatsiia», Kyiv, 3.

Nastanova ST-N MOZU 42-7.0:2008 «Likarski zasoby. (2009). Nalezhna klinichna praktyka», 48.

ICH E6: Good Clinical Practice: Consolidated guideline, CPMP/ICH/135/95. (n.d.).

Helsinskaya deklaratsiya Vsemirnoy meditsinskoy assotsiatsii. Eticheskie printsipyi provedeniya meditsinskih issledovaniy s uchastiem cheloveka v kachestve sub'ekta (2013).

Lapach, S. N., Chubenko, A. V., Babych, P. N. (2002). Osnovnye printcipy primeneniia statisticheskikh metodov v klinicheskikh ispytaniiakh. Kyiv: MORION, 160.

Published

2018-11-29

Issue

Section

Clinical trials