Investigation of the Acute Subacute Toxicity of KL-21® Supplementary Food Product in Rats

Year 2022, Volume: 3 Issue: 3, 190 - 196, 15.12.2022

Mustafa Yaşar , Güliz Saraç , Ali Gök , Nisa Sipahi , Aydan Fülden Ağan

https://doi.org/10.53811/ijtcmr.1121162

Abstract

Objective: KL21®; It is a food supplement using remember regeneration therapy method (RTM). KL21®. Whereas products that containing combined medicinal plants are expected to be beneficial for health, on the other hand, their toxic properties are able to potentially increase due to the interactions of the active ingredients in the plants. With this study, it was aimed to investigate the toxic effect of KL21®.
Material-Method: In the study conducted with control (n: 8), acute (n: 8), subacute (n: 8) and post-subacute (n: 8) groups; the daily dose of the product was tested by gavage in 8-week-old female Wistar rats. Biochemical parameters P, Ca, ALB, TG, TP, TC, Creatinine, Bilirubin, GGT, ALP, AST and ALT were analyzed. In hematological parameters; WBC, RBC, PLT, HCT, HGB were examined. Liver, lung, spleen, kidney and heart tissues were investigated histopathologicaly. Clinical observation was made throughout the entire process.
Results: When the acute, subacute and post-subacute groups were compared to control, it was observed that there was no significant difference in biochemical, hematological, histopathological terms. No toxicity-related side effects were found in clinical observations.
Conclusion: The potential toxic effect of daily use dose of KL21® containing the combined medicinal plant was investigated in vivo. According to the hemogram, biochemistry and pathology tests, it was determined that it does not show acute and subacute toxicity.

Keywords

KL-21®, Food supplement, Acute, Subacute, Post-subacute toxicity

References

• Lev E, Amar Z. Ethnopharmacological survey of traditional drugs sold in Israel at the end of the 20th century. Journal of Ethnopharmacology. 2000;72(1-2):191-205.
• Yasar M. The remember regeneration therapy method: An overview of new therapy protocol to approach diseases. Journal of Complementary Medicine Research. 2019;10(1):68-80.
• Bayram D. Silibinin İn Vitro Ortamda CCL-228-SW 480 Kolon Kanseri Hücre Hattı Üzerine Apoptotik Etkisinin Araştırılması. SDÜ Sağlık Bilimleri Dergisi. 2017;8(2):1-7.
• Mascolo N, Jain R, Jain S, Capasso F. Ethnopharmacologic investigation of ginger (Zingiber officinale). Journal of ethnopharmacology. 1989;27(1-2):129-140.
• Al-Snafi AE. Medical importance of Cichorium intybus–A review. IOSR Journal of Pharmacy. 2016;6(3):41-56.
• Sharma UR, Surendra V, Jha SK, Chauhan NS, Prakash T, Goli D. Evaluation of Ant-inflamatory Activity of Fumaria Officinalis Linn. Herb Extract on Experimental Animal.
• Joshi BC, Mukhija M, Kalia AN. Pharmacognostical review of Urtica dioica L. International Journal of Green Pharmacy (IJGP). 2014;8(4).
• Takzare N, Hosseini M-J, Hamideh Mortazavi S, Safaie S, Moradi R. The effect of Achillea millefolium extract on spermatogenesis of male Wistar rats. Human & experimental toxicology. 2011;30(4):328-334.
• Tago Y, Wei M, Ishii N, Kakehashi A, Wanibuchi H. Evaluation of the subchronic toxicity of dietary administered Equisetum arvense in F344 rats. Journal of toxicologic pathology. 2010;23(4):245-251.
• Govind P. Active principles and median lethal dose of Curcuma longa Linn. Internafional Research Journal of Pharmacy, 2 (5): 239. 2011;41.
• Gilani AH, Aziz N, Khan MA, Shaheen F, Jabeen Q, Siddiqui BS, Herzig JW. Ethnopharmacological evaluation of the anticonvulsant, sedative and antispasmodic activities of Lavandula stoechas L. Journal of Ethnopharmacology. 2000;71(1):161-167.
• Sweeney B, Vora M, Ulbricht C, Basch E. Evidence-based systematic review of dandelion (Taraxacum officinale) by natural standard research collaboration. Journal of herbal pharmacotherapy. 2005;5(1):79-93.
• Escudero NL, De Arellano ML, Fernández S, Albarracín G, Mucciarelli S. Taraxacum officinale as a food source. Plant Foods for Human Nutrition. 2003;58(3):1-10.
• Agrawal OP, Bharadwaj S, Mathur R. Antifertility Effects of Fruits of Juniperus communis. Planta Med. 1980;40(S 1):98-101.
• Neslihan Şirin, Gülşah Aydın, Nisa Sipahi, Tuğba Türken Akçay, Haydar Göksu. Using Propolis as an Antimicrobial Agent in Syrian Rue Herbal Cream. Paper presented at: 3.rd Internatioanl Cosmetic Congress, Main Theme: Minimalist Cosmetic.2019; Antalya, Turkey.
• Ali BH, Blunden G. Pharmacological and toxicological properties of Nigella sativa. Phytotherapy Research. 2003;17(4):299-305.
• Miraj S, Rafieian K, Kiani S. Melissa officinalis L: A Review Study With an Antioxidant Prospective. Journal of evidence-based complementary & alternative medicine. 2017;22(3):385-394.
• Shahamat Z, Abbasi-Maleki S, Mohammadi Motamed S. Evaluation of antidepressant-like effects of aqueous and ethanolic extracts of Pimpinella anisum fruit in mice. Avicenna journal of phytomedicine. 2016;6(3):322-328.
• Badgujar SB, Patel VV, Bandivdekar AH. Foeniculum vulgare Mill: a review of its botany, phytochemistry, pharmacology, contemporary application, and toxicology. BioMed research international. 2014;2014:842674.
• Hassani S, Alipour A, Darvishi Khezri H, Firouzian A, Emami Zeydi A, Gholipour Baradari A, Ghafari R, Habibi WA, Tahmasebi H, Alipour F, Ebrahim Zadeh P. Can Valeriana officinalis root extract prevent early postoperative cognitive dysfunction after CABG surgery? A randomized, double-blind, placebo-controlled trial. Psychopharmacology. 2015;232(5):843-850.
• Monga M, Sausville E. Developmental therapeutics program at the NCI: molecular target and drug discovery process. Leukemia. 2002;16(4):520-526.
• Saygı Ş, BD Gat. Deneysel Toksikolojide Toksisite Testleri Ve Test Sonuçlarının Önemi. Gülhane Tıp Dergisi (GTD) Gülhane Medıcal Journal (GMJ). 2003:291.
• Nair AB, Jacob S. A simple practice guide for dose conversion between animals and human. Journal of Basic and Blinical Pharmacy. 2016;7(2):27.
• Rehan T, Tahira R, Ullah H, Tareen U, Rehan T, Anees M, Murtaza I, Sultan A. In vitro bioactivities and subacute toxicity study of O. basilicum, T. vulgaris and R. officinalis. Turkish Journal of Biochemistry. 2018;43(4):447-455.
• Abdel-Moneim A, Morsy BM, Mahmoud AM, Abo-Seif MA, Zanaty MI. Beneficial therapeutic effects of Nigella sativa and/or Zingiber officinale in HCV patients in Egypt. EXCLI journal. 2013;12:943.
• Yassine EZ, Dalila B, El MansouriLatifa BS, Lebtar S, Sanae A, Abdellah F. Phytochemical Screening, Anti-inflammatory Activity and Acute Toxicity of Hydro-ethanolic, Flavonoid, Tannin and Mucilage Extracts of Lavandula stoechas L. from Morocco. Int J Pharm Phytochem Res. 2016;8(1):31-37.
• Komeili G, Hashemi M, Bameri-Niafar M. Evaluation of Antidiabetic and Antihyperlipidemic Effects of Peganum harmala Seeds in Diabetic Rats. Cholesterol. 2016;2016:7389864-7389864.
• Karakuş A, Değer Y, Yıldırım S. Protective effect of Silybum marianum and Taraxacum officinale extracts against oxidative kidney injuries induced by carbon tetrachloride in rats. Renal failure. 2017;39(1):1-6.
• Ghaffari A, Rafraf M, Navekar R, Asghari-Jafarabadi M. Effects of turmeric and chicory seed supplementation on antioxidant and inflammatory biomarkers in patients with non-alcoholic fatty liver disease (NAFLD). Advances in Integrative Medicine. 2018;5(3):89-95.
• Di Pierro F, Bellone I, Rapacioli G, Putignano P. Clinical role of a fixed combination of standardized Berberis aristata and Silybum marianum extracts in diabetic and hypercholesterolemic patients intolerant to statins. Diabetes Metab Syndr Obes. 2015;8:89-96.