Sub-chronic Toxicity Study Of T-AYU-HMTM Premium: A Herbo-mineral Formulation
Abstract
To perform a sub-chronic toxicity study and to generate scientific data regarding the safety profile of T-AYU-HMTM Premium, a herbo-mineral formulation used for sickle cell disease. Experimental animals (Mice) were divided into six groups and were acclimatized and treated with 125 mg T-AYU-HMTM Premium/kg body weight (T1 LD), 625 mg T-AYU-HMTM Premium/kg body weight (T2 MD), and 1250 mg T-AYU-HMTM Premium/kg body weight (T3 HD) and two group of satellite daily for 90 days. 0.5% CMC was administered to the control group as a vehicle. The satellite groups were treated with 125 mg T-AYU-HMTM Premium/kg body weight (S1 LD) & 1250 mg T-AYU-HMTM Premium/kg body weight (S2 HD, 1250 mg/kg) receiving low & high dose respectively. The mice were closely observed for a clinical sign of toxicity, stereotypical behavior and alteration in autonomic activity during the entire study period. Hematological and blood biochemical parameters were observed on days 0, 60, 90. Motor coordination activity and sensory stimuli assessment were performed after the 11th week. At the termination of the study, all animals were sacrificed, and organs such as the heart, brain, kidney, liver, etc., were collected & observed for histopathology. There was no change in the normal gross behavior of animals in the sensory and motor assessment activity in the treatment group compared to the control group. Evaluation of hematological parameters shows a significant increase in red blood corpuscles. Histopathological examination of various organs shows a normal architecture in all the treated groups. T-AYU-HMTM Premium was found to be safe on repeat dose oral administration in NOAEL, dose up to 1250 mg/kg body weight when administered orally for 90 days in both the sexes of Swiss Albino mice.
Keywords:
Subchronic toxicity, T-AYU-HMTM Premium, Herbo-mineral formulation, Sickle Cell DiseaseDOI
https://doi.org/10.25004/IJPSDR.2022.140101References
Desai C, Desai J, Desai S, Kajal K. A brief review on the management options available for sickle cell anemia. Journal of Pharmaceutical Science and Bioscientific Research. 2015; 5(2): 230-238
Desai C and Shah B. A review on Pathophysiology of sickle cell anemia and its impact on various organ Systems. Journal of Pharmaceutical science and Bioscientific Research. 2015; 5(2): 197-206
World Health Organization, 59th World Health Assembly. Sickle Cell Anemia, report by Secretariat. 2006. [Last Accessed on 2011 June]. Available from: http:// apps.who.int/gb/ebwha/pdf_files/ WHA59/A59_9-en.pdf.
Barakat P, Simon K, Schwartz L, Radcliffe J. Correlates of pain-rating concordance for adolescents with sickle cell disease and their caregivers. Clinical Pain Journal. 2008; 24(5): 438-446
Serjeant GR. The emerging understanding of sickle cell disease. British journal of hematology. 2001; 112(1): 3-18
Saraf MN, Desai AM, Kshtriya A. Investigation of selected Herbomineral formulation T-AYU-H & T-AYU-HM™ Premium as an anti-sickling agent for sickle cell anemia. IJPSR. 2018; 9(12): 5522- 33. doi: 10.13040/IJPSR.0975-8232.9(12).5522-33.
Desai AM, Saraf MN, Desai C, Desai H and Dalal M. Clinical Evaluation of T-AYU-HM in the management of Sickle Cell Anemia. IJPSR. 2018; 9(8): 3573-3578.
Desai AM, Desai H, Desai C, Patel M. An acute oral toxicity study of T-AYU-HM premium tablet in rats: an initiative for sickle cell anemia management. IJPSR. 2020; 11(12): 6157-60. doi: 10.13040/ IJPSR.0975-8232.11(12).6157-60.
OECD, Test no. 408: repeated dose 90-day oral toxicity study in rodents, OECD Guidelines for the Testing of Chemicals, Section 4, OECD Publishing, Paris, 2018.
Mathiasen JR and Moser VC. The Irwin Test and Functional Observational Battery (FOB) for Assessing the Effect of Compounds on behaviour, physiology, and safety Pharmacology in Rodents. Current Protocols in Pharmacology. Wiley Online Library. 2018;43
Moser VC. Neurobehavioral Screening in Rodents. Current Protocol in Toxicology. 1999; 11.2.1- 11.2.16.
Goyal RK. Practicals in Pharmacology. Edition. 8th, B S Shah Prakashan, 2008-2009. pp 121-130.
Bhosale UA, Yegnanarayan R, Pophale PD, Zambare MR, Somani RS. Study of central nervous system depressant and behavioral activity of an ethanol extract of Achyranthes Aspera (Agadha) in different animal models. International Journal of Applied and Basic Medical Research. 2011; 1(2): 104-109.
Robert MJ Deacon. Measuring Motor Coordination in Mice. Journal of Visual Experiments. 2013; 75: e2609.
Komada M, Takao K, Miyakawa T. Elevated Pluz Maze for Mice. Journal of Visualized Experiments. 2008; 22: e1088.
Published
Abstract Display: 1041 
PDF Downloads: 977 
