Cargando…

Acute and sub-chronic toxicity of Liberin, an anti-diabetic polyherbal formulation in rats

BACKGROUND: The polyherbal formulation (PHF) liberin, is known to exert anti-hyperglycemic effects in type 2 diabetes mellitus. Hence, it is important to study the safety profile of PHF in the current study through acute and chronic toxicity evaluation. OBJECTIVES: This research aims to assess the a...

Descripción completa

Detalles Bibliográficos
Autores principales: Suvarna, Renuka, Suryakanth, Varashree Bolar, Bakthavatchalam, Pugazhandhi, Kalthur, Guruprasad, Nayak M, Deepak, Prabhu, M. Mukhyaprana, Hadapad, Basavaraj S., Shenoy, Revathi P.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Elsevier 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10585375/
https://www.ncbi.nlm.nih.gov/pubmed/37847964
http://dx.doi.org/10.1016/j.jaim.2023.100804
_version_ 1785122942392205312
author Suvarna, Renuka
Suryakanth, Varashree Bolar
Bakthavatchalam, Pugazhandhi
Kalthur, Guruprasad
Nayak M, Deepak
Prabhu, M. Mukhyaprana
Hadapad, Basavaraj S.
Shenoy, Revathi P.
author_facet Suvarna, Renuka
Suryakanth, Varashree Bolar
Bakthavatchalam, Pugazhandhi
Kalthur, Guruprasad
Nayak M, Deepak
Prabhu, M. Mukhyaprana
Hadapad, Basavaraj S.
Shenoy, Revathi P.
author_sort Suvarna, Renuka
collection PubMed
description BACKGROUND: The polyherbal formulation (PHF) liberin, is known to exert anti-hyperglycemic effects in type 2 diabetes mellitus. Hence, it is important to study the safety profile of PHF in the current study through acute and chronic toxicity evaluation. OBJECTIVES: This research aims to assess the acute and sub-chronic toxicity of PHF in rats. MATERIALS AND METHODS: PHF was administered once orally (1000 mg/kg body weight), and the rats (male and female) were monitored for toxicity signs for a 14-day period. For a 28-day chronic toxicity study, rats were daily administered with PHF dose of 500 mg/kg and 1000 mg/kg body weight. Rats were followed up for mortality, weight changes, and other morbidities. Further haematological, biochemical, and histopathological changes were assessed. RESULTS: No death related to treatment or toxicity signs were recorded in the acute single-dose administration group. The results showed that the PHF was tolerated well up to a dose of 1000 mg/kg body weight. Even at the high dose of 1000 mg/kg body weight, sub-chronic tests did not show any significant difference between the dosed and normal groups. No significant changes were seen in the histopathological analysis of the liver, spleen, and kidney as well as haematological and biochemical parameters in acute, sub-chronic and satellite groups following the administration of PHF. CONCLUSION: The results confirmed that there was no adverse effect of this PHF at the maximum dose of 1000 mg/kg body weight in Wistar rats. Further, no adverse delayed effects related to PHF were observed in the satellite group. Therefore, this PHF appears safe for therapeutic purposes in the Ayurvedic medicinal system.
format Online
Article
Text
id pubmed-10585375
institution National Center for Biotechnology Information
language English
publishDate 2023
publisher Elsevier
record_format MEDLINE/PubMed
spelling pubmed-105853752023-10-20 Acute and sub-chronic toxicity of Liberin, an anti-diabetic polyherbal formulation in rats Suvarna, Renuka Suryakanth, Varashree Bolar Bakthavatchalam, Pugazhandhi Kalthur, Guruprasad Nayak M, Deepak Prabhu, M. Mukhyaprana Hadapad, Basavaraj S. Shenoy, Revathi P. J Ayurveda Integr Med Original Research Article BACKGROUND: The polyherbal formulation (PHF) liberin, is known to exert anti-hyperglycemic effects in type 2 diabetes mellitus. Hence, it is important to study the safety profile of PHF in the current study through acute and chronic toxicity evaluation. OBJECTIVES: This research aims to assess the acute and sub-chronic toxicity of PHF in rats. MATERIALS AND METHODS: PHF was administered once orally (1000 mg/kg body weight), and the rats (male and female) were monitored for toxicity signs for a 14-day period. For a 28-day chronic toxicity study, rats were daily administered with PHF dose of 500 mg/kg and 1000 mg/kg body weight. Rats were followed up for mortality, weight changes, and other morbidities. Further haematological, biochemical, and histopathological changes were assessed. RESULTS: No death related to treatment or toxicity signs were recorded in the acute single-dose administration group. The results showed that the PHF was tolerated well up to a dose of 1000 mg/kg body weight. Even at the high dose of 1000 mg/kg body weight, sub-chronic tests did not show any significant difference between the dosed and normal groups. No significant changes were seen in the histopathological analysis of the liver, spleen, and kidney as well as haematological and biochemical parameters in acute, sub-chronic and satellite groups following the administration of PHF. CONCLUSION: The results confirmed that there was no adverse effect of this PHF at the maximum dose of 1000 mg/kg body weight in Wistar rats. Further, no adverse delayed effects related to PHF were observed in the satellite group. Therefore, this PHF appears safe for therapeutic purposes in the Ayurvedic medicinal system. Elsevier 2023 2023-10-15 /pmc/articles/PMC10585375/ /pubmed/37847964 http://dx.doi.org/10.1016/j.jaim.2023.100804 Text en © 2023 The Authors https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
spellingShingle Original Research Article
Suvarna, Renuka
Suryakanth, Varashree Bolar
Bakthavatchalam, Pugazhandhi
Kalthur, Guruprasad
Nayak M, Deepak
Prabhu, M. Mukhyaprana
Hadapad, Basavaraj S.
Shenoy, Revathi P.
Acute and sub-chronic toxicity of Liberin, an anti-diabetic polyherbal formulation in rats
title Acute and sub-chronic toxicity of Liberin, an anti-diabetic polyherbal formulation in rats
title_full Acute and sub-chronic toxicity of Liberin, an anti-diabetic polyherbal formulation in rats
title_fullStr Acute and sub-chronic toxicity of Liberin, an anti-diabetic polyherbal formulation in rats
title_full_unstemmed Acute and sub-chronic toxicity of Liberin, an anti-diabetic polyherbal formulation in rats
title_short Acute and sub-chronic toxicity of Liberin, an anti-diabetic polyherbal formulation in rats
title_sort acute and sub-chronic toxicity of liberin, an anti-diabetic polyherbal formulation in rats
topic Original Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10585375/
https://www.ncbi.nlm.nih.gov/pubmed/37847964
http://dx.doi.org/10.1016/j.jaim.2023.100804
work_keys_str_mv AT suvarnarenuka acuteandsubchronictoxicityofliberinanantidiabeticpolyherbalformulationinrats
AT suryakanthvarashreebolar acuteandsubchronictoxicityofliberinanantidiabeticpolyherbalformulationinrats
AT bakthavatchalampugazhandhi acuteandsubchronictoxicityofliberinanantidiabeticpolyherbalformulationinrats
AT kalthurguruprasad acuteandsubchronictoxicityofliberinanantidiabeticpolyherbalformulationinrats
AT nayakmdeepak acuteandsubchronictoxicityofliberinanantidiabeticpolyherbalformulationinrats
AT prabhummukhyaprana acuteandsubchronictoxicityofliberinanantidiabeticpolyherbalformulationinrats
AT hadapadbasavarajs acuteandsubchronictoxicityofliberinanantidiabeticpolyherbalformulationinrats
AT shenoyrevathip acuteandsubchronictoxicityofliberinanantidiabeticpolyherbalformulationinrats