Acute and subacute toxicity studies of a poly herbal formulation used for diabetes

Abstract

Objectives: PHF-dia (Poly Herbal Formulation Diabetes) is a polyhedral formulation possessing antihyperglycemic and antihyperlipdimic effects. This study aims to assess acute and sub-acute toxicity of PHF-dia in rats.
 Methods: This is an experimental study conducted in two different phases. Acute toxicity was conducted for 14 days and sub-acute toxicity was conducted for 28 days. Both studies were conducted in animal house of Jinnah University for Women, Karachi, Pakistan. Acute toxicity was evaluated in vivo with single time oral administration of 400 mg/kg and 2000 mg/kg doses for two weeks. Sub-acute toxicity was investigated with the application of repeated doses of 150 mg/kg/day, 250 mg/kg/day and 500 mg/kg/day for 28 days.
 Results: Acute toxicity study results showed no toxic symptoms, behavioral changes or death in rats up to 2000 mg/kg. Therefore, LD50 of oral toxic dose must be more than 2000 mg/ml. Similarly, sub-acute toxicity studies confirmed the safety of PHF-dia and showed no clinical symptoms nor biochemical or histological variation in rats treated with 150 mg/kg, 250 mg/kg and 500 mg/kg compared to the control group (p <0.05).
 Conclusion: This indicates safe nature of PHF-dia for the further clinical trials. However, mechanism of action of PHF-dia is not fully understood.
 Abbreviations:ANOVA: Analysis of variance, ALT: Alanine transaminase, AST: Aspartate transaminase,EDTA: Ethylene diamine tetra-acetic acid, H & E: Haematoxylin and Eosin,HDL: High density lipoprotein, LD50: Median lethal dose, LDL: Low density lipoprotein,PLT: Platelet count, RBC: Red blood cell, SPSS: Statistical package for social science,VLDL: Very low-density lipoprotein, WBC: White blood cell, PHF-dia (Poly Herbal Formulation Diabetes).
 doi: https://doi.org/10.12669/pjms.38.6.5928
 How to cite this:Ghauri AO, Mohiuddin E, Rehman T, Siddiqui HSM. Acute and subacute toxicity studies of a poly herbal formulation used for diabetes. Pak J Med Sci. 2022;38(6):---------. doi: https://doi.org/10.12669/pjms.38.6.5928
 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Safety evaluation of a polyherbal formulation: Acute and sub-acute toxicity study using Wistar Albino rats

“…Clinical observations performed during the trial in animals assigned to the dosage and surveillance groups showed that oral administration of VNC during the sub-acute toxicity study period had no adverse effect on rat development and physiological functions. The current sub-acute toxicity investigation estimated biochemical and hematological assessments because they are among the essential indicators for gauging the safety of the formulation (Ghauri et al, 2022). There was no recovery in the surveillance group, and the male rats in the therapy group exhibited no signs of improvement in HGB, RBC count, PCV, PLT count, or MCH [Table 7)].…”