Acute and Sub-acute toxicity studies of a herbal formulation Kadukkai chooranam

Abstract

Introduction: Kadukkai chooranam is an effective drug composition from siddha medicine used for the management of Menorrhagia/Dysfunctional Uterine bleeding (Pitha perumbaadu) which is referenced from a classical age-old text Agathiyar attavanai vaagadam. Aim of this study The aim of study was to assess the acute and sub-acute toxicity of the polyherbal composition kadukkai chooranam. Methodology: In the acute toxicity study, a single dose of 2000 mg/kg was administered to wistar albino female rat (200-220g) after the proper acclimatization and fasting procedures was made as per the OECD 423 – acute toxicity guidelines. All the animals were observed for physical symptoms and behavioral changes for first 72 h. In sub-acute toxicity study repeated doses of the polyherbal composition was administered to Wistar albino rats of both genders, separately acclimatized for 7 days and fasted as per OECD -407 guidelines. The animals received two doses of drug (100 mg/kg/day and 200 mg/kg/day) for a period of 28 days. On 28th day of experiment, blood sampling of animals was done for hematological and biochemical analysis i.e. liver and renal function parameters, lipid profile and then sacrificed for histopathological study of liver and kidney. The rats were observed daily during the period of study, and sacrificed on the 29th day. Observation parameters of the animals included a comparative evaluation of general appearance/behaviour, morbidity/mortality, body weights, haematology, biochemistry, lipid profile and histopathology of major organs of treated and control groups. Results There was no morbidity and mortality noticed with single dose administration in acute toxicity study in wistar rats. In sub-acute toxicity study, no morphological changes were observed in kidney, liver and spleen of animals at dose of 100 mg/kg/day and 200 mg/kg/day. Conclusions The results of the present study show that oral administration of kadukkai chooranam did not produce any severe toxic effects in both acute and sub-acute studies in Wistar rats. Therefore, usage of an appropriate dosage will be preferable and considered as safe.