Acute and Subacute Toxicity studies on Siddha Herbo-mineral Anti-arthritic formulation "Pooneeru Diravagam" in experimental animal models

Ethno pharmacological Relevance: 60% of the world's population depends on traditional medicine [1]. It is in use for primary health care and general health care among rural, urban, semi urban in both developed and developing countries parallel to the usage of western medicines. Pooneeru diravagam is an indigenous Siddha medicine [2]. There is a huge cry, tall fake claims regarding the safety and efficacy of Siddha formulations. The present study is aimed to evaluate the safety of Pooneeru diravagam by determining any toxicity changes through acute and sub-acute toxicity studies per oral administration in swiss albino rats. Materials and Methods: Acute toxicity study was carried out as per OECD Guideline-423 in healthy swiss albino female rat weighing 200?245 gm. The Study was carried out in three female rats under fasting condition; signs of toxicity were observed for every one hour for first 24 hours and every day for fortnight from the beginning of the study. Sub acute toxicity study was carried out as per OECD guidelines-407 in swiss albino rats of either sex weighing 220?245 gm of three groups of 6 rats each (Three male and three female) at two dosage levels 0.2 ml and 0.4 ml of 28 days continuous drug administration (oral route). Results: The animals were sacrificed on the 29th day and various blood biochemical parameters haematological and clinical signs were measured. The organ morphology such as kidney, liver, heart, lungs, spleen, pancreas, brain, ovaries and testes were processed for Histopathological study. The results of sub-acute toxicity on 29th day did not show any evidence of changes. Physiological, Hematological as well as Histopathological parameters remained unaltered when compared with control animals throughout the dosing period. Conclusions: From the results it is concluded that usage of pooneeru diravagam at the dosage of 0.4 ml/kg p.o is safe for the population suffering from rheumatoid arthritis.