SAFETY EVALUATION OF SIDDHA FORMULATION THEER ANDHASKHAN MATHIRAI BY ACUTE AND SUB-ACUTE TOXICITY STUDIES IN WISTAR RATS

R. Naveen Kumar*, N. Anbu and D.Sivaraman

ABSTRACT

In Siddha system of medicine, thousands of raw drugs are used to treat various kinds of diseases. These drugs are categorized into four groups namely Metals, Minerals, Herbals and Animal products. But in certain life-threatening diseases and especially in many chronic diseases, the herbal medicines alone have not been much effective. Herbal and herbo mineral preparations are being traditionally used in Indian system of Medicine especially in Siddha system. According to the Shelf life Herbo mineral preparations have more actions then any other drugs. Here THEER ANDHASKHAN MATHIRAI(TAM) is prepared as per Siddha classical text book Anuboga vaithiya Navaneetham, part 4, page no:105 – 106 to treat RA. Before clinical study there should be a need to undergone Preclinical trial as per WHO guidelines. The Clinical study was approved by Institutional Ethics Committee (IEC) and the approval number is IEC No: GSMC-CH-ME-5/004/2018. It was registered in Clinical Trials Registry-India (CTRI) and the registered number is CTRI/2019/08/020797.The present preclinical study aims to carry out safety and toxicity of the experimental protocol Theer Andhaskhan Mathirai was approved by Institutional Animal Ethics Committee (IAEC) of Sathyabama University, Chennai, Tamil Nadu, India. The approval number is SU/CLATR/IAEC/XIII/125/2019. Acute & Sub acute toxicity studies were carried out as per OECD guidelines 423 and 407. Hematological Parameters, biochemical parameters histopathological studies were performed for all animals. The study concludes that on oral administration of 100mg/kg of bodyweight of TAM to Wistar albino rats, there was no change in behaviour movements and no characteristic clinical sign of toxicity or mortality observed. From the result it was concluded that the Siddha preparation TAM offers wide margin of safety in tested rodents and further long term usage of drugs will be considered as safe for the ailment of various disease.7

Keywords: Siddha, OECD guidelines, Acute, Sub-acute, TAM, IAEC.