Assessment of Long-term Toxicity of Siddha Polyherbal formulation Thiripalathi Kashayam in Wistar Rats

Abstract

ABSTRACT: 
Introduction: Medicines derived from natural sources have long served as a foundation for the development of pharmaceutical drugs. Traditional herbal medicines consist of naturally occurring plant-based substances that have been widely used for the prevention, treatment and management of various diseases as well as for nutritional support. Toxicological evaluation plays a crucial role in ensuring safety by assessing the potential risks and benefits of both synthetic and natural substances. Several investigations have reported the toxicity assessment of different medicinal plants and herbal formulations. Thiripalathi kashayam is an antidiabetic medicine mentioned in the Siddha literature; its toxicological evaluation is essential, particularly in the present context of the increasing demand for safe herbal antidiabetic drugs.
  Objectives: Objective of this study to evaluate the adverse effect of Thiripalathi Kashayam after long term   administration for 90 days in Wistar albino rats
.Methods: Animals were divided into five groups, each treated with 4, 8, 16 ml/kg body weight of Thiripalathi Kashayam corresponding to half, one and double times the proposed human therapeutic dose, for 90 consecutive days. The fifth group (satellite) received 16 ml/body weight of Thiripalathi Kashayam for 120 days. Body weight and food intake were measured weekly. At the end of the study, all animals were euthanised & serum, blood, and organs were collected and analysed using serum biochemistry, haematology and histopathology. The satellite group was kept for 4 weeks after treatment.
Results: No significant treatment-related toxicological findings were noted in the clinical features, bodyweight, laboratory investigations and pathological findings of the high-dose treated groups, when compared to those of the control group.
Conclusions: No observed adverse effect level for Thiripalathi kashayam at the dose of 16 ml/kg bodyweight.