Acute and sub acute toxicity of Amirdha Gandhi Kukkil Vallathy an effective Siddha herbo mineral formulation used in the treatment of rheumatoid arthritis in wistar albino rat model.

ABSTRACT

OBJECTIVES: Amirdha Gandhi Kukkil Vallathy (AGKV) is a herbo mineral Siddha formulation which has Sulphur, Kukkil, Seendhil and Serankottai as major ingredients and it is indicated for 80 types of Vatham diseases. Uthiravatha suronitham is one among the vatham diseases and it's clinical symptoms are correlated with Rheumatoid arthritis (RA). Since AGKV is a promising drug for RA, the safety of this drug has been validated by performing the acute and 28 days repeated oral dose toxicity study following the OECD guidelines 423 and 407. METHODS: The acute toxicity study has been performed by administering orally with a single dose of 300 and 2000 mg/kg body weight in rat models and the animals were observed for 14 consecutive days. Gross pathology was observed and animals were sacrificed at the end of the study. In 28 days repeated oral toxicity study, limit test has been carried out with a dose of 1,000 mg/kg body weight. RESULTS: No significant abnormality has been observed in the body weight, organ weight, biochemical parameters and histopathology studies. It has been revealed that this drug is safe upto 2000 mg/kg body weight in single dose study and 1,000 mg is a safer dose in the 28 days repeated oral toxicity study. CONCLUSIONS: The results of acute and 28 days repeated oral toxicity studies revealed no adverse effects in animals and hence this drug AGKV is safe and can be administered in human.