PA02.12. Toxicity studies on shankha vati

PURPOSE: Shankha Vati, a classical Ayurvedic formulation that is widely used by the practitioners of Ayurveda, contains a heavy metal i.e. Parada (mercury) and a poisonous herbal drug i.e. Vatsanabha (Aconitum chasmantum Staff.ex.Holmes) along with other ingredients. There are certain apprehensions on this formulation, mainly due to the presence of its ingredient Vatsanabha. Shankha Vati (Bhaishajya Ratnavali 10/186 – 187, also in Ayurvedic Formulary of India Part1), is one of the formulations in which Vatsanabha is used without its usual coingredient and antidote Tankana (borax). With an hypothesis that classical combination of Shankha Vati is not completely safe and there could be some adverse effects due to the presence of poisonous ingredient Vatsanabha in it, and any possible adverse effects of Shankha Vati due to the presence of Vatsanabha will be nullified by the addition of Tankana to the formulation, another modified formulation with the addition of purified Tankana equal to the quantity of Vatsanabha in the classical Shankha Vati, was also taken up for the study. METHOD: Acute toxicity study as per OECD Guideline 425, and Chronic toxicity study (90 days with the recovery period of 30 days) as per AYUSH170 guideline (Guidelines for preclinical safety evaluation for Ayurveda, Siddha and Unani drugs and other traditional medicines in India) were carried out. Biochemical and haematological investigations were carried out on 30th, 60th, 90th and 120th days. Histopathological study of acute chronic toxicity study were carried out. RESULT: Histopathological study of both acute and chronic toxicity study were also carried out. There were no toxicity related changes found in the animals treated classical Shankha Vati as well as modified Shankha Vati in both acute and chronic toxicity study. Similarly biochemical and haematological investigations also did not toxicity related changes. CONCLUSION: Classical formulation of Shankha Vati is completely safe and there is no need to modify the composition to make it safer.