Abstract

Background The trial drug Nerunji ver kudineer poly herbal combination which is referenced from Aathma ratchamirtham Ennum Vaidhya Sarasangiragam, and primarily indicated for Kalladaippu (Urolithiasis). Even though it is from herbal origin, the safety profile such as acute and sub acute toxicity has to be evaluated for the purpose of safety concern. Objective: To investigate the acute and sub-acute toxicity of Siddha poly herbal formulation Nerunji ver kudineer (NVK). Method: Acute oral toxicity and sub acute toxicity of NVK is carried out as per the OECD-423 guidelines after obtaining the animal ethical clearance from Institutional Animal Ethics Committee no IAEC/P.BERNATH/TNMGRMU/MD(S)/321611002/KMCP/24/2018. In the acute toxicity study female albino mice administered single oral dose (0,300,2000 mg/kg/bw) of NVK, while in sub-acute toxicity study male and female Wistar rats administered daily oral doses (50, 100,200 and 400 mg/kg/bw) of NVK for 28 days. At the end of the study, the animals were humanely sacrificed and assessed for the effect of NVK on body weight and relative organ weights and haematological, biochemical and histopathological parameters. Results: In the acute toxicity study no mortality or behavioural changes were observed in mice treated with a single dose of NVK upto 2000 mg/kg/bw .So that dose is taken as LD50 . Similarly there is no such altered behaviours seen in Sub acute toxicity when trail drug is administered daily oral doses (50, 100,200 and 400 mg/kg/bw). Conclusion: These results exhibit the absence of acute and sub-acute oral toxicity after treatment of NVK in female albino mice and wistar rats respectively. However, further clinical studies humans are needed in order to have sufficient safety evidence for its use in humans.