Preclinical Evaluation and Standardization of Seenakara Parpam in the management of Kalladaippu Noi (Urolithiasis)

The present investigation was carried out to evaluate the safety and efficacy of the siddha formulation Seenakara parpam in the management of Kalladaippu noi (Urolithiasis) by suitable in-vitro and in-vivo experimental models. • Physiochemical evaluation of SKP proves the standard and genuinity of the prepared formulations. • Presence of biologically active functional groups like C-N, N-H and O-H renders promising efficacy to the drugs against urolithiasis. Further AAS analysis of sample shown that the presences of heavy metals are very low and below the prescribed limit. • Uniform distribution of nano particles may enhance the bio-availability and therapeutic property of the formulation. • Characteristic pattern of diffraction peaks observed at XRD analysis reveals the presence of polycrystalline nano particle with unique planes. • Standardization and analytical evaluation studies shows that the formulation SKP is of high standard and has good stable nano particles with active functional groups and devoid of toxic trace metals. Hence forth the biological activity of the drug may also be due to the presence of bio-active nano particle and other significant functional group present with in the formulation. • In-vitro DPPH, NO and H2O2 analysis exhibits that SKP has potential antioxidant property against the free radicals. • In vitro struvite crystal growth inhibition assay clearly reflects that SKP added medium shows significantly less number of crystal when compare to that of the control system. The average weight of crystals belongs to SKP added medium seems to be less when compare to that of the control medium. SKP has tendency to halt the growth and progression of crystal growth and hence it may serves as a better therapeutic drug for the clinical management of metabolic disorder like urolithiasis. • The acute toxicity study results have revealed that the drug SKP was safe at the maximum dose level of 2000mg/kg which was higher than the normal therapeutic dose of the drug. • The results of sub-acute and sub- chronic toxicity studies shows that long term administration of SKP at the dose level of 200 and 400 mg/kg was absolutely safe and has no evidence of adverse or toxic effect in any of the animals subjected to the study. Results of clinical biochemistry, Hematology and histopathological findings support the evidence of safety of the drug SKP in rodents upon long term administration. • The results of anti-urolithiatic activity by Ethylene glycol method revealed that the drug SKP at the dose of 100, 200 and 300 mg/kg has significantly increased the urine volume and also lowers the level of calcium, excretion in treated animals. Further there was a considerable decrease in the level of phosphate, protein, uric acid and creatinine in the urine sample. • The anti-urolithiatic evaluation by zinc implantation method revealed that the drug SKP at the dose level of 200 and 400 mg/kg was effective both in preventive and curative aspects. The drug significantly reduced the stone size and X-ray findings too revealed the same. • The anti-urolithiatic activity SKP are more convincing and promising when compare to that of the standard cystone in both ethylene glycol and Zinc implantation models. • The drug SKP at the dose of 100,200 and 300 mg/kg has significantly increased the urine output and excretion of urinary sodium and had no effect on the urinary potassium excretion. This proves the diuretic potential of the formulation. CONCLUSION: In conclusion the siddha formulation Seenakara Parpam belongs to Indian system of traditional medicines showed potential anti-oxidant, anti-urolithiatic and diuretic activity in the experimental animals. Hence this study provides evidence based results on the use of Seenakara Parpam for clinical management of kidney stone related metabolic disorders in humans.