Preclinical evaluation of safety and therapeutic efficacy of siddha herbo mineral compound Kara Sooda sathu parpam for kalladaippu noi Urolithiasis

Abstract

The present study was carried to evaluate the safety and efficacy of the siddha herbo mineral drug, Kara sooda sathu parpam in the management of Kalladaippu noi (Urolithiasis) with animal experimentations and in vitro methods. The drug analysis was also carried out to explore the chemical nature of the drug. The drug analysis revealed the presence of elements like calcium, sodium, boron, potassium, magnesium, zinc and iron. The groups present were carbonate, sulphate, chloride and nitrate. The XRD revealed the presence of calcium in oxide and carbonate form. The particle size ranged from nano to micro size which enhances the bioavailability of the drug. In vitro anti-oxidant studies revealed that the drug is a good antioxidant and is efficacious as that of ascorbic acid both in DPPH and Nitric oxide scavenging assays. The drug inhibited the growth of calcium oxalate crystals in vitro by single diffusion gel growth technique and the inhibition was dose dependent manner. The drug exhibited a moderate anti-microbial activity against E.coli and Proteus mirabilis, which are the most common pathogens causing UTI on patients suffering from urolithiasis. The acute and long term toxicity study revealed that the drug KSSP was safe up to 10 times the therapeutic dose as mentioned in the literature. The histopathological studies supported the same. The diuretic study revealed that the drug KSSP increased the urine output and also the excretion of electrolytes. The activity was in par with the standard drug. The drug also showed potent anti-inflammatory activity. To conclude the drug KSSP exerts its beneficial effect in Kalladaippu noi (Urolithiasis) by being a good anti urolithiatic, diuretic, antioxidant, anti-inflammatory and a moderate anti-microbial. The drug Kara sooda sathu parpam (KSSP) should be subjected to clinical trial to validate the efficacy of the drug for human use. The drug is also recommended to be validated for its preventive effects and also as a supportive therapy to other conventional medical expulsive therapies.