A Prospective open labelled single arm non randomized single centric phase II clinical trial on vedigara silasathu parpam in the management of Azhal neerchurukku (Urinary tract infection)

This is A Prospective, open labelled, single arm,non randomized, single centric,phase II clinical trail on vedigara silasathu parpam inthe management of Azhal neerchurukku ( Urinary tract infection). The trial drug Vedigara silasathu parpam is freshly prepared and administered at a dosage of 130 mgs (Twice a day orally) with Ghee ( pasu nei) as adjuvant for 10 days for 40 known Urinary tract infective patients (20 OP & 20 IP patients). The primary outcome will be to determine the  therapeutic efficacy of vedigara silasathu parpam in management of Azhal neerchurukku (UTI). The secondary outcome will be to collect various aspects of Azhal neer churukku in Siddha literatures, to evaluate physico chemical,phyto chemical and bio chemical characters of Vedigara silasathu parpam, to evaluate safety profile for assessing acute and sub-acute toxicity of trial drug – Vedigara silasathu parpam, to study antimicrobial activity of Vedigara silasathu parpam against various pathogenic micro organism, to evaluate pharmacological analysis of vedigara silasathuparpam, study about the prevalence of Azhal neerchurukku in relation between diet and life style, to evaluate siddha parameters (including Envagai thervu) changes in Azhal neerchurukku during the study period, to evaluate modern parametric changes in Azhal neerchurukku, to evaluate the efficacy of vedigara silasathu parpam on Azhal neerchurukku by the Bio statistical analysis.