Evaluation of Safety and Efficacy of a Siddha Herbal Preparation Parangipattai Rasayanam for Kalanjagapadai Psoriasis and Its Clinical Management

Abstract

The raw drugs of PRM were identified and authentication certificate was obtained. The physicochemical analysis of the prepared drug revealed that it was in the standard quality. HPTLC were done to identify phyto-chemicals and their Rf values were calculated. By comparing with flavonoid standards Gallic acid and quercetin, the PRM sample exactly match with Rf value and it was confirmed that it contains Gallic acid and quercetin. The toxic elements like Mercury, Arsenic and Cadmium are not detected. The Lead present in PRM is within the WHO permissible limit. The study shows that PRM did not produce any toxic effect at dose of 2000 mg/kg. So No-Observed-Adverse-Effect-Level (NOAEL) of PRM is 2000 mg/kg. NOAEL of PRM was found to be greater than 900 mg/kg/p.o/day in rats. The disease Kalanjagapadai was taken for the clinical study with Parangipattai Rasayanam and 40 cases were selected based on the approved protocol. Hence the study was safely executed on patients and there was no adverse drug reactions noted during the study period. The detailed study on Kalanjagapadai with reference to its etiology, pathogenesis, investigations, clinical features, diagnosis and treatment with trial drug was done. The mean standard error of mean of PASI score at before and after treatment were 41.083+ 1.385 and 9.583+41.136 respectively which is. Statistically significant (t= 18.854, p lt 0.0001). The results were observed by Psoriasis Area and Severity Index (PASI) score. Among the 40 cases treated, 29 (72.5%) cases showed Good improvement, 7 (17.5%) cases showed Moderate improvement and 4 (10%) cases showed Poor improvement. The poly herbal formulation Parangipattal Rasayanam (PRM) exhibited no toxicity on short term administration. The present clinical study confirms the efficacy and safety of the trial drug Parangipattai Rasayanam which is Siddha poly herbal formulation. It was found to be good resulting on Kalanjagappadai patients in reducing clinical signs and symptoms like itching, scaling and erythema.