BackgroundNuna Kadugu (NK), a Siddha medicine prepared from leaves and fruits of Morinda Pubescens, used for the treatment of various skin diseases. Though NK has been widely used for several decades, no scientific report was available on its safety. Present study was undertaken to demonstrate the oral toxicity of NK in Sprague Dawley rats.MethodsAcute and 28-day repeated oral toxicity studies were performed following OECD test guidelines 423 and 407, respectively, with minor modifications. In acute oral toxicity study, NK was administered at 2000mg/kg b.wt., p.o and animals were observed for toxic signs at 0, 0.5, 1, 4, 24 h and for next 14 days. Gross pathology was performed at the end of the study. In repeated dose, the 28- day oral toxicity study, NK was administered at 300, 600 and 900 mg/kg b.wt./p.o/day. Two satellite groups (control and high dose) were also maintained to determine the delayed onset toxicity of NK. Animals were observed for mortality, morbidity, body weight changes, feed and water intake. Haematology, clinical biochemistry, electrolytes, gross pathology, relative organ weight and histopathological examination were performed.ResultsIn acute toxicity study, no treatment related death or toxic signs were observed with NK administration. In the repeated dose study, no significant differences in body weight changes, food / water intake, haematology, clinical biochemistry and electrolytes content were observed between control and NK groups. No gross pathological findings and difference in relative organ weights were observed between control and NK treated rats. Histopathological examination revealed no abnormalities with NK treatment.ConclusionAcute study reveals that the LD50 of NK is greater than 2000mg/kg, b.wt. in fasted female rats and can be classified as Category 5. 28-day repeated oral toxicity demonstrates that the No Observed Adverse Effect Level of NK is greater than 900 mg/kg b.wt./day, p.o in rats. There were no delayed effects in NK satellite group. In conclusion, NK was found to be non-toxic in the tested doses and experimental conditions.

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The symptoms of dermatophytosis goes congruent with the disease entity Padarthamarai in Siddha medicine. Kandhaga Rasayanam (KR) is a Siddha herbo-mineral formulation indicated for padarthamarai. In recent times, treatment of dermatophytosis challenge to dermatologists. The present study was carried out to clinically evaluate the efficacy of KR as a trial drug for Dermatophytosis. The objective of the present study was to study the efficacy of the drug KR in giving mycological and clinical cure. This was an open-label, non-randomized, single -arm clinical study in which 51 patients of either gender diagnosed with padarthamarai were included. The trial was registered in Clinical trials registry India with CTRI number CTRI/2012/01/002362. The treatment period was 45 days. Out of the 51 participants enrolled in this study, 45 participants were included in the final analysis based on their adherence to the conditions. 66.67% showed skin scraping negative for dermatophytes. There was a significant reduction in the clinical signs after the treatment without any adverse reactions. This trial has brought to limelight the efficacy of the Siddha drug Kandhaga Rasayanam in treating padarthamarai . Further, randomized controlled clinical trials are necessary to substantiate the traditional claim and make KR a plausible treatment option for Dermatophytosis.