Evaluation of preclinical toxicity of a Siddha formulation Kandhaga Rasayanam and its therapeutic efficacy in padarthamarai (dermatophytoses) by an open clinical trial

The evaluation of the safety and efficacy of Kandhaga Rasayanam by preclinical and clinical methods was carried out to have a documentary evidence for the safety and efficacy of the compound formulation. The work was a reverse pharmacological work. The scientific validation was done by doing preliminary analytical studies, acute and long term toxicity studies and an open clinical trial. The results of the physico-chemical analysis showed the drug was free from heavy metals. The pesticide residues, aflatoxins, microbial load were within normal limits with reference to WHO/AYUSH standards. The toxicity studies proved the non- toxic nature of the drug Kandhaga Rasayanam. Hence, the drug was safe for human consumption. The efficacy of Kandhaga Rasayanam for padarthamarai (dermatophytoses) was studied by invitro methods. The results showed that KR has invitro antidermatophytic activity against three tested dermatophytes namely Trichophyton rubrum, Trichophyton mentagrophytes and Epidermophyton floccossum. An open clinical trial on tinea infections gave encouraging results. The above results have provided evidence for the therapeutic efficacy of KR in padarthamarai. The drug compliance was good and no adverse drug reactions were reported during the treatment period. After the end of follow up period recurrence of symptoms was seen in 4 patients who failed to strictly adhere to the hygienic measures. The hyperpigmentation in the skin remained the same before and after treatment. CONCLUSION: To conclude, the Siddha herbomineral drug Kandhaga Rasayanam can be used as a safe and effective drug for dermatophytoses in its initial stage