Preclinical and open clinical trail of Gandhi Mathirai (Internal Medicine) and Sagala Ranangalukum Kalimbu (External Medicine) in the treatment of Madhumega Viranam (Diabetic Ulcer)

The raw drugs of GM 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. The toxic elements like Mercury, Arsenic and Cadmium are not detected. The Lead present in GM is within the WHO permissible limit. The study shows that GM did not produce any toxic effect in repeated oral toxicity study for 90 days. This study has been approved by NIS/IEC/2016/11-15/14.10.2016. The disease diabetic ulcer was taken for the clinical study with Gandhi mathirai andSagala ranagalukum kalimbu 30 cases were selected based on the approved protocol. Animal studies were done after obtaining approval from the Animal Ethical Committee (IAEC). Hence the study was safely executed on patients and there was no adverse drug reactions noted during the study period. The detailed study on diabetic ulcer with reference to its aetiology, pathogenesis, investigations, clinical features, diagnosis and treatment with trial drug was done. According to BJWAT scoring, before treatment 28 patients were score between the no on 27-52 and 2 patients were score between 53-65.After treatment 15 patients was score 13,10 patients were scored 14-26,5 patients were scored 27-52. The results were observed by BJWAT score. Among the 30 cases treated, 15(50%) cases showed Good improvement, 7(23.4%) cases showed Moderate improvement and 8(26.6%) cases showed Poor improvement. The mean± standard error of mean of BJWAT score at before and after treatment were 39.93 ± 8.072 and 18.66±7.288 respectively which is statistically significant (t= 11.9576, p