A Clinical Study of the effect and validation of Vranari Guggulu and Karanjadi Vranalepa in the management of Madhumehajanya Vrana (Diabetic Foot Ulcer)

A clinical trial is initiated to generate evidence for the scientific validation of the clinical efficacy and safety of classical Ayurvedic formulation Vranari Guggulu twp tablets(500mg) and Karanjadi Vranalepa(external application) in Madhumehajanya Vrana (Diabetic Foot Ulcer) at Dr.NRS Govt. Ayurvedic College, Vijayawada for the PhD study under Dr.NTR University of Health Sciences, Vijayawada.  In the study Vranari Guggulu 500 mg b.i.d. internal administration and Karanjadi Vrana lepa as external application given for Group I patients (i.e. 50 patients), Kanchanara Guggulu 500 mg b.i.d. internal administration and Vajraka thailam as external application given for Group II patients (another 50 patients). This study will be conducted in India and completed in 4 years duration.  The primary outcome measures will be relief in signs and symptoms,  Mean percentage change in wound area, Recognized clinical prognostic factors like reduction in wound area, depth and wound healing.  Proportion of patients with complete wound closure (i.e. complete skin epithelialization) after initiation of study treatment.  Any adverse drug reaction or event occurs during the trial also will be documented.   Kanchanara Guggulu consists of bauhinia varigata, terminalia chebula, terminalia bellerica, emblica officinalis, zingiber officinale, piper nigrum, piper longum, crataeva nurvala, elettaria cardamomum, cinnamomum zeylanicum, commiphora mukul. Vajraka thailam consists of saptaparna, karanja, malathi, chitraka, sariva, vatsaka, langali and gomutra and thailam. Vranari Guggulu consists of pippali(piper logum) 1 part, guggulu(commiphora mukul)5parts, triphala each 3 parts, rasa sindura 1 part. Karanjadi vrana lepa consists of sasi(camphor) 1 part, Girivara 2 parts, Tutha(CuSo4) 3 parts, yashti(glycerrhiza) 4 parts, bakuchi(psoralia) 5 parts Karanja 6 parts.