A Comparative Study on Assessing the Efficacy and Safety of Combination of Palmitoylethanolamide, Genistein, Diadzein )(Capsule Palmitole) as an add on therapy with Standard therapy in patients with Diabetic Neuropathy-A Randomised Open Labelled Prospective Study

This study is aimed to assess the safety and efficacy of Palmitoylethanolamide, Genistein, Daidzein in treatment of diabetic neuropathy as an add on therapy to standard therapy in comparison with standard therapy alone. This can pave the way for a new promising drug in treating neuropathic pain without CNS depressive effect. Patients with Diabetes neuropathy and fulfilling the inclusion criteria will be included in the study.On enrolling for the study, all the participants will be assessed clinically by Tip-Therm test, Monofilament test, Biothesiometry and using Self reported Leeds Assessment of Neuropathic Symptoms and Signs(S-LANSS); Neuropathic pain Diagnostic Questionnaire(DN4).Clinically diagnosed participants with pain score more than 12 on S-LANSS and more than 4 on DN4 will be included for the study. Baseline investigations including CBC,RFT,LFT,FBS,PPBS, Lipid profile before the start of the study. Participants will be randomized  into two groups;Participants in the control group will take standard therapy for diabetic neuropathy whereas the participants in study group  will receive C.Palmitole354mg BD for 12weeks as an add on therapy along with Standard therapy for 12weeks.Participants will be followed up at 4weeks,8 weeks and 12 weeks-pain will be assessed using BPI-DPN Pain scale along with FBS,PPBS at each visit. Participants will be assessed clinically by Tip-Therm test, Monofilament test, Biothesiometry at 12weeks. CBC, RFT, LFT, Lipid profile will be done at 12 weeks of study.All ADRs will be noted, analyzed and reported to the Regional Pharmacovigilance centre using the CDSCO ADR Reporting form.