Study of Efficacy,Safety and Tolerability of Ayurvedic Formulation in participants with Diabetic Kidney Disease

Diabetic kidney disease is an important health hazard with increasing no of cases. Management of established diabetic kidney disease according to conventional science demands for effort to achieve good glycaemic control and a normal blood pressure and to correct any other risk factors for CVD. There is no targeted therapy for nephroprotection , only serious threats are been taken care of. The present study is undertaken to trace the genesis of diabetic kidney disease and eventually enable to study the effect of specific nephroprotective drug mentioned in Ayurvedic literature in slowing progression of the disease or to protect or even revert the disease process. The aim of the study was to study the safety, efficacy and tolerability of Bruhatyadi Kashay Ghana â€“ a polyherbal formulation in management of diabetic kidney disease. Clinical study was carried out at OPD department of both study centers. Institutional Ethics Committee approval was obtained from both IEC. Single blind randomized placebo-controlled phase 3 clinical trial was executed with sample size of 90 participants duly calculated by statistician. Specifications regarding Diagnostic criteria, Inclusion and Exclusion criteria were defined. CKD stage 3a and 3b were targeted in present study.  Standard care included oral hypoglycemic agents, antihypertensive drugs (ACE inhibitors/ARB blockers) and antilipid molecule.  Microcrystalline cellulose was used as placebo. The study drug, Bruhatyadi Kashay Ghanawas prepared strictly observing principles mentioned in classics. Study drug was administered in dose of 4 gm / day as human dose in two divided doses before food. Contemplating the progressive nature of the disease, review of time span on its progression, feasibility in terms of retaining participants under clinical trial, the actual medication duration of six months was decided for this study with follow up at every month. Specially designed case record form was maintained for record keeping. ACR, eGFR (according to EPI equation), Serum Creatinine, Blood Sugar Fasting and Post Lunch, HbA1c, Urine Routine and Microscopic, Lipid Profile, Serum Electrolyte were the objective parameters assessed in this study at baseline, after 90 days and at end of the study (180 days). Symptoms were graded on the 4-grade scale (0-III) and were assessed at each follow-up. Total 99 participants were enrolled in the study after strictly observing diagnostic parameter and inclusion and exclusion criteria within approximately period of 3 years. 90 participants completed study whereas 9 dropped out. Randomization schedule provided by the statistician was considered for allocation of participants in two groups. Observed findings were subjected to suitable statistical techniques and results were interpreted. Conclusion was drawn on basis of obtained results.