Abstract

EFFECTIVENESS OF THE NEPHRO ABHAYA (A PLANT BASED FORMULATION MANUFACTURED BY SDM PHARMACY) ON GLOMERULAR FILTRATION RATE IN PATIENTS OF CHRONIC DIABETIC NEPHROPATHY

Acharya G. Shrinivasa, Naveen Chandra* and Ballal Muralidhara

Abstract

Objective: To investigate whether the medication with the plant based formulation Nephro abhaya is effective in improving the glomerular filtration rate in patients suffering from morbidity of basti marma / diabetic nephropathy thus improving the life expectancy of patients. Design: Study Type - Interventional; Allocation - Randomized; Endpoint Classification - Efficacy Study; Intervention Model - Parallel Assignment; Masking: double blind (Subject, Investigator,); Primary Purpose – Treatment. Setting: 100 patients suffering from diabetic nephropathy attending the out patient department of Sri Dharmasthala Manjunatheshwara Ayurveda hospital, Udupi during the period January 2016 to January 2018. Participants: 97 patients with diabetic nephropathy were randomly assigned 1:1 to oral administration of Nephro abhaya (n=50) or placebo (n=47). The randomization sequence was done by computer generated permuted block randomization with block size of 6 and is concealed using sealed sequentially numbered drug containers. Main outcome measures: Primary outcome measures - Cystatin c, eGFR, and microalbuminuria. Secondary outcome measures - serum creatinine, blood urea and HbA1c. Results: the initial value of Cystatin c in Nephro abhaya group at base line was 1.331 (SE 0.0355) and which reduced 1.160 (SE0.0355) after the medication. The initial mean value of eGFR in Nephro abhaya group was 56.693 ml/minU.73m2 (SE 2.152) that improved to 69.739 ml/minU.73m2 (SE2.902) following medication thus recording an improvement to the tune of 13.383 ml/minU.73m2. The mean value of microalbuminuria at base line in Nephro abhaya group was 92.420 mg/dl (SE 14.021) that came down to 53.360 mg/ dl (SE8.494) after 96 days of medication thus recording a mean reduction of 39.06 mg/ dl. Also this change was statistically significant as analyzed by paired t test showing p = 0.019. Conclusion: Nephro abhaya is effective in reducing the Cystatin c and improving the eGFR with out elevating the blood sugar level. The serum creatinine and blood urea level is also improved by the medication with Nephro abhaya. The observed improvement in the renal function, point towards the requirement of continuing the same for the longer duration for improving the life of ailing kidney. Trial registration: RGU:R&D:Res.Wing:2014-15 DATED:13-03-2015

Keywords: Prameha, Nephro abhaya, morbidity of basti marma, diabetic nephropathy.