A Prospective clinical trial of RENOCHLOR (Sodium Copper Chlorophyllin complex) formulations as an add-on therapy for the Management of Chronic Renal Failure (CRF)
Authors: Gharpure Milind , Varma Nikhil , Mote Ravindra , Rao Ramesh , sawant chaitanya , Shukla Anurag 
Published: June 2022

Abstract
Background: The study was performed to evaluate the efficacy of Renochlor tablet in comparison with Renochlor syrup for the Management of Chronic Renal Failure (CRF) / Chronic Kidney Disease. The primary objective of this study was to evaluate (Already proven) comparative performance of Tablet and Syrup dosage forms/Formulations and correlation of TGS-beta 1 as indicator of kidney function status in Chronic Renal failureHypothesis : to Access the efficacy of sodium copper chlorophyllin complies through Controlled randomized trial using primary end point as e GFR and secondary as decrease in fibrosis marker TGFb1 and albumin creatinine ratio. Study design: It was a Prospective, Observational, Randomized, Open labelled, Multicentre, Parallel-Group, Two-arm, clinical trial to evaluate comparative performance of Tablet and Syrup dosage forms/FormulationsMethod: It was a Prospective, Observational, Randomized, Open labelled, Multicentre, Parallel-Group, Two-arm, clinical trial to evaluate comparative performance of Tablet and Syrup dosage forms/Formulations and correlation of TGS-beta 1 as indicator of kidney function status as an add on to the standard of care ( pl give standard care details) for the management of Chronic Renal Failure (CRF). In the study, patients were randomized in the ratio of 1:1. All the subjects were asked to take Renochlor Tablet (Sodium Copper Chlorophyllin) plus Standard Care of Treatment (1 tablet of 40 mg Sodium Copper Chlorophyllin Complex (active ingredient), TID) or Renochlor Syrup (Sodium Copper Chlorophyllin Complex) plus Standard Care of Treatment (10 ml TID, Each 10 ml contains 40 mg of Sodium Copper Chlorophyllin). The study medication was continued for 90±5 days with periodic follow-up of 30 days. On visit 2 visit 3visit 4 and visit 5 from start of treatment. This was CTRI registered trial (CTRI/2021/04/032987) with 5 clinical trial sites across India. Results: The study showed the percentage increased eGFR from baseline to end of study treatment for Renochlor Tablet (n=22) and Renochlor Syrup (n=21). The eGFR increased by 12.45 %, 13.53 % and 27.33 % in respective visits in patients treated with Renochlor Syrup. The eGFR increased by 11.27 %, 23.64 % and 36.04 % in respective visits in patients treated with Renochlor Tablets. The mean percentage reduction in Serum Creatinine was by8.82%, 16.5%, 23.5% in Renochlor Tablet; whereas mean percentage reduction in Serum Creatinine was by 9.44%, 8.89%, 17.8% in Renochlor Syrup The mean percentage reduction in Albumin to Creatinine Ratio was by 20.08%, 26.09%, 29.91% in Renochlor Tablet whereas mean percentage reduction in Albuminn to Creatinine Ratio was by 22.48%, 26.27%, 30.76% in Renochlor Syrup ( remove – sign). The mean percentage reduction in Serum Urea was by 11.64% in Renochlor Tabletwhereas mean percentage reduction in Serum Urea was by 9.76% in Renochlor Syrup ( remove – sign).The mean percentage reduction in Blood Urea Nitrogen was by 10.38%, 21.27%, 22.40% in Renochlor Tablet whereas mean percentage reduction in Blood Urea Nitrogen was by 10.99%, 11.06%, 14.51% in Renochlor Syrup. The mean percentage reduction was observed in Serum Electrolytes in both Renochlor Syrup. The mean percentage reduction in TGF β-1 was by 14.56% in Renochlor Tablet whereas in Renochlor Syrup was by 10.55% when compared with baseline to end of study visit.( Above differences in the clinical parameters of Tablet group and Syrup group are statistically significant.There were 10 clinical adverse events ( AEs) reported in 10 patients. Out of total 10 AES, 04 AEs were reported in Renochlor Tablet and 06 AEs were reported in Renochlor Syrup. There were no SAEs (Serious Adverse Events) reported in overall conduct of the clinical study. Conclusion: Both dosage forms on RENOCHLOR,ie syrup and tablets (Sodium Copper Chlorophyllin Complex) is safe and efficacious . Reduction in TGF β-1 , S Creatinine, BUN , ACR ration. Increase in eGFR. Clinically and statistically significant in chronic renal failure, However tablets in Renochlor Tablet proved marginally superior in primary and secondary efficacy end points when compared with Renochlor Syrup