Topical Application of Glycerine – Paraffin Combination in CKD-associated Pruritus and Uremic Xerosis: Study Protocol for a Randomized Control Trial

Abstract

Background: Chronic kidney disease associated pruritus (CKD-ap) and xerosis is intensely annoying and unpleasant manifestations associated with maintenance renal dialysis (MRD) among chronic kidney disease (CKD) patients. It severely compromises the quality of life by disturbing normal sleep pattern and also adversely affect the mental health in CKD patients. Many proposed treatment plan for CKD –ap is tested but none of the treatment plan provide complete relief from itch associated with MRD. Glycerine accelerate barrier repair and also has rapid hydrating and smoothing effect while Paraffin preserve the barrier function against irritant. As a comparator Mustard oil is used as it is commonly used home remedy by people in Indian sub-continent for dry skin.
 Objectives: The primary objective of the study is to compare the efficacy of Glycerine –paraffin combination with mustered oil on skin related quality of life among CKD patients with CKD-ap and xerosis.
 Methodology: A randomised, single blind, controlled, clinical trial intending to investigate and compare the efficacy of Glycerine – Paraffin combination with mustard oil in CKD –ap and xerosis and overall SRQOL among CKD patients. The study aims to enrol 140 CKD patients having moderate to severe CKD-ap and xerosis by using GI gammal score (standardized tool for assessment of xerosis). They will be randomly distributed among 2 parallel group, experimental & control group. Allocation concealment will be maintained by using SNOSE technique. Experimental group will be instructed to apply glycerine paraffin combination and mustard oil to control group twice a day for 4 weeks. participant will be evaluated for xerosis and pruritus score at baseline, day 7, day 28 and day 56. Scores of SRQOL will be assessed at baseline and on 56 days. 
 Conclusion: The RCT aims to identify & compare the efficacy of Glycerine –paraffin combination with mustard oil on skin related quality of life among CKD patients with CKD-ap and xerosis.