Homeopathy as an add-On treatment in Pre-dialysis chronic kidney disease (HOPE): A randomised, double-blind, three-arm, placebo-controlled trial.

Chronic kidney disease (CKD) is a non-communicable, slowly progressive, irreversible loss in the functioning of kidneys that usually develops over a period of years. According to World Health organization (WHO) Global Burden of Disease project, diseases of the kidney and urinary tract contribute to global burden with approximately 850,000 deaths every year and 115,010,107 disability adjusted life years. CKD is the 12th leading cause of death and 17th cause of disability. Complementary and alternative medicine (CAM) may provide new therapeutic options for the patients with CKD progressing to ESRD with the goal of improving symptoms and QOL. There are very primitive studies undertaken in homoeopathy to evaluate the role of homoeopathy in CKD, whereas studies on QOL is still lacking. No quality works have been carried out upon QOL among CKD patients. Therefore this study has been proposed to determine the effectiveness of add-on homoeopathy to the standard care among pre-dialysis patients suffering from chronic kidney disease. It is a randomized, placebo-controlled, double-blind, double-dummy, three parallel arm study to be conducted at Agartala Govt. Medical College, Tripura and Regional Research Institute (H), Gudivada. Patients of both genders, 18-70 years of age with stage II or stage III  CKD as per Kidney Disease: Improving Global Outcomes (KDIGO) guidelines & having albumin-to-creatinine ratio (ACR) more than or equal to 30mg/g [more than or equal to 3mg/mmol] and who gave written informed consent will be included. After inclusion, patients will be randomly assigned in a 1:1:1 ratio using a computer-generated random allocation sequence to either one of three groups:  Standard care along with Active homeopathic medicine in CH-potency plus dummy-LM potency;  Standard care along with Active homeopathic medicine in LM-potency plus dummy-CH potency; and  Standard care along with CH potency placebo plus LM potency placebo. The medicines which the participant is taking before enrolment will be continued during the study period. The study duration is of 3 years and sample size calculated is 100 participants in each group. The primary outcome is to note the changes in Serum Creatinine levels and eGFR value over 12 months. All the data will be collected and statistical analysis will be done as appropriate i.e. parametric for continuous data and non- parametric for ordinal or count data.