Evaluation of efficacy and safety of CKD Formulation in the management of Chronic Kidney Disease: A prospective, multicenter, interventional study.

Chronic kidney disease (CKD) is a syndrome defined
as persistent alterations in kidney structure, function or both with
implications for the health of the individual. It is a non-communicable
disease usually caused by diabetes and hypertension. Cardiovascular disease
is the major cause of the early morbidity and mortality sustained by patients
with CKD. Characteristic features of chronic kidney disease (CKD) involve
progressive destruction of the renal parenchyma and the loss of functional
nephrons. The loss of functional nephrons triggers molecular and cellular
events responsible for compensatory growth of the remaining ones. These
mechanisms may become pathological and result in the development of renal
lesions and lead to end-stage renal disease (ESRD).

According to lancet globally, in 2017, 1·2 million people died from CKD. The global all-age mortality rate from CKD increased 41·5% between 1990 and 2017. However, in India as we have no renal registry or a standardized diagnostic method the actual burden is still unknown and it varied widely from 2.9% to 16.54% in different studies using different methods. Lack of both awareness and treatment facilities make diagnosis possible, only at late stages of 4 or 5.

The three treatment options for CKD are medical management, dialysis or transplant. There is no cure for CKD. Advanced CKD needs dialysis or kidney transplant to maintain life. Because of the high cost and problems of availability, in India only 5 -10% of kidney patients get treatment like dialysis and kidney transplant, while the rest die without getting any definitive therapy. Therefore, early detection and meticulous conservative medical management is the only feasible and less expensive way to manage CKD and delay the need for dialysis or transplant.

Also it is known that, environmental factors also have a role in human health of which nutrition is of utmost importance, since dietary habits heavily influence the incidence and progression of a variety of pathologies, particularly non-communicable diseases (NCDs). The importance of nutrition in nephrology, with a special focus on protein and salt restriction, has long been recognized as crucial for the management of CKD patients, along with pharmacological therapy to slow down disease progression and correct the signs and symptoms of uremia In a systemic and functional view of nutrition, controlling low-grade chronic inflammation is crucial for renal damage prevention. In this regard, functional molecules and nutrients such as fiber and fatty acids, and plant-derived nutraceuticals, play a key role, either influencing pro- and anti-inflammatory pathways or acting at the gut mucosal level. A variety of nutraceutical products are being promoted as being able to support, protect and or heal renal injuries. The mechanisms by which these nutraceuticals may benefit patients with chronic kidney disease include – reduction of inflammation, modulation of oxidative stress, and inhibition of interstitial fibrosis, promotion of renal blood flow and glomerular filtration rate and stimulation of tubular regeneration. In this study we intend to evaluate the efficacy and safety of nutraceutical CKD Formulation in the management of chronic kidney disease.