A novel clinically-proven herbal product for renal care
- Product type: Nutraceutical
- Registration: Europe & Asia
- Application: Nephrology – Renal Failure
- Dosage form: Liquid
- Recommended dosage: 3 doses per day (10ml per dose)
- Manufacturing counties: Italy, Poland, India
1. Overview of the advantages of Alfa RenoCare
- A novel therapy for renal care.
- A 100% natural product derived from FDA approved phyto-ingredients.
- Clinically tested and proven to be effective in CKD patients.
- Recommended for people who are at risk of kidney disorders.
- Completely safe to consume on a daily basis.
- Filed in 11 Jurisdictions and 83 countries. In receipt of clean International search report (ISR)
2. Clinical Evidence
A single arm prospective study comprising of 34 patients, who were administered 3 doses (10 ml per dose) of the formulation for a period of 2 months with a follow-up of no medicine for one month thereafter, was conducted. For all the patients, standard care of the treatment was continued during the follow-up period. Inclusion criteria included CRF non-dialysis patients aged between 18 and 70 years with Serum Creatinine more than 1.8 mg/dL. Assessment of QoL was based on a WHO questionnaire which has been specifically designed for CRF patients. The primary objective of the trial was to study the efficacy of Syrup RenoCare in reducing Serum Creatinine in CRF patients and the secondary objective was to see the efficacy of Syrup RenoCare in reducing blood urea, increasing hemoglobin and improving Quality of Life (QoL) in CRF patients.
The results of the clinical study are as follows:
- Observed a marked decline in Serum Creatinine in the first 30 days of exposure to the IP (p value< 0.05)
- Observed a striking upsurge in eGFR in the first 30 days of exposure (p Value < 0.05)
- Observed decline in Serum Urea levels when patient was on IP and immediate upsurge when patient is off the IP
- Increase in Serum Creatinine as well as decrease in eGFR when patient is off IP from 60 to 90 days, suggesting a strong drug disease relation.
- QoL with respect to various parameters showed a significant improvement (P value <0.01)
The active molecule of RenoCare is Sodium Copper Chlorophyllin. During the synthesis of chlorophyllin, the magnesium atom at the centre of the ring is replaced with copper and the phytol tail is lost. Unlike natural chlorophyll, chlorophyllin is water-soluble. The formulation is not poly-herbal and contains sorbitol and glycerin as adjuvants for better drug delivery
4. Technical Data
- Dosage form: Dark brown viscous thick syrup
- Primary packaging:300 ML pet bottle with a majoring cup in a mono carton
- Secondary packaging:
- Net weight:
- Shelf life: xxx
5. Product background
What is Sodium Copper Chlorophyllin?
Traditionally Sodium copper chlorophyllin is used as a food colour. It has 21 CFR declaration as safe for human consumption (19862 Federal Register / Vol. 55, No. 82 / Friday, May 21, 1990) and USFDA monograph (19862 Federal Register / Vol. 55, No. 82 / Friday, May 21, 1990). In Europe it is acceptable as a safe food additive, Ref no. E140 and is a GRAS Product (Generally recognised as safe)
What is Chronic Renal Failure (CRF)
Markers of CRF – The major markers of CRF are oedema on the body, nausea, increase in the level of serum creatinine and serum urea. The patient starts feeling weak with a decrease in haemoglobin levels and a substantial loss of immunity. The Glomerular Filtration Rate (GFR) is also affected.
Stages of CRF – The GFR rate aids in accessing the advancement of Chronic Renal Failure. Advancement of CRF can be classified into the following stages:
- Stage 1 with normal or high GFR where GFR is greater than 90 millilitres per minute.
- Stage 2 is classified as mild CRF/CKD were GFR is in the range of 60-89 millilitre per minute.
- Stage 3A is classified as moderate CRF/CKD where GFR is in the range of 45-59 millilitre per minute.
- Stage 3B is also classified as moderate CRF/CKD where GFR falls further in the range of 30-44 millilitre per minute.
- Stage 4 is classified as severe CRF/CKD with GFR in the range of 15-29 millilitre per minute.
- Stage 5 is classified as end-stage CRF/CKD with GFR lower than 15 millilitre per minute.
Outcomes of CRF – Untreated CRF in the absence of change in food habits and medical treatment leads to a progressive loss of kidney function, fast reaching to the life-threatening stage. The current treatment is dialysis as per requirement, ranging from once a day to once in several weeks. This does not treat the basic cause but helps in eliminating the wastes accumulated in the blood. Dialysis alone does not provide any remedy to declining haemoglobin, which ultimately becomes a major cause for further deterioration and decrease in immunity.
Kidneys – The Natural Filters of the Body – Kidneys are two bean-shaped organs situated below the rib cage on either side of the spine. Their primary function is to excrete wastes from the body in the form of urine. Urine is excreted by the filtration of blood by nephrons, the microscopic structural and functional unit of the kidneys. A single kindly can contain up to 1,000,000 nephrons.
Advent of Chronic Renal Failure – Over a long period of time, there might be a slow and progressive loss of kidney functions due to diabetes, high blood pressure, glomerulonephritis and polycystic kidney disease leading to cardiovascular morbidity, premature mortality and reduced Quality of Life. This condition is called Chronic Renal Failure (CRF). CRF is also known as chronic renal disease or chronic kidney disease. CRF eventually leads to permanent kidney failure. As CRF is asymptomatic until later stages, it is often undiagnosed or undetected.
CRF may be more common than diabetes – A research study from 2016 titled – ‘Global Prevalence of Chronic Kidney Disease – A Systematic Review and Meta-Analysis’, suggests the prevalence of CRF stages 1-5 as 13.4% and that of Stages 3-5 as 10.6%. The study suggests that CRF can be more common than diabetes as diabetes has an estimated prevalence of 8.2%.