RENOHELP NATURAL KIDNEY SUPPLEMENT - CLINICAL STUDY

Therapeutic Efficacy of Renohelp in Patients with Chronic Kidney Disease

Prof. Dr. Emil PASKALEV DIMITROV, PhD, DMSc

Head of Clinic of Nephrology and Transplantation
Aleksandrovska University Hospital. Sofia, Bulgaria

Renohelp USA contains dry extract of Lespedeza capitata, dry extract of birch (Betula platyphylla Suk.), dry extract of cranberry (Vaccinium hitrum thunb), vitamin E (D-alpha tocopherol), iron (Ferrous gluconate), and vitamin B6 (Pyridoxine HCl). RENOHELP can be used in patients with impaired renal function, i.e. chronic kidney disease (CKD).

In the course of the development of chronic renal disease there is an increase in oxidative stress and asymmetric dimethyl arginine (ADMA) levels. This results in the depletion of nitrogen oxide, impaired vascular tone, impaired vasodilatation, decreased free radicals release, and plaque disruption with thrombus formation. For the treatment of CKD, it is important to overcome these pathogenetic mechanisms.

The use of α-tocopherol by the proximal tubule cells of the kidney reduces cisplatin-induced reactive oxygen species (oxygen free radicals) and increases cell viability. Studies have shown that regular intake of α-tocopherol contributes to supporting healthy ADMA levels.

Elevated homocysteine and reduced folate concentrations or pyridoxal-5- phosphate (PLP - active metabolite of vitamin B6) are characteristic of CKD development. They can cause excessive production of reactive oxygen species leading to greater oxidative stress and reduced antioxidant enzyme activity. The use of vitamin B6 (Pyridoxine HCl) contributes for the reduction of oxidative stress and the possible risks of cardiovascular events.

Oral intake of iron salts is commonly used to treat iron deficiency anemia in CKD patients. Iron ferrous forms are used for better absorption of iron. Good absorption of ferrous gluconate gives better control of iron deficiency in CKD and implies greater safety in its use.

The amounts of vitamin E (α-tocopherol), vitamin B6 (Pyridoxine HCl) and iron (Ferrous gluconate) added to RENOHELP are consistent with the recommended daily intake of vitamins and minerals. This makes them suitable for long-term use.

Patients with CKD are characterized by increase in their number. RENOHELP suggests a new treatment option for these patients. This allowed us to conduct a clinical trial. It includes 30 patients (15 men and 15 women) and lasts for 3 (three) months. The aim of the clinical study was to determine the therapeutic effect of treatment with Renohelp USA on the kidney function of CKD patients.

Patients are initially controlled prior to initiation of treatment and have at least two other controls, one of which is at the end, i.e. the end of the 3rd month.
Measurements include: Serum creatinine, glomerular filtration (GFR), urea, uric acid, cholesterol, 3-glycerides, GOT, GPT, AF, GTP, bilirubin, blood sugar, K +, Na +, blood count, Fe, Iron binding capacity, blood pressure, microbiological urine test, and side effects of the preparation.

Starting Value Ranges of Study Participants

  • Мale to Female  1:1
  • Average Age  47 (±6)
  • Average GFR at the beginning (ml/min)  56 (±12)
  • Mean value of creatinine at baseline (μmol/l)  157 (±18)
  • Mean value of creatinine at baseline (μmol/l)  157 (±18)
  • Average uric acid value at the beginning (μmol/l)  432 (±27)
  • Hemoglobin g/l  112 (±5)
  • Average blood pressure (mmHg)   145 (±10)  /  85 (±15)
  • Average cholesterol values (mmol/l)   6, 5 (±0) ,7
  • Serum iron  14,5±5

Conclusions

On the basis of the obtained results we made the following main conclusions:

  • Administration of Renohelp results in a significant decrease in serum creatinine respectively increased glomerular filtration GFR in patients with CKD. This is undoubtedly related to the slowdown of CKD progression.
  • Administration of Renohelp USA in patients with CKD results in a decrease in uric acid and cholesterol levels, increase in hemoglobin and serum iron, which are not statistically significant but have a tendency to stabilize the condition of patients.
  • There were no side effects reported by patients participating in the study, and those found by the medical control tests.
  • The application of Renohelp has a positive effect on the slowdown of CKD progression.

Study Data Results

In hemoglobin monitoring, we found a tendency to increase, without statistical justification of the change, presented in the following graph

Renohelp kidney hemoglobin chart

We found a marked change in the serum creatinine level of statistical significance, which clearly demonstrates the effect of improving the renal function of the study
product presented on the following graph. The results showed an increase in serum iron level without statistical justification presented in the following graph

Renohelp naturally improves kidney renal function chart

We found a marked change in the serum creatinine level with statistical significance, which clearly demonstrates
the effect of improving the renal function, presented in the following graph

Renohelp naturally reduces kidney creatinine levels chart

Changes in glomerular filtration in the direction of increase are significantly expressed with statistical significance, which also confirms
the positive effect of the product on renal function presented on the following graph:

Renohelp naturally improves kidney GFR  chart

Changes in the uric acid level are in the direction of decrease, but without statistical significance, are presented on the following graph

Renohelp naturally reduces kidney uric acid chart

Changes in cholesterol level are downward but not statistically significant, as shown in the following chart

Renohelp kidney health cholesterol chart

Blood pressure of patients subject to the test continues to be stable within the target values presented on the following graph

Renohelp kidney health blood pressure chart

Conclusions (repeated from above)

On the basis of the obtained results we made the following main conclusions:

  • Administration of Renohelp results in a significant decrease in serum creatinine respectively increased glomerular filtration GFR in patients with CKD. This is undoubtedly related to the slowdown of CKD progression.
  • Administration of Renohelp USA in patients with CKD results in a decrease in uric acid and cholesterol levels, increase in hemoglobin and serum iron, which are not statistically significant but have a tendency to stabilize the condition of patients.
  • Administration of Renohelp USA in patients with CKD results in a decrease in uric acid and cholesterol levels, increase in hemoglobin and serum iron, which are not statistically significant but have a tendency to stabilize the condition of patients.
  • There were no side effects reported by patients participating in the study, and those found by the medical control tests.
  • The application of Renohelp has a positive effect on the slowdown of CKD progression.

*These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any diseases or medical conditions.

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