Bioequivalence & Bioavailability

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Received: January 01, 1970 | Published: ,

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Abstract

The present patent‒pending invention relates to a herbal nano mix for renal failure. The herbal mix extract for treating this problem is formed of a natural nano herbal mix, corn silk extract, black seed (Nagilla Sativa Linn.) extract, gum arabic and frozen-dried camel milk powder or extract of them. In particular the formulation is given orally in capsules. Observed results showed excellent results for chronic renal failure (CRF) with no adverse or side effects.

Keywords: natural nano, renal failure, formulation, kidney disease, blood tests

Description of the invention

Chronic kidney disease or kidney damage is caused by one of the following:

Diabetes, Hypertension, kidney inflammation, polycystic kidney disease (PKD), obstruction of urinary tract cause of BHP, kidney stones or chemical drug poisoning. Treatment of renal failure usually consists of either dialysis or kidney transplant when case becomes complicated and does not respond to dialysis.

Till this moment no renal failure cure was found anywhere in the world. Our natural composition is the first cure of its kind to renal failure. Formulation used to treat renal failure is composed of the following ingredients, including, corn silk extract, black seed (Nagilla Sativa Linn.) extract, gum arabic and frozen-dried camel milk powder.

In a recent study performed by Elin Yulinah Sukandar et al.,¹ in 2013 Corn silk extract has been found to repair kidney functions using rat models. Blood tests showed both serum creatinine and urea, were improved. The extract was further revealed to reduce renal damage histologically.

Zafar Ansari et al.,² conducted a new research on the effect of black seed (Nagilla Sativa) extract on renal functions on stage 3 and 4 of PKD patients. After 12 weeks of treatment, there was a progressive improvement in clinical features and biochemical parameters. There was a reduction in blood glucose, blood urea, serum creatinine, and 24-hr total urine protein. Moreover there was an increase in hemoglobin.

Black seed was recommended by Prophet Mohammad (pbuh) 1400 years ago to cure all diseases except death.

Khan, N; and Sultana, S found that black seed extract inhibited two stage renal carcinogenesis, and oxidative damage in Wistar rats.³

Adil Ali et al.,⁴ studied effect of oral treatment of gum Arabic on 36 chronic renal failure(CRF)under regular haemodialysis for 3 months and found big improvement in renal functions. Biochemical parameters of creatinine, urea ,and uric acid, decreased significantly up to 11.7%, 44.18% and 19.9% respectively.

Badreldin Ali et al.,⁵ used gum Arabic on animal model of human CRF (feeding adenine) for 4 weeks. Significant decrease of serum creatinine and urea showed a big promise of using gum Arabic for CRF. Agrawal RP et al.,⁶carried out a study to determine the efficacy of camel milk in controlling diabetic nephropathy. Twenty-four type-1 diabetic patients were randomly recruited from the outpatient diabetic clinic in PBM Hospital, Bikaner, India. Patients were given camel milk for 6 months. There was a significant improvement in the microalbuminuria after receiving camel milk for 6 months. A significant reduction in the mean dose of insulin for obtaining glycemic control was achieved. This may be due to good glycemic control or to the direct effect of camel milk.

Nephrotoxicity is a major complication factor for cisplatin therapy. Cisplatin mediated nephrotoxicity is remarkably documented by reactive oxygen species. Camel’s milk has good nutritive value, antigenotoxic and anticytotoxic effects. Afifi M⁷ carried out a study using camel’s milk against side effects of Cisplatin on renal functions. He concluded the renoprotective potential of camel’s milk against cisplatin-induced oxidative stress and renal dysfunction in mice. Hence, camel’s milk has a potential to be used as therapeutic adjuvant in cisplatin nephrotoxicity.

Summary of the invention

The present invention relates to an oral naturaceutical formulation for treatment of chronic renal failure. The formulation for treating renal failure is formed ofa natural nano herbal mix, corn silk extract, black seed (Nagilla Sativa Linn.) extract, gum arabic and frozen-dried camel milk powder.

Examples of pre‒clinical results

From Table 1 which shows results of 6 month-course of our herbal mix it is clear the very positive effect on all renal failure cases.

Case	Age	CRF Type	Treatment Time	Status
				Before	After
1	42	Diabetic	6 months	severe	cured
2	59	Diabetic	3 months	severe	cured
3	70	Diabetic	4 months	severe	cured
4	53	Hypertension	2 weeks	mild	cured
5	47	Cisplatin-induced	4 week	mild	cured
6	50	Diabetic	4 months	severe	cured
7	52	Diabetic	6 months	severe	cured
8	25	Hypertension	4 months	severe	cured
9	28	Polycystic	3 months	severe	cured
10	59	Hypertension	2 weeks	mild	cured

Table 1 Effect of nano renotech capsules on CRF

Safety and toxicity study

Toxicity study performed on mice in the animal house of Jordan University of Science and Technology showed that the formulation is safe and free of side on different organs.

Conclusion

This patented botanical nano formulation is expected to help chronic renal failure patients worldwide. Double blind is still needed to give more reliable results.