NIGELLA SATIVA OIL AS AN ADD-ON IN THE CONSERVATIVE MANAGEMENT OF DIABETIC NEPHROPATHY: A NOVEL SYNERGISTIC APPROACH

  • MOHD ASHRAF ALAM Department of Pharmacology, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh, Uttar Pradesh, India.
  • MOHAMMAD NASIRUDDIN Department of Pharmacology, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh, Uttar Pradesh, India.
  • SHAHZAD F HAQUE Department of Medicine, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh, Uttar Pradesh, India.
  • RAHAT A KHAN Department of Pharmacology, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh, Uttar Pradesh, India.

Abstract

Objective: The objective of the study was to evaluate efficacy and safety Nigella sativa oil as an add-on therapy in addition to alpha-keto analog of essential amino acids in patients diabetic nephropathy (DN).


Methods: The study was conducted in a tertiary care center of North India on patients of DN. It was a prospective, comparative, and open labeled study. Patients were randomly divided into two interventional groups. Group I (control) received conservative management of chronic kidney disease consisting of alpha-keto analog (600 mg tab. 3 times a day), while Group II (test) received conservative management along with alpha-keto analog and N. sativa oil (2.5 ml, per orally, once daily) for 12 weeks. Hemogram and renal function, serum electrolytes tests were done, and adverse events were recorded at baseline, 4, 8, and 12 weeks of treatment.


Results: After 12 weeks of treatment, there was a marked improvement in clinical features and biochemical parameters in both the control and test groups, but it was more statistically significant in the test group as compared to control group especially in renal function (p≤0.05). Both groups showed steady improvement in the biochemical parameters as compared to their pre-treated values which were more marked in N. sativa oil supplemented group. There was a reduction in blood glucose, blood urea, serum creatinine, and 24-h total urine protein, and an increase in hemoglobin, 24-h total urine volume, and glomerular filtration rate.


Conclusion: N. sativa oil supplementation along with alpha-keto analog is more efficacious and safer in delaying the progression of disease patients of DN.

Keywords: end-stage renal disease, diabetic nephropathy, diabetes mellites, chronic kidney disease, glomerular filtration rate,, alpha keto analogue, Nigella sativa oil

Author Biographies

MOHAMMAD NASIRUDDIN, Department of Pharmacology, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh, Uttar Pradesh, India.

Pharmacology, Professor And Chairman

SHAHZAD F HAQUE, Department of Medicine, Jawaharlal Nehru Medical College and Hospital, Aligarh Muslim University, Aligarh, Uttar Pradesh, India.

MEdicine, Professor

References

1. World Health Organization. Diabetes. Geneva: World Health Organization; 2015.
2. International Diabetes Federation. IDF Diabetes Atlas. 6th ed. Brussels: International Diabetes Federation; 2014.
3. Lim AK. Diabetic nephropathy - complications and treatment. Int J Nephrol Renovasc Dis 2014;7:361-81.
4. Cheng W, Hua S, Chun Z. Role of NADPH oxidase in metabolic disease-related renal injury: An update. Oxid Med Cell Longev 2016;2016:1-8.
5. Hojs R, Ekart R, Bevc S, Hojs N. Markers of inflammation and oxidative stress in the development and progression of renal disease in diabetic patients. Nephron 2016;133:159-62.
6. Kher V. End-stage renal disease in developing countries. Kidney Int 2002;62:350-62.
7. Qiu HY, Liu F, Zhao LJ, Huang SM, Zuo C, Zhong H, et al. Comparison of the effects of alpha-keto/amino acid supplemented low protein diet and diabetes diet in patients with diabetic nephropathy. Sichuan Da Xue Xue Bao Yi Xue Ban 2012;43:425-8.
8. Prakash S, Pande DP, Sharma S, Sharma D, Bal CS, Kulkarni H, et al. Randomized, double-blind, placebo-controlled trial to evaluate efficacy of ketodiet in predialytic chronic renal failure. J Ren Nutr 2004;14:89 96.
9. El-Shamy KA, Mosa MM, El-Nabarawy SK, El-Qattan GM. Effect of Nigella sativa tea in Type 2-diabetic patients as regards glucose homeostasis, liver and kidney functions. J Appl Sci Res 2011;7:2524 34.
10. Mohtashami R, Amini M, Huseini HF, Ghamarchehre M, Sadeqhi Z, Hajiagaee R, et al. Blood glucose lowering effects of Nigella sativa L. seeds oil in healthy volunteers: A randomized, double-blind, placebo controlled clinical trial. J Med Plants 2011;10:90-4.
11. Martínez-Castelao A, Navarro-González JF, Górriz JL, de Alvaro F. The concept and the epidemiology of diabetic nephropathy have changed in recent years. J Clin Med 2015;4:1207-16.
12. Gheith O, Farouk N, Nampoory N, Halim MA, Al-Otaibi T. Diabetic kidney disease: World wide difference of prevalence and risk factors. J Nephropharmacol 2016;5:49-56.
13. Lipska KJ, Krumholz H, Soones T, Lee SJ. Polypharmacy in the aging patient: A review of glycemic control in older adults with Type 2 diabetes. JAMA 2016;315:1034-45.
14. Schwartz AV, Vittinghoff E, Sellmeyer DE, Feingold KR, de Rekeneire N, Strotmeyer ES, et al. Diabetes-related complications, glycemic control, and falls in older adults. Diabetes Care 2008;31:391-6.
15. Shurraw S, Hemmelgarn B, Lin M, Majumdar SR, Klarenbach S, Manns B, et al. Association between glycemic control and adverse outcomes in people with diabetes mellitus and chronic kidney disease: A population-based cohort study. Arch Intern Med 2011;171:1920-7.
16. Ricks J, Molnar MZ, Kovesdy CP, Shah A, Nissenson AR, Williams M, et al. Glycemic control and cardiovascular mortality in hemodialysis patients with diabetes: A 6-year cohort study. Diabetes 2012;61:708-15.
17. Wild S, Roglic G, Green A, Sicree R, King H. Global prevalence of diabetes: Estimates for the year 2000 and projections for 2030. Diabetes Care 2004;27:1047-53.
18. Gupta R. Trends in hypertension epidemiology in India. J Hum Hypertens 2004;18:73-8.
19. Jha V. ESRD in India and Pakistan 2013. Kidney Int Suppl 2013;3:157 60.
20. Jeloka TK, Upase S, Chitikeshi S. Monthly cost of three exchanges a day peritoneal dialysis is same as of thrice a week hemodialysis in self-paying Indian patients. Indian J Nephrol 2012;22:39-41.
21. Jha V, Garcia-Garcia G, Iseki K, Li Z, Naicker S, Plattner B, et al. Chronic kidney disease: Global dimension and perspectives. Lancet 2013;382:260-72.
22. Khan IA, Nasiruddin M, Haque SF, Khan RA. A randomized clinical trial to evaluate the efficacy and safety of ?-keto amino acids supplementation in stage 3 and 4 patients of chronic kidney disease. Asian J Pharm Clin Res 2014;7:21-4.
23. Sayed-Ahmed MM, Nagi MN. Thymoquinone supplementation prevents the development of gentamicin-induced acute renal toxicity in rats. Clin Exp Pharmacol Physiol 2007;34:399-405.
24. Ansari ZM, Nasiruddin M, Haque SF, Khan RA. Evaluation of efficacy and safety of Nigella sativa oil supplementation in patients of chronic kidney disease. Asian J Pharm Clin Res 2016;9:107-10.
25. Chang JH, Kim DK, Park JT, Kang EW, Yoo TH, Kim BS, et al. Influence of ketoanalogs supplementation on the progression in chronic kidney disease patients who had training on low-protein diet. Nephrology (Carlton) 2009;14:750-7.
26. Yusuksawad M, Chaiyabutr N. Restoration of renal hemodynamics and functions during black cumin (Nigella sativa) administration in streptozotocin-induced diabetic rats. J Exp Pharmacol 2012;4:1-7.
27. Teplan V. Supplements of keto acids in patients with chronic renal failure. Nefrol Derg 2004;13:3-7.
28. Chen N, Jin Y, Ren H, Jing X, Shen P, Huang X. Anti-inflammatory effects of low protein diet supplemented with keto-amino acid in the treatment of Type 2 diabetic nephropathy. Kidney Res Clin Pract 2012;31:A24.
29. Bamosa AO, Kaatabi H, Lebdaa FM, Elq AM, Al-Sultanb A. Effect of Nigella sativa seeds on the glycemic control of patients with Type 2 diabetes mellitus. Indian J Physiol Pharmacol 2010;54:344-54.
30. Dehkordi FR, Kamkhah AF. Antihypertensive effect of Nigella sativa seed extract in patients with mild hypertension. Fundam Clin Pharmacol 2008;22:447-52.
31. Kaatabi H, Bamosa AO, Lebda FM, Al Elq AH, Al-Sultan AI. Favorable impact of Nigella sativa seeds on lipid profile in Type 2 diabetic patients. J Family Community Med 2012;19:155-61.
32. Ragheb A, Attia A, Eldin WS, Elbarbry F, Gazarin S, Shoker A, et al. The protective effect of thymoquinone, an anti-oxidant and anti-inflammatory agent, against renal injury: A review. Saudi J Kidney Dis Transpl 2009;20:741-52.
33. Najmi A, Nasiruddin M, Khan RA, Haque SF. Effect of Nigella sativa oil on various clinical and biochemical parameters of insulin resistance syndrome. Int J Diabetes Dev Ctries 2008;28:11-4.
34. Heshmati J, Namazi N, Memarzadeh MR, Taghizadeh M, Kolahdooz F. Nigella sativa oil affects glucose metabolism and lipid concentrations in patients with Type 2 diabetes: A randomized, double-blind, placebo-controlled trial. Food Res Int 2015;70:87-93.
35. Fallah Huseini H, Amini M, Mohtashami R, Ghamarchehre ME, Sadeqhi Z, Kianbakht S, et al. Blood pressure lowering effect of Nigella sativa L. Seed oil in healthy volunteers: A randomized, double-blind, placebo-controlled clinical trial. Phytother Res 2013;27:1849-53.
Statistics
96 Views | 1 Downloads
How to Cite
MOHD ASHRAF ALAM, MOHAMMAD NASIRUDDIN, SHAHZAD F HAQUE, and RAHAT A KHAN. “NIGELLA SATIVA OIL AS AN ADD-ON IN THE CONSERVATIVE MANAGEMENT OF DIABETIC NEPHROPATHY: A NOVEL SYNERGISTIC APPROACH”. Asian Journal of Pharmaceutical and Clinical Research, Vol. 12, no. 10, Sept. 2019, pp. 230-6, https://innovareacademics.in/journals/index.php/ajpcr/article/view/34985.
Section
Original Article(s)