Toxicity effect of nigella sativa on the liver function of rats. Effectiveness of Nigella sativa oil in the management of rheumatoid arthritis patients: a placebo controlled study. Protective role of Nigella sativa in diabetic nephropathy: A randomized clinical trial. Effect of Nigella sativa seeds on the glycemic control of patients with type 2 diabetes mellitus. Effects of Nigella sativa on outcome of hepatitis C in Egypt. Effect of Nigella sativa (black seed) on subjective feeling in patients with allergic diseases. Clinical evaluation of Nigella sativa seeds for the treatment of hyperlipidemia: a randomized, placebo controlled clinical trial. Nigella sativa Oil for Prevention of Chronic Cyclosporine Nephrotoxicity: An Experimental Model Effect of Nigella sativa supplementation over a one-year period on lipid levels, blood pressure and heart rate in type-2 diabetic patients receiving oral hypoglycemic agents: nonrandomized clinical trial Comparing Nigella sativa Oil and Fish Oil in Treatment of Vitiligo Blood pressure lowering effect of Nigella sativa L. seed oil in healthy volunteers: a randomized, double-blind, placebo-controlled clinical trial. The effect of Nigella sativa Linn. seed on memory, attention and cognition in healthy human volunteers. Efficacy of black seed (Nigella sativa L.) on kidney stone dissolution: A randomized, double-blind, placebo-controlled, clinical trial. Nigella sativa oil with a calorie-restricted diet can improve biomarkers of systemic inflammation in obese women: A randomized double-blind, placebo-controlled clinical trial.
PURPOSE The aim of this study was to determine the toxic effect of Nigella sativa powder on the liver function which was evaluated by measuring liver enzymes and through histopathological examination of liver tissue . METHODS Twenty four male Sprague Dawley rats were allotted r and omly to four groups including : control ( taking normal diet ) ; low dose ( supplemented with 0.01 g/kg/day Nigella sativa ) ; normal dose ( supplemented with 0.1 g/kg/day Nigella sativa ) and high dose ( supplemented with 1 g/kg/day Nigella sativa ) . All of supplements administered in powder form mixed with rats ' pellet for 28 days . To assess liver toxicity , liver enzymes measurement and histological study were done at the end of supplementation . RESULTS The finding revealed that there was no significant change in serum alanine aminotransferase ( ALT ) and aspartate aminotransferase ( AST ) between treatment groups . Histopathological study showed very minimal and mild changes in fatty degeneration in normal and high doses of Nigella sativa treated group . Inflammation and necrosis were absent . CONCLUSION The study showed that supplementation of Nigella sativa up to the dose of 1 g/kg supplemented for a period of 28 days result ed no changes in liver enzymes level and did not cause any toxicity effect on the liver function The constituents of Nigella sativa modulate the immune system . The aim of the present work was to study the effectiveness of Nigella sativa oil in RA patients . Data from 40 female RA patients diagnosed according to the 2010 ACR/EULAR were analysed and discussed . The patients took two placebo ( starch filled ) capsules daily for 1 month . This was followed by a month of Nigella sativa oil capsules 500 mg twice/day . The disease activity score ( DAS-28 ) significantly decreased after receiving the Nigella sativa capsules ( 4.55 ± 0.82 ) compared with before and after placebo ( 4.98 ± 0.79 and 4.99 ± 0.72 , respectively ) ( p = 0.017 ) . Similarly , the number of swollen joints and the duration of morning stiffness improved . A marked improvement in the disease activity was shown by both the ACR20 and EULAR response criteria in 42.5 % and 30 % of the patients , respectively , after intake of Nigella . Supplementation with Nigella sativa during DMARD therapy in RA may be considered an affordable potential adjuvant biological therapy This study aims to evaluate efficacy and safety of Nigella sativa oil supplementation in patients with chronic kidney disease Stage 3 and 4 due to diabetic nephropathy . It was a prospect i ve , comparative , and open-label study . Patients were r and omized into two groups . Group 1 ( Control ) received conservative management of diabetic nephropathy , whereas Group 2 ( Test ) received N. sativa oil ( 2.5 mL , once daily and per orally ) along with conservative management for 12 weeks .  Blood glucose , hemogram , and kidney function test were done at 0 , 6 , and 12 weeks of treatment . Significance of differences between pre- and post-treatment values in each group was assessed using Student 's paired t-test and between the groups using unpaired t-test . We found a drop in blood glucose , serum creatinine , blood urea , and 24 h total urinary protein levels and a rise in glomerular filtration rate , 24 h total urinary volume , and hemoglobin level in the treatment group compared to the control group UNLABELLED Diabetes mellitus is a common chronic disease affecting millions of people world wide . St and ard treatment is failing to achieve required correction of blood glucose in many patients . Therefore , there is a need for investigating potential hypoglycemic drugs or herbs to improve glycemic control in diabetic patients .  Nigella sativa seeds were used as an adjuvant therapy in patients with diabetes mellitus type 2 added to their anti-diabetic medications . A total of 94 patient were recruited and divided r and omly into three dose groups . Capsules containing Nigella sativa were administered orally in a dose of 1 , 2 and 3 gm/day for three months . The effect of Nigella sativa on the glycemic control was assessed through measurement of fasting blood glucose ( FBG ) , blood glucose level 2 hours postpr and ially ( 2 hPG ) , and glycosylated hemoglobin ( HbA1c ) . Serum C-peptide and changes in body weight were also measured . Insulin resistance and beta-cell function were calculated usin the homeostatic model assessment ( HOMA2 ) . Nigella sativa at a dose of 2 gm/day caused significant reductions in FBG , 2hPG , and HbA1 without significant change in body weight . Fasting blood glucose was reduced by an average of 45 , 62 and 56 mg/dl at 4 , 8 and 12 weeks respectively . HbAlC was reduced by 1.52 % at the end of the 12 weeks of treatment ( P<0.0001 ) . Insulin resistance calculated by HOMA2 was reduced significantly ( P<0.01 ) , while B-cell function was increased ( P<0.02 ) at 12 weeks of treatment . The use of Nigella sativa in a dose of 1 gm/day also showed trends in improvement in all the measured parameters but it was not statistically significant from the baseline . However , no further increment in the beneficial response was observed with the 3 gm/day dose . The three doses of Nigella sativa used in the study did not adversely affect either renal functions or hepatic functions of the diabetic patients throughout the study period . IN CONCLUSION the results of this study indicate that a dose of 2 gm/ day of Nigella sativa might be a beneficial adjuvant to oral hypoglycemic agents in type 2 diabetic patients AIM To evaluate the safety , efficacy and tolerability of Nigella sativa ( N. sativa ) in patients with hepatitis C not eligible for interferon (IFN)-α . METHODS Thirty patients with hepatitis C virus ( HCV ) infection , who were not eligible for IFN/ribavirin therapy , were included in the present study . Inclusion criteria included : patients with HCV with or without cirrhosis , who had a contraindication to IFN-α therapy , or had refused or had a financial constraint to IFN-α therapy . Exclusion criteria included : patients on IFN-α therapy , infection with hepatitis B or hepatitis I virus , hepatocellular carcinoma , other malignancies , major severe illness , or treatment non-compliance . Various parameters , including clinical parameters , complete blood count , liver function , renal function , plasma glucose , total antioxidant capacity ( TAC ) , and polymerase chain reaction , were all assessed at baseline and at the end of the study . Clinical assessment included : hepato and /or splenomegaly , jaundice , palmar erythema , flapping tremors , spider naevi , lower-limb edema , and ascites . N. sativa was administered for three successive months at a dose of ( 450 mg three times daily ) . Clinical response and incidence of adverse drug reactions were assessed initially , periodically , and at the end of the study . RESULTS N. sativa administration significantly improved HCV viral load ( 380808.7 ± 610937 vs 147028.2 ± 475225.6 , P = 0.001 ) and TAC ( 1.35 ± 0.5 vs 1.612 ± 0.56 , P = 0.001 ) . After N. sativa administration , the following laboratory parameters improved : total protein ( 7.1 ± 0.7 vs 7.5 ± 0.8 , P = 0.001 ) , albumin ( 3.5 ± 0.87 vs 3.69 ± 0.91 , P = 0.008 ) , red blood cell count ( 4.13 ± 0.9 vs 4.3 ± 0.9 , P = 0.001 ) , and platelet count ( 167.7 ± 91.2 vs 198.5 ± 103 , P = 0.004 ) . Fasting blood glucose ( 104.03 ± 43.42 vs 92.1 ± 31.34 , P = 0.001 ) and postpr and ial blood glucose ( 143.67 ± 72.56 vs 112.1 ± 42.9 , P = 0.001 ) were significantly decreased in both diabetic and non-diabetic HCV patients . Patients with lower-limb edema decreased significantly from baseline compared with after treatment [ 16 ( 53.30 % ) vs 7 ( 23.30 % ) , P = 0.004 ] . Adverse drug reactions were unremarkable except for a few cases of epigastric pain and hypoglycemia that did not affect patient compliance . CONCLUSION N. sativa administration in patients with HCV was tolerable , safe , decreased viral load , and improved oxidative stress , clinical condition and glycemic control in diabetic patients Nigella sativa ( black seed ) is an important medicinal herb . In many Arabian , Asian and African countries , black seed oil is used as a natural remedy for a wide range of diseases , including various allergies . The plant 's mechanism of action is still largely unknown . Due to the lack of study data on its efficacy in allergies , four studies on the clinical efficacy of Nigella sativa in allergic diseases are presented . In these studies , a total of 152 patients with allergic diseases ( allergic rhinitis , bronchial asthma , atopic eczema ) were treated with Nigella sativa oil , given in capsules at a dose of 40 to 80 mg/kg/day . The patients scored the subjective severity of target symptoms using a predefined scale . The following laboratory parameters were investigated : IgE , eosinophil count , endogenous cortisol in plasma and urine , ACTH , triglycerides , total cholesterol , LDL and HDL cholesterol and lymphocyte sub population s. The score of subjective feeling decreased over the course of treatment with black seed oil in all four studies . A slight decrease in plasma triglycerides and a discrete increase in HDL cholesterol occurred while the lymphocyte sub population s , endogenous cortisol levels and ACTH release remained unchanged . Black seed oil therefore proved to be an effective adjuvant for the treatment of allergic diseases BACKGROUND Natural products are proved to play a good role as an alternative to synthetic chemicals in many clinical conditions . Hypercholesterolemia is the most important risk factor for atherosclerosis . Previous studies showed that Nigella sativa L. has both antioxidant and lipid lowering potentials . THE AIM OF THIS STUDY To evaluate the efficacy of the seeds of Nigella sativa on the treatment of hyperlipidemia . METHODS In this r and omized , placebo controlled clinical trial which was conducted in Isfahan city ( Iran ) , 88 subjects aged > or = 18 years with a total cholesterol concentration > 200 mg/dl were included . According to the patients " profiles number , they were r and omized to receive either N. sativa capsules or the matching placebo . Each N sativa capsule contained 500 + /- 10 mg N. sativa crushed seeds , and patients had to take 2 g N. sativa per day for 4 weeks . Fasting baseline laboratory values ( fasting blood sugar , total cholesterol , low density lipoprotein , high density lipoprotein and triglyceride ) were obtained for all parameters on each subject prior to the start of the study and at the end of 4 weeks . RESULTS In our study a significant decrease was observed in the concentration of total cholesterol ( 4.78 % ) , Low density lipoprotein ( 7.6 % ) and Triglyceride ( 16.65 % ) , and this decrease was more significant for TG concentration .  N. sativa had not any beneficial effects on Fasting blood sugar and High density lipoprotein . CONCLUSION According to the results of our present study it seems that N. sativa may have some beneficial therapeutic effects in the treatment of hyperlipidemia . However , further investigations with a larger sample size are necessary Nephrotoxicity is the main secondary effect of cyclosporine A ( CsA ) treatment . The antioxidant action of Nigella sativa oil ( NSO ) may explain the protective effect of these agents against various hepatotoxic and nephrotoxic models in vivo and in vitro . This study was design ed to investigate the possible protective effects of NSO , in prevention of chronic CsA-induced nephrotoxicity in rats . Animals were r and omly divided into four experimental groups : the control group received sunflower oil , the other groups were treated with CsA ( 25 mg/kg/day b.w . orally ) or NSO ( 2 ml/kg orally ) or CsA + NSO , respectively . Urine and serum creatinine levels , tissue superoxide dismutase , glutathione peroxidase and catalase enzyme activities , and nitric oxide and malondialdehyde levels were measured , and histological examination was performed . In our study , CsA caused a significant deterioration in the renal function , morphology and gave rise to severe oxidative stress in the kidney . NSO significantly improved the functional and histological parameters and attenuated the oxidative stress induced by CsA. In conclusion , our study demonstrated for the first time that NSO protects kidney tissue against oxygen free radicals , preventing renal dysfunction and morphological abnormalities associated with chronic CsA administration BACKGROUND Diabetic patients with hypertension and dyslipidemia are at a high risk of cardiovascular complications . OBJECTIVES To determine the effect of Nigella sativa supplementation on the lipid profile , mean arterial pressure , and heart rate in persons with type 2 diabetes on oral hypoglycemic agents ( OHA ) .  DESIGN Single-blind , nonr and omized . SETTING Diabetes clinic of a university hospital in Saudi Arabia . PATIENTS AND METHODS Type-2 diabetic patients were recruited by purposive sampling and assigned to treatment or control at the discretion of the investigator with the patient blinded to treatment . Before the intervention and every 3 months thereafter until the end of the treatment period , the following parameters were measured : triglycerides ( TG ) , total cholesterol ( TC ) , low density lipoprotein cholesterol ( LDL-C ) , high density lipoprotein cholesterol ( HDL-C ) , systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , mean arterial pressure ( MAP ) , heart rate ( HR ) , and body mass index ( BMI ) . Results at the baseline and each subsequent visit were compared between the two groups . MAIN OUTCOME MEASURE(S ) Lipid and cardiovascular parameters , and BMI . RESULTS Fifty-seven patients were assigned to receive N sativa 2 g daily for one year and 57 were assigned to receive an identical regimen of placebo , along with OHA . A significant decrease in HDL-C and increase in the TC/HDL-C and LDL-C/HDL-C ratios were seen in the control group . The N sativa group had a significant decline in TC , LDL-C , TC/HDL-C and LDL-C/HDL-C ratios , compared with the respective baseline data and the control group . HDL-C was significantly elevated in the N sativa group . The control group showed a significant elevation in MAP . The N sativa group had a significant reduction in SBP , DBP , MAP and HR and a significant decrease in DBP , MAP and HR as compared with the control group . CONCLUSION N sativa supplementation improves total cholesterol , mean arterial pressure and heart rate in type 2 diabetes patients on oral hypoglycemic agents .  LIMITATIONS There were 9 subjects in each group lost to follow up ; thus the sample size could not be maintained as per the sample size calculation . The study was nonr and omized and thus there was a possibility of allocation bias . ( Clinical trial registration number : CTRI/2013/06/003781 , Clinical Trial Registry of India ) Background : Vitiligo is one of the autoimmune skin diseases that destroy the melanocytes of the skin . Moreover , its prevalence varies in different countries and regions . Objectives : The aim of this study was to compare the effect of Nigella sativa and fish oil on vitiligo lesions of the patients referred to a dermatology clinic . Material s and Methods : This r and omized , double blind clinical trial was conducted in the dermatology clinic of the Imam Khomeini Hospital Ahvaz , Iran , from June to December 2011 . We used a r and omized simple sampling . From 96 patients with vitiligo , 52 eligible patients were selected and allocated to two groups with equal size . The study medications were applied twice a day by patients on their lesions . After six months , the improvement rate of lesions was assessed by the Vitiligo Area Scoring Index ( VASI ) . Data were analyzed using SPSS v. 15 ; P value < 0.05 was considered as statistically significant . Results : After six months , a mean score of VASI decreased from 4.98 to 3.75 in patients applying topical Nigella sativa and from 4.98 to 4.62 in those using topical fish oil . Most of the percent improvement observed in upper extremities , trunk , head , and neck of those who received Nigella sativa and head , neck , trunk , and feet of those who received fish oil .  No adverse effect was reported by the patients . Conclusions : Nigella sativa oil and fish oil were effective in reduction the size of patient ’s lesions ; however , Nigella sativa was more effective in comparison to the fish oil . Therefore , using Nigella sativa with the major drugs in the treatment of vitiligo is recommended Nigella sativa L. seeds ( N. sativa ) have been used as a traditional remedy for a wide range of diseases including hypertension . The present study was performed to explore the effects of N. sativa oil on blood pressure ( BP ) in healthy volunteers . In a double-blind , r and omized study , 70 healthy volunteers aged 34 to 63 years with systolic BP from 110 to 140 mmHg and diastolic BP from 60 to 90 mmHg were r and omly allocated to receive 2.5 mL N. sativa oil or placebo two times a day for 8 weeks . The systolic and diastolic BPs , body mass index and blood levels of aspartate transaminase , alanine transaminase , alkaline phosphatase , creatinine and blood urea nitrogen were determined at baseline and endpoint . Results showed that in N. sativa oil treated group the systolic and diastolic BPs decreased significantly compared with baseline and placebo group at the endpoint . Other parameters did not significantly change in both groups at the endpoint . No adverse effects were reported . In conclusion , oral daily administration of 5 mL N. sativa oil to healthy volunteers for 8 weeks lowers systolic and diastolic BPs without any adverse effects BACKGROUND Experimental evidence s have demonstrated that Nigella sativa Linn . seed ( NS ) has positive modulation effects on aged rats with memory impairments , prevents against hippocampal pyramidal cell loss and enhances consolidation of recall capability of stored information and spatial memory in rats .  NS has neuroprotective , nephroprotective , lung protective , cardioprotective , hepatoprotective activities as established by previous studies on animals . Several clinical trials with NS on human have also demonstrated beneficial effect . AIM OF THE STUDY The present study was design ed to investigate the effects of NS on memory , attention and cognition in healthy elderly volunteers . Furthermore , safety profile of NS was assessed during the nine-week study period . METHODS Forty elderly volunteers were recruited and divided r and omly into group A and group B -- each consisting of 20 volunteers . The treatment procedure for group A was 500 mg NS capsule twice daily for nine weeks and Group B received placebo instead of NS in the similar manner . All the volunteers were assessed for neuropsychological state and safety profile twice before treatment and after nine weeks . The neuropsychological tests were logical memory test , digit span test , Rey-Osterrieth complex figure test , letter cancellation test , trail making test and stroop test . Safety profile was assessed by measuring biochemical markers of Cardiac ( total cholesterol , triglycerides and high density lipoprotein cholesterol , very low density lipoprotein , low density lipoprotein cholesterol , creatine kinase-MB ) ; Liver ( aspartate aminotransferase , alanin aminotransferase , alkaline phosphatase , total protein , albumin , bilirubin ) and Kidney ( creatinine and blood urea nitrogen ) through using commercial kits . RESULTS There was significant difference ( p<0.05 ) in the score of logical memory test-I and II , total score of digit span , 30 min delayed-recall , percent score in Rey-Osterrieth complex figure test , time taken to complete letter cancellation test , time taken in trail making test-A and test-B , score in part C of stroop test due to ingestion of NS for nine weeks . There were not statistically significant changes ( p>0.05 ) in any of the biochemical markers of cardiac , liver , kidney function during this nine-week study period . CONCLUSIONS The current study demonstrates the role of NS in enhancing memory , attention and cognition . Therefore , whether NS could be considered as potential food supplement for preventing or slow progressing of Alzheimer disease needs further investigations . However , study with Alzheimer 's patients with large population size for longer period of time is recommended before using NS daily and extensive phytochemical investigations are recommended for novel drug discovery from NS for treating cognitive disorders Pre clinical studies have shown beneficial effects of black seed ( Nigella sativa L. ) in the prevention and treatment of renal stones .  Hence , we design ed a study to evaluate the renal-stone-dissolving efficacy of black seed .  Sixty patients with renal stones were r and omly enrolled in two arms of a r and omized , triple-blind , placebo-controlled , clinical trial . The patients were treated by black seed capsules ( 500 mg ) or placebo two times per day for 10 weeks . Patients were assessed in terms of size of renal stones by using sonography before and after intervention . In the black seed group , 44.4 % of patients excreted their stones completely , and the size of the stones remained unchanged and decreased in 3.7 % and 51.8 % of patients , respectively . In contrast , in the placebo group , 15.3 % of the patients excreted their stones completely , 11.5 % had reduction in stone size , 15.3 % had increase in stone size , and 57.6 % had no change in their stone size . The difference in the mean size of renal stones after the study was significant between the two groups ( p < 0.05 ) . N. sativa L. , as compared with placebo , is demonstrated to have significant positive effects on disappearance or reduction of size of kidney stones BACKGROUND Inflammation is one of the primary mechanisms in the development of metabolic complications . Although anti-inflammatory characteristics of Nigella sativa ( NS ) have been indicated in animal models , clinical trials related to the effects of NS on inflammatory parameters are relatively scarce . OBJECTIVE The aim of the present study was to determine the effects of NS oil combined with a calorie-restricted diet on systemic inflammatory biomarkers in obese women . METHODS In this double-blind placebo-controlled r and omized clinical trial , 90 volunteer obese ( body mass index = 30 - 34.9 kg/m(2 ) ) women aged 25 - 50 years were recruited . Participants were r and omly divided into two groups , an intervention group ( n = 45 ) and a placebo group ( n = 45 ) . Each group received either : ( 1 ) a low-calorie diet with 3 g/day of NS oil or ( 2 ) a low-calorie diet with 3 g/day placebo for 8 weeks . RESULTS A total of 84 females ( intervention group = 43 ; placebo group = 41 ) completed the trial . Subjects in the intervention group did not report any side effects with the NS oil supplementation . NS oil decreased serum levels of tumor necrosis factor-alpha ( -40.8 % vs -16.1 % , P = .04 ) and high-sensitivity C-reactive protein ( -54.5 % vs -21.4 % , P = .01 ) compared to the placebo group . However , there were no significant changes in interleukin-6 levels ( -8.6 vs -2.4 % , P = .6 ) in the NS group compared to the placebo group . CONCLUSIONS NS oil supplementation combined with a calorie-restricted diet may modulate systemic inflammatory biomarkers in obese women . However , more studies are needed to clarify the efficacy of NS oil as an adjunct therapy to improve inflammatory parameters in obese subjects
Our data suggested that N.S supplementation had significant impacts on liver and kidney parameters leading to a decrease in ALP and BUN levels .
The aim of this systematic review and dose-response meta- analysis was to determine the effect of Nigella Sativa ( N.S ) supplementation on  liver and kidney parameters .