Background and ObjectiveOxidative stress plays an important role in pathogenesis of diabetes mellitus and its complications. Our previous study has shown glucose lowering effect produced by 3 months supplementation of Nigella sativa (NS) in combination with oral hypoglycemic drugs among type 2 diabetics. This study explored the long term glucose lowering effect (over one year) of NS in patients with type 2 diabetes mellitus on oral hypoglycemic drugs and to study its effect on redox status of such patients.Methods114 type 2 diabetic patients on standard oral hypoglycemic drugs were assigned into 2 groups by convenience. The control group (n = 57) received activated charcoal as placebo and NS group (n = 57) received 2g NS, daily, for one year in addition to their standard medications. Fasting blood glucose (FBG), glycosylated hemoglobin (HbA1c), C- peptide, total antioxidant capacity (TAC), superoxide dismutase (SOD), catalase (CAT), glutathione and thiobarbituric acid reactive substances (TBARS) at the baseline, and every 3 months thereafter were determined. Insulin resistance and β-cell activity were calculated using HOMA 2 calculator.ResultsComparison between the two groups showed a significant drop in FBG (from 180±5.75 to 180±5.59 in control Vs from 195±6.57 to 172 ±5.83 in NS group), HbA1c (from 8.2±0.12 to 8.5±0.14 in control VS from 8.6±0.13 to 8.2±0.14 in NS group), and TBARS (from 48.3±6.89 to 52.9 ±5.82 in control VS from 54.1±4.64 to 41.9 ±3.16 in NS group), in addition to a significant elevation in TAC, SOD and glutathione in NS patients compared to controls. In NS group, insulin resistance was significantly lower, while β-cell activity was significantly higher than the baseline values during the whole treatment period.ConclusionLong term supplementation with Nigella sativa improves glucose homeostasis and enhances antioxidant defense system in type 2 diabetic patients treated with oral hypoglycemic drugs.Trial RegistrationClinical Trials Registry-India (CTRI) CTRI/2013/06/003781

BACKGROUNDNigella sativa and its derivatives have been reported to have anti-inflammatory and bronchodilator effects, but the effects have been evaluated in only a few clinical studies.OBJECTIVESTo determine the effect of N sativa supplementation on inflammation of the airways and limitation of airflow in partly controlled asthma patients.DESIGNSingle-blind, placebo-controlled, randomized study.SETTINGAsthma and allergy clinic of a university hospital in eastern Saudi Arabia.PATIENTS AND METHODSPatients were divided into three groups. A control group (n=24) received the placebo, while NS-1 and NS-2 groups (n=26 each) received 1 and 2 g/day of N sativa, respectively, for 3 months along with maintenance inhaled therapy.MAIN OUTCOME MEASURE(S)Asthma control test (ACT) score, fractional exhaled nitric oxide (FeNO), peak expiratory flow (PEF) variability and other pulmonary function tests, IgE, serum cytokines, and frequency of exacerbations.RESULTSFEF25-75% and FEV1 (% predicted) increased significantly (P<.05) at both 6 and 12 weeks in the NS-2 group. PEF variability significantly improved in both NS-1 and NS-2 groups at 6 and 12 weeks as compared with the controls (P<.05). FeNO and serum IgE decreased significantly after 12 weeks in both the NS-1 and NS-2 groups vs baseline (P<.05). Both doses of N sativa produced a significant increase in the serum IFN-γ at 12 weeks vs baseline (P<.05) as well as a significant improvement in the ACT score at 6 and 12 weeks vs baseline (P<.001, <.01). Significantly fewer patients had exacerbations in the NS-1 group (P<.05).CONCLUSIONN sativa supplementation with inhaled maintenance therapy improves some measures of pulmonary function and inflammation in partly controlled asthma.LIMITATIONSNo bronchoalveolar lavage or sputum samples taken for measurement of asthma markers.

BACKGROUNDDiabetic patients with hypertension and dyslipidemia are at a high risk of cardiovascular complications.OBJECTIVESTo 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).DESIGNSingle-blind, nonrandomized.SETTINGDiabetes clinic of a university hospital in Saudi Arabia.PATIENTS AND METHODSType-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.RESULTSFifty-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.CONCLUSIONN sativa supplementation improves total cholesterol, mean arterial pressure and heart rate in type 2 diabetes patients on oral hypoglycemic agents.LIMITATIONSThere 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 nonrandomized and thus there was a possibility of allocation bias. (Clinical trial registration number: CTRI/2013/06/003781, Clinical Trial Registry of India).

Background/Aim:A large number of diseases are ascribed to Helicobacter pylori (H. pylori), particularly chronic active gastritis, peptic ulcer disease and gastric cancer. Successful treatment of H. pylori infection with antimicrobial agents can lead to regression of H. pylori–associated disorders. Antibiotic resistance against H. pylori is increasing, and it is necessary to find new effective agents. Nigella sativa seed (NS), a commonly used herb, possesses in vitro anti-helicobacter activity. The present study was undertaken to evaluate the efficacy of NS in eradication of H. pylori infection in non-ulcer dyspeptic patients.Materials and Methods:The study was conducted on 88 adult patients attending King Fahd Hospital of the University, Al-Khobar, Saudi Arabia, from 2007 to 2008, with dyspeptic symptoms and found positive for H. pylori infection by histopathology and urease test. Patients were randomly assigned to four groups, receiving i) triple therapy (TT) comprising of clarithromycin, amoxicillin, omeprazole [n= 23], ii) 1 g NS + 40 mg omeprazole (OM) [n= 21], iii) 2 g NS + OM [n= 21] or iv) 3 g NS + OM [n= 23]. Negative H. pylori stool antigen test four weeks after end of treatment was considered as eradication.Results:H. pylori eradication was 82.6, 47.6, 66.7 and 47.8% with TT, 1 g NS, 2 g NS and 3 g NS, respectively. Eradication rates with 2 g NS and TT were statistically not different from each other, whereas H. pylori eradication with other doses was significantly less than that with TT (P < 0.05). Dyspepsia symptoms improved in all groups to a similar extent.Conclusions:N. sativa seeds possess clinically useful anti-H. pylori activity, comparable to triple therapy. Further clinical studies combining N. sativa with antibiotics are suggested.