Nigella Abstracts 2

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The possible prophylactic effect of Nigella sativa seed aqueous extract on respiratory symptoms and pulmonary function tests on chemical war victims: a randomized, double-blind, placebo-controlled trial.
            (Boskabady and Farhadi, 2008) Download
BACKGROUND:  In previous studies, the relaxant, anticholinergic (functional antagonism), and antihistaminic effects of various extracts and oils of Nigella sativa seed have been demonstrated. In the present study, the prophylactic effect of a boiled aqueous extract of nigella seed on chemical war victims was examined. METHODS:  Forty (40) chemical war victims were randomly divided into control group (20 patients) and study group (20 patients), and they were studied for 2 months. In the study group 0.375 mL/kg of 50 g% boiled extract and in the control group a placebo solution were administered daily throughout the study. Respiratory symptom score and wheezing were recorded in the beginning (first visit), 30 days after treatment (second visit), and at the end of the study (third visit). Pulmonary function tests (PFTs) were also measured, and the drug regimen of the patients was evaluated at 3 different visits. RESULTS:  All respiratory symptoms, chest wheezing, and PFT values in the study group significantly improved in the second and third visits compared to the first visit (p < 0.05 to p < 0.001). In addition, further improvement of chest wheezing and some PFT values on the third visit were observed compared to the second visit in this group (p < 0.05 to p < 0.001). In the third visits, all PFT values and most symptoms in the study group were significantly different from those of the control group (p < 0.01 to p < 0.001). However, in the control group, there were only small improvements in some parameters in the second and third visits. The use of inhaler and oral beta-agonists and oral corticosteroid in the study group decreased at the end of the study, while there were no obvious changes in use of the drugs in control subjects. CONCLUSIONS:  The results of this study suggest a prophylactic effect of N. sativa on chemical war victims and warrant further research regarding this effect.

Nigella sativa improves glucose homeostasis and serum lipids in type 2 diabetes: A systematic review and meta-analysis.
            (Daryabeygi-Khotbehsara et al., 2017) Download
BACKGROUND & OBJECTIVE(S):  Global prevalence of type 2 diabetes (T2D) is very high and is currently growing alarmingly. With respect to recent researchers' attention to the potential role of herbal medicine in disease prevention and management, the present meta-analysis review investigates the effectiveness of Nigella sativa (N. sativa), a popular herb, in T2D. METHODS:  Literature search was conducted covering PubMed/Medline, Scopus, and Cochrane Registry of Clinical Trials up to February 2017 to obtain the relevant published intervention studies. Study selection, quality rating and data extraction of studies were investigated by two independent reviewers. Heterogeneity was assessed using I-squared (I2) statistics test. Subgroup analysis was done to assess type of N. sativa supplement as source of heterogeneity. Effect sizes of eligible studies were pooled using STATA software version 12 (STATA corp, College Station, TX, USA). RESULTS:  Seven trials were included in the meta-analysis of glycemic and serum lipid profile end points. Supplementation with N. sativa significantly improved fasting blood sugar (FBS) [-17.84mg/dl, 95% CI: -21.19 to -14.49, p<0.001], HbA1c [-0.71%, 95% CI: -1.04 to -0.39, p<0.001], total-cholesterol (TC) [WMD: -22.99mg/dl, 95% CI: -32.16 to -13.83, p<0.001] and LDL-cholesterol (LDL-c) [-22.38mg/dl, 95% CI: -33.60 to -11.15, p<0.001]. The overall effects for triglyceride (TG) [-6.80mg/dl, 95% CI: -33.59 to 19.99, p=0.61] and HDL-cholesterol (HDL-c) [0.37mg/dl, 95% CI: -1.59 to 2.33, p=0.71] were insignificant. Subgroup analysis revealed significant reduction on TG with N. sativa seed oil [-14.8mg/dl, 95% CI: -23.1 to -6.5, p<0.001], while TG was increased with seed powder [29.4mg/dl, 95% CI: 16.9-42.0, p<0.001]. All measures, but HbA1c, showed no evidence of publication bias. CONCLUSION:  Although, the meta-analysis conducted included a few number of studies, but has shown promising results on the effectiveness of N. sativa on glucose homeostasis and serum lipids. Current findings suggest N. sativa supplementation a suitable choice in managing the complications of T2D, although future researches are necessary.

Antihypertensive effect of Nigella sativa seed extract in patients with mild hypertension.
            (Dehkordi and Kamkhah, 2008) Download
Hypertension (HT) is a lifestyle-related disease and dietary modifications are effective for its management and prevention. We conducted a randomized, double-blind, placebo-controlled trial to evaluate the efficacy of treatment with an oral Nigella sativa (NS) seed extract supplement in patients with mild HT. Subjects were randomized into three groups: a placebo and two test groups that received 100 and 200 mg of NS extract twice a day. After 8 weeks, systolic blood pressure (SBP) values in both case groups were found to be significantly reduced when compared with the baseline values for each group. In addition, the decrease in SBP in the two case groups was statistically significant relative to the placebo group (P < 0.05-0.01). Meanwhile, diastolic blood pressure (DBP) values in the case groups were found to be significantly reduced from the baseline and a significant reduction was also observed in these groups (P < 0.01) when compared with the placebo group. In addition, extract administration reduced both SBP and DBP in a dose-dependent manner. Meanwhile, NS extract caused a significant decline in the level of total and low-density-lipoprotein (LDL)-cholesterol relative to baseline data. No complications caused by NS were observed. The results suggest that the daily use of NS seed extract for 2 months may have a blood pressure-lowering effect in patients with mild HT.

Symptomatic treatment of acute tonsillo-pharyngitis patients with a combination of Nigella sativa and Phyllanthus niruri extract.
            (Dirjomuljono et al., 2008) Download
Acute tonsillopharyngitis is characterized by tonsil or pharyngeal inflammation and mostly is a virus in origin; thus, treatment that covers both the inflammation and inadequate immune response against the pathogenic organism is needed. NSPN extract containing Nigella sativa and Phyllanthus niruri extracts has both antiinflammatory and immunomodulatory effects. A comparative, parallel, randomized, double-blind, placebo-controlled study with a treatment period of 7 days was conducted to examine clinical effectiveness of Nigella sativa and Phyllanthus niruri extract (NSPN extract). Of 200 enrolled patients, 186 patients completed the study, 12 patients withdrew and 2 patients were principally screened failure but inadvertently included. NSPN capsules, each containing 360 mg Nigella sativa and 50 mg Phyllanthus niruri extracts, were orally administered 3 times 1 capsule daily for 7 days. At Hour 5 or 6 of the first dosing of study medication, the sore throat assessed as swallowing pain and difficulty, was markedly alleviated in the NSPN group. In line with the significant alleviation of pain, from Days 0 to 2 of treatment, subjects in the NSPN group also needed significantly less escape âanalgesicâ therapy (paracetamol tablets) than those in the placebo group. At the end of treatment (Day 7), a significantly greater proportion of patients in the NSPN group than in the placebo group had their sore throat completely relieved. NSPN extract was also found to be safe and well tolerated in acute tonsillopharyngitis patients. This study proved significant benefits of NSPN extract in the treatment of acute tonsillopharyngitis as compared to placebo.

Blood pressure lowering effect of Nigella sativa L. seed oil in healthy volunteers: a randomized, double-blind, placebo-controlled clinical trial.
            (Fallah Huseini et al., 2013) Download
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, randomized 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 randomly 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.

The effects of Nigella sativa on thyroid function, serum Vascular Endothelial Growth Factor (VEGF) - 1, Nesfatin-1 and anthropometric features in patients with Hashimoto's thyroiditis: a randomized controlled trial.
            (Farhangi et al., 2016) Download
BACKGROUND:  Hashimoto's thyroiditis is an autoimmune disorder and the most common cause of hypothyroidism. The use of Nigella sativa, a potent herbal medicine, continues to increase worldwide as an alternative treatment of several chronic diseases including hyperlipidemia, hypertension and type 2 diabetes mellitus (T2DM). The aim of the current study was to evaluate the effects of Nigella sativa on thyroid function, serum Vascular Endothelial Growth Factor (VEGF) - 1, Nesfatin-1 and anthropometric features in patients with Hashimoto's thyroiditis. METHODS:  Forty patients with Hashimoto's thyroiditis, aged between 22 and 50 years old, participated in the trial and were randomly allocated into two groups of intervention and control receiving powdered Nigella sativa or placebo daily for 8 weeks. Changes in anthropometric variables, dietary intakes, thyroid status, serum VEGF and Nesfatin-1 concentrations after 8 weeks were measured. RESULTS:  Treatment with Nigella sativa significantly reduced body weight and body mass index (BMI). Serum concentrations of thyroid stimulating hormone (TSH) and anti-thyroid peroxidase (anti-TPO) antibodies decreased while serum T3 concentrations increased in Nigella sativa-treated group after 8 weeks. There was a significant reduction in serum VEGF concentrations in intervention group. None of these changes had been observed in placebo treated group. In stepwise multiple regression model, changes in waist to hip ratio (WHR) and thyroid hormones were significant predictors of changes in serum VEGF and Nesgfatin-1 values in Nigella sativa treated group (P < 0.05). CONCLUSIONS:  Our data showed a potent beneficial effect of powdered Nigella sativa in improving thyroid status and anthropometric variables in patients with Hashimoto's thyroiditis. Moreover, Nigella sativa significantly reduced serum VEGF concentrations in these patients. Considering observed health- promoting effect of this medicinal plant in ameliorating the disease severity, it can be regarded as a useful therapeutic approach in management of Hashimoto's thyroiditis. TRIAL REGISTRATION:  Iranian registry of clinical trials (registration number IRCT2015021719082N4 - Registered March-15-2015).

Effectiveness of Nigella sativa oil in the management of rheumatoid arthritis patients: a placebo controlled study.
            (Gheita and Kenawy, 2012) Download
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.

Comparing Nigella sativa Oil and Fish Oil in Treatment of Vitiligo.
            (Ghorbanibirgani et al., 2014) Download
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. MATERIALS AND METHODS:  This randomized, 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 randomized 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.

Thymoquinone, a bioactive component of Nigella sativa, normalizes insulin secretion from pancreatic β-cells under glucose overload via regulation of malonyl-CoA.
            (Gray et al., 2016) Download
Thymoquinone (2-isopropyl-5-methylbenzo-1,4-quinone) is a major bioactive component of Nigella sativa, a plant used in traditional medicine to treat a variety of symptoms, including elevated blood glucose levels in type 2 diabetic patients. Normalization of elevated blood glucose depends on both glucose disposal by peripheral tissues and glucose-stimulated insulin secretion (GSIS) from pancreatic β-cells. We employed clonal β-cells and rodent islets to investigate the effects of thymoquinone (TQ) and Nigella sativa extracts (NSEs) on GSIS and cataplerotic metabolic pathways implicated in the regulation of GSIS. TQ and NSE regulated NAD(P)H/NAD(P)(+) ratios via a quinone-dependent redox cycling mechanism. TQ content was positively correlated with the degree of redox cycling activity of NSE extracts, suggesting that TQ is a major component engaged in mediating NSE-dependent redox cycling. Both acute and chronic exposure to TQ and NSE enhanced GSIS and were associated with the ability of TQ and NSE to increase the ATP/ADP ratio. Furthermore, TQ ameliorated the impairment of GSIS following chronic exposure of β-cells to glucose overload. This protective action was associated with the TQ-dependent normalization of chronic accumulation of malonyl-CoA, elevation of acetyl-CoA carboxylase (ACC), fatty acid synthase, and fatty acid-binding proteins following chronic glucose overload. Together, these data suggest that TQ modulates the β-cell redox circuitry and enhances the sensitivity of β-cell metabolic pathways to glucose and GSIS under normal conditions as well as under hyperglycemia. This action is associated with the ability of TQ to regulate carbohydrate-to-lipid flux via downregulation of ACC and malonyl-CoA.

Effects of Nigella sativa oil extract on inflammatory cytokine response and oxidative stress status in patients with rheumatoid arthritis: a randomized, double-blind, placebo-controlled clinical trial.
            (Hadi et al., 2016) Download
OBJECTIVE:  Nigella sativa is a medicinal plant that has long been used in traditional medicine for treating various conditions. Numerous animal studies provided evidences that the seed may elicit a broad anti-inflammatory/anti-oxidant activity. The aim of the present clinical trial was to evaluate anti-inflammatory and antioxidant properties of Nigella sativa oil in patients with rheumatoid arthritis (RA). MATERIALS AND METHODS:  Forty-two patients with RA were assigned into two groups in this randomized, double blind, placebo-controlled clinical trial. Subjects in intervention group received two capsules, 500 mg each, of Nigella sativa oil, each day for 8 weeks. The other group consumed two capsules as placebo per day for the same period of time. Serum TNF-α, IL-10, and whole blood levels of oxidative stress parameters were measured at baseline and end of the trial. RESULTS:  The serum level of IL-10 was increased in the Nigella sativa group (p<0.01). Moreover, treatment with Nigella sativa led to significant reduction of serum MDA and NO compared with baseline (p<0.05). There were no significant differences in the TNF-α, SOD, catalase, and TAS values between or within the groups, before and after the intervention (p>0.05). CONCLUSION:  This study indicates that Nigella sativa could improve inflammation and reduce oxidative stress in patients with RA. It is suggested that Nigella sativa may be a beneficial adjunct therapy in this population of patients.

Effectiveness of Topical Nigella sativa Seed Oil in the Treatment of Cyclic Mastalgia: A Randomized, Triple-Blind, Active, and Placebo-Controlled Clinical Trial.
            (Huseini et al., 2016) Download
Cyclic mastalgia is common in women and has no optimal therapy. Analgesic effects of Nigella sativa have been reported. Thus, the effect of a standardized N. sativa seed oil (600 mg applied to the site of pain bis in die for 2 months) on the 10-centimeter visual analog scale scores of pain severity in 52 women with cyclic mastalgia was compared to that of topical diclofenac (20 mg bis in die) (n = 51) and placebo (n = 53). There was no significant difference between the 1- and 2-month pain scores in the active treatment groups (p > 0.05). The pain scores of the active treatment groups did not differ significantly at 1 and 2 months (p > 0.05). The endpoint pain scores of the active treatment groups decreased significantly compared with the baseline (both p < 0.001). The pain scores of the active treatment groups at 1 and 2 months were significantly smaller than those of the placebo group (both p < 0.001). The pain scores of the placebo group at 1 and 2 months were not significantly different from the baseline (p > 0.05). No adverse effect was observed. In conclusion, topical N. sativa seed oil is safe, more effective than placebo, and has clinical effectiveness comparable to topical diclofenac in the treatment of cyclic mastalgia.

A randomised controlled trial on hypolipidemic effects of Nigella Sativa seeds powder in menopausal women.
            (Ibrahim et al., 2014) Download
BACKGROUND:  The risk of cardiovascular diseases (CVD) is increased tremendously among menopausal women, and there is an increasing demand for alternative therapies for managing factors like dyslipidemia that contribute to CVD development. METHODS:  In this study, Nigella sativa was evaluated for its hypolipidemic effects among menopausal women. In a randomised trial, hyperlipidemic menopausal women were assigned to treatment (n=19) or placebo groups (n=18), and given N. sativa or placebo for two months after their informed consents were sought. At baseline, blood samples were taken and at one month intervals thereafter until one month after the end of the study. RESULTS:  The results showed that N. sativa significantly improved lipid profiles of menopausal women (decreased total cholesterol, low density lipoprotein cholesterol and triglyceride, and increased high density lipoprotein cholesterol) more than the placebo treatment over 2 months of intervention. One month after cessation of treatment, the lipid profiles in the N. sativa-treated group tended to change towards the pretreatment levels. CONCLUSIONS:  N. sativa is thought to have multiple mechanisms of action and is cost-effective. Therefore, it could be used by menopausal women to remedy hypercholesterolemia, with likely more benefits than with single pharmacological agents that may cause side effects. The use of N. sativa as an alternative therapy for hypercholesterolemia could have profound impact on the management of CVD among menopausal women especially in countries where it is readily available.

Cannabis-induced Moto-Cognitive Dysfunction in Wistar Rats: Ameliorative Efficacy of Nigella Sativa.
            (Imam et al., 2016) Download
BACKGROUND:  Cannabis is a widely used illicit drug with various threats of personality syndrome, and Nigella sativa has been widely implicated as having therapeutic efficacy in many neurological diseases. The present study investigates the ameliorative efficacy of Nigella sativa oil (NSO) on cannabis-induced moto-cognitive defects. METHODS:  Scopolamine (1 mg/kg i.p.) was given to induce dementia as a standard base line for cannabis (20 mg/kg)-induced cognitive impairment, followed by an oral administration of NSO (1 ml/kg) for 14 consecutive days. The Morris water maze (MWM) paradigm was used to assess the memory index, the elevated plus maze was used for anxiety-like behaviour, and the open field test was used for locomotor activities; thereafter, the rats were sacrificed and their brains were removed for histopathologic studies. RESULTS:  Cannabis-like Scopolamine caused memory impairment, delayed latency in the MWM, and anxiety-like behaviour, coupled with alterations in the cerebello-hippocampal neurons. The post-treatment of rats with NSO mitigated cannabis-induced cognitive dysfunction as with scopolamine and impaired anxiety-like behaviour by increasing open arm entry, line crossing, and histological changes. CONCLUSIONS:  The observed ameliorative effects of NSO make it a promising agent against moto-cognitive dysfunction and cerebelo-hippocampal alterations induced by cannabis.

Potential adjuvant effects of Nigella sativa seeds to improve specific immunotherapy in allergic rhinitis patients.
            (Işik et al., 2010) Download
OBJECTIVE:  To investigate the effects of Nigella sativa seed supplementation on symptom levels, polymorphonuclear leukocyte (PMN) functions, lymphocyte subsets and hematological parameters of allergic rhinitis. SUBJECTS AND METHODS:  Twenty-four patients randomly selected from an experimental group of 31 (mean age 34 years) sensitive to house dust mites with allergic rhinitis and a control group of 8 healthy volunteers (mean age 23 years) were treated with allergen-specific immunotherapy in conventional doses for 30 days. After a month of immunotherapy, 12 of the 24 patients and the 8 healthy volunteers were given N. sativa seed supplementation (2 g/day orally) for 30 days. The remaining 12 patients continued only on immunotherapy during the same period. The other 7 patients were given 0.1 ml saline solution subcutaneously once a week as a placebo. The symptom scores, PMN functions, lymphocyte subsets and other hematological parameters were evaluated before and after all treatment periods. RESULTS:  There was a statistically significant increase in the phagocytic and intracellular killing activities of PMNs of patients receiving specific immunotherapy, especially after the addition of N. sativa seed. The CD8 counts of patients receiving specific immunotherapy plus N. sativa seed supplementation significantly increased compared to patients receiving only specific immunotherapy. PMN functions of healthy volunteers significantly increased after N. sativa seed supplementation compared to baseline. CONCLUSION:  N. sativa seed supplementation during specific immunotherapy of allergic rhinitis may be considered a potential adjuvant therapy.

Nigella sativa improves glycemic control and ameliorates oxidative stress in patients with type 2 diabetes mellitus: placebo controlled participant blinded clinical trial.
            (Kaatabi et al., 2015) Download
BACKGROUND AND OBJECTIVE:  Oxidative 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. METHODS:  114 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. RESULTS:  Comparison 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. CONCLUSION:  Long term supplementation with Nigella sativa improves glucose homeostasis and enhances antioxidant defense system in type 2 diabetic patients treated with oral hypoglycemic drugs. TRIAL REGISTRATION:  Clinical Trials Registry-India (CTRI) CTRI/2013/06/003781.

Effect of Nigella sativa (black seed) on subjective feeling in patients with allergic diseases.
            (Kalus et al., 2003) Download
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 subpopulations. 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 subpopulations, endogenous cortisol levels and ACTH release remained unchanged. Black seed oil therefore proved to be an effective adjuvant for the treatment of allergic diseases.

The Protective Effects of Nigella sativa and Its Constituents on Induced Neurotoxicity.
            (Khazdair, 2015) Download
Nigella sativa (N. sativa) is an annual plant and widely used as medicinal plant throughout the world. The seeds of the plant have been used traditionally in various disorders and as a spice to ranges of Persian foods. N. sativa has therapeutic effects on tracheal responsiveness (TR) and lung inflammation on induced toxicity by Sulfur mustard. N. sativa has been widely used in treatment of various nervous system disorders such as Alzheimer disease, epilepsy, and neurotoxicity. Most of the therapeutic properties of this plant are due to the presence of some phenolic compounds especially thymoquinone (TQ), which is major bioactive component of the essential oil. The present review is an effort to provide a comprehensive study of the literature on scientific researches of pharmacological activities of the seeds of this plant on induced neurotoxicity.

Effects of Nigella sativa L. seed oil on abnormal semen quality in infertile men: a randomized, double-blind, placebo-controlled clinical trial.
            (Kolahdooz et al., 2014) Download
In recent years, wide utilization of herbal drugs has encouraged scientists to determine their impressive effects on health. Since Nigella sativa L. seed (N. sativa) has many uses including infertility in traditional medicine, the effects of Nigella sativa L. seed oil on abnormal semen quality in infertile men with abnormal semen quality are of interest. This study was conducted on Iranian infertile men with inclusion criteria of abnormal sperm morphology less than 30% or sperm counts below 20×10(6)/ml or type A and B motility less than 25% and 50% respectively. The patients in N. sativa oil group (n=34) received 2.5mlN. sativa oil and placebo group (n=34) received 2.5ml liquid paraffin two times a day orally for 2 months. At baseline and after 2 months, the sperm count, motility and morphology and semen volume, pH and round cells as primary outcomes were determined in both groups. Results showed that sperm count, motility and morphology and semen volume, pH and round cells were improved significantly in N. sativa oil treated group compared with placebo group after 2 months. It is concluded that daily intake of 5ml N. sativa oil for two months improves abnormal semen quality in infertile men without any adverse effects.

Effect of Topical Application of Nigella Sativa Oil and Oral Acetaminophen on Pain in Elderly with Knee Osteoarthritis: A Crossover Clinical Trial.
            (Kooshki et al., 2016) Download
BACKGROUND:  Limited evidence supports Nigella sativa's role as an effective complementary and alternative medicine and the anti-inflammatory effects of Nigella sativa on patients with allergic rhinitis. OBJECTIVE:  The aim of this study was to investigate the effect of topical application of Nigella sativa oil and oral acetaminophen on pain in the elderly with knee osteoarthritis residing in a parents' home in Sabzevar. METHODS:  This study is done as a crossover clinical trial. After obtaining written consent of elderly patients with osteoarthritis of the knee, they were randomly divided into two groups. In step 1, in group 1, 1 cc of Nigella sativa oil was applied on the knee joint every 8 hours for 3 weeks; for the second group, every 8 hours for 3 weeks, patients were given 1 tablet of 325 mg acetaminophen. After a period of 1 month without medication to wash out each group, in step 2, each treatment group received the drug interaction in the same way as above. Pain was determined using a visual scale (VAS) before and after the first and second stages. Treatment response was defined as a decrease in pain scores over 1.5. Data analysis was performed with an R software mixed model. RESULTS:  This study was done on 40 elderly patients: 18 (45%) men and 22 (55%) women. Their mean year and weight were 75.66±8.9 years and 69.67±14.33 kg, respectively. Study results showed that topical application of Nigella sativa oil and oral acetaminophen reduced pain in elderly with knee osteoarthritis; after using Nigella sativa oil, the reduction of pain was higher (p=0.01). CONCLUSION:  The results of this study showed that topical application of Nigella sativa oil was effective in reducing pain in patients with knee osteoarthritis; therefore, it is recommended as a safe supplement for these elderly. TRIAL REGISTRATION:  The trial was registered at TCTR (http://www.clinicaltrials.in.th/) with the ID: TCTR20160125003. FUNDING:  This study was approved and supported by the Sabzevar University of Medical Sciences.

 


References

Boskabady, MH and J Farhadi (2008), ‘The possible prophylactic effect of Nigella sativa seed aqueous extract on respiratory symptoms and pulmonary function tests on chemical war victims: a randomized, double-blind, placebo-controlled trial.’, J Altern Complement Med, 14 (9), 1137-44. PubMed: 18991514
Daryabeygi-Khotbehsara, R, et al. (2017), ‘Nigella sativa improves glucose homeostasis and serum lipids in type 2 diabetes: A systematic review and meta-analysis.’, Complement Ther Med, 35 6-13. PubMed: 29154069
Dehkordi, FR and AF Kamkhah (2008), ‘Antihypertensive effect of Nigella sativa seed extract in patients with mild hypertension.’, Fundam Clin Pharmacol, 22 (4), 447-52. PubMed: 18705755
Dirjomuljono, M, et al. (2008), ‘Symptomatic treatment of acute tonsillo-pharyngitis patients with a combination of Nigella sativa and Phyllanthus niruri extract.’, Int J Clin Pharmacol Ther, 46 (6), 295-306. PubMed: 18541126
Fallah Huseini, H, et al. (2013), ‘Blood pressure lowering effect of Nigella sativa L. seed oil in healthy volunteers: a randomized, double-blind, placebo-controlled clinical trial.’, Phytother Res, 27 (12), 1849-53. PubMed: 23436437
Farhangi, MA, et al. (2016), ‘The effects of Nigella sativa on thyroid function, serum Vascular Endothelial Growth Factor (VEGF) - 1, Nesfatin-1 and anthropometric features in patients with Hashimoto’s thyroiditis: a randomized controlled trial.’, BMC Complement Altern Med, 16 (1), 471. PubMed: 27852303
Gheita, TA and SA Kenawy (2012), ‘Effectiveness of Nigella sativa oil in the management of rheumatoid arthritis patients: a placebo controlled study.’, Phytother Res, 26 (8), 1246-48. PubMed: 22162258
Ghorbanibirgani, A, A Khalili, and D Rokhafrooz (2014), ‘Comparing Nigella sativa Oil and Fish Oil in Treatment of Vitiligo.’, Iran Red Crescent Med J, 16 (6), e4515. PubMed: 25068060
Gray, JP, et al. (2016), ‘Thymoquinone, a bioactive component of Nigella sativa, normalizes insulin secretion from pancreatic β-cells under glucose overload via regulation of malonyl-CoA.’, Am J Physiol Endocrinol Metab, 310 (6), E394-404. PubMed: 26786775
Hadi, V, et al. (2016), ‘Effects of Nigella sativa oil extract on inflammatory cytokine response and oxidative stress status in patients with rheumatoid arthritis: a randomized, double-blind, placebo-controlled clinical trial.’, Avicenna J Phytomed, 6 (1), 34-43. PubMed: 27247920
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