Nutraceutically-enhanced oral delivery of vitamin D3 via Bio-SNEDDS: Demonstrating in vivo superiority over pediatric formulations.

BACKGROUND: Vitamin D3 (VD3) deficiency among children in Saudi Arabia remains a pressing concern due to its poor bioavailability and the limitations of current pediatric formulations. To address this challenge, we developed a groundbreaking pediatric self-nanoemulsifying drug delivery system (Bio-SNEDDS) for VD3, fortified with black seed oil and moringa seed oil for dual therapeutic benefits. Through meticulous formulation optimization using ternary phase diagrams and comprehensive testing, our Bio-SNEDDS demonstrated exceptional performance. METHODS: Bio-SNEDDS were manufactured by incorporating Black seed oil and moringa seed oil as bioactive nutraceutical excipients along with various cosurfactant and surfactants. Bio-SNEDDS were systematically optimized through ternary phase diagrams, visual tests, droplet size analysis, drug solubilization studies, dispersion assessments, and pharmacokinetic testing in rats compared to Vi-De 3®. RESULTS: Pseudoternary phase diagrams identified oil blends producing large nanoemulsion regions optimal for SNEDDS formation. The optimized F1 Bio-SNEDDS showed a mean droplet diameter of 33.7 nm, solubilized 154.46 mg/g VD3 with no metabolite formation, and maintained >88% VD3 in solution during 24 h dispersion testing. Notably, in vivo pharmacokinetic evaluation at a high VD3 dose demonstrated an approximately two-fold greater relative bioavailability over Vi-De 3®, validating the superb oral delivery performance of Bio-SNEDDS even under challenging high-dose conditions. CONCLUSIONS: The Bio-SNEDDS provides an effective VD3 delivery strategy with established in vivo superiority over marketed products, along with offering additional health benefits from the natural oils.

Optical Characteristics of the Black Seed Oil: Fluorescence and Adulteration Detection.

Understanding the optical characteristics, especially the fluorescence properties of vegetable oils, particularly black seed oil (BSO), is an essential prerequisite for the development of the future applications in both medicinal and nutritional fields. In this way, it is essential to identify the roles played by the components such as unsaturated fatty acids, carotenoids, flavonoids, vitamin E, and chlorophylls in the BSO fluorescence spectra. In the current landscape, challenges arise from the adulteration of BSO with impurities such as sunflower oil (SO), complicating efforts to obtain pure BSO. Here, dependence of the BSO fluorescence on excitation wavelength has been examined using UV- visible diode lasers (λ = 355, 405, 440, 532 and 660 nm) as excitation sources. Though conjugated unsaturated fatty acids, flavonoids and chlorophylls are mainly contributed to the fluorescence due to UV excitation, wavelengths in the visible range specifically excite carotenoids, vitamin E, and chlorophylls. By utilizing the laser-induced fluorescence (LIF) technique, we explored the effects of inner filters and setup geometry to gain deeper insights into the BSO fluorescence dynamics. Differential spectral analysis (DSA) revealed that adulteration of BSO with SO alters its fluorescence features. As a result, a novel approach is proposed for adulteration detection, based on the simultaneous excitation of BSO and SO by a 405 nm laser, benefit to indirect excitation of the carotenoids of BSO by fluorescence emission of SO within the spectral range of 400-500 nm, which results in the enhancement of BSO fluorescence in the region of 500-600 nm.

A Study on Thymoquinone: Antioxidant Capacity and Anticancer Activities in LoVo Colorectal Cancer Cells.

Thymoquinone has antioxidant and anticancer effects. This study investigates the cytotoxic, genotoxic, and apoptotic effects of black seed and its active ingredient, thymoquinone on colorectal cancer cells. The antioxidant content of Black seed methanolic extracts (BSME) with different concentrations (50, 500 and 1000 µg/mL) were determined by the photometric methods. The reactive oxygen production (iROS) of BSME and thymoquinone on colorectal cancer cells (LoVo) and normal epithelial cells (CCD18Co) were analyzed by the fluorometric methods. A luminometric glutathione kit was employed to observe the changes in intracellular glutathione (GSH) levels. Cytotoxicity was determined by the ATP method, genotoxicity was determined by Comet Assay, and the apoptosis was identified by the Acridine Orange/Ethidium Bromide (AO/EB) double dye method. The cytotoxicity was increased by BSME and thymoquinone in LoVo cells in a dose-dependent manner (p<0.001). BSME and thymoquinone also increased iROS, and induced apoptosis and DNA damage (p<0.001). High doses of BSME and thymoquinone on cancer and healthy cells have cytotoxic, genotoxic and apoptotic effects with pro-oxidant effects. Colorectal cancer cells are more sensitive than healthy cells.

Evaluating the Protective Effects of Thymoquinone on Methamphetamine-induced Toxicity in an In Vitro Model Based on Differentiated PC12 Cells.

Methamphetamine (Meth) is a highly addictive stimulant. Its potential neurotoxic effects are mediated through various mechanisms, including oxidative stress and the initiation of the apoptotic process. Thymoquinone (TQ), obtained from Nigella sativa seed oil, has extensive antioxidant and anti-apoptotic properties. This study aimed to investigate the potential protective effects of TQ against Meth-induced toxicity by using an in vitro model based on nerve growth factor-differentiated PC12 cells. Cell differentiation was assessed by detecting the presence of a neuronal marker with flow cytometry. The effects of Meth exposure were evaluated in the in vitro neuronal cell-based model via the determination of cell viability (in an MTT assay) and apoptosis (by annexin/propidium iodide staining). The generation of reactive oxygen species (ROS), as well as the levels of glutathione (GSH) and dopamine, were also determined. The model was used to determine the protective effects of 0.5, 1 and 2 µM TQ against Meth-induced toxicity (at 1 mM). The results showed that TQ reduced Meth-induced neurotoxicity, possibly through the inhibition of ROS generation and apoptosis, and by helping to maintain GSH and dopamine levels. Thus, the impact of TQ treatment on Meth-induced neurotoxicity could warrant further investigation.

SLN and chitosan nano-delivery systems for antibacterial effect of black seed (Nigella sativa) oil against S. aureus.

Staphylococcus aureus with current universal importance represents a main carrier of emerging antimicrobial resistance determinatives of global health concerns that have developed drug resistance mechanisms to the various available antibiotics. On the other hand, due to the antimicrobial potential of Nigella Sativa oil (NSO), it was hypothesized that incorporation of nano-carriers (NS-SLN and NS-chitosan (CH) nanoparticles) can enhance its antibacterial effects. This study evaluated the physico-chemical and antibacterial characteristics of NS-SLN and NS-CH. TEM images revealed a round shape with clear edges for both nanoparticles, and the average sizes were reported to be 196.4 and 446.6 nm for NS-SLN and NS-CH, respectively. The zeta potential and encapsulation efficiency were -28.9 and 59.4 mV and 73.22% and 88% for NS-SLN and NS-CH, respectively. The Minimum Inhibitory Concentrations for NSO, NS-SLN, and NS-CH against S. aureus were 480, 200, and 80 µg/mL, respectively. The results confirm significantly stronger antibacterial influences of NSO when loaded into chitosan nanoparticles as a potential candidate for nano-delivery of antimicrobial agents.

Systematic Review of Randomized Controlled Trials in Uses of Nigella Sativa (Black Seed) in Metabolic Syndrome.

BACKGROUND: Metabolic syndrome as defined by The National Cholesterol Education Panel-Adult Treatment Panel III (NCEPATP III), is the presence of obesity, dyslipidaemia, the elevation of arterial blood pressure, and glucose intolerance. It affects 25% to 40% of the adult population of Malaysia and is associated with other medical conditions, especially cardiovascular disease. In this systematic review, the objective is to assess the effects of Nigella Sativa on parameters that reflect metabolic syndromes, such as lipid profile, blood pressure, blood glucose, and anthropometry indices. METHODS: This systematic review was conducted by performing searches for relevant publications on two databases (PubMed and Scopus). The publication period was limited from January 2011 to December 2021. Cochrane collaboration tools were used for the risk of bias assessment of each trial. RESULT: Six out of 8 randomised controlled trials (n:776) demonstrated a significant improvement in lipid profile (p <0.05), 5 out of 7 trials (n:701) showed a significant reduction in glycaemic indices (p <0.05), 1 out of 5 trials (n:551) demonstrated significant improvements in blood pressure (p <0.05), and 2 out of 7 trials (n:705) showed a significant reduction in anthropometric measurements (p <0.05). CONCLUSION: Nigella Sativa has proved to have a significant positive effect on lipid profile and glycaemic index. The results showed in the parameters of blood pressure and anthropometric indices are less convincing, as results were inconsistent across studies. Nigella Sativa can therefore be recommended as an adjunct therapy for metabolic syndrome.

CONTEXTE: Le syndrome métabolique, tel que défini par le National Cholesterol Education Panel-Adult Treatment Panel III (NCEP-ATP III), se caractérise par la présence d'obésité, de dyslipidémie, d'hypertension artérielle et d'intolérance au glucose. Il affecte 25% à 40% de la population adulte en Malaisie et est associé à d' autres affections médicales, notamment les maladies cardiovasculaires. L'objectif de cette revue systématique est d'évaluer les effets de Nigella Sativa sur des paramètres reflétant le syndrome métabolique, tels que le profil lipidique, la pression artérielle, la glycémie et les indices anthropométriques. MÉTHODES: Cette revue systématique a été réalisée en effectuant des recherches de publications pertinentes dans deux bases de données (PubMed et Scopus). La période de publication était limitée de janvier 2011 à décembre 2021. Les outils de la collaboration Cochrane ont été utilisés pour évaluer le risque de biais de chaque essai. RÉSULTATS: Six des huit essais contrôlés randomisés (n : 776) ont montré une amélioration significative du profil lipidique (p <0,05), cinq des sept essais (n : 701) ont montré une réduction significative des indices glycémiques (p <0,05), un des cinq essais (n : 551) a démontré des améliorations significatives de la pression artérielle (p<0,05), et deux des sept essais (n : 705) ont montré une réduction significative des mesures anthropométriques (p <0,05). CONCLUSION: Nigella Sativa a prouvé avoir un effet positif significatif sur le profil lipidique et les indices glycémiques. Les résultats concernant les paramètres de la pression artérielle et des indices anthropométriques sont moins convaincants, car les résultats étaient incohérents entre les études. Nigella Sativa peut donc être recommandée comme thérapie adjuvante pour le syndrome métabolique. MOTS CLÉS: Nigella Sativa, Graines de nigelle, Essai contrôlé randomisé, Syndrome métabolique.

Development and Optimization of Methylcellulose-Based Nanoemulgel Loaded with Nigella sativa Oil for Oral Health Management: Quadratic Model Approach.

The present study aimed to develop a local dental nanoemulgel formulation of Nigella sativa oil (NSO) for the treatment of periodontal diseases. NSO purchased from a local market was characterized using a GC-MS technique. A nanoemulsion containing NSO was prepared and incorporated into a methylcellulose gel base to develop the nanoemulgel formulation. The developed formulation was optimized using a Box-Behnken statistical design (quadratic model) with 17 runs. The effects of independent factors, such as water, oil, and polymer concentrations, were studied on two dependent responses, pH and viscosity. The optimized formulation was further evaluated for droplet size, drug release, stability, and antimicrobial efficacy. The developed formulation had a pH of 7.37, viscosity of 2343 cp, and droplet size of 342 ± 36.6 nm. Sustained release of the drug from the gel for up to 8 h was observed, which followed Higuchi release kinetics with non-Fickian diffusion. The developed nanoemulgel formulation showed improved antimicrobial activity compared to the plain NSO. Given the increasing emergence of periodontal diseases and antimicrobial resistance, an effective formulation based on a natural antibacterial agent is warranted as a dental therapeutic agent.

Nigella sativa L. and COVID-19: A Glance at The Anti-COVID-19 Chemical Constituents, Clinical Trials, Inventions, and Patent Literature.

COVID-19 has had an impact on human quality of life and economics. Scientists have been identifying remedies for its prevention and treatment from all possible sources, including plants. Nigella sativa L. (NS) is an important medicinal plant of Islamic value. This review highlights the anti-COVID-19 potential, clinical trials, inventions, and patent literature related to NS and its major chemical constituents, like thymoquinone. The literature was collected from different databases, including Pubmed, Espacenet, and Patentscope. The literature supports the efficacy of NS, NS oil (NSO), and its chemical constituents against COVID-19. The clinical data imply that NS and NSO can prevent and treat COVID-19 patients with a faster recovery rate. Several inventions comprising NS and NSO have been claimed in patent applications to prevent/treat COVID-19. The patent literature cites NS as an immunomodulator, antioxidant, anti-inflammatory, a source of anti-SARS-CoV-2 compounds, and a plant having protective effects on the lungs. The available facts indicate that NS, NSO, and its various compositions have all the attributes to be used as a promising remedy to prevent, manage, and treat COVID-19 among high-risk people as well as for the therapy of COVID-19 patients of all age groups as a monotherapy or a combination therapy. Many compositions of NS in combination with countless medicinal herbs and medicines are still unexplored. Accordingly, the authors foresee a bright scope in developing NS-based anti-COVID-19 composition for clinical use in the future.

Improvement in quality and storage ability of rabbit semen by using black or thyme seed as dietary supplementation.

The quality of incubated or chilled rabbit semen is quickly lowered with time due to high-rate production of reactive oxygen species (ROS). Black seed (BS) and thyme (THY) are rich sources of natural antioxidants, which may be able to control ROS production and improve semen quality for use in artificial insemination. In this study, V-line rabbit bucks, seven months old, were fed diets supplemented with 50 or 100 g of BS or THY for 60 days. Semen was collected twice weekly. The quality of fresh sperm was measured, and diluted sperm was incubated for up to 12 h. Chilled, diluted sperm, stored at 4℃ for up to 3 days, was evaluated. The results indicated that BS and THY increased rabbit libido, decreased abnormal sperm and non-viable sperm percentages and significantly lowered total bacteria counts of diluted sperm. In conclusion, bucks fed a diet supplemented with BS or THY had enhanced semen quality and storage life, because of the antioxidant properties of BS and THY. The best incubation results were obtained with the THY100 treatment, whereas the best-chilled results were obtained with the BS100 group.

Effect of Nigella sativa in the treatment of nonalcoholic fatty liver disease: A systematic review and meta-analysis of randomized controlled trials.

The effectiveness of Nigella sativa (NS) treatment for nonalcoholic fatty liver disease (NAFLD) remains controversial. This systematic review, and meta-analysis, was conducted to evaluate potential benefits of NS for NAFLD. Up to June 11, 2020, randomized controlled trials (RCTs) evaluating NS for the treatment of NAFLD were searched and included from PubMed, Embase, Cochrane Library, and Web of science. Mean differences (MD) or risk ratio (RR) and 95% confidence intervals (CI) were calculated. Six articles from five trails with a total of 358 participants were included. Although NS has no beneficial effect on the levels of total cholesterol (TC) and low-density lipoprotein cholesterol (LDL), triglyceride (TG), insulin, and tumor necrosis factor α (TNF-α), its supplementation did improve the levels of alanine transaminase (ALT), aspartate transaminase (AST), fasting blood sugar (FBS), high-density lipoprotein cholesterol (HDL), high-sensitivity C reactive protein (hs-CRP), and grade of fatty liver compared with placebo. In summary, this study showed that NS supplementation was effective in the treatment of NAFLD and could improve the levels of ALT, AST, FBS, HDL, and hs-CRP in patients with NAFLD, as well as the severity of NAFLD. High-quality large sample RCTs are necessary to confirm the benefit of NS supplementation for NAFLD.

Thymoquinone Loaded Topical Nanoemulgel for Wound Healing: Formulation Design and In-Vivo Evaluation.

Thymoquinone is a natural bioactive with significant therapeutic activity against multiple ailments including wound healing. The poor aqueous solubility and low skin permeability limit its therapeutic efficacy. The present investigation aimed to improve the biopharmaceutical attributes of thymoquinone to enhance its topical efficacy in wound healing. A nanoemulsion-based hydrogel system was designed and characterized as a nanotechnology-mediated drug delivery approach to improve the therapeutic efficacy of thymoquinone, utilizing a high-energy emulsification technique. The black seed oil, as a natural home of thymoquinone, was utilized to improve the drug loading capacity of the developed nanoemulsion system and reduced the oil droplet size to <100 nm through ultrasonication. The influence of formulation composition, and the ultrasonication process conditions, were investigated on the mean globule size and polydispersity index of the generated nanoemulsion. Irrespective of surfactant/co-surfactant ratio and % concentration of surfactant/co-surfactant mixture, the ultrasonication time had a significant (p < 0.05) influence on the mean droplet size and polydispersity index of the generated nanoemulsion. The developed nanoemulgel system of thymoquinone demonstrated the pseudoplastic behavior with thixotropic properties, and this behavior is desirable for topical application. The nanoemulgel system of thymoquinone exhibited significant enhancement (p < 0.05) in skin penetrability and deposition characteristics after topical administration compared to the conventional hydrogel system. The developed nanoemulgel system of thymoquinone exhibited quicker and early healing in wounded Wistar rats compared to the conventional hydrogel of thymoquinone, while showing comparable healing efficacy with respect to marketed silver sulfadiazine (1%) cream. Furthermore, histopathology analysis of animals treated with a developed formulation system demonstrated the formation of the thick epidermal layer, papillary dermis along with the presence of extensive and organized collagen fibers in newly healed tissues. The outcome of this investigation signifies that topical delivery of thymoquinone through nanoemulgel system is a promising candidate which accelerates the process of wound healing in preclinical study.

The effect of a hydrogel made by Nigella sativa L. on acne vulgaris: A randomized double-blind clinical trial.

Nigella sativa L. (black seed) is one of the main medicinal plants frequently cited in traditional Persian medicine manuscripts for management of acne vulgaris. The present study was designed to investigate the efficacy of a topical preparation from N. sativa in acne vulgaris. In a randomized double-blind controlled clinical trial, 60 patients (30 patients in treatment and 30 in placebo group) were randomly received N. sativa hydrogel (standardized based on thymoquinone) or placebo hydrogel, twice daily for 60 days. The Investigator's Global Assessment (IGA) grading score was recorded for each patient. Moreover, acne disability index (ADI) was evaluated using a standard questionnaire filled out by the patients at the beginning and end of the study. A 78% mean reduction in the IGA score on the N. sativa-treated group was recorded compared with 3.3% on the vehicle-treated one. Significant reductions in the number of comedones, papules, and pustules were observed in the treatment group compared with placebo after 2 months. Also, ADI was decreased 63.49% in the treatment versus 4.5% in the placebo groups. No adverse event was recorded. N. sativa hydrogel had significant effects on improving the symptoms of acne vulgaris with acceptable tolerability.

Hematologic, lipid profile, immunity, and antioxidant status of growing rabbits fed black seed as natural antioxidants.

It is known that using antibiotics by way of growth promoters has harmful side effects on both animals and consumer health due to cross-resistance among pathogens and residues in meat. Using antibiotic to promote growth has been banned in the most countries for this reason; so, we must search for feed additives alternative in animal production. One of them is the black seed (Nigella sativa). Fifty-four growing V-line unsexed rabbits, 4 weeks of age, with an average weight of 776.7 g were randomly allocated to one of three treatments (n = 18): rabbits fed the basal diet (control), rabbits supplemented with either 300 or 600 mg of Nigella sativa seed (NSS)/kg diet. At 12 weeks of age, NSS supplementation significantly improved final body weight, weight gain, feed conversion ratio (FCR), and performance index with significantly reduced feed consumption. Addition of 300 and 600 mg NSS/kg diet resulted in a significant increase in the number of RBCs and WBCs as compared to basal diet group. Compared to controls, NSS supplementation significantly stimulated the IgG and IgM immune responses of rabbits, significantly reduced serum total lipids, triglycerides, and low-density lipoprotein, and significantly increased the high-density lipoprotein concentration. All NSS treatments significantly increased the observed blood total antioxidant capacity and significantly decreased the malondialdehyde values, compared to the basal diet group. In conclusion, the results displayed that addition of NSS in rabbit diets improved productive performance, blood lipid profile, immunity, and antioxidant status, and supplementation with 600 mg/kg NSS was more effective than 300 mg/kg NSS seed supplementation.

Efficacy of black seed (Nigella sativa L.) on kidney stone dissolution: A randomized, double-blind, placebo-controlled, clinical trial.

Preclinical studies have shown beneficial effects of black seed (Nigella sativa L.) in the prevention and treatment of renal stones. Hence, we designed a study to evaluate the renal-stone-dissolving efficacy of black seed. Sixty patients with renal stones were randomly enrolled in two arms of a randomized, 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.

The effects of black seed supplementation on cardiovascular risk factors in patients with nonalcoholic fatty liver disease: A randomized, double-blind, placebo-controlled clinical trial.

Nonalcoholic fatty liver disease (NAFLD) is highly related to cardiovascular disorders risk factors. This study aimed to evaluate the effects of black seed (Nigella sativa) supplementation on cardiovascular disorders risk factors in patients with NAFLD. This randomized, double-blind, placebo-controlled clinical trial was conducted on 50 patients with NAFLD. Participants were assigned to receive a lifestyle modification plus 2 g/day of either N. sativa or placebo for 12 weeks. Compared with the placebo, N. sativa supplementation led to significant reductions in serum glucose (-7.95 vs. -1.22; p = .041), serum insulin (-3.87 vs. -1.07; p = .027), homeostatic model of assessment for insulin resistance (-1.02 vs. -0.28; p = .021), and a significant increase in quantitative insulin sensitivity check index (0.03 vs. 0.006; p = .002). All of these changes were remained significant after adjusting for known confounding variables; however, there was no significant difference in lipid profile changes between the two groups (p = .05). N. sativa supplementation significantly decreased hepatic steatosis percentage compared with the placebo after adjustment for confounding variables (p = .005). In conclusion, our results indicate that daily intake of 2-g N. sativa plus lifestyle modification is superior to lifestyle modification alone in amelioration of insulin resistance and hepatic steatosis in patients with NAFLD.

Effect of Nigella sativa seed administration on prevention of febrile neutropenia during chemotherapy among children with brain tumors.

PURPOSE: Seeds of Nigella sativa (NS) are used to combat various disease conditions through their antibacterial effects. To evaluate the seeds' potential, we studied their effect on the prevention of febrile neutropenia (FN) in children with brain tumors. METHODS: A randomized pretest-post-test control group study including 80 children (2-18 years) with brain tumors undergoing chemotherapy were equally allocated into two groups. Intervention group received 5 g of NS seeds daily throughout treatment while controls received nothing. CBC with differentials, incidence of FN, and LOS were noted on each follow-up. RESULTS: The majority of children 38/40 (95%), of the intervention group, took the seeds for 3-9 consecutive months. Eight out of 372 (2.2%) FN episodes were experienced by children of intervention group compared to controls 63/327 (19.3%) (p = 0.001) and a shorter LOS (median = 2.5 days) vs 5 days in the control group (p = 0.006). Children in both groups belonged to almost same geographical area with similar socio-economic background. Weights of children were almost equal at diagnosis. CONCLUSION: NS seeds showed a decrease in incidence of FN in children with brain tumors with shortening of subsequent LOS which may improve their outcome and thereby quality of life. Larger scale studies are needed to further evaluate the seeds' potential.

Nigella sativa Supplementation Improves Asthma Control and Biomarkers: A Randomized, Double-Blind, Placebo-Controlled Trial.

Poor compliance with conventional asthma medications remains a major problem in achieving asthma control. Nigella sativa oil (NSO) is used traditionally for many inflammatory conditions such as asthma. We aimed to investigate the benefits of NSO supplementation on clinical and inflammatory parameters of asthma. NSO capsules 500 mg twice daily for 4 weeks were used as a supplementary treatment in a randomized, double-blind, placebo-controlled trial in asthmatics (clinicaltrials.gov: NCT02407262). The primary outcome was Asthma Control Test score. The secondary outcomes were pulmonary function test, blood eosinophils and total serum Immunoglobulin E. Between 1 June and 30 December 2015, 80 asthmatics were enrolled, with 40 patients in each treatment and placebo groups. After 4 weeks, ten patients had withdrawn from each group. Compared with placebo, NSO group showed a significant improvement in mean Asthma Control Test score 21.1 (standard deviation = 2.6) versus 19.6 (standard deviation = 3.7) (p = 0.044) and a significant reduction in blood eosinophils by -50 (-155 to -1) versus 15 (-60 to 87) cells/µL (p = 0.013). NSO improved forced expiratory volume in 1 second as percentage of predicted value by 4 (-1.25 to 8.75) versus 1 (-2 to 5) but non-significant (p = 0.170). This randomized, double-blind, placebo-controlled trial demonstrated that NSO supplementation improves asthma control with a trend in pulmonary function improvement. This was associated with a remarkable normalization of blood eosinophlia. Future studies should follow asthmatics for longer periods in a multicentre trial. Copyright © 2017 John Wiley & Sons, Ltd.

The impact of formulation attributes and process parameters on black seed oil loaded liposomes and their performance in animal models of analgesia.

This study aimed to formulate black seed oil (Nigella sativa) loaded liposomes using the ethanol injection method to enhance oral bioavailability and improve therapeutic activity in small animal studies of analgesia. The impact of formulation attributes and process parameters on the liposomal system was evaluated with key quality attributes being particle size, morphology, and entrapment efficiency. The particle size and entrapment efficiency of the liposome preparation were found to be between the range of 50-900 nm and 34-87% respectively. Particle size distribution data suggested that increasing the percentage of oil, up to a certain concentration, reduced the size of the liposomes significantly from 520 ± 81.2 nm to 51.48 ± 1.31 nm. Stirring and injection rate were shown to have marked impact on the average particle size of liposome. It was observed that entrapment efficiency of liposomes was greatly influenced by the amount of cholesterol and type of cryoprotectant used during formulation. The stability study indicated that the liposomal preparation was stable at ambient conditions for one month. In vivo studies showed that the liposomal preparation demonstrated significant analgesic activity in mice.

Medicinal benefits of Nigella sativa in bronchial asthma: A literature review.

Nigella sativa L. (NS) seeds, known as black seed, is a spice and a traditional herbal medicine used in various diseases including bronchial asthma. This review aimed to assess the studies supporting the medicinal use of NS in asthma and to highlight future research priorities. Various medical databases were searched for the effects of NS and its active secondary metabolites in asthma inflammation and outcomes. There were fourteen preclinical studies describing multiple effects of NS in animal or cellular models of asthma including bronchodilation, anti-histaminic, anti-inflammatory, anti-leukotrienes and immunomodulatory effects. Furthermore, seven clinical studies showed improvements in different asthma outcomes including symptoms, pulmonary function and laboratory parameters. However, often these studies are small and used ill-defined preparations. In conclusion, NS could be therapeutically beneficial in alleviating airway inflammation and the control of asthma symptoms, but the evidence remains scanty and is often based on poorly characterised preparations. Accordingly, well-designed large clinical studies using chemically well characterised NS preparation are required.

Schistosoma mansoni: Antiparasitic effects of orally administered Nigella sativa oil and/or Chroococcus turgidus extract.

Schistosoma mansoni is one of the parasites causing schistosomiasis, a disease which threatens millions of people all over the world. Traditional chemical drugs are not fully effective against schistosomaisis due to the evolving drug resistant worm strains, so exploring new remedies derived from natural products is a good way to fight schistosomiasis. In the present investigation two natural products, Nigella sativa oil and Chroococcus turgidus extract were used separately or in a combination to explore their effect on S. mansoni. The infected mice treated with Chroococcus turgidus extract or/and sativa seed oil showed a significant decrease in the total worm burden. The total number of deposited eggs by females of S. mansoni was significantly decreased in the liver of mice treated with Chroococcus turgidus extract or/and sativa seed oil. However, in the intestine, the number of eggs was significantly reduced in mice treated with algal extract and those treated with both algal extract and oil. Fecundity of female S. mansoni showed a significant decrease from mice treated with algal extract or/and sativa seed oil. According to SEM investigations the tegmental surface, oral and ventral suckers of worms also showed considerable changes; as the tubercles lost their spines, some are swollen and torn out. The suckers become edematous and enlarged while the tegmental surface is damaged due to the treatment with Chroococcus turgidus extract or/and sativa seed oil. In conclusion, the Nigella sativa oil and Chroococcus turgidus extract are promising natural compounds that can be used in fighting schistosomiasis.