Background: Allergic rhinitis (AR) or seasonal allergy characterized by sneezing, nasal congestion, nasal itching, and nasal discharge, triggered by immune reactions to environmental allergens. Present day customers also monitor the personal improvements in the area of Evidence-Based natural medicines/supplements
Methods: A randomized, double-blind, placebo-controlled study was conducted on 65 participants aged 18 to 60 years having 2 or more allergic symptoms like sneezing, rhinorrhoea, nasal obstruction, and nasal itching for a cumulative period greater than 1 hour per day. The study participants received a capsule of NSO (250 mg) with 2.5 mg piperine (BioPerine) as a bioavailability enhancer or a placebo, twice a day, after food for 15 days. The primary objectives were evaluated by mean change in Total Nasal Symptom Score and the duration of AR symptoms per day from baseline to Day 15. Secondary endpoints were changes in Total Ocular Symptoms Score, AR symptom frequency and severity, serum Immunoglobulin E levels, and Patient Global Impression of Change scale. Adverse events were monitored throughout the study.
Results: Sixty-five patients were enrolled and all of them completed the study, N = 33 in NSO and N = 32 in placebo. A significant reduction in Total Nasal Symptom Score and Total Ocular Symptoms Score was observed in the NSO group compared to the placebo, highlighting the potential of NSO in alleviating AR symptoms. The episodes of AR symptoms per day and the frequency of symptoms in 24 hours reduced significantly in 15 days in both groups, but the extent of improvement was significantly higher in NSO compared to placebo. Improvement in Patient Global Impression of Change was also significantly better in NSO compared to the placebo. Serum Immunoglobulin E levels decreased in NSO but were not significantly different from placebo. No clinically significant changes were observed in vital signs, liver and renal function, lipid profile, hematology, fasting blood sugar, or urine analysis at the end of the study.
Conclusion: The result of the study demonstrates that NSO 250 mg with 2.5 mg piperine is an effective and well-tolerated supplement for the management of AR symptoms.
The outcomes of this study suggested a positive impact of NSO standardized for 5% TQ (NigellinR Amber) in AR caused by seasonal allergens. Further studies in larger populations in different ethnic backgrounds will help to position NSO as an effective and safe supplement to manage the symptoms of AR.
Keywords: allergic rhinitis, Immunoglobulin E, Patient Global Impression of Change, randomized controlled trial, thymoquinone, total nasal symptom score, total ocular symptom scale
A randomized, double-blind, placebo-controlled study to evaluate the benefits of a standardized Nigella sativa oil containing 5% thymoquinone in reducing the symptoms of seasonal allergy - Medicine 103(32):p e39243, August 09, 2024 - Anju Majeed, Shaheen Majeed, Avinash Kadasiddappa Parameswarappa, Avinash Murali, Satish Gudimallam, Chikkalingaiah Siddegowda, Harshith Chandrashekar, Lakshmi Mundkur.

Introduction: A range of traditional and commercial preparations of NS is frequently used in the treatment of several inflammatory diseases. Often, these preparations have poor preclinical characterization that may lead to variable pharmacological effects.
Objective: To assess the in vitro effects of different chemically defined preparations of NS on some asthma-related mediators of inflammation. Methods: Different NS preparations were obtained by either seed extraction with a spectrum of solvents ranging from lipophilic to hydrophilic, or commercial products were collected. The TQ concentration of NS was analyzed by HPLC. Immunomodulatory activity was assessed by the release of mediators (IL-2, IL-6, PGE2) in primary human T-lymphocytes, monocytes, and A549 human lung epithelial cells.
Results: Ten distinct NS preparations showed variability in TQ concentration, being highest in the oily preparations extract-7 (2.4% w/w), followed by extract-10 (0.7%w/w).
Similarly, the release of mediators was varied, being greatest in extract-7 and 10 via significantly (<0.05) suppressing IL-2, IL-6, and PGE2 in T-lymphocytes as well as IL-6 and PGE2 in monocytes. Also, PGE2 release in A549 cells was significantly enhanced by both extracts.
Conclusion: The TQ concentration and in vitro activity were variable among the different NS preparations. TQ-rich oily NS preparations produced potent favorable immunomodulation in asthma inflammation and can be used in future studies.
Comparative Immunomodulatory Activity of Nigella sativa L. Preparations on Proinflammatory Mediators: A Focus on Asthma - Abdulrahman E. Koshak, Nizar M. Yousif, Bernd L. Fiebich, Emad A. Koshak and Michael Heinrich
The oily extracts 7 (Nigellin by Sabinsa) and 10 (aby Marnys ),

Background: The medicinal plant Nigella sativa L. (NS) known as black cumin seed is used traditionally for diabetes, hypertension and asthma.
The anti-inflammatory / immunomodulatory (AI) effects is attributed to thymoquinone (TQ).
Different methods of NS preparation and administration resulted in a poorly understood chemical and pharmacological variability.
Objectives: To investigate variations in the AI effect and TQ level among different extracts of NS. Methods: Eleven different black seed extracts were obtained. Of these, extracts 1-6 prepared using different ratios of extraction solvents (ethanol:water) [extract 1(100:0), 2(80:20), 3(60:40), 4(30:70), 5(0:100), 6(0:100 with boiling water)] and extracts 7-11 were commercial oil products [ 7 = Sabinsa Sami Labs Ltd, India , 10 (MARNYS®, Spain), 8,9,11 (other companies)].
High-performance liquid chromatography (HPLC) was utilized to quantify the level of TQ. In addition, LPS-induced monocytes, SEB-induced T-cells, and IL-1β-induced A549 lung epithelial cell line were used to preliminary screening the production of inflammatory markers (PGE-2, IL-6, IL-2) and inflammatory signalling pathways (p38, ERK). Results: TQ levels were highest in extract 7 (TQ=2.7% w/w), followed by extracts 10 (TQ=0.7%w/w), 1 (TQ=0.4%w/w) and 9 (TQ=0.2%w/w). Extracts 1,3,8,10 (500µg/ml each), 7 (100 µg/ml) and TQ (10µM) inhibited min 50% of T-Cells inflammatory mediators PGE-2, IL-6, IL-2. Monocytes inflammatory mediators (PGE-2, IL-6) were inhibited by min 50% using extracts 7,10 (100 µg/ml) and TQ (10µM). However, PGE2 / IL-6 in A549 cells were mainly inhibited by 3,4,6 (500 µg/ml). Extracts 4,8,10 (500 µg/ml) and 7 (100 µg/ml) inhibited min 50% of ERK and p38 signalling pathway proteins.
Conclusion: The oil preparations (extracts 7,10) appeared to be more potent active extracts by inhibiting inflammatory mediators and signalling pathways in more than one type of cells.
There was a positive correlation between this activity and the level of TQ content. In the future, developing a TQ-enriched NS herbal medicinal product is suggested for complementary use in inflammatory diseases.
Comparative anti-inflammator y /immunomodulatory effect of different extracts of the medicinal plant Nigella sativa
Conference: European Academy of Allergy and Clinical Immunology Congress, At Barcelona, Spain, Volume: 104874

Abstract: Several different pharmacological effects have been described for Nigella sativa (Siah-Daneh), including an anti-inflammatory effect. In the present study, the effect of the extract of N. sativa on lung pathology and blood interleukin-4 (IL-4) and interferon-γ (IFN-γ) of sensitized guinea pigs was examined. Three groups (n=8 for each group) of guinea pigs sensitized to ovalbumin (OA) were given drinking water alone, and drinking water containing low and high concentrations of the plant extract, respectively. The animals of the control group (n=8) were treated with saline instead of OA and were given drinking water. The pathological changes of the lung, including infiltration of eosinophils and lymphocytes, local epithelial necrosis, the presence of oedema, thickening of the basement membrane, smooth muscle layer hypertrophy, mucosal secretion, and the presence of mucosal plug, and blood IL-4 and IFN-γ of sensitized guinea pigs were evaluated. The lungs of the sensitized group showed significant pathological changes (P max 0.001). Blood IL-4 and IFN-γ were increased in sensitized animals compared to the controls (P max 0.01 and P max 0.001, respectively). Treatment of sensitized animals with the extract led to a significant decrease in pathological changes of the lung (P max 0.01 to P max 0.001), except for the oedema in the sensitized group treated with low concentration of the extract, but an increased IFN-gamma. These results confirm a preventive effect of N. sativa extract on lung inflammation of sensitized guinea pigs.
Key words: Nigella sativa, Asthma, Sensitization, Inflammation, Cytokine
Potential immunomodulation effect of the extract of Nigella sativa on ovalbumin sensitized guinea pigs - Mohammad-Hossein BOSKABADY, Rana KEYHANMANESH, Saeed KHAMENEH, Yousef DOOSTDAR, Mohammad-Reza KHAKZAD, Boskabady et al. / J Zhejiang Univ-Sci B (Biomed / Biotechnol) 2011 12(3):201-209

Context: Nigella sativa (NS) has been used as an herbal remedy for the treatment and prevention of a variety of diseases. In this review, we aimed to summarize the current evidence on the effects of NS consumption on non-alcoholic fatty liver disease (NAFLD) characteristics.
Evidence Acquisition: We reviewed the existing literature published by the end of 2017 using the following key words: “Nigella sativa”, “black seeds”, “black cumin”, “thymoquinone”, “NAFLD”, “NASH”, and “diabetes”. Papers used in this study were collected by searching the PubMed, Google Scholar, Science Direct and Scopus databases. Our search was limited to English-language articles. All the articles published between 2000 and 2017 meeting the inclusion criteria were included in the study.
Results: The results of current studies indicate that NS has many biological effects such as anti-inflammatory, anti-hyperlipidemic, anti-microbial, anti-cancer, anti-oxidative, anti-diabetic, anti-hypertensive and wound healing activities. In summary, it can be used as a valuable plant for designing therapeutic strategies in NAFLD.
Conclusions: Results from available studies indicate that NS can ameliorate the main metabolic disturbances related to NAFLD including hyperglycemia, hyperlipidemia, and overweight. These effects are mainly attributed to the anti-oxidative and anti-inflammatory properties of thymoquinone. Clinical trials on human subjects are highly essential to confirm the results found in in vivo and in vitro studies.
Discussion : Results from available studies indicate that NS can ameliorate the main metabolic disturbances related to NAFLD including hyperglycemia, hyperlipidemia and overweight. These effects are mainly attributed to antioxidative and anti-inflammatory properties of TQ. Clinical trials on human subjects are highly essential to confirm the results found in in vivo and in vitro studies.
Keywords: Nigella sativa, NAFLD, NASH, Fatty Liver
Nigella sativa and Non-Alcoholic Fatty Liver Disease: A Review of the Current Evidence Mina Darand, Seyed Moayed Alavian and Azita Hekmatdoost, Hepat Mon. 2018 October

Abstract : The spread of the global COVID-19 pandemic, the lack of specific treatment and the urgent situation requires use of all resources to remedy this scourge. In the present study, using molecular docking, we identify new probable inhibitors of COVID-19 by molecules from Nigella sativa L, which is highly reputed healing herb in North African societies and both Islamic and Christian traditions. The discovery of the Mpro protease structure in COVID-19 provides a great opportunity to identify potential drug candidates for treatment. Focusing on the main proteases in CoVs (3CLpro/Mpro) (PDB ID 6LU7 and 2GTB); docking of compounds from Nigella Sativa and drugs under clinical test was performed using Molecular Operating Environment software (MOE). Nigelledine docked into 6LU7 active site gives energy complex about -6.29734373 Kcal/mol which is close to the energy score given by chloroquine (-6.2930522 Kcal/mol) and better than energy score given by hydroxychloroquine (-5.57386112 Kcal/mol) and favipiravir (-4.23310471 kcal/mol). Docking into 2GTB active site showed that α- Hederin gives energy score about-6.50204802 kcal/mol whcih is better energy score given by chloroquine (-6.20844936 kcal/mol), hydroxychloroquine (-5.51465893 kcal/mol) and favipiravir (-4.12183571kcal/mol). Nigellidine and α- Hederin appeared to have the best potential to act as COVID-19 treatment. Further, researches are necessary to testify medicinal use of identified and to encourage preventive use of Nigella Sativa against coronavirus infection.
Keyword : COVID-19, Nigella Sativa, 6LU7, 2GTB, molecular docking, MOE software
Identification of Compounds from Nigella Sativa as New Potential Inhibitors of 2019 Novel Coronasvirus (Covid-19): Molecular Docking Study. Bouchentouf Salim and Missoum Noureddine

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 bene􀂡cial effect on the levels of total cholesterol (TC) and low-density lipoprotein cholesterol (LDL), triglyceride (TG), insulin, and tumor necrosis factor alpha (TNF-alpha), 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.
Effect of Nigella sativa in the treatment of nonalcoholic fatty liver disease: A systematic review and meta-analysis of randomized controlled trials. Tang G, Zhang L, Tao J, Wei Z, Phytother Res. 2021 Mar 16.

Abstract : Various metabolic parameters are risk factors related to the amplified risk of atherosclerotic cardiovascular disease. A wide variety of data exist on Nigella sativa (NS) and metabolic parameters. The current study is designed to examine NS supplementation on lipid profile, blood pressure, glycemic control, anthropometric indices, and insulin resistance in individuals with coronary artery disease (CAD). In a randomized, double-blind, placebo-controlled clinical trial, 60 patients with CAD received either 2 g of NS oil or sunflower oil as a placebo for 8 weeks. Biochemical and anthropometric measurements were assessed. NS significantly reduced weight (-1.82 Kg; 95% C, [2.72, 4.13]), body mass index (-0.67 kg/m2 ; 95% C, [0.33, 1.01]), waist circumference (-2.15 cm; 95% C, [1.06, 3.23]), hip circumference (-1.26 cm; 95% C, [0.61, 1.910]), waist-to-hip ratio (0.008; 95%C, [0.001, 0.01]), systolic (-9.52 mmHg; 95% C, [7.14, 11.9]), diastolic blood pressure (-8.26 mmHg; 95% C, [4.89, 11.62]), and fasting blood glucose (FBS) (-4.32 mg/dl; 95% C, [-0.51, 9.15]) as compared with the placebo group. The results indicate a potential beneficiary effect of NS on the metabolic parameters in CAD patients including improvements in anthropometric indices, blood pressure, and FBS.
Keywords: Nigella sativa; anthropometric indices; coronary artery disease; fasting blood glucose; lipid profile.
Effects of Nigella sativa oil supplementation on selected metabolic parameters and anthropometric indices in patients with coronary artery disease: A randomized, double-blind, placebo-controlled clinical trial, Omid Mohammad Tavakoli-Rouzbehani , Mohsen Abbasnezhad , Sorayya Kheirouri , Mohammad Alizadeh, Phytother Res. 2021 Apr 13.

Abstract : 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.
Conclusion : The NSO supplementation appeared to be effective in enhancing the control of asthma symptoms with a trend in pulmonary function improvement. Remarkably, NSO showed a reduction of blood eosinophilia. These findings may provide an evidence for the potential benefits of NSO supplementation in the clinical management of asthma. To our knowledge, this is the first RDBPCT that compared the effect of NSO on blood eosinophils and serum total IgE in a relatively larger group of adult patients with asthma versus placebo. Future studies should follow patients for a longer period and use additional outcomes to validate the benefits of NSO in asthma.
Keywords: asthma; allergy; eosinophils; black seed; Nigella sativa; clinical trial.
Nigella sativa Supplementation Improves Asthma Control and Biomarkers: A Randomized, Double- Blind, Placebo-Controlled Trial - Abdulrahman Koshak, Li Wei, Emad Koshak, Siraj Wali, Omer Alamoudi, Abdulrahman Demerdash, Majdy Qutub, Peter Natesan Pushparaj and Michael Heinrich, Phytother. Res. (2017)

ABSTRACT : Background/Aim: Telogen effluvium (TE) is a scalp disorder characterized by the thinning or shedding of hair resulting from the early entry of hair in the telogen phase. Nigella sativa (NS) is a dicotyledonous belonging to the Ranunculacae family. It has been shown that its major constituent, tymoquinon (TQ), exerts anti-oxidant and anti-inflammatory effects by inhibiting proinflammatory mediators, such as cyclooxygenase and prostaglandin D2. The aim of this study is to evaluate the efficacy of NS essential oil as a potential treatment for TE, a pathology characterized by a significant inflammatory component.
Study Design/Methods: Twenty patients affected by TE for this double-blind, placebo controlled and randomized study were enrolled. Ten of these patients were treated with a scalp lotion containing 0.5% NS, daily for 3 months, while the other ten patients were treated with placebo daily for 3 months. Videodermatoscopic analysis (Trichoscan Dermoscope Fotofinder®) and evaluation of three independent dermatologists were performed before treatment (T0), after 3 months of treatment (T3) and at the 6 months follow-up (T6).
Results: The results showed a significant improvement in 70% of patients treated with NS. Videodermatoscopic analysis showed a significant increment of hair density and hair thickness in patients treated with NS. NS was also able to reduce the inflammation observed in the majority of patients affected by TE.
Conclusions: The results of this study suggest that NS can be considered potentially useful for the treatment of TE.
In conclusion, our results confirmed data of previous studies about anti-inflammatory properties of NS and its ability in reducing symptoms, such as trichodynia, typical of patients affected by TE. Moreover, the results obtained indicated that NS is effective in promoting hair growth, thus inducing a significant improvement in terms of hair density and caliber. Considering this, we suggest that topical use of NS for TE treatment can be considered as a valid alternative to traditional therapies such as minoxidil.
Evaluation of a Therapeutic Alternative for Telogen Effluvium: A Pilot Study, Alfredo Rossi and al., Journal of Cosmetics, Dermatological Sciences and Applications, 2013, 3, 9-16

Sleep is essential for physical and mental well-being, and recent studies suggest that sleep disorders contribute to the development of cardiovascular disease, obesity, metabolic syndrome or impaired brain function or impaired immunity. Sleep is schematically composed of a succession of 3 to 6 cycles of 60 to 120 minutes each. A cycle itself consists of an alternation of slow sleep and REM sleep. REM sleep is also called REM (Rapid eye movement) because of the presence under the closed eyelids of frequent rapid eye movements. Nigella contains terpenoids and, in particular, thymoquinone, a powerful antioxidant with anti-inflammatory properties, to which it owes many of its beneficial effects to health. An open-label pilot study evaluated the effects of taking 200 mg of thymoquinone-rich black seed oil extract daily for 28 days on healthy people with sleep disorders. Fifteen people were enrolled in this study. Polysomnography analyses were performed to assess the participants' sleep latency, quality and sleep efficiency. The results indicate, after seven days of supplementation, a significant improvement in total sleep duration, sleep latency and sleep efficiency that was accompanied by an increase in deep sleep. In addition, after 28 days of taking black seed oil, the participants' stress and anxiety were significantly reduced. The serum level of cortisol, the stress hormone, was also lower. Further double-blind studies and studies involving a larger number of people will need to confirm these promising initial results.
Introduction : Insomnia, the inability to get sleep or sleep well at night, is a universal health problem. In the present single-arm, open-label, pilot study, the safety and efficacy of a thymoquinone-rich (5% w/w) black cumin oil (Nigella sativa) (BCO) was investigated for the first time, among healthy subjects characterized with significant sleep problems.
Methods : Fifteen subjects were selected for the study and were provided with softgel capsules of BCO (200 mg × 1/day, after dinner) for 28 days. Polysomnographic analysis was performed to assess sleep quality, sleep efficiency and sleep latency (primary outcomes) at the beginning (visit 2) and after 7 days of supplementation (visit 3). Sleep quality index, anxiety and stress (secondary outcomes) were also measured at the beginning and at the end of the study period (28 days) using the validated questionnaires Pittsburgh Sleep Quality Index (PSQI), Depression Anxiety Stress Scale -21 (DASS-21) and Hamilton Anxiety Rating Scale-A (HAM-A), along with the measurements of cortisol and safety parameters.
Results : The results suggested a significant improvement in primary outcomes such as total sleep time, sleep latency and sleep efficiency with an increase of 82.49 % in Non-Rapid Eye Movement (NREM 3) and 29.38 % increase in Rapid Eye Movement sleep (REM sleep). The secondary outcome measurements also showed a significant reduction (P max 0.05) in anxiety and stress as evident from DASS-21 and HAM-A scales, with significant reduction in Cortisol. Haematological and biochemical analysis demonstrated the safety of BCO during the study period.
Conclusion : Supplementation of BCO was safe and found to significantly improve the sleep quality and ameliorate stress and anxiety.
Thymoquinone-rich black cumin oil improves sleep quality, alleviates anxiety/stress on healthy subjects with sleep disturbances- a pilot polysomnography study, Das S et al., Journal of Herbal Medicine Volume 32, March 2022

Abstract Cardiovascular diseases (CVD) are the leading causes of mortality worldwide. Flow-mediated dilation (FMD) is a marker of vascular function. Beneficial cardiometabolic effects of Nigella sativa (N. sativa) have been observed. We evaluated the effect of N. sativa oil on FMD, plasma nitrite, and nitrate (NOx) as nitric oxide (NO) metabolites, and inflammatory markers in subjects with CVD risk factors. Fifty participants were randomly assigned to either the N. sativa (two capsules of 500 mg N. sativa oil) or the placebo group (two capsules of 500 mg mineral oil), for 2 months. The brachial FMD, plasma NOx, vascular cellular adhesion molecule-1 (VCAM-1), and intracellular adhesion molecule-1 (ICAM-1) were measured. FMD and plasma NOx levels was significantly increased in the N. sativa group compared to the placebo group (changes: 2.97 ± 2.11% vs. 0.71 ± 3.19%, p max 0.001 for FMD and 4.73 ± 7.25 μmol/L vs. 0.99 ± 5.37 μmol/L, p = 0.036 for plasma NOx). However, there was no significant difference in ICAM-1 and VCAM-1 levels between groups. Therefore, N. sativa oil improves vascular NO and FMD in subjects with cardiovascular risk factors. However, more studies are warranted to confirm the beneficial impacts of the N. sativa oil on vascular inflammation.
Keywords: CVD; FMD; Nigella sativa; inflammation; vascular function.
The effect of Nigella sativa oil on vascular dysfunction assessed by flow-mediated dilation and vascular-related biomarkers in subject with cardiovascular disease risk factors: A randomized controlled trial Hadi Emamat et al, Phytother Res . 2022 Apr 12. doi: 10.1002/ptr.7441

BACKGROUND AND AIMS: Diabetes is a leading cause of renal failure. High levels of oxidative stress and inflammation inpatients with renal diabetes lead to various disorders and mortality. This study was performed to determine the effect of Nigellasativa (NS) supplementation on superoxide dismutase (SOD), malondialdehyde (MDA), total antioxidant capacity (TAC), high-sensitivity C-reactive protein (hs-CRP), glycosylated hemoglobin (HbA1c), fasting blood sugar (FBS), and insulin (INS) inpatients with diabetes mellitus undergoing hemodialysis (HD).
METHODS: In this randomized, double-blind, placebo-controlled clinical trial, a total of 46 diabetic HD patients were randomlydivided into NS (n = 23) and placebo (n = 23) groups. NS group received 2 g/day of NS oil, and the placebo group receivedparaffin oil for 12 weeks. Serum levels of SOD, MDA, TAC, hs-CRP, HbA1C, FBS, and INS were measured before and after thestudy.
RESULTS: Compared to baseline values, SOD, TAC, and INS levels increased, whereas MDA, hs-CRP, HbA1c, and FBSsignificantly decreased. After adjusting for covariates using the ANCOVA test, changes in the concentrations of SOD (p = .040),MDA (p = .025), TAC (p= max .001), hs-CRP (p = .017), HbA1c (p = .014), and FBS (p = .027) were statistically significant comparedto the placebo group. Intergroup changes in INS were not significant. Additionally, there were no notable side effects during theresearch.
CONCLUSIONS: This study found that NS supplementation significantly enhanced the levels of SOD, MDA, TAC, hs-CRP, HbA1c,and FBS in diabetic HD patients.
Effect of Nigella Sativa Oil on Oxidative Stress, Infl ammatory, and Glycemic Control Indices in Diabetic Hemodialysis Patients: ARandomized Double-Blind, Controlled Trial. Rahmani A, Niknafs B, Naseri M, Nouri M, Tarighat-Esfanjani A 15 avril 2022 Evid Based Complement Alternat Med. 2022. 20222753294

Abstract : The efficacy, safety, and utility of Nigella sativa seeds oil as a complementary treatment for hypertension, glucose control, and lipid metabolism were evaluated. Hypertensive patients in the intervention (n = 26) and placebo (n = 29) groups received 2.5 ml of N. sativa seeds oil and sunflower oil twice daily for 8 weeks, respectively. The levels of systolic and diastolic blood pressure (SBP, DBP), blood lipid profile, and fasting blood sugar (FBS), at different stages of the treatment period (0, 3, 6, 8 weeks), and malondialdehyde (MDA) and glutathione reductase (GR), at the baseline and end of the study, were assessed. SBP level in the intervention group was significantly reduced, compared with the baseline values (p max .001) and the placebo group (p max .05). A significant decline was observed in the levels of DBP, total cholesterols, and low density lipoprotein (LDL) (p max .000), MDA, and FBS (p max .001); also, a significant increase was observed in the levels of high density lipoprotein (HDL) and GR (p max .001). The use of N. sativa seeds oil as an adjunct to common medications exhibited additional antihypertensive effects as well as beneficial effects on glucose control and lipid metabolism in hypertensive patients with no renal, hepatic, and patient-reported adverse events. To conclude, N. sativa seeds oil exhibited antihypertensive and lipid-lowering effects. Keywords: Nigella sativa seeds oil; glucose metabolism; hypertension; lipid metabolism; thymoquinone.
A randomized, double-blind, placebo-controlled, clinical trial to evaluate the benefits of Nigella sativa seeds oil in reducing cardiovascular risks in hypertensive patients, Parisa Shoaei-Hagh, Farzaneh Kamelan Kafi, Sara Najafi, Mansoureh Zamanzadeh, Alireza Heidari Bakavoli, Javad Ramezani, Samira Soltanian, Javad Asili, Hossein Hosseinzadeh, Saeid Eslami, Zhila Taherzadeh, Phytother Res. 2021 May 6

OBJECTIVES: Obesity is a global concern which is associated with several complications and disease.
DESIGN: Present study is the first crossover, double-blind, placebo-controlled, randomized clinical trial aimed to evaluate the effect of Nigella Sativa (N. sativa) intervention on anthropometric and body composition parameters as well as dietary intake and appetite in a crossover design.
METHOD: Forty-five healthy women with obesity or overweight were randomized into two groups of intervention and placebo, and the study conducted in two 8-week periods of intervention separated by a 4-week washout period. Anthropometric and body composition indices and dietary intake were measured. Also, appetite sensation was evaluated via a standard visual analog scale (VAS) questionnaire. Pkcross procedure was performed for statistical analysis using STATA. Cohen's d effect size was estimated for all outcomes to determine the magnitude of the effects.
RESULTS: Supplementation with 2000 mg of N. sativa oil found to have a considerable increment in the measures of body mass index (P max 0.001, Cohen's d = 0.5), body weight (P max 0.001, Cohen's d = 0.6) and waist circumference (P = 0.020, Cohen's d = 0.4) with a medium effect size measure, and a significant decrease in body fat mass (P = 0.019, Cohen's d = 0.2), body fat percent (P max 0.001, Cohen's d = 0.2) and visceral fat area (P = 0.011, Cohen's d = 0.2) with a small effect size measure.
CONCLUSION: The overall improvements in anthropometric and body composition parameters and a significant decrease in appetite represents the beneficial effects of N. sativa supplements in the treatment of obesity. More studies with different dosages, a larger number of participants, and longer intervention duration are recommended to illustrate the exact effects of N. sativa as a complementary therapy for obesity.
Keywords: Anthropometry; Appetite; Body composition; Nigella sativa; Obesity
The effect of Nigella sativa on appetite, anthropometric and body composition indices among overweight and obese women: A crossover, double-blind, placebo-controlled, randomized clinical trial, Sara Safi, Elham Razmpoosh, Hossien Fallahzadeh, Mahta Mazaheri, Nooshin Abdollahi, Majid Nazari, Azadeh Nadjarzadeh, Amin Salehi-Abargouei, Complement Ther Med. 2020 Dec 15