NICEVIVA
MONOGRAPH SPEC LATEST 2026

Black Seed Oil (Nigella sativa)

BOTANICALS · Evidence Monograph

Black Seed Oil (Nigella sativa) is an evidence-graded botanicals monograph evaluated across 34 peer-reviewed PubMed studies (6 meta-analyses, 3 systematic reviews, and 8 randomized controlled trials, encompassing n = 7,459 cumulative participants). Current clinical evidence is rated GRADE High (4.0 / 4.0) for phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways.

Evidence Grade (GRADE) High (4.0 / 4.0)
Indexed PubMed Studies 34 Studies
Meta-Analyses · Reviews 6 Meta · 3 Systematic Reviews
Randomized Trials (RCT) 8 RCTs (2 Double-Blind)
Cumulative Participants n = 7,459
Reported Trial Dosages 4600 mg/day · 1 g/day · 910 mg/day
Trial Duration Range 48 weeks · 8 weeks · 14 days
Reading Time ~17 min
RECOMMENDED FOR Clinical Indication

Evidence Supports Supplementation When:

  1. 01 Individuals seeking evidence-backed support for phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways (supported by 34 indexed PubMed studies, GRADE High).
  2. 02 Adults matching clinical trial dosing protocols (4600 mg/day · 1 g/day · 910 mg/day) over a structured 48 weeks evaluation window.
  3. 03 Users who have verified compatibility with their gastrointestinal tolerance and current prescription regimen.
FORMULATION SPECIFICATION · Preferred Form Standardized Marker-Compound Botanical Extract
Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.
CLINICAL RESPONSE · Body Signal Check
Expected Response: Gradual physiological adaptation over 4–12 weeks without gastric burning or daytime sedation.
Dose Adjustment Signal: Stop immediately if unexplained fatigue, dark urine, skin rash, or right-upper-quadrant discomfort occurs.
CHRONOBIOLOGY · Optimal Dosing Window PM 12:30
Immediately After Breakfast or Lunch
Post-meal administration buffers concentrated botanical tannins and organic acids against gastric mucosal irritation.
Primary Clinical Endpoints & Physiological Biomarkers Studied Based on Indexed PubMed Trials
cancer (PubMed clinical endpoint)
kidney (PubMed clinical endpoint)
diabetes (PubMed clinical endpoint)
alopecia (PubMed clinical endpoint)
hair (PubMed clinical endpoint)
01

What Is Black Seed Oil (Nigella sativa) & Why Does Form Matter?

Black Seed Oil (Nigella sativa) is classified under BOTANICALS and has been investigated across 34 peer-reviewed PubMed publications for its role in phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways.

In clinical nutrition, physiological efficacy depends heavily on the specific chemical salt, chelate, or standardized extract used, as well as adherence to trial-validated dosing (4600 mg/day, 1 g/day, 910 mg/day).

02

Who Benefits Most & Common Depletion Factors

Suboptimal status or increased physiological demand for Black Seed Oil (Nigella sativa) frequently arises from restrictive dietary patterns, age-related declines in gastrointestinal absorption, chronic metabolic stress, or medication-induced nutrient depletion.

Before initiating supplementation, identify whether your primary goal aligns with the endpoints evaluated in human randomized controlled trials (8 RCTs indexed) rather than generalized marketing claims.

03

Physiological Mechanism of Action

Within human physiology, Black Seed Oil (Nigella sativa) acts on pathways governing phytochemical receptor modulation, adaptogenic stress response, and vascular/inflammatory pathways. Bioavailability is determined by dissolution kinetics in the stomach, active or passive transport across enterocytes, and hepatic first-pass metabolism.

Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.

04

PubMed Clinical Evidence & GRADE Evaluation

NICEVIVA assigns Black Seed Oil (Nigella sativa) an overall evidence rating of GRADE High (4.0 / 4.0) based on 34 PubMed studies: 6 meta-analyses, 3 systematic reviews, and 8 randomized controlled trials (2 double-blind, n = 7,459 total participants).

Representative peer-reviewed findings include: • PMID:41858302 (2026) — "The Effect of Nigella sativa Supplementation on Cardiometabolic Health in Patients With Metabolic Diseases: A GRADE-Assessed Systematic Review and Meta-Analysis." (However, no significant effects were observed for measures of insulin resistance or central adiposity, and the findings should be interpreted cautiously given variability in study quality and outcomes.) • PMID:41731134 (2026) — "Systematic review of prophylactic antibacterial agents for radiation-induced oral mucositis in head and neck cancer." (CONCLUSION: The systematic review highlights limited and inconsistent evidence supporting antibacterial prophylaxis for preventing and reducing RIOM severity in patients with HNC undergoing RT.) • PMID:41116039 (2026) — "A holistic guide to effective prevention and treatment for kidney stones: a systematic review exploring anti-urolithiasis approaches." (For instance, these trials demonstrated promising outcomes for several herbs: Portulaca oleracea significantly increased urinary citrate and reduced calcium, Traditional Persian Medicine-based Mofatet powder markedly reduced stone size and improved urinary parameters, Alhagi maur)

Quantitative Clinical Effect-Size Distribution (Forest Plot)

Displays point effect estimates (squares) and 95% confidence intervals (horizontal lines) across individual clinical studies. Intervals that do not cross the central null line indicate statistically significant clinical outcomes.

Study (PMID · Year)MD Effect Size & 95% CI DistributionEstimate (95% CI)PMID 41858302-1.59 (-3.03–-0.15)PMID 40210172-21.43PMID 41472641-0.72 (-1.1–0.02)PMID 40465634-0.79 (-1.2–-0.39)-25Null (0)3.2Metric: MD
05

Formulation Selection, Dosing & Chronobiology

Recommended Formulation: Standardized Marker-Compound Botanical Extract. Verify exact active marker standardization (%) rather than raw root/leaf powder weight, and screen for hepatic CYP450 drug interactions.

Clinical Trial Dosing & Timing: Published studies most commonly utilize 4600 mg/day · 1 g/day · 910 mg/day · 1,365 mg/day over 48 weeks · 8 weeks · 14 days · 2 months. Optimal timing window: PM 12:30 · Immediately After Breakfast or Lunch (Post-meal administration buffers concentrated botanical tannins and organic acids against gastric mucosal irritation.).

06

Body Response Monitoring & Dose Adjustment

Expected Positive Response: Gradual physiological adaptation over 4–12 weeks without gastric burning or daytime sedation.

Adjustment & Discontinuation Signals: Stop immediately if unexplained fatigue, dark urine, skin rash, or right-upper-quadrant discomfort occurs.

07

Prescription Drug Interactions & Contraindications

No major high-risk prescription contraindications are flagged in the primary index for Black Seed Oil (Nigella sativa), but divalent minerals, fat-soluble compounds, and botanical extracts can still alter absorption or CYP450 metabolism of concurrent medications.

Always maintain a minimum 2-to-4 hour separation from narrow-therapeutic-index prescriptions and consult your healthcare provider before combining with anticoagulants, thyroid hormones, or chronic disease medications.

08

4 Essential Safety Rules Before & After Dosing

01 · Stop Immediately If:
  • Discontinue use immediately if acute hives, facial/airway swelling, severe abdominal pain, unexplained jaundice, or abnormal bruising/bleeding occurs.
  • Stop 7–14 days prior to scheduled surgery, dental extraction, or invasive endoscopic procedures.
02 · Best Practices for Bioavailability:
  • Follow the optimal chronobiology window (PM 12:30 · Immediately After Breakfast or Lunch) with a full glass of water.
  • Stay within clinically studied daily dosages (4600 mg/day · 1 g/day · 910 mg/day) and re-evaluate efficacy after 48 weeks.
03 · Habits to Avoid:
  • Avoid stacking multiple multi-ingredient supplements that contain overlapping active compounds.
  • Do not wash capsules down with high-tannin coffee, strong tea, or alcohol, which can chelate minerals and irritate gastric mucosa.
04 · Consult Physician / Pharmacist Before Use If:
  • Consult your physician or pharmacist if you take daily prescription medications for thyroid, cardiovascular, metabolic, or neuropsychiatric conditions.
  • Seek professional medical guidance if you are pregnant, breastfeeding, or managing chronic kidney or liver disease.
09 · PUBMED CLINICAL STUDIES

Indexed PubMed Clinical Studies & Abstracts (34 Studies) · 17 Quantitative Analyses

01
META-ANALYSIS Endocrinology, diabetes & metabolism (2026) PMID: 41858302 ↗
The Effect of Nigella sativa Supplementation on Cardiometabolic Health in Patients With Metabolic Diseases: A GRADE-Assessed Systematic Review and Meta-Analysis.
Clinical Trial Synthesis 2026 Meta-Analysis published in Endocrinology, diabetes & metabolism involving n = 2,145 participants (MD -1.59). Key conclusion: However, no significant effects were observed for measures of insulin resistance or central adiposity, and the findings should be interpreted cautiously given variability in study quality and outcomes.
View Original PubMed Abstract ↓

BACKGROUND: Metabolic diseases, including type 2 diabetes and obesity, are primary drivers of cardiovascular disease (CVD) through the exacerbation of intermediate risk factors such as dysglycemia, hypertension, and central adiposity. Nigella sativa supplementation has been studied for its potential cardiometabolic benefits, but evidence from clinical trials remains inconsistent. In relation to this matter, a meta-analysis was undertaken to present a more precise evaluation of the effect of N. sativa supplementation on cardiovascular risk factors in patients with metabolic diseases. METHODS: The review was conducted in accordance with PRISMA guidelines. A random-effects meta-analysis was performed to calculate weighted mean differences (WMDs) with 95% confidence intervals. Heterogeneity was assessed using the I2 statistic, and sensitivity analyses were conducted to examine the robustness of pooled estimates. Primary outcomes included obesity and glycemic indices, while blood pressure outcomes were considered secondary. RESULTS: Meta-analysis of 31 trials with 2145 participants revealed significant reductions in weight (WMD: -1.59 kg; 95% CI: -3.03 to -0.15), and BMI (WMD: -0.51 kg/m2; 95% CI: -0.85 to -0.18), SBP (WMD = -3.25 mmHg; 95% CI: -4.44, -2.06), and DBP (WMD = -2.75 mmHg; 95% CI: -4.62, -0.89), FBS (WMD = -18.62 mg/dL; 95% CI: -23.30, -13.95), and HbA1c (WMD = -0.56; 95% CI: -0.79, -0.33) following N. sativa supplementation. Also, N. sativa had no effect on other indices such as WC, HC, WHR, HOMA-IR, and insulin. CONCLUSION: This meta-analysis suggests that N. sativa supplementation is associated with modest improvements in several cardiovascular risk factors. However, no significant effects were observed for measures of insulin resistance or central adiposity, and the findings should be interpreted cautiously given variability in study quality and outcomes. Further well-designed trials are needed to clarify its clinical relevance. © 2026 The Author(s). Endocrinology, Diabetes & Metabolism published by John Wiley & Sons Ltd.

02
SYSTEMATIC REVIEW Supportive care in cancer (2026) PMID: 41731134 ↗
Systematic review of prophylactic antibacterial agents for radiation-induced oral mucositis in head and neck cancer.
Clinical Trial Synthesis 2026 Systematic Review published in Supportive care in cancer. Key conclusion: CONCLUSION: The systematic review highlights limited and inconsistent evidence supporting antibacterial prophylaxis for preventing and reducing RIOM severity in patients with HNC undergoing RT.
View Original PubMed Abstract ↓

OBJECTIVE: To examine the use of treatments with antibacterial properties as prophylaxis prior to radiotherapy (RT), either alone or in combination with chemotherapy (CT), to prevent and reduce radiation-induced oral mucositis (RIOM) in patients with head and neck cancer (HNC). DATA SOURCES: A systematic search following PRISMA guidelines was conducted across PubMed, Embase, Web of Science, and the Cochrane Library to identify relevant studies published in English through March 2025. REVIEW METHODS: Eligible studies assessed prophylactic antibacterial interventions aimed at preventing RIOM. RESULTS: From 86 retrieved citations, 9 articles met inclusion criteria. Antibacterial agents assessed included polymyxin, tobramycin, amphotericin (PTA), povidone iodine, SAMITAL, and Nigella sativa (NS). Evidence supporting povidone iodine, PTA, and SAMITAL was inconclusive or failed to demonstrate statistically significant reductions in RIOM severity. Several studies reported discordant findings, with statistically significant improvements in patient-reported symptoms or quality-of-life measures despite nonsignificant clinician-assessed scores. NS demonstrated potential benefits in reducing RIOM incidence and severity compared with standard of care and other antibacterial agents. CONCLUSION: The systematic review highlights limited and inconsistent evidence supporting antibacterial prophylaxis for preventing and reducing RIOM severity in patients with HNC undergoing RT. Discrepancies between patient-reported outcomes and clinical-assessed grading suggest some treatments may provide symptomatic benefit not captured by traditional scoring systems. NS mouthwashes showed preliminary promise; however, evidence remains insufficient to establish superiority, and safety and regulatory concerns are persistent, particularly in immunosuppressed patients. Given the role of bacterial colonization and microbial dysbiosis in RIOM pathogenesis, larger, well-designed clinical trials with rigorous safety evaluations are warranted to investigate bacterial-directed preventive therapies. © 2026. The Author(s).

03
SYSTEMATIC REVIEW Naunyn-Schmiedeberg's archives of pharmacology (2026) PMID: 41116039 ↗
A holistic guide to effective prevention and treatment for kidney stones: a systematic review exploring anti-urolithiasis approaches.
Clinical Trial Synthesis 2026 Systematic Review published in Naunyn-Schmiedeberg's archives of pharmacology. Key conclusion: For instance, these trials demonstrated promising outcomes for several herbs: Portulaca oleracea significantly increased urinary citrate and reduced calcium, Traditional Persian Medicine-based Mofatet powder markedly reduced stone size and improved urinary parameters, Alhagi maur
View Original PubMed Abstract ↓

Urolithiasis, a disease of kidney stones, is a prevalent and recurrent condition characterized by the formation of hard mineral deposits in the urinary tract, leading to significant morbidity and a substantial healthcare burden worldwide. With recurrence rates ranging from 30 to 50% and a lifetime prevalence of 9-12% in industrialized populations, effective prevention and management strategies are crucial. Traditional approaches to urolithiasis, including pharmacological agents and surgical interventions, emphasize medical interventions and lifestyle changes; however, the persistent recurrence and impact on quality of life underscore the necessity for more comprehensive solutions. Recent advancements have focused on the potential of nutraceuticals, including herbal extracts, vitamins, and minerals, as adjuncts in the prevention and treatment of kidney stones. These agents may exert beneficial effects by inhibiting stone crystal formation, modulating urinary pH, reducing urinary calcium and oxalate excretion, enhancing diuresis, and supporting overall renal function. Moreover, these plant-based therapies may help alleviate symptoms such as pain and inflammation related to stone episodes. This systematic review synthesizes findings from 14 randomized controlled trials to assess the therapeutic impact and safety profile of various herbal interventions in patients with diagnosed kidney or ureteral stones. Thus, evidence from these recent clinical trials has increasingly supported the efficacy of single-herb and polyherbal formulations, such as Nigella sativa, Alhagi maurorum, Subap Plus, and Palasha Kshara, in modulating urinary risk factors and promoting stone expulsion. For instance, these trials demonstrated promising outcomes for several herbs: Portulaca oleracea significantly increased urinary citrate and reduced calcium, Traditional Persian Medicine-based Mofatet powder markedly reduced stone size and improved urinary parameters, Alhagi maurorum distillates and extracts showed comparable efficacy to hydrochlorothiazide in stone expulsion, and Nigella sativa performed as well as or better than tamsulosin in both pain relief and stone passage. Additional polyher

04
CLINICAL STUDY BMC complementary medicine and therapies (2025) PMID: 41029669 ↗
The efficacy and safety of herbal medicines for glycaemic control and insulin resistance in individuals with type 2 diabetes: an umbrella review.
Clinical Trial Synthesis 2025 Systematic Review published in BMC complementary medicine and therapies. Key conclusion: CONCLUSIONS: Current evidence supports the use of ginger and turmeric for glycaemic control in type 2 diabetes, however, given the high clinical heterogeneity and low quality of the review, our confidence in this finding is somewhat limited.
View Original PubMed Abstract ↓

AIM: The global prevalence of diabetes is increasing rapidly. While glycaemic control remains the cornerstone of type 2 diabetes (T2DM) management, hypoglycaemic medications are associated with side effects. Many individuals with T2DM use herbal medicines despite potential risks. This review aims to comprehensively evaluate the efficacy and safety of herbal medicines for T2DM. METHODS: Four electronic databases were searched from August 2018-August 2023 for umbrella reviews, meta-analyses, and systematic reviews on herbal medicine for T2DM. The primary outcome was glycaemic control assessed by glycated haemoglobin (HbA1c); secondary outcomes included measures of insulin resistance, quality of life and adverse events. Quality assessment was performed using A Measurement Tool to Assess Systematic Reviews Version 2 (AMSTAR 2) and certainty of evidence for the primary outcome was assessed using the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach. RESULTS: Eight meta-analyses and two systematic reviews were included. Ginger, turmeric, and Jinlida granules significantly decreased HbA1c compared to placebo (mean differences (MD): -0.467%, -0.486%, -0.283%, respectively) with moderate to high certainty evidence. Berberis vulgaris, Gegen Qinlian decoction and pycnogenol may potentially decrease HbA1c (very low certainty evidence). Ginger, turmeric, cardamom, Berberis vulgaris, Nigella sativa, and various Chinese herbal medicines demonstrated improvements in insulin resistance measures. However, overall confidence in these findings is limited due to the low to very low quality of the included reviews. Few mild adverse effects were reported, but data was incomplete. CONCLUSIONS: Current evidence supports the use of ginger and turmeric for glycaemic control in type 2 diabetes, however, given the high clinical heterogeneity and low quality of the review, our confidence in this finding is somewhat limited. Herbal medicines should be used only as an adjunct to conventional treatment, with shared decision-making between clinicians and patients. Careful monitoring for hypoglycaemia is essential, particularly when herbal medicines are used con

05
META-ANALYSIS Inflammopharmacology (2025) PMID: 40839182 ↗
Effects of Nigella sativa and its constituents on inflammatory markers in ovalbumin-induced asthma model: a preclinical systematic review and meta-analysis.
Clinical Trial Synthesis 2025 Meta-Analysis published in Inflammopharmacology. Key conclusion: CONCLUSION: Based on current meta-analysis results, N.
View Original PubMed Abstract ↓

BACKGROUND: Research demonstrates that Nigella sativa (N. sativa) and its principal constituents, including thymoquinone, thymol, carvacrol, and α-hederin, possess anti-inflammatory, antioxidant, and immunomodulatory properties. This meta-analysis aims to evaluate the preclinical evidence of N. sativa in an animal model of ovalbumin-induced asthma. METHODS: An investigation into the role of N. sativa and its constituents in an animal model of ovalbumin-induced asthma was conducted, covering the period from the beginning until July 2025, utilizing the Scopus, PubMed, and Web of Science databases. The methodological quality of the studies was evaluated using the 15-point CAMARADES checklist. Data analysis was performed using STATA software. RESULTS: A total of eighteen studies encompassing 502 animals, with 251 assigned to the intervention group and 251 to the ovalbumin-induced group, were subjected to analysis. The findings from the meta-analysis indicated that N. sativa and its constituents significantly reduced the levels of interleukin (IL)-4, IL-5, IL-13, and IL-17. Furthermore, there was a notable decrease in immunoglobulin E (IgE) following the intervention with N. sativa and its active components. However, the levels of interferon-gamma (IFN-γ) remained unchanged as a result of the intervention with N. sativa and its active ingredients. CONCLUSION: Based on current meta-analysis results, N. sativa and its constituents may have the potential to modulate the asthma model induced by ovalbumin through their anti-inflammatory and antioxidant effects. Therefore, it is advisable to conduct further clinical trials to assess the efficacy of N. sativa in patients diagnosed with asthma. © 2025. The Author(s), under exclusive licence to Springer Nature Switzerland AG.

06
META-ANALYSIS Pharmacological research (2025) PMID: 40714301 ↗
Does Nigella sativa supplementation improve cardiovascular disease risk factors? A comprehensive GRADE-assessed systematic review and dose-response meta-analysis of 82 randomized controlled trials.
Clinical Trial Synthesis 2025 Meta-Analysis published in Pharmacological research involving n = 5,026 participants. Key conclusion: sativa could be a promising adjunct therapy for improving cardiovascular disease (CVD) risk factors.
View Original PubMed Abstract ↓

AIM: This systematic review and meta-analysis aimed to evaluate the effects of Nigella sativa (N. sativa) supplementation on metabolic and cardiovascular health outcomes. METHODS: A comprehensive search of EMBASE, Scopus, PubMed, CENTRAL, and Web of Science databases was conducted up to August 2024. Study quality and certainty of evidence were assessed using the Cochrane Risk of Bias and Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) tools, respectively. RESULTS: Eighty-two studies, including 79 quantitative and 3 qualitative studies published between 2008 and 2024, involving 5026 participants with interventions ranging from 1 to 48 weeks and doses varying from 200 to 4600 mg/day, were included. N. sativa supplementation significantly improved body fat percentage (BF%), body mass index (BMI), skeletal muscle mass (SMM), waist circumference (WC), weight, waist-to-hip ratio (WHR), diastolic blood pressure (DBP), systolic blood pressure (SBP), mean arterial pressure (MAP), fasting blood sugar (FBS), hemoglobin A1c (HbA1c), postprandial blood glucose (PPBG), quick insulin sensitivity check index (QUICKI), C-reactive protein (CRP), high-sensitivity CRP (hs-CRP), intercellular adhesion molecule-1 (ICAM-1), interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), vascular cell adhesion molecule-1 (VCAM-1), atherogenic index (AI), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC) to HDL-C ratio, TC, triglycerides (TG), very-low-density lipoprotein cholesterol (VLDL-C), alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine, urea, catalase (CAT), malondialdehyde (MDA), superoxide dismutase activity (SOD) activity, and total antioxidant capacity (TAC). CONCLUSIONS: Our findings suggest that N. sativa could be a promising adjunct therapy for improving cardiovascular disease (CVD) risk factors.

07
SYSTEMATIC REVIEW Respiratory medicine (2025) PMID: 40490159 ↗
Efficacy and safety of phytotherapy and anthroposophic medicine in bronchial asthma: A systematic review.
Clinical Trial Synthesis 2025 Systematic Review published in Respiratory medicine. Key conclusion: CONCLUSION: This systematic review suggests several medications from European/Western PT and AM that may be beneficial and appear to be safe in the treatment of bronchial asthma.
View Original PubMed Abstract ↓

BACKGROUND: Bronchial asthma is a highly prevalent health condition associated with low quality of life and high economic costs. Treatments from traditional, complementary and integrative medicine (TCIM) are commonly used by individuals with bronchial asthma. However, a synthesis of the evidence on plant-derived medications is lacking. OBJECTIVE: This review aims to systematically summarize the evidence on the efficacy, effectiveness and safety of European/Western phytotherapy (PT) and medications from anthroposophic medicine (AM) in individuals with bronchial asthma. METHODS: Four electronic databases and additional references were screened for clinical trials published between 1990 and 2023. The findings of the included studies were qualitatively synthesized and study quality was assessed. RESULTS: Of 23 included studies, 19 examined European/Western PT and four investigated AM medications. Nine studies of sufficient quality reported beneficial effects of various plants (e.g., Nigella sativa) on asthma symptoms, pulmonary function and immunological parameters. The medications were considered safe in studies that reported on safety. CONCLUSION: This systematic review suggests several medications from European/Western PT and AM that may be beneficial and appear to be safe in the treatment of bronchial asthma. However, further rigorous studies are needed to provide evidence-based guidance on add-on treatment options for individuals with bronchial asthma.

08
META-ANALYSIS Complementary therapies in medicine (2025) PMID: 40210172 ↗
Effects of black seed (Nigella sativa L.) on cardiometabolic indices in type 2 diabetic patients: A systematic review and meta-analysis of RCTs.
Clinical Trial Synthesis 2025 Meta-Analysis published in Complementary therapies in medicine; statistical significance reported at p = 0.005 (MD -21.43). Key conclusion: However, no significant effects were observed on other metabolic parameters, including insulin, TG, liver enzymes, kidney function, or body weight.
View Original PubMed Abstract ↓

BACKGROUND: Black seed is known for its health benefits in traditional medicine. While recent studies suggest it may improve cardiometabolic health, its impact on type 2 diabetes mellitus (T2DM) remains unclear. This study aims to meta-analysis randomized controlled trials (RCTs) to assess the effects of black seed supplementation on cardiometabolic indices in T2DM patients. METHODS: Following PRISMA guidelines, a comprehensive database search was conducted up to January 2025, and data were extracted from relevant RCTs. Mean differences (MD) and standard deviations (SD) were analyzed using a random-effects model, heterogeneity was assessed, and publication bias was evaluated. RESULTS: The pooled meta-analysis of 16 RCTs showed that black seed supplementation significantly reduced fasting blood glucose (FBG) (MD: -21.43 mg/dL; p = 0.005), hemoglobin A1c (HbA1c) (MD: -0.44; p = 0.01), total cholesterol (TC) (MD: -18.80 mg/dL; p = 0.04) and low-density lipoprotein (LDL) (MD: -19.53 mg/dL; p = 0.003). No significant effects were observed for 2-hour postprandial glucose (2-hpp), fasting insulin, homeostatic model assessment (HOMA), triglycerides (TG), high-density lipoprotein (HDL), aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine, and body weight, or body mass index (BMI). Subgroup analyses revealed that black seed supplementation effectively reduced FBG for longer than 8 weeks; additionally, HbA1c, HOMA, and LDL in higher doses (>1 g/day), shorter durations (≤8 weeks), and use of the oil form. CONCLUSION: Black seed supplementation appears to significantly improve FBG, HbA1c, TC, and LDL levels in patients with T2DM. However, no significant effects were observed on other metabolic parameters, including insulin, TG, liver enzymes, kidney function, or body weight. These findings suggest that black seed may be a beneficial adjunct therapy for glycemic and lipid control in T2DM patients but require further research to confirm its broader metabolic effects.

09
META-ANALYSIS Prostaglandins & other lipid mediators (2025) PMID: 39709091 ↗
Alleviating effects of Nigella sativa supplements on biomarkers of inflammation and oxidative stress: Results from an umbrella meta-analysis.
Clinical Trial Synthesis 2025 Meta-Analysis published in Prostaglandins & other lipid mediators; statistical significance reported at p = 0.001. Key conclusion: Sativa supplementation significantly decreased serum C-reactive protein (CRP) (ES = -0.42; 95 % CI: -0.58, -0.25, p < 0.001), tumor necrosis factor-alpha (TNF-α) (ES= -1.27; 95 % CI: -2.29, -0.25; p = 0.015), and malondialdehyde (MDA) (ES = -0.67; 95 % CI: -0.97, -0.36, p < 0.001
View Original PubMed Abstract ↓

Several meta-analyses have examined the effect of Nigella sativa (N. Sativa) supplementation on inflammatory and oxidative markers, with conflicting results. So, the current study evaluated the effect of N. Sativa on some oxidative and inflammatory parameters. The Embase, Web of Science, Scopus, PubMed databases, and Google Scholar were systemically searched to identify papers indexed before February 2023. The pooled results were calculated with the use of a random-effects model to evaluate the effects of N. Sativa on inflammatory and oxidative markers. Grading of Recommendations Assessment, Development, and Evaluation (GRADE) was used to assess the certainty of evidence. Overall, seven meta-analyses were included in the study. N. Sativa supplementation significantly decreased serum C-reactive protein (CRP) (ES = -0.42; 95 % CI: -0.58, -0.25, p < 0.001), tumor necrosis factor-alpha (TNF-α) (ES= -1.27; 95 % CI: -2.29, -0.25; p = 0.015), and malondialdehyde (MDA) (ES = -0.67; 95 % CI: -0.97, -0.36, p < 0.001) levels, and significantly improved total antioxidant capacity (TAC) (ES = 0.34; 95 % CI: 0.20, 0.47, p < 0.001) and superoxide dismutase (SOD) (ES = 50.66; 95 % CI: 34.15, 67.18, p < 0.001) levels. N. Sativa supplementation had beneficial effects on CRP, TNF-α, MDA, SOD, and TAC. Thus, N. Sativa can be recommended as an adjuvant anti-inflammatory and anti-oxidant agent.

10
META-ANALYSIS Frontiers in pharmacology (2024) PMID: 39372205 ↗
Meta-analysis of randomized controlled trials assessing the efficacy of nigella sativa supplementation for allergic rhinitis treatment.
Clinical Trial Synthesis 2024 Meta-Analysis published in Frontiers in pharmacology; statistical significance reported at p = 0.00001 (OR 1.01). Key conclusion: CONCLUSION: The observation group demonstrated relative safety and had an enhanced effect on allergic rhinitis treatment and total nasal symptom improvement than the control group.
View Original PubMed Abstract ↓

BACKGROUND: Demonstrating the positive effects of Nigella sativa supplementation (Nigella spp) on Allergic Rhinitis (AR) treatment is challenging. To investigate the role of Nigella spp in managing AR, a comprehensive review through systematic reviews and meta-analyses was conducted. PURPOSE: To carry out a meta-analysis of clinical trials that used Nigella spp in treating AR based on current data. STUDY DESIGN: A meta-analysis of randomized controlled trials (RCTs) was performed. METHODS: Various databases, including PubMed, Web of Science, Embase, Science Direct, Springer Link and the Cochrane Library, were searched until October 2023 to obtain RCTs assessing impact of Nigella spp in the control of AR. The current meta-analysis was carried out with a random-effects model. RESULTS: There were 8 studies enrolled, and our meta-analysis findings revealed that, relative to the control group, observation group exhibited the markedly increased total effective rate for allergic rhinitis treatment (odds ratio [OR] = 4.24, 95% confidence interval [CI] (2.57, 7.27), and p < 0.00001); three studies showed that the effect of Nigella spp for nasal symptoms treatment among patients with allergic rhinitis was superior in observation group to control group [mean difference = -2.60, 95% CI (-2.82, -2.38), p < 0.00001]; adverse effects occurred in five studies, all of which were transient, did not require medical intervention, and were not statistically significant between the two groups [OR = 1.01, 95% CI (0.59, 1.73), p = 0.98]. CONCLUSION: The observation group demonstrated relative safety and had an enhanced effect on allergic rhinitis treatment and total nasal symptom improvement than the control group. The inclusion of fewer studies and the lower quality of trial design might affect the stability of the results. However, the evidence-based findings that Nigella spp for allergic rhinitis treatment is more accurate should be validated in future large-scale, multicenter, and well-designed RCTs.

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