Table 2.
Effects of Nigella sativa on cardiovascular, diabetes, and rheumatoid arthritis risk factors in clinical trial studies
| Cardiovascular risk factors | ||||||
|---|---|---|---|---|---|---|
| Author (year) | Country (reference number) | Study design (sex) | Participant numbers | Type and dose of N.S administered | Duration (mean age of subjects) | Outcome measures |
| Darand et al. (2019)[112] | Iran | RCT (male/female) | 50 patients with NAFLD | 2 g/day | 12 weeks | ↓serum glucose and serum insulin ↑quantitative insulin sensitivity |
| Sabzghabaee et al. (2012)[37] | Iran | RCT (male/female) | 88 Hyperlipidemia patients | 2 g/d (capsule contained N.S crushed seeds) | 4 weeks | ↓TC, TG, and LDL, no significant difference in HDL, FBG |
| Dehkordi and Kamkhah (2008)[113] | Iran | RCT (male/female) | Patients with mild hypertension | Two test groups received 100 and 200 mg of N.S extract twice a day | 8 weeks | Significant dose-dependent decline in the levels of TC, TG, LDL, systolic and diastolic blood pressure |
| Najimi et al. (2013)[38] | India | Open labeled RCT (male/female) | 90 patients of metabolic syndrome | 500 mg capsule of N.S per day | 8 weeks | Significant improvement with reference to systolic and diastolic blood pressure and LDL-cholesterol, no significant difference in HDL, TG |
| Ibrahim et al. (2014)[114] | Malaysia | RCT (female) | 37 hyperlipidemic menopausal women | 500 mg capsule of N.S per day | 2 months | ↓ TC, LDL and TG, and increased HDL and FBG. No significant difference in diastolic and systolic blood pressure |
| Tasawar et al. (2011)[115] | Pakistan | RCT (male/female) | 80 patients with coronary artery diseases | 500 mg capsule of N.S per day | 6 months | ↓TC, LDL, VLDL, and TG ↑HDL-C |
| Bamosa et al. (1997)[116] | Saudi Arabia | CT (male) | 16 male adolescents | 2 capsules of 500 mg N.S twice daily | 2 weeks | ↓ glucose No significant difference for TG change |
| Farzaneh et al. (2014)[117] | Iran | RCT (female) | 20 sedentary overweight females | 3 capsules of 500 mg N.S daily | 8 weeks | ↓TC, LDL, TG, and body mass index, and ↑HDL-C |
| Najimi et al. (2008)[118] | India | CT (male/female) | 60 patients of metabolic syndrome | N.S oil 2.5 ml twice daily | 6 weeks | ↑TC, LDL, FBG No effect on TG, HDL, postprandial glucose, body weight, BMI, and waist circumference |
| Mahdavi et al. (2015)[119] | Iran | RCT (female) | 90 obese women | 3 g per day (1 g before each meal) N.S oil | 8 weeks | ↓VLD, TG, and BMI No effect on HDL, TC, and LDL |
| Rashidmayvan et al. (2019)[66] | Iran | RCT (male/female) | 44 patients with NAFLD | N.S oil | 8 weeks | ↓FBS, TG, TC, LDL, VLDL, AST and ALT, hs-CRP, IL-6, TNF-α ↑HDL-C N.S oil had no significant effect on serum levels of insulin, blood pressure, and GGT |
| Pelegrin et al. (2019)[69] | France | Pilot RCT (male) | 30 healthy male volunteers | N.S powder (1 g/day) | 4 weeks | ↓TC, LDL |
| Farhangi et al. (2018)[120] | Iran | RCT (male/female) | 40 patients with Hashimoto’s thyroiditis | 2 g N.S powder per day | 8 weeks | ↓ BMI, LDL, and TG ↑ HDL |
| Bhatti et al. (2016)[121] | Pakistan | CT (male/female) | 60 hyperlipidemic smokers | 1 g of N.S (kalonji) seed | 30 days | ↓TC, LDL, and TG, ↑ HDL |
| Diabetes risk factors | ||||||
| Bamosa et al. (2010)[64] | Saudi Arabia | RCT (male/female) | 94 patients with T2D | Capsules containing N.S (1, 2, and 3 g/day) | 12 weeks | ↓ FBS, 2hPG, and HbA1c |
| Kaatabi et al. (2012)[122] | Saudi Arabia | 94 diabetic patients | CT (F) | 1, 2, and 3 g/day of powdered N.S | 12 weeks | 1gr: ↑HDL-C 2gr: ↑ HDL; ↓TC, TG, and LDL-C; 3gr: ↑HDL; ↓ TC, TG, and LDL-C |
| Hosseini et al. (2013)[123] | Iran | RCT (male/female) | 70 patients with T2D | 5 ml/day N.S oil | 12 weeks | ↓FBS, 2hPG, BMI |
| Mirmiran et al. (2015)[68] | Iran | RCT (male/female) | 43 patients with T2D | 1000 mg extract of black seed oil | 8 weeks | ↓FBS, LDL, total cholesterol, and LDL/HDL |
| Heshmati et al. (2015)[124] | Iran | RCT (male/female) | 72 patients with | 3 g/day N.S oil or soft gel capsules | 12 weeks | ↓FBS, HbA1c, ↓LDL-C, and TG |
| Farhangi et al. (2018)[120] | Iran | RCT male/female) |
40 patients with Hashimoto’s thyroiditis | 2 g N.S powder per day | 8 weeks | ↓BMI ↑HDL ↓Serum concentrations of LDL and tri-TG |
| Rashidmayvan et al. (2019)[66] | Iran | RCT (male/female) |
44 patients with NAFLD | 1000 mg N.S oil per day | 8 weeks | ↓ FBS level ↓TG, TC, LDL, VLDL ↑ HDL |
| Pelegrin et al. (2019)[69] | France | Pilot RCT (male) | 30 healthy male volunteers | N.S powder (1 g/day) | 4-weeks | Ineffective on glucose-induced insulin secretion and insulin sensitivity |
| Rheumatoid arthritis risk factors | ||||||
| Hadi et al. (2016)[77] | Iran | RCT (female) | 45 patients with rheumatoid arthritis | two capsules 500 mg/day N.S oil | 8 weeks | ↓ MDA, NO ↑ Serum level of IL-10 |
| Kheirouri et al. (2016)[91] | Iran | RCT (female) | 45 patients with rheumatoid arthritis | two capsules 500 mg/day N.S oil | 8 weeks | ↓ hs-CRP level, cytotoxic T-cells (CD8+), DAS-28 score, and an improved number of swollen joints. ↓ Serum level of CD4+ T-cell percentage, T regulatory cell percentage (CD4+CD25+ T-cell) and CD4+/CD8+ ratio |
| Gheita and Kenawy (2012)[78] | Egypt | RCT (female) | 40 patients with rheumatoid arthritis | Two capsules 500 mg/day N.S oil | 4 weeks | ↓DAS-28, joint inflammation, and morning stiffness |
| Kooshki et al. (2016)[125] | Iran | RCT (male/female) | 40 elderly patients with knee osteoarthritis | Topical application of 3cc N.S oil on knee | 3 weeks | Pain reduction in the black seed group was greater than that of the acetaminophen group |
N.S=Nigella sativa; RCT=Randomized controlled trial; TG=Triglyceride; TC=Total cholesterol; LDL=Low-density lipoprotein; HDL=High-density lipoprotein; VLDL=Very-lowdensity lipoprotein; FBG=Fasting blood glucose; BMI=Body mass index; AST=Aspartate aminotransferase; ALT=Alanine aminotransferase; GGT=Gamma-glutamyltransferase; hs-CRP; high-sensitive C-reactive protein; IL-6=Interleukin-6; TNF-α=Tumor necrosis factor-α; T2D=Type 2 diabetes; FBS=Fasting blood sugar; 2hPG=2-h postprandially glucose; HbA1c=Glycosylated hemoglobin; NAFLD=Nonalcoholic fatty liver disease; MDA=Malondialdehyde; NO=Nitric oxide; DAS-28=Disease Activity Score-28