Cardioprotective Effect of Nigella sativa in Pediatric Patients with Type 1 Diabetes Mellitus: A Randomized Controlled Study

Randomized controlled study in pediatric patients with type 1 diabetes mellitus from the pediatric endocrinology outpatient clinic of Tanta University hospitals in Egypt. The included children and adolescents were 10 to 18 years old, could swallow capsules, and had diabetes duration > 1 year; each arm had 30 participants.

Nigella sativa seed oil (Baraka; Pharco Pharmaceuticals, Cairo, Egypt) was given at 450 mg twice daily after meals for 3 months, added to insulin therapy. Route was not explicitly stated but was implied to be oral.

Nigella sativa seed oil appeared to improve subclinical left ventricular dysfunction and several cardiometabolic and inflammatory markers, while glycemic measures did not differ meaningfully. After 3 months, the active group showed better between-group values for cholesterol (153 ± 13.5 vs 163 ± 17.4; p = 0.024), LDL-C (78.9 ± 9.8 vs 89.4 ± 11.5; p < 0.001), MDA (3.8 ± 0.9 vs 4.74 ± 1.16; p < 0.001), nitric oxide (40.5 ± 3.7 vs 49 ± 4; p < 0.001), TNF-α (8.5 ± 2.4 vs 10.3 ± 2.9; p = 0.009), TGF-β (7.4 ± 2.5 vs 8.9 ± 2.94; p = 0.02), and troponin I (0.04 ± 0.02 vs 0.061 ± 0.02; p = 0.002). Echocardiography also improved, with LV E'/A' ratio rising to 1.33 ± 0.16 from 1.2 ± 0.17 (p = 0.008) and 2D-LVGLS improving from -17.6 ± 1.56 to -20.1 ± 1.5 (p < 0.001). FBG and HbA1c were not significantly different between groups after treatment, and no adverse effects were observed.

The study was small, with only 30 participants per active arm, and was conducted at a single center. Follow-up was short at 3 months, so durability and long-term safety are uncertain. Generalizability is limited to pediatric patients with type 1 diabetes who could swallow capsules, and the report did not provide a clearly stated allocation ratio or full route details.