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

Dalia El-Afify, Doaa El Amrousy

Journal: Paediatric drugs 2025;27(4):481-489

PMID: 40048139

Abstract

BACKGROUND AND OBJECTIVE

Nigella sativa is a widely used medicinal plant with several potential therapeutic uses. This study aimed to investigate the possible beneficial cardioprotective effect of Nigella sativa in pediatric patients with type 1 diabetes mellitus.

METHODS

Sixty children and adolescents with type 1 diabetes were randomized into two groups: group I (n = 30) who received Nigella sativa seed oil 450 mg twice daily after meals for 3 months in addition to insulin, and group II (n = 30) who received insulin alone. Echocardiographic examinations were performed before and after the treatment. The lipid profile, malondialdehyde, nitric oxide, tumor necrosis factor-α, transforming growth factor-β, and troponin I were also measured before and after Nigella sativa treatment.

RESULTS

After 3 months of Nigella sativa administration, group I had significantly lower cholesterol and low-density lipoprotein-cholesterol, malondialdehyde, nitric oxide, tumor necrosis factor-α, transforming growth factor-β, and troponin I levels compared with their pretreatment levels and compared with group II. In addition, group I had a significantly higher left ventricular E'/A' ratio and two-dimensional left ventricular global longitudinal strain (2D-LV GLS) compared with baseline values and compared with group II after treatment.

CONCLUSIONS

Nigella sativa can improve subclinical left ventricular dysfunction in pediatric patients with type 1 diabetes mellitus.

CLINICAL TRIAL REGISTRATION

this clinical trial was registered at www.pactr.org with ID: PACTR202302478939306.

© 2025. The Author(s).

Address: Clinical Pharmacy Department, Faculty of Pharmacy, Tanta University, Tanta, Egypt.; Pediatric Department, Faculty of Medicine, Tanta University, 6 Motasem Street, Tanta, Egypt. [email protected].
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