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Randomized Controlled Trial
. 2025 Jul;27(4):481-489.
doi: 10.1007/s40272-025-00687-5. Epub 2025 Mar 6.

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

Dalia El-Afify  1 , Doaa El Amrousy  2
Affiliations
Randomized Controlled Trial

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

Dalia El-Afify et al. Paediatr Drugs. 2025 Jul.

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.

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Conflict of interest statement

Declarations. Funding: Open access funding provided by The Science, Technology & Innovation Funding Authority (STDF) in cooperation with The Egyptian Knowledge Bank (EKB). No funding was received for the preparation of this article. Conflicts of Interest: Dalia El-Afify and Doaa El Amrousy have no conflicts of interest that are directly relevant to the content of this article. Ethics Approval: The study obtained ethical approval from the Faculty of Medicine’s local ethical committee at Tanta University. The human subjects were enrolled following the principles of the Declaration of Helsinki. Consent to Participate: Participants and their parents signed a consent form. Consent for Publication: Not applicable. Availability of Data and Material: All the data from the study are available from the corresponding author upon reasonable request. Code Availability: Not applicable. Authors’ Contributions: DE and DE: conceptualization and methodology. DE: methodology, writing (reviewing and editing of the manuscript). DE: data curation and methodology. The manuscript was reviewed and the final version agreed by all authors.

Figures

Fig. 1
Fig. 1
Flow chart of the study
See this image and copyright information in PMC

Comment in

References

    1. Cosentino F, Grant PJ, Aboyans V, Bailey CJ, Ceriello A, Delgado V, et al. 2019 ESC guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD. Eur Heart J. 2020;41:255–323. - PubMed
    1. Adal E, Koyuncu G, Aydın A, Celebi A, Kavunoğlu G, Cam H. Asymptomatic cardiomyopathy in children and adolescents with type 1 diabetes mellitus: association of echocardiographic indicators with duration of diabetes mellitus and metabolic parameters. J Pediatr Endocrinol Metab. 2006;19:713–26. - PubMed
    1. El Razaky O, El Amrousy D, Elrifaey S, Elgendy M, Ibrahim W. Three-dimensional speckle tracking echocardiography: is it the magic wand in the diagnosis of subclinical myocardial dysfunction in children with type 1 diabetes mellitus? Echocardiography. 2018;35(10):1657–63. - PubMed
    1. Vazeou A, Papadopoulou A, Miha M, Drakatos A, Georgacopoulos D. Cardiovascular impairment in children, adolescents, and young adults with type 1 diabetes mellitus (T1DM). Eur J Pediatr. 2008;167:877–84. - PubMed
    1. Khattab AA, Soliman MA. Biventricular function and glycemic load in type 1 diabetic children: Doppler tissue-imaging study. Pediatr Cardiol. 2015;36:423–31. - PubMed

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