Cardioprotective Effect of Nigella sativa in Pediatric Patients with Type 1 Diabetes Mellitus: A Randomized Controlled Study.
- 2025-03-06
- Paediatric drugs 27(4)
- Dalia El-Afify
- Doaa El Amrousy
- PubMed: 40048139
- DOI: 10.1007/s40272-025-00687-5
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Sample size
- n = 30
- Population
- 60 children and adolescents with type 1 diabetes
- Methods
- Randomized into two groups: group I received Nigella sativa seed oil 450 mg twice daily after meals for 3 months in addition to insulin, group II received insulin alone. Echocardiographic examinations and lab measurements performed before and after treatment.
- Blinding
- Open-label
- Duration
- 3 months
- Funding
- Unclear
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.Research Insights
group I had a significantly higher left ventricular E'/A' ratio ... compared with baseline values and compared with group II after treatment
- Effect
- Beneficial
- Effect size
- Small
- Dose
- 450 mg twice daily after meals for 3 months
group I had a significantly higher ... two-dimensional left ventricular global longitudinal strain (2D-LV GLS) compared with baseline values and compared with group II after treatment
- Effect
- Beneficial
- Effect size
- Small
- Dose
- 450 mg twice daily after meals for 3 months
group I had significantly lower ... low-density lipoprotein-cholesterol ... compared with their pretreatment levels and compared with group II
- Effect
- Beneficial
- Effect size
- Moderate
- Dose
- 450 mg twice daily after meals for 3 months
group I had significantly lower ... malondialdehyde ... levels compared with their pretreatment levels and compared with group II
- Effect
- Beneficial
- Effect size
- Small
- Dose
- 450 mg twice daily after meals for 3 months
group I had significantly lower ... nitric oxide ... levels compared with their pretreatment levels and compared with group II
- Effect
- Beneficial
- Effect size
- Small
- Dose
- 450 mg twice daily after meals for 3 months
group I had significantly lower cholesterol ... compared with their pretreatment levels and compared with group II
- Effect
- Beneficial
- Effect size
- Moderate
- Dose
- 450 mg twice daily after meals for 3 months
group I had significantly lower ... transforming growth factor-β ... levels compared with their pretreatment levels and compared with group II
- Effect
- Beneficial
- Effect size
- Small
- Dose
- 450 mg twice daily after meals for 3 months
group I had significantly lower ... troponin I ... levels compared with their pretreatment levels and compared with group II
- Effect
- Beneficial
- Effect size
- Small
- Dose
- 450 mg twice daily after meals for 3 months
group I had significantly lower ... tumor necrosis factor-α ... levels compared with their pretreatment levels and compared with group II
- Effect
- Beneficial
- Effect size
- Small
- Dose
- 450 mg twice daily after meals for 3 months