Sains Malaysiana 54(8)(2025): 1995-2006

http://doi.org/10.17576/jsm-2025-5408-10

 

The Safety Profiles of Nigella sativa Oil as a Supplement in Diabetic Neuropathy Patients: Assessment on Hematology and Hepatorenal Functions

(Profil Keselamatan Minyak Nigella sativa sebagai Tambahan pada Pesakit Neuropati Diabetik: Penilaian ke atas Fungsi Hematologi dan Hepatorenal)

 

SYUHADA^1,3, KUSNANDAR ANGGADIREDJA^1,*, NENG FISHERI KURNIATI¹ & AKROM²

 

¹Department of Pharmacology and Clinical Pharmacy, School of Pharmacy, Institut Teknologi Bandung, Bandung, Indonesia

²Department of Clinical Pharmacy, Faculty of Pharmacy, Universitas Ahmad Dahlan, Yogyakarta, Indonesia

³Department of Pharmacy, Politeknik Kaltara, Tarakan, Indonesia

 

Diserahkan: 13 Mac 2025/Diterima: 17 Jun 2025

 

Abstract

The potential effectiveness of Nigella sativa oil (NSO) has been shown in patients with diabetic neuropathy. However, its safety profiles in this group of patients remain underexplored. This study aimed to evaluate the hematological and biochemical safety profiles of NSO in this population. A single-center clinical trial was conducted involving 24 patients with diabetic neuropathy who received NSO at a dose of 2 mL/day for 30 days. Hematological and biochemical parameters were assessed before and after intervention. The hematological parameters included hemoglobin (HGB), white blood cell (WBC) count, red blood cell (RBC) count, hematocrit (Hct), and platelet (Plt) count. Meanwhile, aspartate aminotransferase (AST), alanine aminotransferase (ALT), and creatinine were measured representing hepatorenal parameters. Other adverse events accompanying NSO supplementation were also recorded. The results showed no significant changes in hematological parameters or hepatorenal function markers. A slight increase in mean corpuscular hemoglobin concentration (p = 0.0483) was observed, but values remained within normal physiological limits. Other adverse events reported were categorized non-serious, except one transient case of tachycardia that resolved without clinical consequences. The findings suggest that NSO is safe for patients with diabetic neuropathy. Further long-term studies with larger sample sizes are recommended to confirm these results.

Keywords: Diabetic neuropathy; hematological parameters; liver and kidney function; Nigella sativa; safety evaluation

 

Abstrak

Keberkesanan potensi minyak Nigella sativa (NSO) telah ditunjukkan pada pesakit dengan neuropati diabetik. Walau bagaimanapun, profil keselamatannya dalam kumpulan pesakit ini masih kurang diterokai. Penyelidikan ini bertujuan untuk menilai profil keselamatan hematologi dan biokimia NSO dalam populasi ini. Percubaan klinikal pusat tunggal telah dijalankan melibatkan 24 pesakit dengan neuropati diabetik yang menerima NSO pada dos 2 mL/hari selama 30 hari. Parameter hematologi dan biokimia dinilai sebelum dan selepas intervensi. Parameter hematologi merangkumi hemoglobin (HGB), kiraan sel darah putih (WBC), kiraan sel darah merah (RBC), hematokrit (Hct) dan kiraan platelet (Plt). Sementara itu, aspartate aminotransferase (AST), alanine aminotransferase (ALT) dan kreatinin diukur mewakili parameter hepatorenal. Kejadian buruk lain yang mengiringi suplementasi NSO juga direkodkan. Keputusan menunjukkan tiada perubahan ketara dalam parameter hematologi atau penanda fungsi hepatorenal. Sedikit peningkatan dalam min kepekatan hemoglobin korpuskular (p = 0.0483) telah diperhatikan, tetapi nilai kekal dalam had fisiologi normal. Kejadian buruk lain yang dilaporkan dikategorikan sebagai tidak serius, kecuali satu kes sementara takikardia yang diselesaikan tanpa kesan klinikal. Keputusan menunjukkan bahawa NSO adalah selamat untuk pesakit dengan neuropati diabetik. Kajian lanjut jangka panjang dengan saiz sampel yang lebih besar disyorkan untuk mengesahkan keputusan ini.

Kata kunci: Fungsi hati dan buah pinggang; neuropati diabetik; Nigella sativa; parameter hematologi; penilaian keselamatan

 

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