| Introduction: The objective of this trial was to determine the efficacy and safety of topical and oral application of
Nigella sativa (N.Sativa) oil compared to the placebo in knee osteoarthritis (KOA) patients.
Methods: Patients with mild to moderate KOA were enrolled in this double-blind randomized controlled trial and
randomly assigned to receive oral (2.5 ml of N. Sativa oil twice a day) or topical N.Sativa oil (2.5 ml of N.Sativa
oil three times a day) or placebo for 6 weeks. The primary outcome measures were the Western Ontario and
McMaster Universities Osteoarthritis Index (WOMAC), visual analogue scale (VAS), and timed up & go test
(TUG) scores. The secondary outcome measures were WOMAC subscale (pain, stiffness, and limitations of
physical function) scores.
Results: In total, 40 patients completed the study. VAS, WOMAC pain, WOMAC limitations of physical function
and WOMAC total score improved significantly in the oral and topical N.Sativa groups. However, VAS (4.60 ±
1.79–2.53 ± 2.03) and WOMAC pain (6.90 ± 3.34–3.86 ± 2.52) improved more significantly only in the Topical
N.Sativa group compared to the placebo group (p = 0.005 and p = 0.015). Additionally, topical N.Sativa oil was
more efficient than oral N.Sativa oil in improving WOMAC limitations of physical function (26.73 ± 10.29–11.73
± 6.74 vs. 27.41 ± 10.79–19.35 ± 9.11, respectively) and WOMAC total scores 35.70 ± 13.63–17.13 ± 9.80 vs.
38.47 ± 15.03–27.35 ± 12.76, respectively) in patients (all p-values<0.05).
Conclusions: Topical application of N.Sativa oil was more efficient than the oral intake of N.Sativa oil in
improving WOMAC total and limitations of physical function scores in patients with KOA |