Efficacy of Momiai in Tibia Fracture Repair: A Randomized Double-Blinded Placebo-Controlled Clinical Trial

研究概要

One hundred and sixty patients with tibial shaft fractures scheduled to undergo surgery were randomized to receive an oral remedy known in Persian medicine as 'Momiai' (n=80) or a wheat flour placebo (n=80) for 28 days. The primary outcome of interest was bone healing, including healing time and the time to tibial bone union. Secondary outcomes of interest included the incidence of adverse events, the level of liver enzymes (alanine amino transferase (ALT), aspartate amino transferase (AST)), blood urea nitrogen, and creatinine after 28 days. The results of this study demonstrated that the mean healing time was statistically significantly shorter in the Momiai group compared to the placebo group (132.9 days vs 155.6 days; p=0.046). Moreover, the mean time to tibial bone union was statistically significantly shorter in the Momiai group compared to the placebo group (p=0.049).The incidence of adverse events were not statistically significantly different between the 2 treatment groups (p>0.05). Finally, levels of liver enzymes including ALT and AST, level of blood urea nitrogen, and levels of creatinine at 28-days post-surgery were all within the normal range in both groups, with no statistical differences between groups observed (p>0.05)