Renal protective effects of oral Achillea millefolium in patients with type 2 diabetes: A double-blind, randomized, placebo-controlled trial

Background: Diabetic kidney disease is a highly prevalent and serious long-term complication of Type 2 Diabetes Mellitus (T2DM). Phytotherapeutic interventions are increasingly explored as adjunctive therapies. Achillea millefolium (AM), a traditional medicinal plant, has been postulated to possess renoprotective properties.Objectives: This study aimed to investigate the efficacy and renoprotective effects of AM supplementation on serum urea and creatinine levels in patients with T2DM as an adjunct therapy.Methods: In this double-blind, randomized, placebo-controlled trial (IRCT20230612058459N1), we enrolled 60 patients with T2DM. Participants were randomly assigned to receive either 500 mg/day of an AM capsule (n=30) or an identically appearing placebo (cellulose) capsule (n=30) for three months. Serum urea and creatinine concentrations were measured at baseline and after the intervention. Results: Following the three-month intervention, the AM group exhibited significant within-group reductions in both serum creatinine (from 1.17 ± 0.36 mg/dL to 0.84 ± 0.15 mg/dL; p < 0.0001) and serum urea (from 37.7 ± 10.02 mg/dL to 30.93 ± 6.12 mg/dL; p < 0.0001). In the placebo group, changes in these parameters were not statistically significant. However, the between-group analysis revealed that the post-intervention reductions in serum creatinine and urea in the AM group were not statistically significantly different from those observed in the placebo group (p = 0.117 and p = 0.221, respectively).Conclusion: Our results demonstrate that a three-month supplementation with 500 mg/day of AM significantly reduces serum creatinine and urea levels from baseline in patients with T2DM. However, the lack of a statistically significant between-group difference compared to placebo tempers the conclusion of efficacy, suggesting that the observed effect may not be attributable solely to the active intervention. Further large-scale studies are warranted to confirm these findings and elucidate the underlying mechanisms.