Therapeutic effects of crocin in alleviating diabetic neuropathy: a preliminary randomized triple-blind placebo-controlled trial.

Abstract

Introduction: Diabetic neuropathy is a prevalent and debilitating complication of type 2 diabetes, resulting in functional impairments. Crocin, a bioactive constituent of saffron (Crocus sativus), has long been utilized in traditional medicine for its potential therapeutic effects. This study aimed to evaluate the efficacy of Crocin in alleviating neuropathic symptoms in patients with type 2 diabetes.

Methods: In this triple-blind, randomized, placebo-controlled clinical trial, patients with type 2 diabetes and confirmed peripheral neuropathy were randomly assigned to receive either 15 mg/day of Crocin or a matching placebo for 12 weeks. Neuropathic symptoms were assessed using the Total Symptom Score (TSS), Visual Analog Scale (VAS), and the Michigan Neuropathy Screening Instrument (MNSI) at baseline and at 3-week intervals.

Results: Forty-two patients completed the study, with 21 participants in each group. By week 9, the Crocin group exhibited a significantly lower mean TSS (5.1 ± 1.39) compared to the placebo group (6.6 ± 1.00, P = 0.005). Similarly, VAS scores, reflecting pain intensity, were significantly reduced in the Crocin group at both weeks 6 and 9 (P = 0.019). MNSI scores at week 9 also favored the Crocin group (5.7 ± 1.1 vs. 6.8 ± 0.9, P = 0.03).

Conclusion: Crocin may offer promising therapeutic benefits in reducing pain and neuropathic symptoms in patients with type 2 diabetes. Its neuroprotective, antioxidant, and antihyperglycemic properties may contribute to these effects. While the findings support the potential beneficial effect of crocin in the management of diabetic neuropathy, further large-scale and more robust clinical trials are warranted to validate these results.

Trial registration: https//irct.ir/ IRCT20190810044500N8, Registration date 01/01/2021.