Effect of saffron supplementation on Parkinson's disease: a study protocol for a triple-blind randomised controlled clinical trial

Abstract

Introduction Although there are some drugs to control Parkinson's disease (PD), they have several side effects and cannot control the inflammation and oxidative stress, the leading causes of PD progression. On the other hand, there is a growing interest in herbal medicine as a safe and cheap adjunctive therapy to prevent PD progression. In this regard, limited human studies investigated the effect of saffron, a rich source of antioxidants, on PD. Nevertheless, due to low sample size, saffron dosage and study duration, they could not completely affirm the efficacy of saffron on PD. Therefore, this triple-blind randomised controlled clinical trial aimed to investigate this subject in human patients with a proper sample size, saffron dosage and duration study. Methods and analysis In this parallel, randomised, triple-blind controlled clinical trial, 92 patients with PD will be randomised into two groups to receive either (1) a daily tablet containing 100 mg/d saffron for 12 weeks or (2) placebo tablets for the same duration. The following variables will be assessed before and after the intervention, as the outcomes of interest: serum values of C-reactive protein, total antioxidant capacity, malondialdehyde, glutathione, zonulin, the activity of catalase enzyme, PD stage, symptoms of PD (motor symptoms, non-motor symptoms), quality of life, mental health, sleep quality, cognitive status, anthropometric indices, blood pressure, gastrointestinal symptoms, appetite and fatigue. The intention-to-treat approach will be used for patients who were lost to follow-up. Additionally, to adjust for the potential confounders, a one-way analysis of covariance will be performed. Ethics and dissemination This study was confirmed by the Ethics Committee of Isfahan University of Medical Sciences with the code of IR.MUI.PHANUT.REC.1402.072. Written informed consent to participate will be obtained from all participants. Final findings will be presented in future publications and scientific congresses.