The Safety and Efficacy of Rosa Damascena Extract in Patients with Type II Diabetes: preliminary Report of a Triple Blind Randomized Acarbose Controlled Clinical Trial

Abstract

Background: Diabetes is a global health problem that its prevalence is increasing rapidly. Rosa damascena extract has shown to have an intensive non-competitive inhibitory effect on α-glucosidase in an animal study. The aim of this study was to assess the safety and efficacy of Rosa damascena (RD) Mill in diabetic patients and healthy subjects. Methods: In a triple-blind, placebo and Acarbose-controlled randomized trial in Kerman in the south-east of Iran, we randomly allocated diabetic patients (n=32) and healthy volunteers (n=28) to 100mg Acarbose, 200 mg RD-methanolic extract, 400mg RD-methanolic extract and placebo groups. Over 15 days, the participants were followed up to monitor the changes in blood biochemical parameters and apparent symptoms. Analyses were carried out by intention to treat. Results:RD extract decreased postprandial blood glucose levels comparable to the effects of Acarbose, demonstrating its α-glucosidase inhibitory activity. Besides, fasting plasma glucose levels significantly decreased in patients treated with 400 mg/day RD-methanolic extract compared to the 200 mg RD-methanolic extract (127.6±26.8vs. 165.5±27.1, p=0.041), suggesting that Rosa damascena Mill is effective in a dose dependent manner. No major or minor hypoglycemic event was observed. NO adverse event was observed in the RD treatment groups in comparison with Acarbose or placebo groups. Serum levels of biochemical parameters did not fluctuate significantly in RD treatment groups compared to Acarbose and placebo controls. Conclusion:Rosa damascena not only decreases blood glucose levels, but also is safe to be used for the purpose of controlling blood glucose levels in drug naive patients with type II diabetes.