Safety and Efficacy of Processed Citrullus colocynthis L. Fruit in Treatment of Hyperlipidemic Type II Diabetic Patients: A Randomized, Placebo-controlled Clinical Trial

Due to high prevalence of diabetes with hyperlipidemia and associated high risk of cardiovascular disease, much interest exists for safe medications including medicinal plants. Considering traditional use of Citrullus colocynthis L. (C. colocynthis) for treatment of diabetes and hyperlipidemia despite toxicity, clinical evaluation of safety and efficacy of the processed C. colocynthis fruit is necessary. In this clinical trial the safety and efficacy of the processed C. colocynthis fruit in hyperlipidemic type II diabetic patients were evaluated. 60 hyperlipidemic type 2 diabetic patients were randomly allocated to C. colocynthis and placebo groups, but only 28 patients in each group completed the study. The patients in C. colocynthis and placebo groups were treated with processed C. colocynthis (100 mg) and placebo capsules (100 mg) three times a day respectively for 1 month. The fasting blood glucose, cholesterol, LDL, HDL, and triglyceride levels as primary outcome and aspartate transaminase, alanine transaminase and creatinine levels as secondary outcome were measured in both groups at the baseline and the endpoint. In the C. colocynthis group fasting blood glucose, cholesterol and LDL levels were significantly reduced at the endpoint compared with the baseline. There were no significant changes in any blood parameters in C. colocynthis group compared with placebo at the endpoint. There were no gastrointestinal, liver and kidney function adverse effects during the study in both groups. The results suggest that processed C. colocynthis fruit extract may be a safe anti-hyperglycemic and anti-hypercholesterolemic agent in hyperlipidemic type II diabetic patients.