Clinical Trial comparing the effect of alcoholic extract of saffron (Crocus satious L.) and placebo in the treatment of mild to moderate mixed depression - anxiety and related metabolic parameters in type 2 diabetes mellitus

This study will conduct at diabetes society of Natanz. All of the registered diabetes patients in the society will invite for depression and anxiety screening by telephone. Beck depression inventory and Beck anxiety inventory will write from the patients. the patients will select according to these criteria: Beck depression scores higher than 10 as depression, Beck anxiety scores higher than 8 as anxiety. Then,the patients will assess with DSM-IV by a psychologist to conclusive diagnosis. patients with both depression and anxiety will write Hamilton depression and anxiety questionnaires to determine depression and anxiety severity.patients with 14 to 24 scores at the anxiety questionnaire and 15 to 39 scores at the depression questionnaire will assume as suffer from mild to moderate anxiety and depression and will select according to inclusion criteria. Fifty four patients will select randomly among them. The selected patients will invite to central laboratory of Natanz. Fasting blood sugar, 2hour plasma glucose, Hemoglobin A1C and lipid profiles including triglyceride, HDL, and total cholesterol will calculate. LDL will calculate by Friedwalds' formula. ALT, AST, ALP and BUN, Creatinine and uric acid will also measure. Height and weight of the patient will measure at the same day. Then, 54 patients randomly assign to intake saffron or placebo capsules. Of the patients, 27 patients intake 15 mg saffron capsules twice a day (30 mg/day) and 27 patients intake 15 mg placebo capsules (30 mg/day) for 8-weeks.

Tehran University of Medical Sciences