mixed depression and anxiety, type 2 diabetes. Non-insulin-dependent diabetes mellitus, Other single mood [affective] disorders
Conditions
Interventions
Intervention 1: saffron group patients treat with 15 mg saffron extract capsules twice a day (30 mg per day) for 8 weeks. the patients will recruit to not change their physical activity and diet duri
Treatment - Drugs
Placebo
saffron group patients treat with 15 mg saffron extract capsules twice a day (30 mg per day) for 8 weeks. the patients will recruit to not change their physical activity and diet during the intervent
Placebo group patients intake placebo capsules 15 mg twice a day (30 mg daily) for 8 weeks. The patients will recruit to not change their diet and physical activity during the study. Placebo capsules
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
54 Years to 29 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria were: type 2 diabetes mellitus; 40 to 65 years old; mild to moderate anxiety and depression; fasting blood glucose under 170 mg/dl; Body Mass Index (BMI) between 18.5 to 40 kg/m2. Exclusion criteria were: less than 40 and more than 65 years old; mental related drugs (such as anti-depression and anti-anxiety drugs) using; severe depression and anxiety; tobacco or opium using; insulin using; uncontrolled blood glucose; severe physical activity; severe stress at the near past; emotional defeat at the near past; hospitalization at the near past; pregnancy or lactating or patients programmed for pregnancy; other diseases than depression and anxiety; mental disorders in the first degree relatives; BMI less than 18.5 or more than 40 kg/m2.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Beck depression score. Timepoint: 8 weeks. Method of measurement: Beck questionnaire.;Beck anxiety. Timepoint: 8 weeks. Method of measurement: Beck questionnaire.;Hamilton depression score. Timepoint: 8 weeks. Method of measurement: Hamilton questionnaire.;Hamilton anxiety score. Timepoint: 8 weeks. Method of measurement: Hamilton questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Placebo and saffron capcules side effects. Timepoint: 8 weeks. Method of measurement: Ask from the patients during periodical examinations.;Hemoglobin A1C. Timepoint: 8 weeks. Method of measurement: Blood examination.;Fasting blood sugar. Timepoint: 8 weeks. Method of measurement: Blood examination.;2 Hour blood glucose. Timepoint: 8 weeks. Method of measurement: Blood examination.;Alanine amino teransferase. Timepoint: 8 weeks. Method of measurement: Blood examination.;Aspartate amino teransferase. Timepoint: 8 weeks. Method of measurement: Blood examination.;Alkaline phosphatase. Timepoint: 8 weeks. Method of measurement: Blood examination.;Creatinine. Timepoint: 8 weeks. Method of measurement: Blood examination.;Blood urea nitrogen. Timepoint: 8 weeks. Method of measurement: Blood examination.;Uric acid. Timepoint: 8 weeks. Method of measurement: Blood examination.;Low density lipoprotein. Timepoint: 8 weeks. Method of measurement: Blood examination.;High density lipoprotein. Timepoint: 8 weeks. Method of measurement: Blood examination.;Trigelyceride. Timepoint: 8 weeks. Method of measurement: Blood examination. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAbolgassem Djazayeri
Tehran university of medical sciences
Outcome results
None listed