Effect of saffron in treatment of depression in diabetes patients

Phase 3

Conditions: Mild to moderate depression.
Major depressive disorder, single episode

Registration Number: IRCT20220309054235N1

Lead Sponsor: Ahvaz University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 60

Inclusion Criteria

Age 18-60 years
Diabetes mellitus type 2
Mild to moderate depression
Fasting blood sugar less than 170 mg/dl
Body mass index between 18.5 to 40
Consent to participate in the study

Exclusion Criteria

Consumption of psychiatric drugs before the study
Substance abuse
Insulin consumption
Uncontrolled diabetes (HbA1c above 8%)
History of severe stress
Pregnancy
Lactation
other psychiatric illnesses including anxiety disorders
Previous history of depression
Mental disability

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The severity of depression. Timepoint: Before and after intervention (the end of 8 week of treatment). Method of measurement: Measurement of severity of depression based on the Hamilton Rating Scale for Depression (HRSD) score.;Incidence of treatment-related complication. Timepoint: During the intervention every week until the end of 8 week of treatment. Method of measurement: Based on the evaluation of patients' symptoms at weekly visits and incidence of any side effects related to treatment such as dry mouth, sleep disorders, headaches, digestive problems, urinary problems, sexual function problems and etc.

Secondary Outcome Measures