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Effect of saffron in treatment of depression in diabetes patients

The effect of adding saffron to fluoxetine in the treatment of mild to moderate depression in type 2 diabetes mellitus patients: A Randomized Double-Blinded Study

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20220309054235N1
Enrollment
60
Registered
2022-03-27
Start date
2022-04-21
Completion date
Unknown
Last updated
2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild to moderate depression. Major depressive disorder, single episode

Interventions

Intervention 1: Intervention group: Fluoxetine 10 mg, once a day (Abidi Pharmaceutical Company, Iran) will be prescribed for 4 weeks and then the patients will be received Deprofade saffron capsule 20

Sponsors

Ahvaz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMasumeh Ebrahimilagha

Ahvaz University of Medical Sciences

Dr_masumelagha@yahoo.com+98 933 312 7369

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026