Saffron Effect on Depression in Patients with Epilepsy

The Effect of Saffron on Depression, Resilience, and Quality of Life in Patients with Epilepsy and Mild to Moderate Depression

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20251208068253N1

Enrollment

Registered

2025-12-11

Start date

2026-01-21

Completion date

Unknown

Last updated

2026-02-02

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

Conditions

Epilepsy. Epilepsy and recurrent seizures

Interventions

Intervention 1: Intervention group: Participants in this group will receive one standardized saffron tablet daily for 8 weeks. Each tablet contains 15 mg of crocin (as the main active ingredient) whic

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Definitive diagnosis of epilepsy by a neurologist Age between 18-65 years Mild to moderate depression score on the BDI-II (score 14-28) Drug stability in the past 3 months Informed consent to participate

Exclusion criteria

Exclusion criteria: Allergy to saffron Liver disease (liver enzymes more than 3 times of the upper limit normal) Renal failure (creatinine clearance less than 60) Pregnancy or lactation Anticoagulant/antiplatelet users or patients with a history of bleeding Suicidal thoughts or suicide attempts

Design outcomes

Primary

Measure	Time frame
Absolute change in the total score of the Beck Depression Inventory-II (BDI-II). Timepoint: At baseline and then at weeks 4 and 8. Method of measurement: Beck Depression Inventory-II (BDI-II).	—

Secondary

Measure	Time frame
Absolute change in the total score of the Connor-Davidson Resilience Scale (CD-RISC-25). Timepoint: At baseline and then at weeks 4 and 8. Method of measurement: Connor-Davidson Resilience Scale (CD-RISC-25).;Absolute change in the total score of the Quality of Life in Epilepsy Inventory (QOLIE-31). Timepoint: At baseline and then at weeks 4 and 8. Method of measurement: Quality of Life in Epilepsy Inventory (QOLIE-31).;Frequency and type of adverse events reported. Timepoint: Weeks 4 and 8. Method of measurement: Adverse event checklist questionnaire, along with patient self-report.;Change in the mean monthly seizure frequency. Timepoint: Weeks 4 and 8. Method of measurement: Seizure diary.	—

Measure

Time frame

Absolute change in the total score of the Connor-Davidson Resilience Scale (CD-RISC-25). Timepoint: At baseline and then at weeks 4 and 8. Method of measurement: Connor-Davidson Resilience Scale (CD-RISC-25).;Absolute change in the total score of the Quality of Life in Epilepsy Inventory (QOLIE-31). Timepoint: At baseline and then at weeks 4 and 8. Method of measurement: Quality of Life in Epilepsy Inventory (QOLIE-31).;Frequency and type of adverse events reported. Timepoint: Weeks 4 and 8. Method of measurement: Adverse event checklist questionnaire, along with patient self-report.;Change in the mean monthly seizure frequency. Timepoint: Weeks 4 and 8. Method of measurement: Seizure diary.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarshad Abedi

Mashhad University of Medical Sciences

Abeditf@mums.ac.ir+98 51 3180 1589

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 7, 2026