Evaluation of crocin in patients with refractory focal epilepsy
- Conditions
- Focal epilepsy disease.Other specified disorders of central nervous systemG96.8
- Registration Number
- IRCT20130418013058N16
- Lead Sponsor
- Mashhad University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 40
Patients with refractory focal epilepsy based on the examination of a specialist doctor
Patients should be taking at least one fixed-dose regimen of one to three anti-epileptic drugs
The number of refractory focal epilepsy attacks in should be at least 5 attacks at 3 months before the study
Written consent to participate
No heart, kidney and liver diseases and not having blood diseases problems and coagulation diseases
Female patients were excluded if they were pregnant, lactating, or of childbearing age and not using approved methods of contraception.
Patients were excluded if they had previously received crocin or participated in any other research trial within the previous 2 months.
Patients were also excluded from the study if they had a history of substance abuse such as alcohol or drugs during the sample collection period.
Any medical conditions that may endanger the patient's health or compromise the patient's ability to participate in the trial will be excluded from the study.
Have a history of severe anaphylaxis or serious blood dyscrasia
Any other significant clinical condition, or recent chronic use of non-AED medications that may interfere with drug absorption, distribution, metabolism, or excretion.
Regular treatment with one of the following drugs that affect the CNS. such as neuroleptics , monoamine oxidase (MAO) inhibitors, barbiturates (except when taken as concomitant anticonvulsant therapy), or narcotic analgesics within 4 weeks prior to enrollment.
Suffering from psychiatric disorders or behavioral disorders, bipolar disorder, schizophrenia or suicidal tendencies or any other mental disorder.
Life-limiting conditions that cause the patient to be unable to complete the course of treatment and need another drug
Allergy to saffron
Suffering from any other serious diseases such as heart, liver and kidney diseases during treatment
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of focal epileptic seizures. Timepoint: After 3 months of medication. Method of measurement: Changes in seizure number and response rate.
- Secondary Outcome Measures
Name Time Method Depression and anxiety disorders. Timepoint: 3 months after taking the drug. Method of measurement: Beck questionnaire.