IRCT20130418013058N16
Recruiting
Phase 2
Evaluation of the effectiveness of crocin as a supplement in patients with refractory focal epilepsy in a randomized double-blind clinical trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Mashhad University of Medical Sciences
- Enrollment
- 40
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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