Focal epilepsy disease. Other specified disorders of central nervous system
Conditions
Interventions
Intervention 1: Intervention group: receiving crocin, who received two 15 mg crocin tablets daily for three months. Intervention 2: Control group: Placebo recipients (placebo), who receive two placeb
Sponsors
Mashhad University of Medical Sciences
Eligibility
Sex/Gender
All
Age
16 Years to 70 Years
Inclusion 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
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 Suffering from any other serious diseases such as heart, liver and kidney diseases during treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of focal epileptic seizures. Timepoint: After 3 months of medication. Method of measurement: Changes in seizure number and response rate. | — |
Secondary
| Measure | Time frame |
|---|---|
| Depression and anxiety disorders. Timepoint: 3 months after taking the drug. Method of measurement: Beck questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. seyed Ahmad Mohajeri
Mashhad University of Medical Sciences
Outcome results
None listed