ABSTRACT
Saffron showed some effects on blood coagulation and platelet aggregation in in vitro and in vivo studies. In a clinical trial with a limited number volunteers, saffron tablets influenced on bleeding time. In this study, the effect of saffron on plasma level of fibrinogen, factor VII (as coagulant agent), C and S protein (as anti-coagulant agent), PT and PTT in a larger sample size was evaluated. The study was a double-blind, placebo-controlled study consisting of 1 week treatment with 200 mg and 400 mg saffron tablets. Sixty healthy volunteers (age range 20-50 years) were selected for the study. The volunteers were divided into three groups of 20 each. Group 1 received placebo; Groups 2 and 3 received 200 mg and 400 mg saffron tablets, respectively, for 7 days (1 tablet per day). Before and after 7 days treatment and also 1 month after that, blood samples were taken. The plasma levels of fibrinogen, factor VII, C and S protein, PT and PTT were evaluated. Statistical analysis showed no difference between groups for any of evaluated factors. This study rejected any effect of saffron with dose of 200 and 400 mg for 1 week on coagulant and anticoagulant system.
Subject(s)
Blood Coagulation/drug effects , Crocus/chemistry , Platelet Aggregation/drug effects , Adult , Anticoagulants/administration & dosage , Anticoagulants/pharmacology , Double-Blind Method , Factor VII/chemistry , Female , Fibrinogen/chemistry , Healthy Volunteers , Humans , Male , Middle Aged , Partial Thromboplastin Time , Protein C/chemistry , Protein S/chemistry , Prothrombin Time , Tablets , Young AdultABSTRACT
INTRODUCTION: despite administration of numerous combinations of epileptic drugs, nearly 15% of childhood seizures are resistant to treatment and it is still a problem in pediatric practice. In traditional medicine, Nigella sativa was known to have anticonvulsant effects. Recent studies also have shown its anticonvulsant effects. Most of the properties of N. sativa or its extracts are mainly attributed to thymoquinone. It has been shown that thymoquinone has several therapeutic effects and no evidence of toxicity or side effects is reported. MATERIALS AND METHODS: in this pilot, double-blinded crossover clinical trial study on children with refractory epilepsy, thymoquinone with dose of 1mg/kg was administered as an adjunctive therapy and its effects on frequency of seizures were compared with those of a placebo. Twenty-two patients entered in the study. They were assigned in two groups and received either thymoquinone or placebo for a period of four weeks, and then during the two weeks of wash out period, they received only their pre-existing anti-epileptic drugs; then, after cross-overing, they received thymoquinone or placebo for a period of four weeks again. During these periods their effects on seizure frequency were investigated. RESULTS: the reduction of frequency of seizures at the end of first period in comparison with the same period before the study demonstrated a significant difference between two groups (thymoquinone and placebo) (P=0.04). Also reduction of frequency of seizure has shown significant difference between two groups at the end of second period in comparison with end of first period (P=0.02). The parental satisfaction showed significant difference between the two groups at the end of the first period (P=0.03). CONCLUSION: it can be concluded that thymoquinone has anti-epileptic effects in children with refractory seizures.