Background: This study aimed to evaluate the efficacy and safety of a herbal compound consisting of 350mg Vosha and 150mg Sakbinaj which has been used traditionally in uncontrolled seizures.
Methods: This was a double-blind, randomized, placebo-controlled, phase-III-trial, conducted at a teaching hospital in Tehran, Iran. In this study, patients were randomly assigned in 1:1 ratio into placebo/drug groups to receive a capsule of drug/identical placebo three times a day for three months. At the end of each month, seizure frequency was recorded. The primary outcome of the study was a decrease in the seizure frequency of patients after taking the full course of the drug/placebo. The safety endpoint was the reported adverse effects.
Results: A total number of 162 individuals were screened for eligibility, 58 were eligible, and were randomized into two groups (27: intervention and 31: control groups). The two groups were not significantly different at baseline characteristics. The median of seizures respectively were 4, 1, 1, 1 at baseline, after one, two, and three months in the intervention group, and 3, 2, 1, 2 in the placebo group. So, Seizure frequency did not reduce significantly in the intervention vs placebo group after one, two, and three months periods. No significant adverse effect was observed during the study.
Conclusion: The present study showed that the administration of Vosha and Sakbinaj, statistically did not reduce seizure frequency significantly. Larger studies with higher doses are recommended for better conclusions. safety was similar to placebo.
Key words: Vosha, Dorema ammoniacum, Ferula persica, Sakbinaj, Seizure, Epilepsy
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