E-ISSN 2577-5669
 

Original Research 


Evaluating the Efficacy and Safety of Dorema Ammoniacum and Ferula Persica oleo-gum Resins Combination Product On Seizure Control In Epileptic Patients: A Randomized, Double-blind, Placebo-controlled Study

Omid Hesami, Mohammad Sistanizad, Behnam Safarpour Lima, Tahereh Hossein Abadi, niloufar Taherpour, *Ladan Ayazkhoo.

Abstract
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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How to Cite this Article
Pubmed Style

Hesami O, Sistanizad M, Lima BS, Abadi TH, Taherpour n, Ayazkhoo L. Evaluating the Efficacy and Safety of Dorema Ammoniacum and Ferula Persica oleo-gum Resins Combination Product On Seizure Control In Epileptic Patients: A Randomized, Double-blind, Placebo-controlled Study. J Complement Med Res. 2022; 13(1): 22-26. doi:10.5455/jcmr.2022.13.01.05


Web Style

Hesami O, Sistanizad M, Lima BS, Abadi TH, Taherpour n, Ayazkhoo L. Evaluating the Efficacy and Safety of Dorema Ammoniacum and Ferula Persica oleo-gum Resins Combination Product On Seizure Control In Epileptic Patients: A Randomized, Double-blind, Placebo-controlled Study. https://www.jocmr.com/?mno=31107 [Access: June 30, 2022]. doi:10.5455/jcmr.2022.13.01.05


AMA (American Medical Association) Style

Hesami O, Sistanizad M, Lima BS, Abadi TH, Taherpour n, Ayazkhoo L. Evaluating the Efficacy and Safety of Dorema Ammoniacum and Ferula Persica oleo-gum Resins Combination Product On Seizure Control In Epileptic Patients: A Randomized, Double-blind, Placebo-controlled Study. J Complement Med Res. 2022; 13(1): 22-26. doi:10.5455/jcmr.2022.13.01.05



Vancouver/ICMJE Style

Hesami O, Sistanizad M, Lima BS, Abadi TH, Taherpour n, Ayazkhoo L. Evaluating the Efficacy and Safety of Dorema Ammoniacum and Ferula Persica oleo-gum Resins Combination Product On Seizure Control In Epileptic Patients: A Randomized, Double-blind, Placebo-controlled Study. J Complement Med Res. (2022), [cited June 30, 2022]; 13(1): 22-26. doi:10.5455/jcmr.2022.13.01.05



Harvard Style

Hesami, O., Sistanizad, . M., Lima, . B. S., Abadi, . T. H., Taherpour, . n. & Ayazkhoo, . L. (2022) Evaluating the Efficacy and Safety of Dorema Ammoniacum and Ferula Persica oleo-gum Resins Combination Product On Seizure Control In Epileptic Patients: A Randomized, Double-blind, Placebo-controlled Study. J Complement Med Res, 13 (1), 22-26. doi:10.5455/jcmr.2022.13.01.05



Turabian Style

Hesami, Omid, Mohammad Sistanizad, Behnam Safarpour Lima, Tahereh Hossein Abadi, niloufar Taherpour, and Ladan Ayazkhoo. 2022. Evaluating the Efficacy and Safety of Dorema Ammoniacum and Ferula Persica oleo-gum Resins Combination Product On Seizure Control In Epileptic Patients: A Randomized, Double-blind, Placebo-controlled Study. Journal of Complementary Medicine Research, 13 (1), 22-26. doi:10.5455/jcmr.2022.13.01.05



Chicago Style

Hesami, Omid, Mohammad Sistanizad, Behnam Safarpour Lima, Tahereh Hossein Abadi, niloufar Taherpour, and Ladan Ayazkhoo. "Evaluating the Efficacy and Safety of Dorema Ammoniacum and Ferula Persica oleo-gum Resins Combination Product On Seizure Control In Epileptic Patients: A Randomized, Double-blind, Placebo-controlled Study." Journal of Complementary Medicine Research 13 (2022), 22-26. doi:10.5455/jcmr.2022.13.01.05



MLA (The Modern Language Association) Style

Hesami, Omid, Mohammad Sistanizad, Behnam Safarpour Lima, Tahereh Hossein Abadi, niloufar Taherpour, and Ladan Ayazkhoo. "Evaluating the Efficacy and Safety of Dorema Ammoniacum and Ferula Persica oleo-gum Resins Combination Product On Seizure Control In Epileptic Patients: A Randomized, Double-blind, Placebo-controlled Study." Journal of Complementary Medicine Research 13.1 (2022), 22-26. Print. doi:10.5455/jcmr.2022.13.01.05



APA (American Psychological Association) Style

Hesami, O., Sistanizad, . M., Lima, . B. S., Abadi, . T. H., Taherpour, . n. & Ayazkhoo, . L. (2022) Evaluating the Efficacy and Safety of Dorema Ammoniacum and Ferula Persica oleo-gum Resins Combination Product On Seizure Control In Epileptic Patients: A Randomized, Double-blind, Placebo-controlled Study. Journal of Complementary Medicine Research, 13 (1), 22-26. doi:10.5455/jcmr.2022.13.01.05