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IRCT20181228042156N1 IRCT 2019-05-06 Zabol University of Medical Sciences The protective effect of Ursodeoxycholic Acid in prevention of hepatic damage in neurological patients treated with Sodium Valporat Evaluation the protective effect of Ursodeoxycholic Acid on hepatic damage in patients with neurological diseases treated with Sodium Valporat 2019-01-21 anticipated 240 Complete https://irct.ir/trial/36410 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The patients were randomized based on a random sequence of numbers (using https://www.randomizer.org online tool), Blinding description: This study was double-blinded in which the researcher and patients who received the drug, as well as the researcher evaluating the outcome were unaware of the type of administrated therapy. 3 Condition 1: Migraine. Condition 2: Epilepsy. Condition 3: Bipolar disorder. Intervention 1: Control group: In this group, patients under Sodium Valproate treatment (15 mg/kg daily) receive placebo. Liver functional tests in this group are measured at the beginning of the study, and after 3, 6 and 9 weeks from the beginning of the intervention. Intervention 2: Intervention group: In this group, patients treated with Sodium Valproate (15 mg/kg daily) are concomitantly treated with Ursodeoxycholic Acid (15 mg/kg daily) acid. Liver functional tests in this group are measured at the beginning of the study, and after 3, 6 and 9 weeks from the beginning of the intervention. Yes - There is a plan to make this available What will be shared: Data from the patients is collected in forms designed by the researcher and at the end of the study, these forms can be made available to relevant individuals and institutions. The results of the study will also be published as a paper and will be publicly available. When: 2018 To whom: Physicians Conditions: For use by doctors and researchers Where to obtain: Dr. Iraj Sharamian Email: Ir_buper@yahoo.com Phone: +989151917652 Dr. Roza Mostafaei Email: mostafaiy.rosa@gmail.com Phone: +989134408810 How to obtain: By submitting a request via email Comments:
public Roza Mostafaei
Amir-Al-Momenin hospital, Kilometer 5 of Zabol-Zahedan highway, Zabol, Iran
Zabol Iran (Islamic Republic of) 9861979917 +98 54 3229 5147 mostafaiy.rosa@gmail.com Zabol University of Medical Sciences scientific Iraj Shahramian
Amir-Al-Momenin hospital, Kilometer 5 of Zabol-Zahedan highway, Zabol, Iran
Zabol Iran (Islamic Republic of) 9861979917 +98 54 3229 5147 Ir_buper@yahoo.com Zabol University of Medical Sciences Iran (Islamic Republic of) Willing to participate in the study Definite diagnosis of migraine, bipolar disorder, or epilepsy Age of <18 years Not being pregnant or lactating no limit 18 years Both Not willing to participate in the study Systemic diseases, acute or chronic hepatic diseases (hepatitis B, C, cirrhosis), diabetes, celiac, hypertension, cardiovascular diseases, pulmonary diseases, renal diseases Age > 18 years old Using hepatotoxic drugs and antibiotics Not taking more than 10% of the administrated Ursodeoxycholic Acid G43 G40 F31 Migraine Epilepsy and recurrent seizures Bipolar disorder Placebo Prevention Control group: In this group, patients under Sodium Valproate treatment (15 mg/kg daily) receive placebo. Liver functional tests in this group are measured at the beginning of the study, and after 3, 6 and 9 weeks from the beginning of the intervention. Intervention group: In this group, patients treated with Sodium Valproate (15 mg/kg daily) are concomitantly treated with Ursodeoxycholic Acid (15 mg/kg daily) acid. Liver functional tests in this group are measured at the beginning of the study, and after 3, 6 and 9 weeks from the beginning of the intervention. Abnormal liver functional tests. Timepoint: The outcomes are measured 3, 6, and 9 months after the initiation of the intervention. Method of measurement: Using serum separated from venous blood and ELISA method. Zabol University of Medical Sciences Approved 2018-12-24 Ethics committee of Zabol University of Medical Sciences Kilometer 5 of Zabol-Zahedan highway, Amir-Al-Momenin Hospital, Zabol, Iran Zabol Sistan-va-Balouchestan Iran (Islamic Republic of)