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IRCT201403101836N8 IRCT 2014-03-18 Shahid Sadoughi University of Medical Sciences Evaluation of efficacy of sodium valproate in cervical and lumbar radicular pain management Evaluation of efficacy of sodium valproate low dose in cervical and lumbar radicular pain management and it’s relation with pharmacokinetic properties 2014-04-05 anticipated 80 Complete https://irct.ir/trial/1414 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. N/A cervical and lumbar radicular pain. Intervention 1: Control group: placebo. Intervention 2: Intervention group: sodium valproate, 200 mg, once a day for 10 days.
public Seyed Mojtaba Sohrevardi
Faculty of Pharmacy- Shahid Sadoughi University of Medical Sciences- Shohadaye Gomnam boulevard- Professor Hesabi boulevard- Yazd
Yazd Iran (Islamic Republic of) +98 35 1820 3410 smsohrevardi@ssu.ac.ir Faculty of Pharmacy- Shahid Sadoughi University of Medical Sciences scientific Seyed Mojtaba Sohrevardi
Faculty of Pharmacy- Shahid Sadoughi University of Medical Sciences- Shohadaye Gomnam boulevard- Professor Hesabi boulevard- Yazd
Yazd Iran (Islamic Republic of) +98 35 1820 3410 smsohrevardi@ssu.ac.ir; smsohrevardi@yahoo.com Faculty of Pharmacy- Shahid Sadoughi University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: 1. Diagnosis of lumbar or cervical radicular pain based on diagnostic of rheumatology specialist. 2. Age between 30 and 60 years. 3. Patients will included if they don’t have possibility of health risk or confounding by other diseases of syndromes, e.g., pregnancy, thyroid disorders, hepatic or kidney disorders, congestive heart failure and diabetes mellitus. 4. Patients havent used sodium valproate or if they have been using, they must remember pain intensity before using sodium valproate and can compare with current pain intensity. 5. Weight between 60 and 90 kg. Exclusion criteria: 1. Intolerance to sodium valproate side effects. 2. Patients will be forced to administerated medicines that change protein binding or clearance of sodium valproate. 3. Patients will be given diseases that affect the results of study. 30 years 60 years Both Placebo Treatment - Drugs Control group: placebo Intervention group: sodium valproate, 200 mg, once a day for 10 days. Pain intensity. Timepoint: Before intervention, 10 days after beginning of intervention. Method of measurement: Visual analog scale. Number of acetaminophen administration. Timepoint: 10 days after beginning of intervention. Method of measurement: Empty acetaminophen blister which will be recieved by patients. Serum concentration of sodium valproate. Timepoint: 10 days after beginning intervention. Method of measurement: Gas chromatography with flame ionization detector. Shahid Sadoughi University of Medical Sciences Approved 2014-03-04 Shahid Sadoughi University of Medical Sciences Faculty of Pharmacy- Shahid Sadoughi University of Medical Sciences- Shohadaye Gomnam boulevard- Professor Hesabi boulevard- Yazd Yazd Iran (Islamic Republic of)