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IRCT201504053449N18 IRCT 2015-12-06 Vice Chancellor for Research, Tehran University of Medical Sciences Valerian for prevention of neuropsychiatric adverse effects of Efavirenz in HIV positive patients Comparing efficacy and safety of Valerian and Placebo for prevention of Efavirenz-induced anxiety and depression in HIV positive patients 2015-09-23 anticipated 50 Complete https://irct.ir/trial/3551 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Other design features: Included patients will be assigned to the Valerian or placebo group based on the block randomization method. Randomization and distribution of the Valerian or placebo will be done by the hospital pharmacy department and researchers, physicians and patients will be blinded regarding type of intervention (Valerian or placebo). 2-3 Neuropsychiatric disorders. Intervention 1: 2 capsules of Sedamin ( 530 mg of dry extract of Valerian root- GolDaru Pharmaceutical Company- Isfahan-IRAN) every night 2 hours before bed time for 4 weeks. Intervention 2: 2 Capsules of Placebo (GolDaru Pharmaceutical Company- Isfahan-IRAN) every night 2 hours before bed time for 4 weeks.
public
scientific Hossein Khalili
Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences
Tehran Iran (Islamic Republic of) +98 21 6658 1598 khalilih@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Inclusion criteria: Patients with confirmed HIV infection, between 18-65 years old, receiving Efavirenz containing antiretroviral treatment. Exclusion criteria: Pregnant and lactating women, previous treatment with Efavirenz, positive history of neuropyschiatric disorders such as severe depression, patients who are receiving mood affecting agents (such as Methadone), positive history of hypersensitivity to herbal products including Valerian, discontinuation of antiretroviral therapy by patient due to any reason, patients who do not tolerate side effects of Valerian (headache, vertigo, stomach pain, nausea, vomiting, diarrhea and palpitation). 18 years 65 years Both F10-19.5 A cluster of psychotic phenomena that occur during or following drug use Treatment - Drugs Placebo 2 capsules of Sedamin ( 530 mg of dry extract of Valerian root- GolDaru Pharmaceutical Company- Isfahan-IRAN) every night 2 hours before bed time for 4 weeks. 2 Capsules of Placebo (GolDaru Pharmaceutical Company- Isfahan-IRAN) every night 2 hours before bed time for 4 weeks Depression, Anxiety, Sleep Disturbance. Positive and Negative Suicide Ideation, Positive and Negative Symptoms of Psychosis. Timepoint: At baseline and 4 weeks later. Method of measurement: The Hamilton Depression and Anxiety, Pittsburgh Sleep Quality, Positive and Negative Suicide Ideation, Positive and Negative Symptoms of Psychosis Scales. Safety of Valerian. Timepoint: During the study. Method of measurement: Patients reports and follow up. Vice Chancellor for Research, Tehran University of Medical Sciences Approved 2015-11-25 Ethics Committee of Tehran University of Medical Sciences Ghods Ave. Tehran Iran (Islamic Republic of)