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IRCT138804252195N1 IRCT 2010-12-04 Neurosciences Research Center (NSRC) Effect of oral herbal oil supplement (Cannabis Sativa L, Oenothera Biennis L) and advising diet with Hot nature on multiple sclerosis patients Effect of oral herbal oil supplement (Cannabis Sativa L, Oenothera Biennis L) and advising diet with Hot nature on clinical signs and symptoms and inflammatory factors in patients with multiple sclerosis 2010-10-27 anticipated 99 Complete https://irct.ir/trial/1823 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 1 Multiple Sclerosis. Intervention 1: Receiving 18-21g of oral supplement oil, (Cannabis Sativa L,Oenothera Biennis L), daily and advising diet with hot nature for 180 days. Intervention 2: Receiving 18-21g of oral supplement oil (Cannabis Sativa L,Oenothera Biennis L), daily for 180 days. Intervention 3: Receiving daily 18-21g of "Olive Oil" as placebo for 180 days.
public Dr Seyed Rafi Aref Hosseini
Tabriz University of Medical Sciences
Tabriz Iran (Islamic Republic of) 5166614711 00984113848757-00984113357580-3 arefhosseinir@tbzmed.ac.ir, srarefhosseini@gmail.com Nutrition and Health Faculty scientific Soheila Rezapour Firouzi
Food & Drug Organization, Tabriz University of Medical Sciences,
Tabriz Iran (Islamic Republic of) 5197617151 00984114760674-00984114421476 s.rfirozi@gmail.com Food & Drug Organization Iran (Islamic Republic of) Iran (Islamic Republic of) Inclusion criteria: All MS patients with clinical form of relapsing-remitting type, EDSS =<6 Exclusion criteria: Secondary or primary progressive MS, patients suffering concomitantly from another chronic diseases such as active coronary heart disease, liver disease, pulmonary disease, diabetes mellitus, other neurological, inflammatory, or autoimmune diseases, Pregnancy, Corticostoid use, Acute phase of MS relapse 14 years 55 years Both G35 Demyelinating diseases of the central nervous system Treatment - Drugs Treatment - Drugs Placebo Receiving 18-21g of oral supplement oil, (Cannabis Sativa L,Oenothera Biennis L), daily and advising diet with hot nature for 180 days. Receiving 18-21g of oral supplement oil (Cannabis Sativa L,Oenothera Biennis L), daily for 180 days. Receiving daily 18-21g of "Olive Oil" as placebo for 180 days. Serum IL-4 concentration. Timepoint: Before intervention -6 month after intervention. Method of measurement: ELISA test. Serum IFN-Y concentration. Timepoint: Before intervention -6 month after intervention. Method of measurement: ELISA test. EDSS (Extended disability status score ). Timepoint: Before intervention - 3month after intervention-6 month after intervention. Method of measurement: Clinical examination. Urinary PLA2 concentration. Timepoint: Before intervention -6 month after intervention. Method of measurement: ELISA test. Blood cells Polyunsaturated Fatty Acid. Timepoint: Before intervention - 6 month after intervention. Method of measurement: GC test. Serum PLA2 concentration. Timepoint: before intervention -6month after intervention. Method of measurement: ELISA test. Serum IL-17 concentration. Timepoint: Before intervention - 6 month after intervention. Method of measurement: ELISA test. Blood cells delta-6-desaturase. Timepoint: Before intervention - 6 month after intervention. Method of measurement: ELISA test. Changes of MRI. Timepoint: before intervention - 6 month after intervention. Method of measurement: imaging. Drug changes of symptomatic therapy. Timepoint: before intervention-3month after intervention-6 month after intervention. Method of measurement: Interview. Soheila Rezapour-Firouzi Neurosciences Research Center (NSRC) Soheila Rezapour-Firouzi Approved 2010-05-28 Local ethics committee, Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Research Vice Chancellor Tabriz Iran (Islamic Republic of)