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IRCT20201219049765N1 IRCT 2021-08-04 Rafsanjan University of Medical Sciences The effect of consuming the liposomal form of pistachio kernel oil on multiple sclerosis Comparison of the effect of liposomal form of pistachio kernel oil and placebo on the level of some inflammatory and anti-inflammatory agents as well as their receptors in mononuclear cells in peripheral blood and change in the severity of clinical symptoms in women with multiple sclerosis 2021-08-19 anticipated 500 Complete https://irct.ir/trial/57607 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method and description of each method: Simple randomization Randomization unit: individual Randomization tool: Excel software How to build a random sequence: with RAND function in excel software Allocation concealment: For allocation concealment, the method of Sequentially numbered, sealed, opaque envelopes (SNOSE) will be used, Blinding description: Participants, lead researcher, healthcare staff responsible for patient care, data collection and outcome assessors, data safety and monitoring committee, and drafters, They will keep blind. To simulate the intervention in 2 groups, similar vials in terms of volume, shape and appearance will be used. 3 Multiple Sclerosis (MS). Intervention 1: Intervention group: once a day, 5 ml, liposomal form of 10% pistachio kernel oil, orally, for 24 weeks. In this study, no special equipment is used and the explanations of this trial are given in printed form to the volunteers. Of course, entering this study does not require special training. The liposomal form of pistachio kernel oil is also prepared and approved by the Research Institute of Basic Medical Sciences of Rafsanjan University of Medical Sciences. Intervention 2: Control group: This group will be given the same as the placebo test group with the same intervention group program. In this study, no special equipment is used and the explanations of this trial are given in printed form to the volunteers. Of course, entering this study does not require special training. Pharmacopoeia is also prepared and approved by the Research Institute of Basic Medical Sciences of Rafsanjan University of Medical Sciences. Yes - There is a plan to make this available What will be shared: Information on primary and secondary outcomes will be available to researchers When: Infinitely after the publication of the article To whom: Researchers and volunteers surveyed Conditions: For research work Where to obtain: Responsible of the project Gholamhossein Hasanshahi alijebal2011@gmail.com How to obtain: Formal request to the university and then refer to the project manager Comments:
public Dr. Gholam Hossein Hassan Shahi
Address: Rafsanjan - Imam Ali Boulevard - Central Organization
Rafsanjan Iran (Islamic Republic of) 7717933777 +98 34 3428 0038 alijebal2011@gmail.com Rafsanjan University of Medical Sciences scientific Ali Jebali
No2, Yaqut building, anbiya shomali Blvd, Yazd
Yazd Iran (Islamic Republic of) 8915897671 +98 35 3833 0756 alijebal2011@gmail.com Rafsanjan University of Medical Sciences Iran (Islamic Republic of) Women aged 18 to 51 years Definite diagnosis of multiple sclerosis with a descriptive measure of disability rate between 1 to 3 18 years 51 years Female Taking corticosteroids during the study Pregnancy and lactation Active cardiovascular disease, liver disease, gastrointestinal disease, patients with Helicobacter pylori positive test, kidney disease, diabetes mellitus, respiratory disease and autoimmune diseases Take multivitamin, mineral, antioxidant and pistachio kernel supplements during the 30 days before the study G35 Multiple sclerosis Treatment - Drugs Placebo Intervention group: once a day, 5 ml, liposomal form of 10% pistachio kernel oil, orally, for 24 weeks. In this study, no special equipment is used and the explanations of this trial are given in printed form to the volunteers. Of course, entering this study does not require special training. The liposomal form of pistachio kernel oil is also prepared and approved by the Research Institute of Basic Medical Sciences of Rafsanjan University of Medical Sciences. Control group: This group will be given the same as the placebo test group with the same intervention group program. In this study, no special equipment is used and the explanations of this trial are given in printed form to the volunteers. Of course, entering this study does not require special training. Pharmacopoeia is also prepared and approved by the Research Institute of Basic Medical Sciences of Rafsanjan University of Medical Sciences. Concentration of inflammatory and anti-inflammatory factors. Timepoint: Intervention time (w0), 6 weeks after intervention (w6), 12 weeks after intervention (w12), 18 weeks after intervention (w18) and 24 weeks after intervention (w24). Method of measurement: With ELISA Kit. Relative expression of genes of receptors of inflammatory and anti-inflammatory agents. Timepoint: Intervention time (w0), 24 weeks after intervention (w24). Method of measurement: By Realtime PCR. The length and severity of the disease. Timepoint: Intervention time (w0), 6 weeks after intervention (w6), 12 weeks after intervention (w12), 18 weeks after intervention (w18) and 24 weeks after intervention (w24). Method of measurement: According to the descriptive measurement of disability rate. Allergies to pistachio compounds. Timepoint: Intervention time (w0), 6 weeks after intervention (w6), 12 weeks after intervention (w12), 18 weeks after intervention (w18) and 24 weeks after intervention (w24). Method of measurement: Qualitative examination with patient self-declaration. Rafsanjan University of Medical Sciences Approved 2020-10-24 Ethics Committee of Rafsanjan University of Medical Sciences Rafsanjan - Imam Ali Boulevard - Central University Organization - Postal Code: 7717933777 Rafsanjan Kerman Iran (Islamic Republic of)