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IRCT20180902040927N6 IRCT 2026-05-14 Rafsanjan University of Medical Sciences Studying the effect of green tea in MS patients MS The Effect of epigallocatchin gallate Enriched Green Tea on some Clinical, Inflammatory, Antioxidant and Cognitive Parameters in Patients with Multiple Sclerosis; A Triple-blind Randomized Placebo Clinical Trial 2020-10-06 anticipated 48 Complete https://irct.ir/trial/89862 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Participants were randomly assigned to green tea and placebo groups using a 1:1 allocation ratio using a block randomization method. The randomization sequence was generated using SPSS software, and blocks of size 4 were used to maintain a balance between the numbers of subjects in the two groups throughout the study. In order to maintain allocation concealment, the allocation sequence was placed in sealed, numbered envelopes so that the assigned group could not be predicted when each participant entered the study, Blinding description: Green tea and placebo capsules were delivered to the researcher in identical cans and packaging from Essans Daru Company. Only the numbers 1 and 2 were written on the cans of the capsules. None of the researchers, project managers, data analysts, outcome assessors, care provider, and participants (patients) knew which drug each number corresponded to. Data analysis was also performed in two groups, 2 and 1, and Essans Daru Company was asked about the type of drug when writing the results. In this study, the safety monitoring committee was not relevant. N/A Multiple sclerosis. Intervention 1: Control group: To receive capsules containing vegetable cellulose, magnesium stearate, silica or maltodextrine as a placebo twice daily for 3 months. Intervention 2: Intervention group: To receive 60 mg capsules containing green tea enriched with 40% effective epigallocatechin gallate twice daily for 3 months. Yes - There is a plan to make this available What will be shared: The main consequence after de-identifying individuals is that they can be shared. When: Access period begins one year after results are published. To whom: Researchers working in academic and scientific institutions Conditions: For meta-analysis studies Where to obtain: Mahdieh Azin by email: mahdieh.azin@gmail.com How to obtain: The application process must be formal, from an academic researcher. The purposes of using the data must be clearly explained. A reference to the published article must be provided. Comments:
public Mahdieh Azin
No. 44, Pasdaran 2 Street
Rafsanjan Iran (Islamic Republic of) ۷۷۱۷۶۳۷۳۱۸ +98 34 3131 5072 mahdieh.azin@gmail.com Rafsanjan University of Medical Sciences scientific Mahdieh Azin
No. 44, Pasdaran 2 Street
Rafsanjan Iran (Islamic Republic of) 7717637318 +98 34 3131 5072 mahdieh.azin@gmail.com Rafsanjan University of Medical Sciences Iran (Islamic Republic of) Willingness to participate Confirmation of Relapsing-Remitting Multiple Sclerosis (RRMS) according to the McDonald protocol Expanded Disability Status Scale (EDSS) score below 3.5 Age 20–50 years 20 years 50 years Both Having other neurological and autoimmune diseases Having cancer Allergy to green tea products Current use of antioxidant supplements Regular green tea consumption Adherence to special diets Alcohol or substance abuse Pregnancy and lactation. G35 Multiple sclerosis Placebo Treatment - Other Control group: To receive capsules containing vegetable cellulose, magnesium stearate, silica or maltodextrine as a placebo twice daily for 3 months Intervention group: To receive 60 mg capsules containing green tea enriched with 40% effective epigallocatechin gallate twice daily for 3 months Cognitive function: working memory and auditory information processing speed. Timepoint: Before the start of the study and 3 months after receiving the drug. Method of measurement: Paced Auditory Serial Addition Test. Overt and covert anxiety. Timepoint: Before and after three months of taking the drug. Method of measurement: Spielberger Overt and Covert Anxiety Questionnaire. Scale of Mini mental status test (MMSE). Timepoint: Before and 3 months after the intervention. Method of measurement: Mini mental status test (MMSE). Depression rate. Timepoint: Before and 3 months after the intervention. Method of measurement: Beck Depression Inventory- II (BDI- II). Degree of fatigue. Timepoint: Before and 3 months after the intervention. Method of measurement: Fatigue Severity Scale: (FSS). Interleukin 10. Timepoint: Before the start of the intervention and three months after the start of the intervention. Method of measurement: Karmania Pars Gene Company Kit. Total antioxidant capacity (TAC). Timepoint: Before the start of the intervention and three months after the start of the intervention. Method of measurement: Karmania Pars Gene Company Kit. Lower limb motor function assessment. Timepoint: Before the start of the intervention and three months after the start of the intervention. Method of measurement: Timed 25-Foot Walk (T25-FW). Upper limb motor function assessment. Timepoint: Before the start of the intervention and three months after the start of the intervention. Method of measurement: Nine-Hole Peg Test. The degree of disability of the MS patient. Timepoint: Before the start of the intervention and three months after the start of the intervention. Method of measurement: Expanded Disability Status Scale (EDSS). Quality of life. Timepoint: Before the start of the intervention and three months after the start of the intervention. Method of measurement: 36-item Quality of Life Questionnaire (SF-36). Rafsanjan University of Medical Sciences Approved 2020-06-15 Ethics Committee of Rafsanjan University of Medical Sciences Imam Ali Boulevard, Central Organization, Building No. 3, Deputy for Research and Technology Rafsanjan Kerman Iran (Islamic Republic of)