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IRCT20180902040927N5 IRCT 2021-04-18 Rafsanjan University of Medical Sciences Effect of Green Tea on Methadone Maintenance Patients The effect of green tea enriched with EGCG on some inflammatory, antioxidant and cognitive factors in methadone maintenance patients; Triple-blind clinical trial 2021-04-21 anticipated 40 Complete https://irct.ir/trial/55155 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The sample size of the present study will be 40 people, which is considered to be 45 people due to the possibility of falling during the study. In order to assign individuals to the two groups, statistical software R version 4.0.3 and simple randomization method were used. Using the command code below, 45 people were randomly divided into two groups a and b. sample (c ("a", "b"), 45, replace = TRUE, prob = c (.5, .5)) By executing this command, the following result was obtained. "b" "b" "a" "b" "a" "a" "b" "a" "a" "a" "b" "b" "a" "a" "a" "b" "a "" b "" a "" b "" a "" b "" b "" a "" b "" b "" a "" a "" a "" b "" b "" a "" b "" b "" b "" a "" a "" a "" b "" b "" b "" a "" a "" b "" b " The first person to enter the study should be in group b, the second person in group b, the third person in group a, the fourth person in group b, and so on. All 45 people will be in the groups. Intervention a and 23 people will be in intervention group b, Blinding description: Green tea capsules and placebo tablets are completely similar in similar box have given to the original researcher by the pharmaceutical company Essential Oil. On the box, only numbers 1 and 2 are recorded, and participants, university researchers, hospital staff, data collection officer, data analyzer are not aware of which box of green tea and which placebo is. The box with 1 label is given to one group and box with 2 label is given to another group. N/A . Intervention 1: Intervention group: To receive 60 mg capsules containing green tea enriched with 40% effective epigallocatechin gallate twice daily for 3 months. Intervention 2: Control group: To receive capsules containing vegetable cellulose, magnesium stearate, silica or maltodextrine as a placebo twice daily for 3 months. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Mahdieh Azin
Faculty of Medicine, Rafsanjan University of Medical Sciences, Pistachio St., Persian Gulf Blvd., Rafsanjan, Iran
Rafsanjan Iran (Islamic Republic of) 7718175911 +98 34 3131 5079 mahdieh.azin@gmail.com Rafsanjan University of Medical Sciences scientific Mahdieh Azin
Faculty of Medicine, Rafsanjan University of Medical Sciences, Pistachio St., Persian Gulf Blvd., Rafsanjan, Iran
Rafsanjan Iran (Islamic Republic of) 7718175911 +98 34 3131 5079 mahdieh.azin@gmail.com Rafsanjan University of Medical Sciences Iran (Islamic Republic of) Patients with methadone maintenance are 20 and 70 years old. Patients who have completed the Consent form. People who have not an underlying inflammatory or infectious disease. 20 years 70 years Male Patients who are allergic to green tea. Patients are taking antioxidant supplements daily and regularly. People who have a special diet like vegetarian. People who consumed green tea daily before the study Treatment - Other Placebo Intervention group: To receive 60 mg capsules containing green tea enriched with 40% effective epigallocatechin gallate twice daily for 3 months Control group: To receive capsules containing vegetable cellulose, magnesium stearate, silica or maltodextrine as a placebo twice daily for 3 months. C-reactive protein. Timepoint: Before taking drug and after 3 months of taking drug. Method of measurement: ELISA method. Tumor necrosis factor -α. Timepoint: Before taking drug and after 3 months of taking drug. Method of measurement: ELISA method. Total antioxidant capacity. Timepoint: Before taking drug and after 3 months of taking drug. Method of measurement: Spectrophotometric method. Superoxide dismutase. Timepoint: Before taking drug and after 3 months of taking drug. Method of measurement: Spectrophotometric method. Catalase. Timepoint: Before taking drug and after 3 months of taking drug. Method of measurement: Spectrophotometric method. Glutathione peroxidase. Timepoint: Before taking drug and after 3 months of taking drug. Method of measurement: Spectrophotometric method. Reactive oxygen species. Timepoint: Before taking drug and after 3 months of taking drug. Method of measurement: Spectrophotometric method. Addiction Severity Index. Timepoint: Before taking drug and after 3 months of taking drug. Method of measurement: Addiction Severity Index questionnaire. Rafsanjan University of Medical Sciences Approved 2021-01-18 Ethics committee of rafsanjan university of medical sciences Rafsanjan University of Medical Sciences, School of Medicine, Pistachio Street, Gulf Blvd., Rafsanjan Rafsanjan Kerman Iran (Islamic Republic of)