The effect of green tea enriched with EGCG on some inflammatory, antioxidant and cognitive factors in methadone maintenance patients; Triple-blind clinical trial

Determination of the effect of green tea enriched with EGCG on some inflammatory, antioxidant and cognitive factors in methadone maintenance patients; Triple-blind clinical trial

این مطالعه از نوع کارآزمایی بالینی تصادفی شده سه سو کور با گروه موازی کنترل میباشد

The methadone maintenance patients with inclusion criteria will be selected from the Mehregan Center in Rafsanjan. participants, university researchers, hospital staff, data collection officer, data analyzer are blinded.

Inclusion criteria: 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. Exclusion criteria: 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

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.

Study variables include inflammatory indicators (C-reactive protein (CRP), Tumor necrosis factor (TNF-α)), antioxidant indicators (Total antioxidant capacity (TAC)), Superoxide dismutase enzyme (Superoxide dismutase) (SOD), Catalase (CAT), Glutathione peroxidase (GPx) and Reactive oxygen species (ROS), Addiction Severity Index, Depression and Anxiety degrees.

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.

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.