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IRCT20190811044513N1 IRCT 2019-09-11 Hamedan University of Medical Sciences The effect of zinc supplements on the oxidative stress and reduction of withdrawal symptoms in opioid addicts in the withdrawal syndrome The effect of zinc supplements on the oxidative stress and reduction of withdrawal symptoms in opioid addicts in the withdrawal syndrome 2019-08-22 anticipated 40 Complete https://irct.ir/trial/41513 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: For this purpose we will use quadratic random blocks method. For this purpose, we provide four sheets of paper for each drug and placebo group separately. We write on two sheets of letter A (intervention group) and on the other two sheets of letter C (comparison group). Mix the sheets together and place in a drawer. By referring to each eligible patient, one sheet was randomly drawn and the A or C sheet was drawn according to one of the two groups (zinc recipient) and control group Will be allocated. It should be noted that the drawn sheets will not be returned to the drawer until all four sheets have been drawn. Once the four sheets have been randomly pulled out, all the sheets are returned to the drawer and the procedure will be repeated for the next four patients until the desired sample size is reached, Blinding description: Patients in the intervention group received 30 mg zinc pills without awareness. The other group uses medication that is a form and color with zinc tablets. Also, the treating physician who will examine patients will not be aware of the type of medication used for patients. In addition, the statistical analyst will not be aware of the drug code used. Therefore, this study will be a triple blind. 3 People with Opioid Addiction. Intervention 1: Intervention group: Opioid addicts who use 30 mg zinc tablets from the US company Naturemade. The pill is given to each patient during one month and one pill for each day. It is recommended to take the pill at night and after dinner to better absorb and reduce the gastrointestinal side effects. Blood sampling was performed once before the intervention and once after the intervention. Intervention 2: Control group: The control group is opioid addicts who use a placebo that completely similar to zinc tablets during one month and one pill for each day. This placebo was made at the Faculty of Pharmacy, Hamadan University of Medical Sciences. It is recommended to be taken at night and after dinner in order to better absorb and reduce the gastrointestinal side effects. Blood sampling was performed once before the intervention and once after the intervention. 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 I haven't decided yet
public Ali Hasanalizadeh
Shahid Fahmide Ave, Hamadan University of Medical Sciences, Faculty of Pharmacy
Hamadan Iran (Islamic Republic of) 6517838678 +98 81 3838 1591 alizadeh01996@gmail.com Hamedan University of Medical Sciences scientific Sara Ataei
Shahid Fahmide Ave, Hamadan University of Medical Sciences, Faculty of Pharmacy
Hamadan Iran (Islamic Republic of) 6517838678 +98 81 3838 1591 s.ataei@umsha.ac.ir Hamedan University of Medical Sciences Iran (Islamic Republic of) Opioid use for two years and more Admission within a maximum of one week from the time of withdrawal Not taking medications away from the specialist opinion Absence of acute and chronic inflammatory diseases and any other acute or chronic infections Lack of AIDS, hepatitis and diabetes 18 years 65 years Both Re-consuming by people before sampling Use of drugs that have an effect on inflammation and oxidative stress Getting any disease during research Attempted suicide or a history of it during the past year Z.81-4 Family history of other substance abuse Treatment - Drugs Placebo Intervention group: Opioid addicts who use 30 mg zinc tablets from the US company Naturemade. The pill is given to each patient during one month and one pill for each day. It is recommended to take the pill at night and after dinner to better absorb and reduce the gastrointestinal side effects. Blood sampling was performed once before the intervention and once after the intervention. Control group: The control group is opioid addicts who use a placebo that completely similar to zinc tablets during one month and one pill for each day. This placebo was made at the Faculty of Pharmacy, Hamadan University of Medical Sciences. It is recommended to be taken at night and after dinner in order to better absorb and reduce the gastrointestinal side effects. Blood sampling was performed once before the intervention and once after the intervention. Oxidative stress factors, reduction of withdrawal symptoms. Timepoint: At the beginning and end of the study. Method of measurement: Serum level measurement by using kits. Antioxidant capacity of serum. Timepoint: At the beginning and end of the study. Method of measurement: Colorimetric method. Lipid Peroxidation Index. Timepoint: At the beginning and end of the study. Method of measurement: Colorimetric method. Thiol groups index. Timepoint: At the beginning and end of the study. Method of measurement: Colorimetric method. Enzymatic activity of glutathione peroxidase. Timepoint: At the beginning and end of the study. Method of measurement: Colorimetric method. Enzymatic activity of superoxide dismutase. Timepoint: At the beginning and end of the study. Method of measurement: Colorimetric method. Evaluation of withdrawal symptoms. Timepoint: At the beginning and end of the study. Method of measurement: COWS questionnaire. Hamedan University of Medical Sciences Approved 2019-07-05 Ethics committee of HamadanUniversity of Medical Sciences Shahid Fahmide Ave, Hamadan University of Medical Sciences, Faculty of Pharmacy Hamadan Hamadan Iran (Islamic Republic of)