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IRCT20170420033551N4 IRCT 2018-12-31 Kashan University of Medical Sciences Effect of crocin supplementation in treatment of methadone maintenance treatment patients A Clinical trial to assess the effect of crocin supplementation compared with the placebo on mental health parameters, metabolic profiles and genetic response in methadone maintenance treatment patients 2018-12-13 anticipated 60 Complete https://irct.ir/trial/36156 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be performed with simple method and random numbers generated by computer software (Stat Trek software) which choose the random numbers. Then, we consider the specific numbers for both groups. , Blinding description: Placebo will be used to achieve participants and investigators masking. The researchers and patients will be concealed until the final analyses by a trained staff. 2 Addiction. Intervention 1: Intervention group: tablet of Crocin, 15 mg, two oral tablet for 8 weeks. Intervention 2: Control group: Placebo tablet, two oral tablet for 8 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is No - There is not a plan to make this available
public Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8814187159 +98 31 5554 0021 asemi_z@kaums.ac.ir Kashan University of Medical Sciences scientific Zatollah Asemi
Ghotbe Ravandi Boulevard, Kashan
Kashan Iran (Islamic Republic of) 8814187159 +98 31 5554 0021 asemi_z@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Currently undergoing MMT and opioid dependence in the past year Age of 18 to 60 years old Evaluated by the drug abuse section of the Structured Clinical Interview for DSM‐IV Beck Depression Scores > 20 and Beck Anxiety > 15 Seeking for treatment 18 years 60 years Male Taking crocin, anti‐inflammatory and antioxidant supplements during the last 3 months before the intervention. History of metabolic diseases including diabetes, hypertension, thyroid, and cardiovascular disease. F19 Mental and behavioural disorders due to multiple drug use and use of other psychoactive substances Treatment - Drugs Placebo Intervention group: tablet of Crocin, 15 mg, two oral tablet for 8 weeks. Control group: Placebo tablet, two oral tablet for 8 weeks. Depression beck score. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Questionnaire. Anxiety beck score. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Questionnaire. Total antioxidant. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Spectrophotometry. HDL. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit. Total cholesterol. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit. Triglycerides. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit. Fasting plasma glucose. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Enzymatic kit. Insulin. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Elisa kit. Nitric oxide. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Spectrophotometry. Hs-CRP. Timepoint: At the beginning of the study and after 8 weeks of intervention. Method of measurement: Elisa kit. Expressed levels of LL-1 gene. Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: PCR. Expressed levels of TNF-a gene. Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: PCR. Expressed levels of PPAR-γ. Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: PCR. Total glutathione. Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: Spectrophotometry. Malondialdehyde. Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: Spectrophotometry. Expressed levels of TGF-β gene. Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: PCR. Expressed levels of LDLR gene. Timepoint: At the beginning of the study and 8 weeks after intervention. Method of measurement: PCR. Kashan University of Medical Sciences Approved 2018-12-11 Ethics committee of Kashan University of Medical Sciences Ghotbe Ravandi Boulevard, Kashan Kashan Isfehan Iran (Islamic Republic of)