]>
IRCT20240311061254N1 IRCT 2024-04-14 Mashhad University of Medical Sciences Investigating the effect of saffron extract on sex hormones and sexual dysfunction in opioid-dependent men undergoing maintenance treatment with methadone, opium tincture and voluntary withdrawal عصاره زعفران- ختلال عملکرد جنسی-متادون، تنتور اوپیوم - ترک اختیاری Effect of saffron (Crocus sativus L.) extract on oxidative stress, sex hormones and sexual dysfunction in opioid-dependent men undergoing methadone, opium tincture maintenance treatment and voluntary abstinence 2024-06-21 anticipated 240 Complete https://irct.ir/trial/75964 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Basic scienece, Other design features: Investigating the sexual dysfunction of opioid-dependent patients that saffron extract can improve sexual function and improve the quality of their sexual life, Randomization description: There are 30 people in each group (180 people in total). With an estimate of 25% attrition, we first include 40 people in each group who are eligible to enter the study. Because the work will be done in several stages, we will use the information of the initial stages to estimate the exact sample size and continue the study until reaching that number of samples, and they will be divided into two groups using blocks of four. 3 Opioid dependent men undergoing maintenance treatment with methadone, opium tincture and voluntary withdrawal. Intervention group: Intervention group: under maintenance treatment with methadone and opium ventor and voluntary withdrawal who are taking saffron extract tablets.. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Hossein Miladi Georgi
Five kilometers from Damghan Road - Semnan Medical School
Semnan Iran (Islamic Republic of) 3513138111 +98 912 531 3069 miladi331@yahoo.com Semnan University of Medical Sciences scientific Hossein Miladi Georgi
Five kilometers from Damghan Road - Semnan Medical School
Semnan Iran (Islamic Republic of) 3513138111 +98 912 531 3069 miladi331@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) The entry of married men knowingly, without coercion and freely, who are literate and literate, will participate in this study by filling and signing a written consent form, and they are psychologically and cognitively healthy, aware and alert. Active use of opioid substances for at least 5 years before the study and people receiving methadone or opium tincture have been under maintenance treatment with methadone or opium tincture for at least 1 year. According to the sexual disorders questionnaire, have sexual problems with a minimum score (average). Patients' evaluation: all the relevant information will be available in accordance with the ethical principles in maintaining and trusting the identity of the patients. 1- Personal characteristics: name, surname, father's name, ID number, place of birth, date of birth 2- Basic demographic characteristics: gender, marital status, level of education, occupation, weight, height, level of physical activity, race (native or not) 3- The type of narcotic used by the patients 4- Determining the dosage and duration of the narcotic in the past months 5- Examining the previous treatment history of the patients in the field of addiction, including outpatient methods, hospitalization, self-medication, staying in camps and camps etc. 6- History of sexual problems, including late or early ejaculation, dysfunction of erectile function, decreased sexual desire, sexual behavior problems, general dissatisfaction with sexual relations 7- History of prison 8- History of physical and special diseases 25 years 50 years Male All patients who have severe anxiety, depression, stress, mental disorders (suicidal thoughts and withdrawal, dementia, autism, mental retardation, psychosis, bipolar disease, etc.) and have cardiovascular, kidney, liver, lung, thyroid, diabetes, Gastrointestinal diseases, blood pressure, all types of cancer and infectious diseases and AIDS, and they also have drug sensitivity, plant allergies, autoimmune diseases, sexual problems and congenital reproductive system, and taking medicine is harmful for them. They have absolute prohibition conditions. Placebo Intervention group: Intervention group: under maintenance treatment with methadone and opium ventor and voluntary withdrawal who are taking saffron extract tablets. Investigation of saffron extract on sexual dysfunction in opioid-dependent men undergoing maintenance treatment with methadone, opium tincture and voluntary withdrawal. Timepoint: Before the intervention of saffron tablets and 1 day after taking the last dose, questionnaires will be filled, sperm sampling and blood sampling will be done to determine the evaluation of the desired parameters. After the statistical analysis of the data in the relevant groups, if the saffron extract is effective after 1 month to ensure the durability of the effect of saffron on sexual function, the sexual disorders questionnaire will be completed by the patients in the form of follow-up and support. Method of measurement: Investigation of sexual disorders based on questionnaire. Investigating saffron extract on oxidative stress, sex hormones, sperm parameters and craving intensity in opioid dependent men undergoing maintenance treatment with methadone, opium tincture and voluntary withdrawal. Timepoint: Before the intervention of saffron tablets and 1 day after taking the last dose, questionnaires, sperm sampling and blood sampling of patients will be done to determine the evaluation of the desired parameters. After the statistical analysis of the data in the relevant groups, if the saffron extract is effective after 1 month to ensure the durability of the effect of saffron on sexual function, the sexual disorders questionnaire will be completed by the patients in the form of follow-up and support. Method of measurement: Investigating oxidative stress, sex hormones through blood sampling and sperm samples through marital relationships and severity of addiction and craving based on questionnaires. Mashhad University of Medical Sciences Approved 2024-03-12 IR.SEMUMS.REC Five kilometers from Damghan road - Semnan University of Medical Sciences Semnan Semnan Iran (Islamic Republic of)