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IRCT20231014059714N1 IRCT 2023-10-26 Kashan University of Medical Sciences Effect of herbal combination of traditional medicine (Rahayesh majoon) in in opium addicts TEffect of herbal combination of traditional medicine (Rahayesh majoon) on withdrawal symptoms, cravings, sleep quality and mental disorders of opium addicts 2023-11-11 anticipated 100 Complete https://irct.ir/trial/73197 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done by block method (Permuted block randomization) so that first all 4 blocks containing two codes A and B are prepared (6 blocks) then random blocks are selected by placement using a table of random numbers. These blocks form a sample-sized sequence of A and B codes, each of which is randomly assigned to one of the groups. The list of relevant codes will remain in the formulation department of Barij Essan Company until the completion of the project and will be provided with this randomization method, Blinding description: This study is double-blind, in order to blind the participants and patients, the drug and placebo are placed in separate packages with codes 1 and 2. 3 Addiction. Intervention 1: Taking the full dose of methadone needed along with 1 to 2 teaspoons of herbal medicine Rahayesh(Barij essence, Kashan, Iran) per day for 4 weeks. Intervention 2: Control group: Receiving the full dose of methadone along with placebo for 4 weeks. 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 Hossein Akbary
5th Qotb_e Ravandi Ave., Kashan university of medical sciences, Kashan, IRAN
kashan Iran (Islamic Republic of) 87159 88111 +98 31 3457 4191 akbari1350@yahoo.com Kashan University of Medical Sciences scientific ŮŽAmir Ghaderi
Kashan University of Medical Sciences, Faculty of Medicine
Kashan Iran (Islamic Republic of) 8715981151 +98 31 3457 4191 gaderiam@yahoo.com Kashan University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 1- Patients with addiction (diagnosis based on DSM-IV criteria) who are treated with methadone Age 65-18 years The patient has not yet reduced the dose The patient should not take a high dose of methadone. The patient should only receive methadone treatment The patient's methadone treatment time is more than 6 months, that is, it has reached a point where it is no longer necessary to increase the dose for the patient (the patient is on a stable dose of methadone) The patient should receive a dose of methadone below 50 cc daily 18 years 65 years Both 1. Every 7 days, the urine test for morphine, methamphetamine, hashish is checked, and if the test is positive, the patient is excluded from the study. The presence of certain diseases including hypothyroidism or hyperthyroidism and... High blood pressure (systolic pressure above 160 and diastolic pressure above 100 mmHg) Taking psychiatric and nerve drugs while studying, such as benzodiazepines, antidepressants, etc. Having psychotic symptoms6. Pregnant women Pregnant women Warfarin users People who are allergic to reading and report side effects caused by taking medicine while studying Use of anti-oxidant and anti-inflammatory drugs and supplements in the last 3 months and during the study. F19 Other psychoactive substance related disorders Treatment - Drugs Placebo Taking the full dose of methadone needed along with 1 to 2 teaspoons of herbal medicine Rahayesh(Barij essence, Kashan, Iran) per day for 4 weeks. Control group: Receiving the full dose of methadone along with placebo for 4 weeks Withdrawal syndrome. Timepoint: At the beginning of the study, the second and fourth week of the study. Method of measurement: Clinical opiate withdrawal symptoms (COWS). Craving. Timepoint: At the beginning of the study, the second and fourth week of the study. Method of measurement: Desire for Drug Questionnaire (DDQ craving). Sleep quality. Timepoint: The beginning of the study, the second and fourth week of the study. Method of measurement: Pittsburgh Sleep Quality Index (PSQI). Anxiety. Timepoint: The beginning of the study, the second and fourth week of the study. Method of measurement: Beck Anxiety Inventory (BAI). Depression. Timepoint: The beginning of the study, the second and fourth week of the study. Method of measurement: Beck Depression Inventory (BDI). Sexual desire. Timepoint: The beginning of the study, the second and fourth week of the study. Method of measurement: (IIEF)International index of erectile function questionnaire. Kashan University of Medical Sciences Approved 2023-10-01 Ethics Committee of Kashan University of Medical Sciences Kashan University of Medical Sciences, Qutb Rawandi Blvd Kashan Isfehan Iran (Islamic Republic of)