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IRCT20170112031893N7 IRCT 2020-06-18 Ghoum University of Medical Sciences Evaluation of safety and efficacy of Jadwar plant in improving the withdrawal symptoms of opioids Evaluation of safety and efficacy of jadwar plant in improving the withdrawal symptoms of opioids: A triple blind trial Study 2020-08-22 anticipated 60 Complete https://irct.ir/trial/48674 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization will be performed by random numbers generated by a computer (Stat Trek software). From list 1 to 60, this list is randomly divided between the two groups of jadwar and controls, and by considering the numbers, the two groups are randomized. Couples will be in the jadwar group and odd numbers will be in the placebo group, Blinding description: In this study, patients, statistical analyst and physicians are not aware of the allocation of drugs and placebo, and someone outside the group is aware of the allocation of treatment.The placebo is a combination of starch with edible color that is similar to the jadwar capsule. 3 mental and behavioural disorders due to use of opioids. Intervention 1: Intervention group: Patients receiving 500 mg capsules of Jadwar plant powder produced by Shefangar Company three times daily for three months. Intervention 2: Control group: Patients receiving 500 mg capsules of placebo (Starch) produced by Shefangar Company three times daily for three months. 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 With attention due to the type of study and publication of the article, there was no need to mention this
public Hossein Yusefi
Clinical Research Development Center, Shahid Beheshti Hospital, Shahid Beheshti Blvd, Azadegan Sq, Qom, Iran
Qom Iran (Islamic Republic of) 3713649373 +98 25 3886 0146 driran1390@yahoo.com Ghoum University of Medical Sciences scientific Hossein Yusefi
Clinical Research Development Center, Shahid Beheshti Hospital, Shahid Beheshti Blvd, Azadegan Sq, Qom, Iran
Qom Iran (Islamic Republic of) 3713649373 +98 25 3886 0146 driran1390@yahoo.com Ghoum University of Medical Sciences Iran (Islamic Republic of) All patients were abusing opioids for at least 1 year All patients were at the beginning of induction phase of Methadone maintenance treatment protocol Subjects should not recieve any other medication which affects withdrawal symptoms no limit no limit Both Any allergies to the active ingredient of the drug or side effects Getting Cancer F11 Opioid related disorders Treatment - Drugs Placebo Intervention group: Patients receiving 500 mg capsules of Jadwar plant powder produced by Shefangar Company three times daily for three months Control group: Patients receiving 500 mg capsules of placebo (Starch) produced by Shefangar Company three times daily for three months Opiate withdrawal syndrome score. Timepoint: Baseline, 4,8 and12 weeks after starting the medication. Method of measurement: Opiate withdrawal syndrome questionnaire. Ghoum University of Medical Sciences Approved 2014-06-03 Ethics committee of Qom University of Medical Sciences Vice chancellor for research of Qom University of Medical Sciences, Safashar road, Qom, Iran Qom Ghoum Iran (Islamic Republic of)