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IRCT20220628055306N1 IRCT 2022-08-31 Arak University of Medical Sciences The effect of Iranian medicine drug on increasing visual response to auditory stimuli in children with autism spectrum disorders درمان گیاهی اوتیسم The effect of Iranian medicine drug on increasing visual response to auditory stimuli in children with autism spectrum disorders; Double-blind clinical trial 2022-08-23 anticipated 70 Complete https://irct.ir/trial/64513 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method will be used to assign people to intervention and control groups, and concealment will also be observed due to the use of this method. In this method, each person is assigned a unique code and it is pasted on the medicine packages, which will also help in the blinding process, Blinding description: In conducting this study, the control group will be given a placebo and the center's therapists will be unaware of the allocation of the participants in the study to the intervention or control group. In this way, a unique code is assigned to each person and it is pasted on the medicine packages, and only the researcher is aware of the presence of each person in the Medakh group. 3 Treatment of autism with traditional medicine products. Intervention 1: Intervention group: 3 to 5 year old children with autism spectrum disorder who are prescribed 5 cc of traditional medicine product three times a day for 8 weeks, which is a combination of basil plant, betel nut and green cardamom fruit. Group members are evaluated every two weeks. Intervention 2: Control group: 3 to 5 year old children with autism, for whom 5 cc of traditional medicine product which is a combination of basil plant and green cardamom fruit is given three times a day for 8 weeks and each time to be Group members are evaluated every two 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 After the study, I will make a decision depending on the circumstances
public Mohsen Dayani
NO.3, Dr Gharib Blvd, Dr Charmdooz Town
Arak Iran (Islamic Republic of) 3819693345 +98 86 3313 6055 najaf2@yahoo.com Arak University of Medical Sciences scientific Mohsen Dayani
No. 3,Dr Gharib Blvd, Dr Charmdooz Town
Arak Iran (Islamic Republic of) 3819693345 +98 86 3313 6055 najaf2@yahoo.com Arak University of Medical Sciences Iran (Islamic Republic of) Having autism Parental consent 3 years 5 years Both taking medication F84.0 Childhood autism Treatment - Drugs Treatment - Drugs Intervention group: 3 to 5 year old children with autism spectrum disorder who are prescribed 5 cc of traditional medicine product three times a day for 8 weeks, which is a combination of basil plant, betel nut and green cardamom fruit. Group members are evaluated every two weeks. Control group: 3 to 5 year old children with autism, for whom 5 cc of traditional medicine product which is a combination of basil plant and green cardamom fruit is given three times a day for 8 weeks and each time to be Group members are evaluated every two weeks Measuring the rate of visual response to multiple auditory stimuli. Timepoint: The second week, the fourth week, the sixth week, the eighth week. Method of measurement: Record the visual response to the auditory stimulus. Arak University of Medical Sciences Approved 2021-12-05 Ethics Committee of Arak University of Medical Sciences No.3, Dr Qarib Blvd, Dr Charmdooz Town Arak Markazi Iran (Islamic Republic of)