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IRCT20230930059556N1 IRCT 2024-02-13 Shiraz University of Medical Sciences Investigating the effect of Violet syrup as an subsidiary treatment for insomnia in children with attention deficit hyperactivity disorder Investigating the effect of Violet syrup as an subsidiary treatment for insomnia in patients with attention deficit hyperactivity disorder treated with Ritalin. In a double-blind clinical trial study in children 6-12 years 2022-11-22 anticipated 60 Complete https://irct.ir/trial/72876 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The researcher enrolled the participants based on the convenience sampling method he does. From NCSS software (Number Cruncher statistical system) and Randomized block method is used to randomize the study. At Randomized block method, participants in 6 blocks (, AABB, ABAB BBAA, BABA, ABBA, BAAB) are classified as each block Includes 4 participants. In this study, "A" belongs to the drug group and "B". It is assigned to the placebo group, for example: in the block ", "ABAB The first person enters the drug group, the second person enters the placebo group, the third One entered the drug group and the fourth entered the placebo group. So , All eligible participants were randomized to one of the arms The study is selected according to the random list, Blinding description: The patients' doctors and drug providers will be blinded to the intervention allocation. It should be noted that the drug container is the same. And the intervention in the two groups are similar in terms of shape, color and method of use. 3 Attention deficit hyperactivity disorder. Intervention 1: Intervention group: In 30 patients with attention deficit hyperactivity disorder aged 6 to 12 years who are treated with Ritalin, Banafshe syrup of Kimiagar company is prescribed with a dose of 5 cc twice a day. Intervention 2: Control group: The people of this group are prescribed placebo syrup with a dose of 5 cc 2 times a day for 8 weeks, which is made by the project's pharmacist at the Faculty of Pharmacy of Shiraz University. 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 Sara dehbozorgi
Zand Ave, Shiraz University of Medical Sciences
Shiraz Iran (Islamic Republic of) 7654971466 +98 71 3228 7237 dehbozorgi_s@sums.ac.ir Shiraz University of Medical Sciences scientific Sara Dehbozorgi
Zand Ave, Shiraz University of Medical Sciences
Shiraz Iran (Islamic Republic of) 7654971466 +98 71 3228 7237 dehbozorgi_s@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Having DSM 5 diagnostic criteria for ADHD Age 6 to 12 years Not taking any medication affecting the mental state at least 2 weeks before the research 6 years 12 years Both Mental retardation The presence of any psychiatric disorder except OCD History of allergy to the drugs used in the study Having a serious medical illness such as heart disease Uncontrolled seizure disorder People who have systolic blood pressure above 125 mm Hg or their resting pulse is less than 60 or more than 115 beats per minute. Weight under 5 13 kg F90 Attention-deficit hyperactivity disorders Treatment - Drugs Placebo Intervention group: In 30 patients with attention deficit hyperactivity disorder aged 6 to 12 years who are treated with Ritalin, Banafshe syrup of Kimiagar company is prescribed with a dose of 5 cc twice a day. Control group: The people of this group are prescribed placebo syrup with a dose of 5 cc 2 times a day for 8 weeks, which is made by the project's pharmacist at the Faculty of Pharmacy of Shiraz University. Sleep score based on Child Sleep Habits Questionnaire (CSHQ). Timepoint: At the beginning of the study (before the intervention) and 4 and 8 weeks after starting to take the drug or placebo. Method of measurement: Children's sleep habits questionnaire. Possible side effects of violet syrup. Timepoint: At any time of study. Method of measurement: Patient statement and clinical examination. Shiraz University of Medical Sciences Approved 2022-10-28 Ethics Committee of Shiraz University of Medical Sciences Zand Ave, Shiraz University Of Medical Sciences Shiraz Fars Iran (Islamic Republic of)