]>
IRCT20230619058530N2 IRCT 2023-10-14 Esfahan University of Medical Sciences Effects of combination treatment with Tizanidine and long-acting Stimulants in ADHD Randomized Clinical Trial, effects of combination treatment with Tizanidine and long-acting Stimulants in ADHD. 2023-10-23 anticipated 40 Complete https://irct.ir/trial/72494 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: according to time sequence of visits, each sample will give specific code between 1-40 and then, by means of an online computer randomization tool(random.org),they will be randomized in intervention or placebo group with a simple randomization manner by a 1:1 ratio. For blinding, each participant would be shown as an numerical code until the end of study, Blinding description: blinding procedure in both intervention and control groups will be done by similarity in shape of drug and placebo. blinding of principle investigator will be done by random placing of participants in both control and intervention groups and each participant will have a numerical code. health care providers offer the drug and placebo base on A and B codes to participants. with a similar process, that mentioned above, data collectors and outcome assessors will be blinded. 3 Attention-deficit hyperactivity disorders. Intervention 1: Intervention group: tizanidine tablet (Tizanidine 4MG TAB, Hakim Pharmacy) with dose 1-4mg daily, divided doses orally for 2 month. Intervention 2: Control group: placebo tablet(School of Pharmacy and Pharmaceutical SciencesSchool of Isfahan University of Medical Sciences) contains starch and calcium diphosphate ,orally and divided daily. 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 Mostafa Haghshenas
Hezar Jerib Street
Esfahan Iran (Islamic Republic of) 8174673461 +98 31 3222 2475 haghshenas2005@gmail.com Esfahan University of Medical Sciences scientific Mostafa Haghshenas
Hezar-Jerib street
Esfahan Iran (Islamic Republic of) 8174673461 +98 31 3222 2475 haghshenas2005@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Clinical diagnosis of Attention Deficit Hyperactivity Disorder according to DSM-5 criteria completing the informed consent form by parent and patient negative history for any chronic medical diseases negative history for drug induced allergy negative history of receiving any Anti hypertensive, Alpha blockers or Beta blockers during recent three months before study Lack of history of any comorbid psychiatric disorder 9 years 18 years Both Any unexpected physical or mental condition that effects on treatment regimen unwillingness of patients or parents to continue study procedure F90 Attention-deficit hyperactivity disorders Treatment - Drugs Placebo Intervention group: tizanidine tablet (Tizanidine 4MG TAB, Hakim Pharmacy) with dose 1-4mg daily, divided doses orally for 2 month Control group: placebo tablet(School of Pharmacy and Pharmaceutical SciencesSchool of Isfahan University of Medical Sciences) contains starch and calcium diphosphate ,orally and divided daily ADHD severity. Timepoint: Before intervention and 1,2 months after intervention. Method of measurement: conners questioner. Blood pressure. Timepoint: Before intervention and 1,2 months after intervention. Method of measurement: Standard mercury sphygmomanometer. Esfahan University of Medical Sciences Approved 2023-08-22 Research Ethics Committee of the "Alzahra Research Centers Hezar-Jerib street esfahan Isfehan Iran (Islamic Republic of)