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IRCT20180723040567N1 IRCT 2018-11-10 Mashhad University of Medical Sciences The effect of Withania somnifera on anxiety symptoms in children with ADHD Effect of Withania somnifera Root Extract on Anxiety Symptoms in Children with Attention deficite and Hyperactivity Disorder 2018-04-05 anticipated 28 Complete https://irct.ir/trial/32868 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are selected through available sampling. They are randomly divided into two groups of case and control according to the random numbers table, Blinding description: The study is double blind: the form of drug and placebo is the same, and the evaluator, the patient and the analyst are not aware of what treatment they are using, and drug intervention is identified by the pharmacist in sealed envelopes with a numeric code. 3 Attention- Deficit Hyperactivity Disorders. Intervention 1: Intervention group: Withania somnifera capsule is orally administered at a dose of 10 mg once daily for 6 weeks. Intervention 2: Control group: The placebo capsule is similar to the Withania somnifera capsule orally at a dose of 10 mg once a day for 6 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 end of the project, according to the scientific performer and consultant of the methodology, the data dissemination will be decided.
public Fatemeh Mohareri
Ebne-sina hospital , Horre Ameli Avenue, Mashhad
Mashhad Iran (Islamic Republic of) 9195983134 +98 51 3700 2301 Moharerif1@mums.ac.ir Mashhad University of Medical Sciences scientific Fatemeh Mohareri
Ebne-sina hospital , Horre Ameli Avenue, Mashhad
Mashhad Iran (Islamic Republic of) 9195983134 +98 51 3700 2301 Moharerif1@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Diagnosis of ADHD based on DSM-5 criteria aged 7-12 years Complete consent form by parent or guardian Normal IQ Symptoms of simultaneous anxiety 7 years 12 years Both The patient's unwillingness to participating in the research project Systemic disease Interventional psychiatric illness intellectual disability F90 Attention-deficit hyperactivity disorders Treatment - Drugs Placebo Intervention group: Withania somnifera capsule is orally administered at a dose of 10 mg once daily for 6 weeks Control group: The placebo capsule is similar to the Withania somnifera capsule orally at a dose of 10 mg once a day for 6 weeks. Anxiety symptoms in children with ADHD. Timepoint: At the beginning of STUDY and the week 3 and 6. Method of measurement: Child Anxiety Test based on the revised child anxiety scale(RCMA). Symptoms of ADHD. Timepoint: Weeks 3 and 6. Method of measurement: ADHD rating scale. Mashhad University of Medical Sciences Approved 2017-08-02 Ethics committee of Mashhad University of Medical sciences Ghoreishi Department, Daneshgah Ave, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)