Efficacy evaluation of the Melissa officinalis syrup in treatment of children's anxiety symptoms with Attention Deficit Hyperactivity Disorder

Efficacy evaluation of the Melissa officinalis syrup in treatment of children's anxiety symptoms with ADHD

Clinical trial with a control group, with parallel groups, double-blind, randomized, phase 3 on 30 patients. Allocation Concealment method

The subjects of the research will be selected from ADHD sufferers, who referred to the pediatric psychiatric clinic in Ibn Sina Hospital in the second half of 1401. the intervention group will receive the syrup. The amount and safety of the above dose have been shown in previous studies and in the control group, in addition to the standard treatment, placebo syrup with a dose of 10 cc per day in two divided doses will be added to the standard medicine. The same color as herbal syrup is prepared in the same jars. At the beginning of the study and at 3 and 6 weeks, the patients were evaluated with the Attention Deficit Hyperactivity Disorder (ADHD-RS) and Revised Children's Manifest Anxiety Scale (RCMAS). The duration of the intervention in both groups is 6 weeks.

Patients suffering from ADHD disorder according to DSM V criteria, absence of other systemic and psychiatric disorders, IQ is within the normal range, their age is 7-12 years, and at least three months have passed since their standard drug treatment, and the informed consent form is completed Exclusion criteria: Patient refusal to continue treatment, occurrence of a systemic disease, initiation of new psychiatric treatment or new onset psychiatric disorder, drug side effects

In addition to the standard treatment, the intervention group will be received dose of 0.2 cc per kilogram of weight The control group will be received a placebo syrup similar to herbal medicine

ADHD-RS scoring questionnaire The Revised Children's Manifest Anxiety Scale (RCMAS)

Block randomization using https://www.sealedenvelope.com Allocation Concealment method: To ensure equal number of study subjects in two groups, permutation block method was used. For this purpose, we will use the website www.sealedenvelope.com in such a way that the number of 8 blocks of 4 members will be randomly created through the above site.

Sealed envelopes

After completing the study and obtaining permission from the Research Vice-Chancellor of Mashhad University of Medical Sciences, the researchers are ready to publish the results of the study in the form of an article.

After the completion of the project (about one year after starting the work) and the resident's defense of his/her thesis, the researchers are ready to publish the results.

Officials of Mashhad University of Medical Sciences and, therapists working in the field of mental health

For the purpose of clinical use of the obtained results in the treatment of patients and in the event of the absence of clinical complications during the research

Mashhad University of Medical Sciences, Research department

Refer to research unit of Mashhad Medical Sciences Faculty, Dissertations Unit and obtain access permission