‏ Evaluation of therapeutic effects of Neurosed syrup on the clinical symptoms of children with ADHD -A randomized double blind trial

Investigating the therapeutic effect of Neurosed syrup on the symptoms of attention deficit hyperactivity disorder (ADHD), investigating the possible side effects of using this drug.

A double-blind, controlled, randomized, phase 3 clinical trial on 50 patients. A and B cards are used for randomization.

50 people from children with ADHD, referring to Imam Ali Clinic in Shahre-kord will be gradually included in the study using the available method. Using cards A and B, people are placed in two intervention or control groups. Neurosed syrup will be given to the intervention group and placebo to the control group. At this time, the symptoms related to ADHD disorder in these children are investigated using the Conners parent questionnaire, which is completed by the child's father or mother. After the completion of the one-month treatment period, the mentioned questionnaire is filled again by the parent. The changes in the obtained score are analyzed to check the effect of the drug. The doctor conducting the trial and the patient do not know the content of syrups A and B until the end of the study, so the study is double-blind.

Inclusion criteria: Children with ADHD, their age should be 5-12 years. Exclusion criteria: Use of Barbiturates, drugs that suppress the central nervous system, and blood sugar-lowering drugs, Presence of other concurrent diseases, not cooperating.

The intervention group (25 people) will receive Neurosed syrup, which contains the active ingredient, once a day for one month. The control group (25 people) consumes the placebo that does not contain the active substance once a day for one month.

Symptoms of ADHD (changes in the scores obtained from the Connors parents' questionnaire before and after the intervention)

Patients will be gradually included in the study according to the available method and will be assigned to two intervention and control groups based on the random allocation method. For this purpose, we place 50 cards with the letter A on 25 of them and the letter B on the other 25 in an envelope and randomly take out one card for each patient. The word that comes out shows the group of the patient.

In order to blind the patients, Norosed syrup and placebo are prepared from the same company and in the same packaging. The doctor conducting the trial and the patient do not know the content of the original syrups and placebo until the end of the study and extracting the results, so the study is double-blind.

To share the data and documents of this research, only the information related to the main outcome will be shared. Also, files that can be published and do not violate people's privacy will be published.

The access period will start 6 months after the results are published.

Our data will only be available to researchers working in academic and scientific institutions.

Except for personal information about people, all of our data will be shared if certain requirements are met. Our data will only be used for comparable study and peer review by other researchers. Anyone working in universities or scientific institutions who wants to do similar study or confirm the accuracy of our data can access our data.

All qualified individuals can collect data by referring to the project manager in order to acquire information. Contact information is available via email at torabimaryam75@gmail.com or the contact number 00989138653570.

To receive information after sending the request, the requests will be reviewed within 10 days. If the above conditions are met, the information will be sent to the provided email within 30 days at most.