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

Determining the effect of violet syrup as an adjunctive treatment in the treatment of insomnia caused by Ritalin in patients with attention deficit hyperactivity disorder (ADHD).

Clinical trial with control group with parallel groups, double-blind, randomized on 60 patients, NCSS software and random block method are used to randomize the study.

60 patients with ADHD who went to Imam Clinic Rezai Shiraz have applied and will be included in the study. Demographic information will be recorded. Then these people will be randomly divided into groups A and B and they will be introduced to the pharmacist with two codes A and B, one of these codes (bottle) contains violet syrup and the other one contains placebo, and the shape and The size of the bottles are completely the same and only the pharmacist knows about their contents, and both the researcher and the patient are unaware of the contents inside the bottle. (for double-blindness of the study) the therapeutic dose of Banafshe syrup is determined as 5 cc twice a day, half an hour before meals.

Inclusion criteria: 1-Having DSM 5 diagnostic criteria for ADHD 2 - Age 6 to 12 years Exclusion criteria: 1- Existence of a serious medical disease such as heart disease 2- Uncontrolled seizure disorder 3- Weight below 13.5 kg

Drug group patients take Ritalin tablets with a daily dose of 1.5 to 3 mg per kilogram of body weight along with violet syrup in the amount of 5 cc twice a day. The placebo group of patients receives daily Ritalin tablets with a daily dose of 1.5 to 3 mg per kilogram of body weight along with Placebo syrup.

The score of children's sleep habits questionnai

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.

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.