insomnia. Unspecified mental disorder
Conditions
Interventions
Intervention 1: In group A or interventional (30 patients): Treatment with Three milligram Melatonin Tab (made by Weber Nature Co) with the dosage of one Tab Po at night is performed for a period of o
Treatment - Drugs
In group A or interventional (30 patients): Treatment with Three milligram Melatonin Tab (made by Weber Nature Co) with the dosage of one Tab Po at night is performed for a period of one month and als
In group B or Control (30 patients): Treatment with Three milligram Placebo Tab (ordered by Dr. Nozari Pharmacy) with the dosage of one Tab Po at night is performed for a period of one month and also
Sponsors
Vice chancellor for research, Qazvin University of Medical Sciences
Eligibility
Sex/Gender
All
Age
7 Years to 12 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: Primary school aged children (7-12 yr, boy or girl); Healthy in physical exam; having the diagnostic criteria for Primary Insomnia based on DSM-4-TR Exclusion criteria: Children with underlying neurologic disorders; children with psychologic disorders including ADHD; children with underlying organic disorders including chronic cardiac, pulmonary, kidney and hematologic diseases; children who have received antibiotics, antihistamines or sedative hypnotics during the recent month; and existence of obvious clinical signs of anemia
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time of the beginning of sleep. Timepoint: At the beginning of the study, on the seventh day of treatment, on the forteenth day of treatment, on the twenty first day of treatment, and on the thirtieth day of treatment. Method of measurement: Questionnaire.;Duration of sleep. Timepoint: At the beginning of the study, on the seventh day of treatment, on the forteenth day of treatment, on the twenty first day of treatment, and on the thirtieth day of treatment. Method of measurement: Questionnaire.;Quality of sleep. Timepoint: At the beginning of the study, on the seventh day of treatment, on the forteenth day of treatment, on the twenty first day of treatment, and on the thirtieth day of treatment. Method of measurement: Questionnaire.;The number of nucturnal awakenesses after falling sleep. Timepoint: At the beginning of the study, on the seventh day of treatment, on the forteenth day of treatment, on the twenty first day of treatment, and on the thirtieth day of treatment. Method of measurement: Questionnaire.;Daily performance. Timepoint: At the beginning of the study, on the seventh day of treatment, on the forteenth day of treatment, on the twenty first day of treatment, and on the thirtieth day of treatment. Method of measurement: Questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Possible adverse drug reactions. Timepoint: weekly, during the one month period of drug therapy. Method of measurement: visual analogue scale. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Shabnam Jalilolgadr
Children Growth Research Center, Qazvin University of Medical Sciences
Outcome results
None listed