Cyproheptadine effect on insomnia and loss of appetite caused by methylphenidate in ADHD childre
Phase 3
- Conditions
- Attention deficit hyperactivity disorder.Disturbance of activity and attention
- Registration Number
- IRCT2015070623099N1
- Lead Sponsor
- Mashhad University of Medical Sciences, School of Pharmacy
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
patient satisfaction; age older than 3 years old; no use of concomitant medications that have a significant impact on sleep or appetite. Exclusion criteria: the risk of renal failure; the risk of cardiovascular diseases; the risk of thyroid diseases; sensitivity to cyproheptadine; intolerance side effects.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Weight. Timepoint: Baseline; second week; forth week; sixth week; eighth week. Method of measurement: In kilograms and is using the Digital Scale.;Height. Timepoint: Baseline; second week; forth week; sixth week; eighth week. Method of measurement: Measured in meters.;Growth rate. Timepoint: Baseline; second week; forth week; sixth week; eighth week. Method of measurement: In grams per day.;Changes in sleep by PSQI scale. Timepoint: Baseline; second week; forth week; sixth week; eighth week. Method of measurement: Using PSQI questionnaire.
- Secondary Outcome Measures
Name Time Method Dry mouth. Timepoint: Baseline; second week; forth week; sixth week; eighth week. Method of measurement: Questionnaire.;Swelling. Timepoint: Baseline; second week; forth week; sixth week; eighth week. Method of measurement: Questionnaire.;Sleepiness during the day. Timepoint: Baseline; second week; forth week; sixth week; eighth week. Method of measurement: Questionnaire.;Gastrointestinal side effects (diarrhea, nausea, vomiting and abdominal pain). Timepoint: Baseline; second week; forth week; sixth week; eighth week. Method of measurement: Questionnaire.;Skin reactions. Timepoint: Baseline; second week; forth week; sixth week; eighth week. Method of measurement: Questionnaire.;Methylphenidate trade name. Timepoint: Baseline; second week; forth week; sixth week; eighth week. Method of measurement: Questionnaire.