A comparative study of piracetam effect

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2010
INTERVENTION: contorol group: administration of placebo in 6 mounth period Intervention 1: Intervention group: administration of piracetam in 6 mounth period with dose of 40/mg/kg/day. Intervention 2: contorol group: administration of placebo in 6 mounth period. Intervention group: administration of piracetam in 6 mounth period with dose of 40/mg/kg/day Placebo Treatment ‐ Drugs CONDITION: breath holding spell. ; Other and unspecified abnormalities of breathing Other and unspecified abnormalities of breathing PRIMARY OUTCOME: BHS duration. Timepoint: before prevention and every 2 month in 6 month. Method of measurement: Filling a questionnarie by asking questions from parents & exam. Interval time between BHS. Timepoint: before prevention and every 2 month in 6 month. Method of measurement: questionnaire & exam. INCLUSION CRITERIA: INCLUSION CRITERIA: 1)Parental consent for participation in the plan 2) Normal EEG 3) absent of systematic disease 4) Normal growth and Development 5)History of breath‐ Holding spell and physical and neurological examination by pediatric neurologist. 6) No Electrolyte Abnormality (Hypoglycemia and Hypocalcaemia ) Exclusion criteria: 1) Children with history of convulsion 2) Children that received Anticonvulsant drugs. 3) Delayed neurotic development 4) all Children with heart diseases 5) all children with anemia 6) Side effects of priacetam including true dizziness, convulsion, extra pyramidal sings, lethargy, headache, sleepiness; gastrointestinal complication including nausea and vomiting, diarrhea, constipation, anorexia, increased weight
Epistemonikos ID: 01239e022f31aa3a2e9079f0546522a5934d1b51
First added on: Aug 22, 2024