At a glance
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Multicenter Double-blind Placebo-controlled Parallel-group Randomized Clinical Trial of Efficacy and Safety of Tenoten for Children Liquid Dosage Form Therapy in Infants With Sequelae of Perinatal Brain Injury
In Brief
A Phase 3 clinical trial evaluating Tenoten for children and Placebo for Sequelae of Perinatal Brain Injury. Completed, enrolled 182 participants across 10 sites.
Detailed Summary
Purpose of the study: * To assess the clinical efficacy of Tenoten for children liquid dosage form therapy (10 oral drops per day for 12 weeks) in Infants with Sequelae of Perinatal Brain Injury (mild-to-moderate cerebral hypoxia-ischaemia and/or mild-to-moderate intracranial haemorrhage). * To assess the safety of Tenoten for children liquid dosage form therapy (10 oral drops per day for 12 weeks) in Infants with Sequelae of Perinatal Brain Injury (mild-to-moderate cerebral hypoxia-ischaemia and/or mild-to-moderate intracranial haemorrhage).
Study Details
Timeline
Interventions
Oral. 10 drops daily, at the same time in the morning, 15 minutes before feeding.
Oral. 10 drops daily, at the same time in the morning, 15 minutes before feeding.