Efficacy and Safety Clinical Trial of Tenoten for Children Liquid Dosage Form Therapy in Infants With Sequelae of Perinatal Brain Injury

Sequelae of Perinatal Brain Injury Clinical Trial

Official title: 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

Status Completed

Clinical Trial 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).

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Brain Injuries
• Sequelae of Perinatal Brain Injury
• Wounds and Injuries

• NCT number: NCT03159611
• Study type: Interventional
• Source: Materia Medica Holding
• Status: Completed
• Phase: Phase 3
• Start date: February 19, 2016
• Completion date: February 9, 2018