Effect of L ‐oxiracetam and oxiracetam on memory and cognitive impairment in mild‐to‐moderate traumatic brain injury patients: Study protocol for a randomized controlled trial
Rattachement africain : cn. Niveau de preuve : code pays fourni par la source.
Le résumé fourni par la source
Objectives: Patients with traumatic brain injury (TBI) often suffer memory and cognitive impairments, and oxiracetam-like drugs are considered to have a positive impact on these symptoms potentially. However, the efficacy and safety of l-oxiracetam and oxiracetam in TBI patients have not been sufficiently investigated. Methods: The study adopts a multicenter, randomized, double-blind, parallel-group, phase 3 clinical trial design in 74 centers across 51 hospitals in China. A total of 590 TBI patients meeting criteria will be randomly allocated into three groups in a 2:2:1 ratio: l-oxiracetam group, oxiracetam group, and placebo group. The treatment period is 14 days, with a follow-up period of 90 days. The primary outcome measure is the change in the Loewenstein Occupational Therapy Cognitive Assessment score at 90 days after treatment. Secondary outcomes include changes in other cognitive assessments, neurological function, activities of daily living, and safety assessments. Discussion: There is no robust evidence to suggest that l-oxiracetam and oxiracetam can enhance memory and cognitive function in patients with mild to moderate TBI. This study has the potential to answer this crucial clinical question. Trial registration: chinadrugtrials.org.cn, identifier CTR20192539; ClinicalTrials.gov, identifier NCT04205565.
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Le contrôle bibliographique ouvert
DOI retrouvé dans Crossref DOI retrouvé, mais le titre doit être comparé manuellement.
- Titre Crossref
- Effect of <scp>L</scp>‐oxiracetam and oxiracetam on memory and cognitive impairment in mild‐to‐moderate traumatic brain injury patients: Study protocol for a randomized controlled trial
- Date Crossref
- 01/06/2024
- Éditeur
- Wiley
- Type
- journal-article
Ce recoupement confirme des métadonnées liées au DOI. Il ne confirme ni la méthode ni les conclusions de l’étude, et il ne compte pas comme une seconde source scientifique indépendante.
Où se fait cette recherche
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Tianjin Medical University General Hospital Department of Neurosurgery Tianjin Neurological Institute pays non établi dans la noticeÉtablissement de santé
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Zhejiang Provincial People's Hospital Department of Rehabilitation Medicine pays non établi dans la noticeÉtablissement de santé
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First People’s Hospital of Zunyi pays non établi dans la noticeÉtablissement de santé
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Jilin University Department of Neurosurgery pays non établi dans la noticeUniversité ou école supérieure
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First Hospital of Jilin University pays non établi dans la noticeÉtablissement de santé
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Department of Clinical Research Center for Neurological Disease The People's Hospital of HongHuaGang District of ZunYi Zunyi China pays non établi dans la noticeStructure de recherche
Department of Neurosurgery Tianjin Neurological Institute — Tianjin Medical University General Hospital, Department of Rehabilitation Medicine — Zhejiang Provincial People's Hospital et First People’s Hospital of Zunyi, avec 3 autres affiliations.
Une affiliation ne permet pas de déduire la nationalité d’un auteur.