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Glutamine and Traumatic Brain Injury

Does Glutamine Therapy Have a Positive Effect on Traumatic Brain Injury Patients?Double Blinded Randomized Clinical Trial

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05569993
Enrollment
60
Registered
2022-10-06
Start date
2022-10-30
Completion date
2023-12-30
Last updated
2022-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Injuries, Traumatic

Brief summary

Glutamate is an important neurotransmitter present in over 90% of all brain synapses and is a naturally occurring molecule that nerve cells use to send signals to other cells in the central nervous system. Glutamate is a non-essential amino acid with restricted passage to the brain from the blood. In the CNS, glutamate is synthesised in neurons as part of the glutamate-glutamine cycle.5,6 so it plays an essential role in normal brain functioning and can improve situations related to impaired cognitive,motor and emotional functions and can be used to improve traumatic brain injury patient general health status

Detailed description

The term brain injury covers a wide range of conditions and injuries relating to the brain, skull, and scalp. A traumatic brain injury (TBI) usually results when the head or body suffers from a violent blow or jolt that results in swelling, bruising, bleeding, or tearing of the brain tissue which any damage to it has the potential to change the way your body operates. Now ,(TBI) is considered one of the major causes of disability and deaths ,As It contributes more than 30% Of deaths worldwide . Those who survive a TBI can face effects that last a few days, or the rest of their lives. Effects of TBI can include impaired motor, cognitive and emotional functioning. These issues not only affect individuals but can have lasting effects on families and communities.TBI can also cause some inflammatory mediators to be released in circulation that affect brain and systemic organs such as cortisol,IL6 and TNF etc. A lot of modialities have been introduced to help in decreasing these side effects. Glutamine,a non-essential amino acid present abundantly throughout the body and is involved in many metabolic processes. It is synthesized from glutamic acid and ammonia. It is the principal carrier of nitrogen in the body and is an important energy source for many cells.glutamine has a restricted passage to the brain from blood but it is synthesised in the brain as a part of the glutamate-glutamine cycle.5,6 so it present in over 90% of all brain synapses and is a naturally occurring molecule that nerve cells use to send signals to other cells in the central nervous system,maintaining normal brain function and can improve situations related to impaired cognitive,motor and emotional functions. Hypothesis of this study; Does glutamine therapy have a positive effect on traumatic brain injury patients ?

Interventions

DRUGGlutamine

.3 mg/kg of glutamine

Patients will recieve placcebo

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Masking description

Double blinded clinical trial Masking for patient,their relatives and outcome assessor

Intervention model description

2 groups will recieve glutamine ,the other will be placcebo group

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

* 18 to 60 years old * mild to moderate head trauma

Exclusion criteria

* patients with concurrent cns dysfunction * Renal failure patient * diabetic patients with neuropathy

Design outcomes

Primary

MeasureTime frameDescription
The duration of ICU stayFirst 30 daysThe duration of ICU stay after glutamine adiminstration

Secondary

MeasureTime frameDescription
Consiousness level by Glagow coma scale30 daysGlasgow coma scale improvement
The incidence of Convulsions30 daysConvulsions controled by glutamine

Contacts

Primary ContactEngy Raafat Youssif, Master student
Engiraafat95@gmail.com01226016909

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026