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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05569993
Other study ID # Traumatic brain injury
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date October 30, 2022
Est. completion date December 30, 2023

Study information

Verified date October 2022
Source Assiut University
Contact Engy Raafat Youssif, Master student
Phone 01226016909
Email Engiraafat95@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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 ?


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date December 30, 2023
Est. primary completion date October 30, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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

Study Design


Intervention

Drug:
Glutamine
.3 mg/kg of glutamine
Other:
Placcebo
Patients will recieve placcebo

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Outcome

Type Measure Description Time frame Safety issue
Primary The duration of ICU stay The duration of ICU stay after glutamine adiminstration First 30 days
Secondary Consiousness level by Glagow coma scale Glasgow coma scale improvement 30 days
Secondary The incidence of Convulsions Convulsions controled by glutamine 30 days
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