Evaluation the Effects of French Maritime Pine Bark Extract on the Clinical Status in Traumatic Brain Injury Patients

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

67

Participants

Timeline

Start Date

April 14, 2019

Primary Completion Date

December 22, 2019

Study Completion Date

February 20, 2020

Conditions
Traumatic Brain Injury
Interventions
DIETARY_SUPPLEMENT

Dietary Supplement (OLIGOPIN)

investigators obtained ethical approval from the Research Ethics Committees of the Mashhad University of medical sciences. investigators enroll 60 patients who are admitted to ICU at hospitals of university. All eligible patients or their first degree relatives give informed consent before participating. Participants are randomly (block stratification) divided in two groups. At the first visit, baseline data are gathered and intervention group (n=30) will receive Oligopin supplement. In order to control the confounding effect of food intake, both the control and the intervention group receive the standard formulas based on their daily required energy via enteral root feeding.

OTHER

Placebo

investigators obtained ethical approval from the Research Ethics Committees of the Mashhad University of medical sciences. investigators enroll 60 patients who are admitted to ICU at hospitals of university. All eligible patients or their first degree relatives give informed consent before participating. Participants are randomly (block stratification) divided in two groups. At the first visit, baseline data are gathered and control group (n=30) will receive oral capsules containing 130 mg Microcrystalline Cellulose. In order to control the confounding effect of food intake, both the control and the intervention group receive the standard formulas based on their daily required energy via enteral root feeding.

Trial Locations (1)

Unknown

Mahsa Malekahmadi, Tehran

All Listed Sponsors
lead

Mashhad University of Medical Sciences

OTHER

NCT03777683 - Evaluation the Effects of French Maritime Pine Bark Extract on the Clinical Status in Traumatic Brain Injury Patients | Biotech Hunter | Biotech Hunter