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IRCT20140611018063N7 IRCT 2020-03-21 Birjand University of Medical Sciences Effects of Citicoline in patients with traumatic concussion effects of citicoline on the healing process of patients with traumatic concussion 2016-05-21 anticipated 30 Complete https://irct.ir/trial/16488 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: All the patients will be distributed randomly into three groups of A, B or C by randomly choosing one card marked with A, B or C out of 30 cards, Blinding description: The study was a double-blind study, in which only the physician was aware of the distribution, and the patient, nurse, and researchers collecting information were unaware of the distribution into three groups. Access to the patient records will be prevented from the patient's nurse and the researches. Only the physician will be aware of patient records. 1 head trauma. Intervention 1: Intervention group 1: In this groups, the patients will be treated with received intravenous (IV) citicoline with a dosage of 0.5 gr/ twice a day(group B) and the treatment period will be 14 days. Intervention 2: Intervention group 2: In this group, the patients will be treated with received intravenous (IV) citicoline with a dosage of 1.5 gr/ twice a day(group C) and the treatment period will be 14 days. Intervention 3: Control group: the patients in this group will not receive citicoline and Only receive instilled sterile water as placebo. Yes - There is a plan to make this available What will be shared: The entire statistical data from this study can be shared as needed based on the ethics committee's criteria. When: The results of this study, after publishing the results as a paper, will be published and shared. To whom: The data from this study will be available to all researchers. Conditions: All academic researchers, in the form of research projects approved by the Ethics Committee, are allowed to access the data and perform the necessary analyzes on the documentation of this research. Where to obtain: Applicants for obtaining documentation of this study can request information by email with the corresponding author. How to obtain: Applicants for obtaining documentation of this study can request information by email with the corresponding author. Comments:
public Soroush Hozeifi
Moallem Blvd.
Birjand Iran (Islamic Republic of) 9717853577 +98 56 3239 5000 soroush.hozeifi@gmail.com Birjand University of Medical Sciences scientific Dr. Jalal Ahmadi
Moallem Blvd.
Birjand Iran (Islamic Republic of) 9717853577 +98 56 3239 5000 jahmadi@bums.ac.ir Birjand University of Medical Sciences Iran (Islamic Republic of) Traumatic Head concussion GCS lower or equal to 8 Hospitalized in ICU and Neurosurgery ward Age between 5 to 60 years 5 years 60 years Both severe cognitive disorders severe systemic disorder penetrating or open skull trauma severe chest or lung trauma subdural or large epidoral hematoma requiring surgery younger than 5 or older than 60 years pregnant women S06.2 Diffuse brain injury Treatment - Drugs Treatment - Drugs Placebo Intervention group 1: In this groups, the patients will be treated with received intravenous (IV) citicoline with a dosage of 0.5 gr/ twice a day(group B) and the treatment period will be 14 days. Intervention group 2: In this group, the patients will be treated with received intravenous (IV) citicoline with a dosage of 1.5 gr/ twice a day(group C) and the treatment period will be 14 days. Control group: the patients in this group will not receive citicoline and Only receive instilled sterile water as placebo. Level of consciousness in a patients. Timepoint: First 7 days and on 14th day of hospitalization. Method of measurement: Glasgow Coma Scale scoring system. Muscle strength degree. Timepoint: The first week, on day 14, 21 and 30 of hospitalization. Method of measurement: Manual Muscle Testing scale. Contusion volume and cerebral edema. Timepoint: Days 1, 3, 5 and 7. Method of measurement: Computed Tomography scans. Length of dependency on a ventilator. Timepoint: 30 days of hospitalization. Method of measurement: Documentary Registry Data. Stay length in the intensive care unit. Timepoint: 30 days of hospitalization. Method of measurement: Documentary Registry Data. Birjand University of Medical Sciences Approved 2016-03-12 ethics committee of Birjand University of Medical Sciences Moallem Blvd Birjand South Khorasan Iran (Islamic Republic of)