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IRCT20231024059828N1 IRCT 2023-11-11 Shahid Beheshti University of Medical Sciences َAstaxanthin in spinal cord injury AST&SCI Investigating the effects of Astaxanthin on the recovery of patients with complete spinal cord injury: A clinical trial study 2023-12-06 anticipated 40 Complete https://irct.ir/trial/73383 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: A straightforward method of randomization using a table of random numbers involves assigning even numbers to intervention A and odd numbers to intervention B, as preferred by the researcher, Blinding description: Patients who have inclusion criteria, sign the informed consent form, and then they are assigned to receive a random code for the treatment including a placebo or drug. Patients are randomly assigned to two groups, A and B. Bottles of drug containing 60 soft gel capsules are labeled A or B as well. Only the principal investigator, not the clinician, care provider, or patient, knows about the content of each bottle (drug or placebo). The patients randomly receive a bottle A or B according to the label. In order to follow up on patients, a detailed schedule of examinations and cross-sectional sampling of patients is prepared. During the follow-up period, two members of the research team will contact patients to remind them for further medical exams and sample collection. 1-2 Spinal Cord Injury. Intervention 1: Intervention group: Patients receive a 12 mg astaxanthin soft capsule (manufactured by Cheeky Nutrition, UK) orally for two months. Astaxanthin is a beta carotenoid that is extracted from micro algae Haematococcus pluvialis. It had high antioxidant properties and is used as a supplement to strengthen the immune system. Intervention 2: Control group: The placebo group receive one soft capsule daily with excipients similar to astaxanthin and without the active ingredient (manufactured by Sana Pharmed Iran) orally for two months. Yes - There is a plan to make this available What will be shared: All the results will be published as an article in an international journal When: The start of the access period after the publication of the article To whom: After the publication of the article, all people can access the results of the study Conditions: With the permission of the Principal investigators Where to obtain: Principal investigators - 1-Masoume Jarjani 2-Alireza Zali How to obtain: Contact the principal investigators Comments: -
public Masoumeh Jorjani
Dept. of Pharmacology & Neurobiology Res. Cent., School of Medicine, Shahid Beheshti Univ. Med. Sci., Koodakyar St., Daneshjoo Blvd., Velenjak,
Tehran Iran (Islamic Republic of) 1983969411​ +98 21 2243 9969 msjorjani@sbmu.ac.ir Shahid Beheshti University of Medical Sciences scientific Alireza Zali
Dept. of Neurosurgery, Shohadaye Tajrish Hospital, Shahrdari St,
Tehran Iran (Islamic Republic of) 1989934148​ +98 21 2271 8000 dr_alirezazali@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients with spinal cord injury at the thoracic level who have complete spinal paralysis. Patients in the acute (one week after the injury) and sub-acute (1 to 8 weeks) stages admitted to Shohada Tajrish Hospital. This study is in patients aged 18-60 years old. 18 years 60 years Both Patients with past medical history of myocardial infarction and coronary artery disease, chronic infections and CKD, pregnancy, concurrent infections or gastrointestinal bleeding. Multiple level spinal injuries Spinal instability of vertebra Traumatic brain injury associated with SCI Isolated radiculopathy Skeletal fracture or muscle atrophy Drug abuse Coexistence of psychiatric disorders T09.3 Injury of spinal cord, level unspecified Treatment - Drugs Placebo Intervention group: Patients receive a 12 mg astaxanthin soft capsule (manufactured by Cheeky Nutrition, UK) orally for two months. Astaxanthin is a beta carotenoid that is extracted from micro algae Haematococcus pluvialis. It had high antioxidant properties and is used as a supplement to strengthen the immune system. Control group: The placebo group receive one soft capsule daily with excipients similar to astaxanthin and without the active ingredient (manufactured by Sana Pharmed Iran) orally for two months. Neuropathic pain. Timepoint: at the beginning of the study and during treatments at the 2, 4, 6 and 8th week, then at the 3rd, 6th, and 12th months. Method of measurement: Questionnaire Neuropathique Douleur 4 scale, Visual Analog Scale. Spasticity. Timepoint: Before starting the study, the first, second and eighth weeks and in the 3rd, 6th and 12th months. Method of measurement: Electromyography (EMG). Neurological disorder (sensory and motor dysfunction). Timepoint: at the beginning of the study and during treatments at the 2, 4, 6 and 8th week, then at the 3rd, 6th, and 12th months. Method of measurement: Questionnaire: American Spinal Injury Association (AISA)، Spinal Cord Independence Measure (SCIM). Serum level of inflammatory factors TNF-α , IL-6and TGFβ. Timepoint: Before starting the study, the first, second and eighth weeks and in the 3rd, 6th and 12th months. Method of measurement: ELISA test. Examination of liver enzymes Alkaline Phosphatase (ALP) , serum glutamic-pyruvic transaminase (SGPT) and serum glutamic-oxaloacetic transaminase (SGOT). Timepoint: at the beginning of the study and during treatments at the 2, 4, 6 and 8th week, then at the 3rd, 6th, and 12th months. Method of measurement: ELISA test. Complete blood count (HB, RBC, WBC, PLT). Timepoint: at the beginning of the study and during treatments at the 2, 4, 6 and 8th week, then at the 3rd, 6th, and 12th months. Method of measurement: spectrophotometer. The size of the injured area. Timepoint: at the beginning of the study, and then at the 3rd, 6th and 12th months. Method of measurement: Magnetic resonance imaging (MRI). Shahid Beheshti University of Medical Sciences Approved 2023-10-17 Research Ethics Committees of School of Public Health and Neuroscience Research Center-Shahid Behesh Dept. of Pharmacology & Neurobiology Res. Cent, School of Medicine, Shahid Beheshti Univ.Med. Sci., koodakyar St., Daneshjoo Blvd., Velenjak Tehran Tehran Iran (Islamic Republic of)