?Astaxanthin in spinal cord injury

Investigating the effects of Astaxanthin on the recovery of patients with complete spinal cord injury: A clinical trial study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20231024059828N1

Enrollment

Registered

2023-11-11

Start date

2023-12-06

Completion date

Unknown

Last updated

2023-11-13

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

Conditions

Spinal Cord Injury. Injury of spinal cord, level unspecified

Interventions

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 f

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
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-a , IL-6and TGFß. 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).	—

Measure

Time frame

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-a , IL-6and TGFß. 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).

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMasoumeh Jorjani

Shahid Beheshti University of Medical Sciences

msjorjani@sbmu.ac.ir+98 21 2243 9969

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026