Effect of Astaxanthin Supplementation on Plasma Malondialdehyde Levels and NIHSS of Stroke Patients

Study Overview
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Brief Summary
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This is an interventional randomized, controlled trial in analyzing the effects of astaxanthin supplementation on plasma malondialdehyde levels and NIHSS of acute ischemic stroke patients. According to published studies, it was hypothesized that acute ischemic stroke patients who were given astaxanthin would have lower plasma malondialdehyde levels and lower NIHSS score compared to the control group.

Detailed Description
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There were a total of 24 subjects, with 12 subjects in the intervention group and 12 subjects in the control group.The participants were divided into an interventional group and a control group. The interventional group was given astaxanthin supplementation 2 x 8mg per day for 7 days, while the control group was given placebo.

Official Title
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Effect of Astaxanthin Supplementation on Plasma Malondialdehyde Levels and National Institute of Health Stroke Scale Score of Acute Ischemic Stroke Patients: A Randomized Trial

Conditions
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Cerebral Stroke, Malondialdehyde, Oxidative Stress

Intervention / Treatment
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* Drug: Astaxanthine
* Drug: Placebo Oral Tablet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 40-65 years old Has acute ischemic stroke with an onset of less than 48 hours before hospital admission NIHSS score of less than or equal to 15 Can consume food orally or enterally Has given their consent to be a participant in the study Exclusion Criteria: Renal failure Liver failure Is taking supplements other than his or her main stroke medications Has taken antioxidant supplements in the last 3 months before stroke onset

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Astaxanthin and Placebo
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Astaxanthin<br>Astaxanthin supplementation will be given at 2 x 8mg for 7 days. | Drug: Astaxanthine<br> <br> * Other names: Astaxanthine 8mg;|
| Placebo Comparator: Control<br>A placebo will be given, which takes the form of a drug with the exact same shape and color as astaxanthin supplementation | Drug: Placebo Oral Tablet<br> <br> * Other names: Astaxanthine placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma Malondialdehyde Levels on Astaxanthine Treated Stroke Patients as Assessed by Wills Spectrophotometry | This method used Thiobarbituric acid reaction (TBAR) with substances such as malondialdehyde. The scale was 0.367 nmol/ml-0.707 nmol/ml. The value above 0.707nmol/ml would be the worse outcome, and value less than 0.367nmol/ml would be the best outcome. Bivariate analysis was used to analyze the results (T-test or the Mann-Whitney Test). | 7 days | 
| National Institute of Health Stroke Scale on Astaxanthine Treated Stroke Patients | Score scale was 4-15, where less than 4 indicates mild neurologic deficit, 4-15 moderate neurologic deficit, and more than 15 severe neurologic deficit. They will be assessed before and after the trial to compare how each participant improved after given the intervention. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Astaxanthin, Antioxidant, Plasma Malondialdehyde, NIHSS score, Ischemic Stroke