Evaluating the Efficacy of Channa Striata in Stabilizing eNOS in Patients With Septic.

Study Overview
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Brief Summary
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Sepsis is an inflammation response produced by the host's immune system, which is agrravated by oxidative stress. One of the adjuvant therapy according to Surviving Sepsis Campaign Guideline is albumin, which has anti-inflammatory and anti-oxidant effects. However, human albumin is quite expensive, and other forms with similar potency and less costs are needed, one of which is Channa striata extract. Therefore, this study is conducted to compare albumin and human albumin, specifically their anti- inflammatory and anti-oxidant properties by assessing the eNOS marker, neutrophil/lymphocyte ratio (NLR) and platelet/lymphocyte ratio (PLR) in patient with sepsis.

Detailed Description
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In summary, this study showed that Channa striata extract has a better outcome in stabilizing eNOS level in patient with sepsis than human albumin 20%, and it has a potential benefit in stabilizing NLR values. However, further studies with a larger sample and a more advanced phase of sepsis are needed.

Official Title
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Evaluating the Efficacy of Channa Striata in Stabilizing eNOS in Patients With Septic: A Randomized Control Trial.

Conditions
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Sepsis

Intervention / Treatment
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* Dietary Supplement: Albumin Channa Striata Extract


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients sepsis who met the qSOFA criteria ≧ 2 [two of which: unconsciousness (Glasgow Coma Scale ≤14) respiratory rate > 22 and systolic blood pressure ≤ 100 mmHg], aged ≧ 18 years admitted to intensive care unit and high care unit at Dr. Moewardi General Hospital Exclusion Criteria: patients with severe trauma blood loss in stage three or higher stress ulcers a history of nephrotic syndrome refusal to participate

Ages Eligible for Study
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Minimum Age: 18 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Albumin Chana Striata Extract<br> | Dietary Supplement: Albumin Channa Striata Extract<br>* This study is a randomized controlled trial of 42 patients at the ICU of Dr. Moewardi General Hospital. The control group received 20 grams of human albumin on the first day and the study group received 15 grams of Channa striata extract daily for two days. Subsequently, eNOS, NLR and PLR are measured before and three days after treatment, and the examiners compare the three markers statistically.<br>* Other names: Human Albumin;|
| Active Comparator: Human Albumin<br> | Dietary Supplement: Albumin Channa Striata Extract<br>* This study is a randomized controlled trial of 42 patients at the ICU of Dr. Moewardi General Hospital. The control group received 20 grams of human albumin on the first day and the study group received 15 grams of Channa striata extract daily for two days. Subsequently, eNOS, NLR and PLR are measured before and three days after treatment, and the examiners compare the three markers statistically.<br>* Other names: Human Albumin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial Nitric Oxide Synthase | Measured before and three days after treatment, and the examiners compare the three markers statistically. | three days after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neutrophil-Lymphocyte Ratio | Measured before and three days after treatment, and the examiners compare the three markers statistically | three days after treatment | 
| Platelet-Lymphocyte Ratio | Measured before and three days after treatment, and the examiners compare the three markers statistically | three days after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sepsis, eNOS, PLR, Channa striata, albumin, inflammation, anti-oxidant, NLR