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NCT Number: NCT05596942

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

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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Moewardi General Hospital

Sukoharjo, Central Jave, 57126, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Albumin Channa Striata Extract

Dietary Supplement

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.

Other names: Human Albumin

Primary outcomes

  1. Endothelial Nitric Oxide Synthase

    Time frame: three days after treatment

    Measured before and three days after treatment, and the examiners compare the three markers statistically.

Secondary outcomes

  1. Neutrophil-Lymphocyte Ratio

    Time frame: three days after treatment

    Measured before and three days after treatment, and the examiners compare the three markers statistically

  2. Platelet-Lymphocyte Ratio

    Time frame: three days after treatment

    Measured before and three days after treatment, and the examiners compare the three markers statistically

Sponsors and collaborators

Lead sponsor

Universitas Sebelas Maret

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 27, 2022
Registry last updated
Oct 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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