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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05596942
Enrollment
42
Registered
2022-10-27
Start date
2021-07-01
Completion date
2021-09-30
Last updated
2022-10-27

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

Conditions

Sepsis

Keywords

sepsis, eNOS, NLR, PLR, Channa striata, albumin, inflammation, anti-oxidant

Brief summary

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

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.

Interventions

DIETARY_SUPPLEMENTAlbumin Channa Striata Extract

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.

Sponsors

Universitas Sebelas Maret
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Endothelial Nitric Oxide Synthasethree days after treatmentMeasured before and three days after treatment, and the examiners compare the three markers statistically.

Secondary

MeasureTime frameDescription
Neutrophil-Lymphocyte Ratiothree days after treatmentMeasured before and three days after treatment, and the examiners compare the three markers statistically
Platelet-Lymphocyte Ratiothree days after treatmentMeasured before and three days after treatment, and the examiners compare the three markers statistically

Countries

Indonesia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026