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

Phase 3

Completed

• Conditions: Sepsis
• Interventions: Dietary Supplement: Albumin Channa Striata Extract

• Registration Number: NCT05596942
• Lead Sponsor: Universitas Sebelas Maret

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.

Study Timeline

• Study Start: 2021-07-01
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Study First Submitted: 2022-09-22
• Status Verified: 2022-10
• Study First Submitted QC: 2022-10-24
• Last Update Submitted: 2022-10-24
• Study First Posted: 2022-10-27
• Last Update Posted: 2022-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Read More

Exclusion Criteria

• patients with severe trauma
• blood loss in stage three or higher
• stress ulcers
• a history of nephrotic syndrome
• refusal to participate

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Human Albumin	Albumin Channa Striata Extract	-
Albumin Chana Striata Extract	Albumin Channa Striata Extract	-

Primary Outcome Measures

Name	Time	Method
Endothelial Nitric Oxide Synthase	three days after treatment	Measured before and three days after treatment, and the examiners compare the three markers statistically.

Secondary Outcome Measures

Name	Time	Method
Neutrophil-Lymphocyte Ratio	three days after treatment	Measured before and three days after treatment, and the examiners compare the three markers statistically
Platelet-Lymphocyte Ratio	three days after treatment	Measured before and three days after treatment, and the examiners compare the three markers statistically

Trial Locations

Locations (1)

Moewardi General Hospital; 🇮🇩 Sukoharjo, Central Jave, Indonesia