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

NCT05596942 | Completed Phase 3 DMC

• 1 other identifier: Septian Adi P
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Endothelial Nitric Oxide Synthase

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

  three days after treatment

Secondary Outcomes (2)

• Neutrophil-Lymphocyte Ratio

  three days after treatment

• Platelet-Lymphocyte Ratio

  three days after treatment

Study Arms (2)

Albumin Chana Striata Extract

EXPERIMENTAL

Dietary Supplement: Albumin Channa Striata Extract

Human Albumin

ACTIVE COMPARATOR

Dietary Supplement: Albumin Channa Striata Extract

Interventions

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.

Also known as: Human Albumin

Albumin Chana Striata Extract; Human Albumin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Universitas Sebelas Maret: lead

Study Sites (1)

Moewardi General Hospital

Sukoharjo, Central Jave, 57126, Indonesia

Location

MeSH Terms

Conditions

Sepsis; Inflammation

Interventions

Serum Albumin, Human

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Serum Albumin; Albumins; Proteins; Amino Acids, Peptides, and Proteins; Blood Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Intensivist

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: October 27, 2022
• Study Start: July 1, 2021
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: October 27, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will share

Locations

ID (1)