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

Primary Purpose

Sepsis

Status
Completed
Phase
Phase 3
Locations
Indonesia
Study Type
Interventional
Intervention
Albumin Channa Striata Extract
Sponsored by
Universitas Sebelas Maret
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Sepsis focused on measuring sepsis, eNOS, NLR, PLR, Channa striata, albumin, inflammation, anti-oxidant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Moewardi General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Albumin Chana Striata Extract

Human Albumin

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 22, 2022
Last Updated
October 24, 2022
Sponsor
Universitas Sebelas Maret
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1. Study Identification

Unique Protocol Identification Number
NCT05596942
Brief Title
Evaluating the Efficacy of Channa Striata in Stabilizing eNOS in Patients With Septic.
Official Title
Evaluating the Efficacy of Channa Striata in Stabilizing eNOS in Patients With Septic: A Randomized Control Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitas Sebelas Maret

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis
Keywords
sepsis, eNOS, NLR, PLR, Channa striata, albumin, inflammation, anti-oxidant

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Albumin Chana Striata Extract
Arm Type
Experimental
Arm Title
Human Albumin
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Albumin Channa Striata Extract
Other Intervention Name(s)
Human Albumin
Intervention Description
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.
Primary Outcome Measure Information:
Title
Endothelial Nitric Oxide Synthase
Description
Measured before and three days after treatment, and the examiners compare the three markers statistically.
Time Frame
three days after treatment
Secondary Outcome Measure Information:
Title
Neutrophil-Lymphocyte Ratio
Description
Measured before and three days after treatment, and the examiners compare the three markers statistically
Time Frame
three days after treatment
Title
Platelet-Lymphocyte Ratio
Description
Measured before and three days after treatment, and the examiners compare the three markers statistically
Time Frame
three days after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Moewardi General Hospital
City
Sukoharjo
State/Province
Central Jave
ZIP/Postal Code
57126
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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