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

Sponsor

Universitas Sebelas Maret (Other)

Overall Status

Completed

CT.gov ID

NCT05596942

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Sepsis	Dietary Supplement: Albumin Channa Striata Extract	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jul 1, 2021

Actual Primary Completion Date :

Sep 30, 2021

Actual Study Completion Date :

Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Albumin Chana Striata Extract	Dietary Supplement: Albumin 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. Other Names: Human Albumin
Active Comparator: Human Albumin	Dietary Supplement: Albumin 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. Other Names: Human Albumin

Arm

Intervention/Treatment

Experimental: Albumin Chana Striata Extract

Dietary Supplement: Albumin 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.

Other Names:

Human Albumin

Active Comparator: Human Albumin

Dietary Supplement: Albumin Channa Striata Extract

Other Names:

Human Albumin

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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