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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05596942
• Other study ID #: Septian Adi P
• Status: Completed
• Phase: Phase 3
• Start date: July 1, 2021
• Est. completion date: September 30, 2021

Study information

• Verified date: October 2022
• Source: Universitas Sebelas Maret
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sepsis

Intervention

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.

Locations

Country	Name	City	State
Indonesia	Moewardi General Hospital	Sukoharjo	Central Jave

Sponsors (1)

Lead Sponsor	Collaborator
Universitas Sebelas Maret

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial Nitric Oxide Synthase	Measured before and three days after treatment, and the examiners compare the three markers statistically.	three days after treatment
Secondary	Neutrophil-Lymphocyte Ratio	Measured before and three days after treatment, and the examiners compare the three markers statistically	three days after treatment
Secondary	Platelet-Lymphocyte Ratio	Measured before and three days after treatment, and the examiners compare the three markers statistically	three days after treatment