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

U

Universitas Sebelas Maret

Status and phase

Completed
Phase 3

Conditions

Sepsis

Treatments

Dietary Supplement: Albumin Channa Striata Extract

Study type

Interventional

Funder types

Other

Identifiers

NCT05596942
Septian Adi P

Details and patient eligibility

About

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.

Full 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.

Enrollment

42 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

42 participants in 2 patient groups

Albumin Chana Striata Extract
Experimental group
Treatment:
Dietary Supplement: Albumin Channa Striata Extract
Human Albumin
Active Comparator group
Treatment:
Dietary Supplement: Albumin Channa Striata Extract

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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