SepsisPhase 3NCT05596942
Evaluating the Efficacy of Channa Striata in Stabilizing eNOS in Patients With Septic.
A Phase 3 study testing Albumin Channa Striata Extract in people with Sepsis, run by Universitas Sebelas Maret at 1 site in Indonesia.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Albumin Channa Striata Extract
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Jul 2021to 30 Sep 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- patients with severe trauma
- blood loss in stage three or higher
- stress ulcers
- a history of nephrotic syndrome
- refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Efficacy of Channa Striata in Stabilizing eNOS in Patients With Septic: A Randomized Control Trial.
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.
Read the 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.
- Conditions
- Sepsis
- Being tested
- Albumin Channa Striata Extract
- Keywords
- sepsis, eNOS, NLR, PLR, Channa striata, albumin, inflammation, anti-oxidant
- Medical subject headings
- Sepsis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albumin Channa Striata ExtractDietary supplement
Also called Human Albumin
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.
| Study group | Role | What they receive |
|---|---|---|
| Albumin Chana Striata Extract | Experimental | Not described Receives: Dietary Supplement: Albumin Channa Striata Extract |
| Human Albumin | Active comparator | Not described Receives: Dietary Supplement: Albumin Channa Striata Extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial Nitric Oxide Synthase
Measured before and three days after treatment, and the examiners compare the three markers statistically.
Measured: three days after treatment
Secondary outcomes (2)
Neutrophil-Lymphocyte Ratio
Measured before and three days after treatment, and the examiners compare the three markers statistically
Measured: three days after treatment
Platelet-Lymphocyte Ratio
Measured before and three days after treatment, and the examiners compare the three markers statistically
Measured: three days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2022
- Study start1 Jul 2021
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sebelas Maret
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Septian Adi Permana, Universitas Sebelas Maret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05596942
- Sponsor's protocol ID
- Septian Adi P
- Status last verified
- Oct 2022
- First submitted
- 22 Sep 2022
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Channa Striata in Stabilizing eNOS in Patients With Septic: A Randomized Control Trial.
- ClinicalTrials.gov ID
- NCT05596942
- Acronym / sponsor ID
- Septian Adi P
- Conditions
- Sepsis
- Keywords
- sepsis, eNOS, NLR, PLR, Channa striata, albumin, inflammation, anti-oxidant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Universitas Sebelas MaretUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 27 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Albumin Chana Striata Extract | Experimental | Dietary Supplement: Albumin Channa Striata Extract |
| Human Albumin | Active comparator | Dietary Supplement: Albumin Channa Striata Extract |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- patients with severe trauma
- blood loss in stage three or higher
- stress ulcers
- a history of nephrotic syndrome
- refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albumin Channa Striata ExtractAlso: Human AlbuminThis 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. | Dietary supplement | Albumin Chana Striata Extract, Human Albumin |
Primary outcome
Endothelial Nitric Oxide Synthase
Time frame: three days after treatment
Measured before and three days after treatment, and the examiners compare the three markers statistically.
2 secondary outcomes
Neutrophil-Lymphocyte Ratio
Time frame: three days after treatment
Platelet-Lymphocyte Ratio
Time frame: three days after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Individual participant dataSharing planned: Yes
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
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Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Albumin Channa Striata Extract in people with Sepsis, run by Universitas Sebelas Maret at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial Nitric Oxide Synthase (time frame: three days after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.