Traumatic Brain InjuryPhase 1/2NCT03777683
Evaluation the Effects of French Maritime Pine Bark Extract on the Clinical Status in Traumatic Brain Injury Patients
A Phase 1/2 study testing Dietary Supplement (OLIGOPIN) in people with Traumatic Brain Injury, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial summary
Introduction: Traumatic brain injury (TBI) is one of the major health and socioeconomic problems in the world. Immune-enhancing enteral formula has been proven to significantly reduce infection rate in TBI patient. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Dietary Supplement (OLIGOPIN)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 67 participants
- Where
- 1 siteIran
- Study dates
- 14 Apr 2019to 20 Feb 2020
- Phase
- Phase 1/2
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admission in ICU due to TBI2
- 18 year ≤ age ≤ 65 year
- GCS score ˃ 8
- Stable hemodynamic and metabolic status in the first 24 to 48 hours
- Having enteral nutritional support
- Fill out the informed consent form by the patient or first-degree relatives of the patient
Who cannot join
- Pregnancy and lactation
- Morbid obesity: BMI ≥ 40
- Failure to start enteral nutrition in the first 24-48 hours
- Suffering from autoimmune disorders and HIV/Aids
- Suffering or having History of cancer and any liver failure
- Receiving positive inotropic medications including Dopamine, Dobutamine and Epinephrine
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- Severe and active bleeding
- Suffering from Sepsis
- Having history of known food allergies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation the Effects of French Maritime Pine Bark Extract Supplementation on the Inflammatory Biomarkers, Nutritional and Clinical Status in Traumatic Brain Injury Patients, in Intensive Care Unit; A Randomized Clinical Trial
Introduction: Traumatic brain injury (TBI) is one of the major health and socioeconomic problems in the world. Immune-enhancing enteral formula has been proven to significantly reduce infection rate in TBI patient. One of the ingredients that can be used in immunonutrition formulas to reduce inflammation and oxidative stress is French maritime pine bark extract.
Objective: The main objective of present study is surveying the effect of French maritime pine bark extract on the clinical, nutritional and inflammatory status of TBI patients as the first human study in the world.
Method: this is double-blind, randomized controlled trial. Block randomization are used. Intervention group will receive French maritime pine bark extract supplement (OLIGOPIN) 150 mg for 10 days. Control group will receive placebo for the same duration. Inflammatory status (IL-6, IL- 1β, C-reactive protein) and oxidative stress status (Malondialdehyde, total antioxidant capacity), at the base line, at the 5th day and at the end of the study (10th day) are measured. APACHE ІІ (acute physiologic and chronic health evaluation II) for assessment of clinical status of patients and Nutric questionnaires for assessment of nutritional status filled out at the base line, 5th day and the end of study. SOFA (sequential organ failure assessment) questionnaire for assessment of organ failure filled out every other day. The mortality rate will be asked by phone within 28 days of the start of the intervention. Weight, body mass index and body composition at baseline, 5th day and 10th day of intervention are measured. All analyses will be conducted by initially assigned study arm in an intention-to-treat analysis. The data will be expressed as mean ± SD.
Read the detailed description
Randomization:
investigators randomly assign eligible patients on enrolment (1:1) to either the control group or the intervention group. Randomization is stratified by site and a randomization list of unique patient identifiers is generated by the study statistician using a computer-generated random block size. The classification is based on age (18 to 40 and 40 to 65 years old), gender (male / female) and APACHEII score (0 to 35 and 35 to 71) using quadruple blocks.
- Conditions
- Traumatic Brain Injury
- Being tested
- Dietary Supplement (OLIGOPIN), Placebo
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary Supplement (OLIGOPIN)Dietary supplement
investigators obtained ethical approval from the Research Ethics Committees of the Mashhad University of medical sciences. investigators enroll 60 patients who are admitted to ICU at hospitals of university. All eligible patients or their first degree relatives give informed consent before participating. Participants are randomly (block stratification) divided in two groups. At the first visit, baseline data are gathered and intervention group (n=30) will receive Oligopin supplement. In order to control the confounding effect of food intake, both the control and the intervention group receive the standard formulas based on their daily required energy via enteral root feeding.
PlaceboOther
investigators obtained ethical approval from the Research Ethics Committees of the Mashhad University of medical sciences. investigators enroll 60 patients who are admitted to ICU at hospitals of university. All eligible patients or their first degree relatives give informed consent before participating. Participants are randomly (block stratification) divided in two groups. At the first visit, baseline data are gathered and control group (n=30) will receive oral capsules containing 130 mg Microcrystalline Cellulose. In order to control the confounding effect of food intake, both the control and the intervention group receive the standard formulas based on their daily required energy via enteral root feeding.
| Study group | Role | What they receive |
|---|---|---|
| Dietary Supplement (OLIGOPIN) | Experimental | Intervention group will receive French maritime pine bark extract supplement (OLIGOPIN) in the form oral capsules containing 50 mg French maritime pine bark extract plus 130 mg Microcrystalline Cellulose. OLIGOPIN powder of each capsule are dissolved in 10 ml deionized water and given to patients via gavage (3 capsule per day) for 10 days Receives: Dietary Supplement: Dietary Supplement (OLIGOPIN) |
| Placebo | Placebo comparator | Control group will receive oral capsules containing 130 mg Microcrystalline Cellulose with 10 ml of deionized water via gavage (3 capsule per day) for 10 days. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of IL-6
Inflammatory markers
Measured: 5 and 10 days
change of IL-1β
Inflammatory marker
Measured: 5 and 10 days
change of CRP
Inflammatory marker
Measured: 5 and 10 days
change of Malondialdehyde
Oxidative stress marker
Measured: 5 and 10 days
change of total anti- oxidant capacity
anti-oxidative stress marker
Measured: 5 and 10 days
change of weight
measurement is done via portable scale
Measured: 5 and 10 days
change of body fat percentage
measurement is done via Bio impedance device "Inbody"
Measured: 5 and 10 days
change of Body mass index
it is calculated by Equation
Measured: 5 and 10 days
change of acute physiologic and chronic health evaluation II score
The Acute Physiology and Chronic Health Evaluation (APACHE II) is a severity score and mortality estimation tool developed from a large sample of ICU patients in the United States.
Interpretation: Score: 0-4: Death Rate (%):4, Score: 5-9:Death Rate (%):8, Score: 10-14:Death Rate (%):15, Score: 15-19:Death Rate (%):25, Score: 20-24:Death Rate (%):40, Score: 25-29:Death Rate (%):55, Score: 30-34:Death Rate (%):75. Score: ˃ 34 :Death Rate (%):85.
Measured: 5 and 10 days
change of sequential organ failure assessment score
The Sequential Organ Failure Assessment (SOFA) is a morbidity severity score and mortality estimation tool developed from a large sample of ICU patients throughout the world. The SOFA was designed to focus on organ dysfunction and morbidity, with less of an emphasis on mortality prediction.
Interpretation: Score: 0-6: Death Rate (%):< 10%, Score: 7-9:Death Rate (%):15 - 20%, Score: 10-12:Death Rate (%):40 - 50%, Score: 13-14:Death Rate (%):50 - 60%, Score: 15:Death Rate (%):> 80%, Score: 15-24:Death Rate (%):> 90%.
Measured: 1, 3, 5, 7, 9, 10 days
change of Nutric score
The NUTRIC score (Nutrition assessment in critically ill) is a rapid assessment of nutritional state based on illness severity, age and co-morbidities.
Sum of points: 6-10: CATEGORY: High Score. Sum of points: 0-5: CATEGORY: LOW Score High score associated with worse clinical outcomes (mortality, ventilation).These patients are the most likely to benefit from the aggressive nutrition therapy.
LOW Score: These patients have a low malnutrition risk
Measured: 5 and 10 days
Secondary outcomes (1)
28-day mortality
the rate of mortality
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start14 Apr 2019
- Primary completion22 Dec 2019
- Study completion20 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahsa Malekahmadi, Mashhad University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03777683
- Sponsor's protocol ID
- 970612
- Status last verified
- May 2020
- First submitted
- 12 Dec 2018
- Last updated
- 21 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Malekahmadi M, Moradi Moghaddam O, Islam SMS, Tanha K, Nematy M, Pahlavani N, Firouzi S, Zali MR, Norouzy A. Evaluation of the effects of pycnogenol (French maritime pine bark extract) supplementation on inflammatory biomarkers and nutritional and clinical status in traumatic brain injury patients in an intensive care unit: A randomized clinical trial protocol. Trials. 2020 Feb 11;21(1):162. doi: 10.1186/s13063-019-4008-x.
PubMed 32046747
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Effects of French Maritime Pine Bark Extract Supplementation on the Inflammatory Biomarkers, Nutritional and Clinical Status in Traumatic Brain Injury Patients, in Intensive Care Unit; A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03777683
- Acronym / sponsor ID
- 970612
- Conditions
- Traumatic Brain Injury
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- 14 Apr 2019 (actual)
- Primary completion
- 22 Dec 2019 (actual)
- Study completion
- 20 Feb 2020 (actual)
- First posted
- 17 Dec 2018 (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.
Introduction: Traumatic brain injury (TBI) is one of the major health and socioeconomic problems in the world. Immune-enhancing enteral formula has been proven to significantly reduce infection rate in TBI patient. One of the ingredients that can be used in immunonutrition formulas to reduce inflammation and oxidative stress is French maritime pine bark extract.
Objective: The main objective of present study is surveying the effect of French maritime pine bark extract on the clinical, nutritional and inflammatory status of TBI patients as the first human study in the world.
Method: this is double-blind, randomized controlled trial. Block randomization are used. Intervention group will receive French maritime pine bark extract supplement (OLIGOPIN) 150 mg for 10 days. Control group will receive placebo for the same duration. Inflammatory status (IL-6, IL- 1β, C-reactive protein) and oxidative stress status (Malondialdehyde, total antioxidant capacity), at the base line, at the 5th day and at the end of the study (10th day) are measured. APACHE ІІ (acute physiologic and chronic health evaluation II) for assessment of clinical status of patients and Nutric questionnaires for assessment of nutritional status filled out at the base line, 5th day and the end of study. SOFA (sequential organ failure assessment) questionnaire for assessment of organ failure filled out every other day. The mortality rate will be asked by phone within 28 days of the start of the intervention. Weight, body mass index and body composition at baseline, 5th day and 10th day of intervention are measured. All analyses will be conducted by initially assigned study arm in an intention-to-treat analysis. The data will be expressed as mean ± SD.
Detailed description
Randomization:
investigators randomly assign eligible patients on enrolment (1:1) to either the control group or the intervention group. Randomization is stratified by site and a randomization list of unique patient identifiers is generated by the study statistician using a computer-generated random block size. The classification is based on age (18 to 40 and 40 to 65 years old), gender (male / female) and APACHEII score (0 to 35 and 35 to 71) using quadruple blocks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dietary Supplement (OLIGOPIN) | Experimental | Dietary Supplement: Dietary Supplement (OLIGOPIN)Intervention group will receive French maritime pine bark extract supplement (OLIGOPIN) in the form oral capsules containing 50 mg French maritime pine bark extract plus 130 mg Microcrystalline Cellulose. OLIGOPIN powder of each capsule are dissolved in 10 ml deionized water and given to patients via gavage (3 capsule per day) for 10 days |
| Placebo | Placebo comparator | Other: PlaceboControl group will receive oral capsules containing 130 mg Microcrystalline Cellulose with 10 ml of deionized water via gavage (3 capsule per day) for 10 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Admission in ICU due to TBI2
- 18 year ≤ age ≤ 65 year
- GCS score ˃ 8
- Stable hemodynamic and metabolic status in the first 24 to 48 hours
- Having enteral nutritional support
Key exclusion criteria (9 listed)
- Pregnancy and lactation
- Morbid obesity: BMI ≥ 40
- Failure to start enteral nutrition in the first 24-48 hours
- Suffering from autoimmune disorders and HIV/Aids
- Suffering or having History of cancer and any liver failure
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 |
|---|---|---|
| Dietary Supplement (OLIGOPIN)investigators obtained ethical approval from the Research Ethics Committees of the Mashhad University of medical sciences. investigators enroll 60 patients who are admitted to ICU at hospitals of university. All eligible patients or their first degree relatives give informed consent before participating. Participants are randomly (block stratification) divided in two groups. At the first visit, baseline data are gathered and intervention group (n=30) will receive Oligopin supplement. In order to control the confounding effect of food intake, both the control and the intervention group receive the standard formulas based on their daily required energy via enteral root feeding. | Dietary supplement | Dietary Supplement (OLIGOPIN) |
| Placeboinvestigators obtained ethical approval from the Research Ethics Committees of the Mashhad University of medical sciences. investigators enroll 60 patients who are admitted to ICU at hospitals of university. All eligible patients or their first degree relatives give informed consent before participating. Participants are randomly (block stratification) divided in two groups. At the first visit, baseline data are gathered and control group (n=30) will receive oral capsules containing 130 mg Microcrystalline Cellulose. In order to control the confounding effect of food intake, both the control and the intervention group receive the standard formulas based on their daily required energy via enteral root feeding. | Other | Placebo |
Primary outcome
change of IL-6
Time frame: 5 and 10 days
Inflammatory markers
change of IL-1β
Time frame: 5 and 10 days
Inflammatory marker
change of CRP
Time frame: 5 and 10 days
Inflammatory marker
change of Malondialdehyde
Time frame: 5 and 10 days
Oxidative stress marker
change of total anti- oxidant capacity
Time frame: 5 and 10 days
anti-oxidative stress marker
change of weight
Time frame: 5 and 10 days
measurement is done via portable scale
change of body fat percentage
Time frame: 5 and 10 days
measurement is done via Bio impedance device "Inbody"
change of Body mass index
Time frame: 5 and 10 days
it is calculated by Equation
change of acute physiologic and chronic health evaluation II score
Time frame: 5 and 10 days
The Acute Physiology and Chronic Health Evaluation (APACHE II) is a severity score and mortality estimation tool developed from a large sample of ICU patients in the United States. Interpretation: Score: 0-4: Death Rate (%):4, Score: 5-9:Death Rate (%):8, Score: 10-14:Death Rate (%):15, Score: 15-19:Death Rate (%):25, Score: 20-24:Death Rate (%):40, Score: 25-29:Death Rate (%):55, Score: 30-34:Death Rate (%):75. Score: ˃ 34 :Death Rate (%):85.
change of sequential organ failure assessment score
Time frame: 1, 3, 5, 7, 9, 10 days
The Sequential Organ Failure Assessment (SOFA) is a morbidity severity score and mortality estimation tool developed from a large sample of ICU patients throughout the world. The SOFA was designed to focus on organ dysfunction and morbidity, with less of an emphasis on mortality prediction. Interpretation: Score: 0-6: Death Rate (%):< 10%, Score: 7-9:Death Rate (%):15 - 20%, Score: 10-12:Death Rate (%):40 - 50%, Score: 13-14:Death Rate (%):50 - 60%, Score: 15:Death Rate (%):> 80%, Score: 15-24:Death Rate (%):> 90%.
change of Nutric score
Time frame: 5 and 10 days
The NUTRIC score (Nutrition assessment in critically ill) is a rapid assessment of nutritional state based on illness severity, age and co-morbidities. Sum of points: 6-10: CATEGORY: High Score. Sum of points: 0-5: CATEGORY: LOW Score High score associated with worse clinical outcomes (mortality, ventilation).These patients are the most likely to benefit from the aggressive nutrition therapy. LOW Score: These patients have a low malnutrition risk
1 secondary outcome
28-day mortality
Time frame: 28 days
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 21 May 2020.
- Derived from this study: PubMed 32046747Malekahmadi M, Moradi Moghaddam O, Islam SMS, Tanha K, Nematy M, Pahlavani N, Firouzi S, Zali MR, Norouzy A. Evaluation of the effects of pycnogenol (French maritime pine bark extract) supplementation on inflammatory biomarkers and nutritional and clinical status in traumatic brain injury patients in an intensive care unit: A randomized clinical trial protocol. Trials. 2020 Feb 11;21(1):162. doi: 10.1186/s13063-019-4008-x.
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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 1/2 study testing Dietary Supplement (OLIGOPIN) in people with Traumatic Brain Injury, run by Mashhad University of Medical Sciences at 1 site in Iran.
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 6 inclusion and 9 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 21 May 2020. 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 Iran. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
change of IL-6 (time frame: 5 and 10 days). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03777683, which also lists 1 linked publication.
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 21 May 2020; AzTrials last refreshed its copy on 7 Nov 2026.