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Trial record 47 of 156 for:    (Dementia pugilistica OR chronic traumatic encephalopathy) AND traumatic brain injury (TBI)

Evaluation the Effects of Pycnogenol Supplementation on the Clinical Status in Traumatic Brain Injury Patients

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ClinicalTrials.gov Identifier: NCT03777683
Recruitment Status : Recruiting
First Posted : December 17, 2018
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Mahsa Malekahmadi, Mashhad University of Medical Sciences

Brief 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. One of the ingredients that can be used in immunonutrition formulas to reduce inflammation and oxidative stress is Pycnogenol (bioflavonoids extracted from the bark of the French maritime pine).

Objective: The main objective of present study is surveying the effect of PYC 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 Pycnogenol 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, IL-10) 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.


Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Dietary Supplement: Dietary Supplement Pycnogenol (OLIGOPIN) Other: Placebo Phase 1 Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: On enrolment, study nutritionist or clinicians take a consecutive sealed opaque envelope containing the unique patient identifier but not the study group, to which they remain masked. A paired set of sealed envelopes are kept in a locked cabinet in the study laboratory, label with the unique patient identifier and containing the study group allocation. These are opened by the nutritionist. Investigators, all study staff hospital attending clinical teams, and patients were masked to the study group allocation.
Primary Purpose: Treatment
Official Title: Evaluation the Effects of Pycnogenol (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
Actual Study Start Date : April 14, 2019
Estimated Primary Completion Date : December 22, 2019
Estimated Study Completion Date : February 20, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dietary Supplement Pycnogenol (OLIGOPIN)
Intervention group will receive Pycnogenol supplement (OLIGOPIN) in the form oral capsules containing 50 mg Pycnogenol 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
Dietary Supplement: Dietary Supplement Pycnogenol (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 Pycnogenol 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.

Placebo Comparator: Placebo
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.
Other: Placebo
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.




Primary Outcome Measures :
  1. change of IL-6 [ Time Frame: 5 and 10 days ]
    Inflammatory markers

  2. change of IL-1β [ Time Frame: 5 and 10 days ]
    Inflammatory marker

  3. change of CRP [ Time Frame: 5 and 10 days ]
    Inflammatory marker

  4. change of IL-10 [ Time Frame: 5 and 10 days ]
    Anti- inflammatory marker

  5. change of Malondialdehyde [ Time Frame: 5 and 10 days ]
    Oxidative stress marker

  6. change of total anti- oxidant capacity [ Time Frame: 5 and 10 days ]
    anti-oxidative stress marker

  7. change of height [ Time Frame: 5 and 10 days ]
    Ulna length method used to estimate height

  8. change of weight [ Time Frame: 5 and 10 days ]
    measurement is done via portable scale

  9. change of body fat percentage [ Time Frame: 5 and 10 days ]
    measurement is done via Bio impedance device "Inbody"

  10. change of Body mass index [ Time Frame: 5 and 10 days ]
    it is calculated by Equation

  11. 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.


  12. 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%.


  13. 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



Secondary Outcome Measures :
  1. 28-day mortality [ Time Frame: 28 days ]
    the rate of mortality



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Severe and active bleeding
  • Suffering from Sepsis
  • Having history of known food allergies

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03777683


Contacts
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Contact: Mahsa Malekahmadi, dr 00989131250467 ext 00989131250467 malekahmadim951@mums.ac.ir

Locations
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Iran, Islamic Republic of
Mahsa Malekahmadi Recruiting
Tehran, Iran, Islamic Republic of
Contact: Mahsa Malekahmadi    00989131250467 ext 00989131250467    malekahmadim951@mums.ac.ir   
Sponsors and Collaborators
Mashhad University of Medical Sciences

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Responsible Party: Mahsa Malekahmadi, principal investigator, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03777683     History of Changes
Other Study ID Numbers: 970612
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: May 21, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Craniocerebral Trauma
Trauma, Nervous System
Central Nervous System Diseases
Nervous System Diseases
Pycnogenols
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Platelet Aggregation Inhibitors