Safety Study of Feeding With Ginger Extract in Acute Respiratory Distress Syndrome
Primary Purpose
Acute Respiratory Distress Syndrome
Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
ginger
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Acute Respiratory Distress Syndrome focused on measuring ginger extract, ARDS, enteral feeding, mechanical ventilation, ICU
Eligibility Criteria
Inclusion Criteria:
- Required positive pressure ventilation via endotracheal tube or tracheostomy and were on enteral nutrition support.
- Also they had to have an acute onset of significantly impaired oxygenation with a PaO2 to FiO2 ratio equal or less than 200, bilateral pulmonary infiltrates on frontal chest radiograph and no clinical evidence of left atrial hypertension according to the American-European Consensus Conference on ARDS .
- Patients had to be enrolled within 48 hours of developing these criteria.
Exclusion Criteria:
- Age younger than 18 years
- Participation in other interventional trials in the previous 30 days
- Neurological conditions that could impair weaning from ventilatory support,
- Severe chronic respiratory disease
- Pregnancy
- Lactation
- Active bleeding
- Head trauma
- Intracranial hemorrhage
- Peptic ulcer
- HIV infection
- Food allergy
- Morbid obesity
- Malignancy or other irreversible conditions for which 6 months mortality was estimated to be 50% or more and who were receiving nonsteroidal anti inflammatory drugs or ketoconazole.
Sites / Locations
- Faculty of Nutrition Sciences and Food Technology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ginger
placebo
Arm Description
Study group received 1200 mg of ginger extract and control group 2 gram of coconut oil as placebo
Study group received 1200 mg of ginger extract and control group 2 gram of coconut oil as placebo
Outcomes
Primary Outcome Measures
changes in oxygenation, respiratory mechanics and serum inflammatory factors
oxygenation
Secondary Outcome Measures
the number of organ failure free days, the occurrence of barotraumas, the number of ventilator free days, the number of ICU free days and ICU mortality.
Full Information
NCT ID
NCT00958685
First Posted
August 3, 2009
Last Updated
August 12, 2009
Sponsor
Shahid Beheshti University
1. Study Identification
Unique Protocol Identification Number
NCT00958685
Brief Title
Safety Study of Feeding With Ginger Extract in Acute Respiratory Distress Syndrome
Official Title
Effect of Enteral Feeding With Ginger Extract in Acute Respiratory Distress Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Shahid Beheshti University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
An enteral diet supplemented with ginger extract in acute respiratory distress syndrome (ARDS) patients may be beneficial for gas exchange and could decrease duration of mechanical ventilation and length of stay in intensive care unit (ICU).
Detailed Description
Rationale: Clinical ARDS occurs primarily as the result of inflammatory injury to the alveoli producing diffuse alveolar damage.
Objective: To evaluate the effects of an enteral diet enriched with ginger extract on inflammatory factors, respiratory profile and outcome of patients with ARDS.
Methods: In this single center, randomized, controlled double blind study, 32 patients with ARDS were randomized to receive a high protein enteral diet enriched with ginger extract or placebo.
Measurements and Main Results: Serum levels of IL-1, IL-6, TNF-α and LTB-4, oxygenation, measured as PaO2/FiO2, static compliance measured on days 0, 5 and 10.
Patients fed enteral diet enriched with ginger extract had significantly lower serum levels of IL-1, IL-6, TNF-α and LTB-4 on days 5 and 10 compared to control group (P<0.05). Significant improvement in oxygenation was observed on day 5 (P=0.02) and 10 (P=0.003) in ginger extract group compared to control group. Static compliance was also increased significantly on day 5 (P=0.01) in ginger extract group compared to control group. A significant difference was found in duration of mechanical ventilation (P0.02) and length of ICU stay (P=0.04) in favor of ginger extract group. We did not find any difference in barotraumas, organ failure and mortality between the study groups.
Conclusions: An enteral diet supplemented with ginger extract in ARDS patients may be beneficial for gas exchange and could decrease duration of mechanical ventilation and length of stay in ICU.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome
Keywords
ginger extract, ARDS, enteral feeding, mechanical ventilation, ICU
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ginger
Arm Type
Experimental
Arm Description
Study group received 1200 mg of ginger extract and control group 2 gram of coconut oil as placebo
Arm Title
placebo
Arm Type
Experimental
Arm Description
Study group received 1200 mg of ginger extract and control group 2 gram of coconut oil as placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
ginger
Other Intervention Name(s)
Zingiber officinale
Intervention Description
Study group received 1200 mg of ginger extract and control group 2 gram of coconut oil as placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Other Intervention Name(s)
Zingiber officinale
Intervention Description
Study group received 1200 mg of ginger extract and control group 2 gram of coconut oil as placebo
Primary Outcome Measure Information:
Title
changes in oxygenation, respiratory mechanics and serum inflammatory factors
Time Frame
21 days
Title
oxygenation
Time Frame
21 days
Secondary Outcome Measure Information:
Title
the number of organ failure free days, the occurrence of barotraumas, the number of ventilator free days, the number of ICU free days and ICU mortality.
Time Frame
after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Required positive pressure ventilation via endotracheal tube or tracheostomy and were on enteral nutrition support.
Also they had to have an acute onset of significantly impaired oxygenation with a PaO2 to FiO2 ratio equal or less than 200, bilateral pulmonary infiltrates on frontal chest radiograph and no clinical evidence of left atrial hypertension according to the American-European Consensus Conference on ARDS .
Patients had to be enrolled within 48 hours of developing these criteria.
Exclusion Criteria:
Age younger than 18 years
Participation in other interventional trials in the previous 30 days
Neurological conditions that could impair weaning from ventilatory support,
Severe chronic respiratory disease
Pregnancy
Lactation
Active bleeding
Head trauma
Intracranial hemorrhage
Peptic ulcer
HIV infection
Food allergy
Morbid obesity
Malignancy or other irreversible conditions for which 6 months mortality was estimated to be 50% or more and who were receiving nonsteroidal anti inflammatory drugs or ketoconazole.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
zahra vahdat shariatpanahi, MD, Ph.D
Organizational Affiliation
Faculty of Nutrition Sciences and Food Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Nutrition Sciences and Food Technology
City
Tehran
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
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Safety Study of Feeding With Ginger Extract in Acute Respiratory Distress Syndrome
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