Safety Study of Feeding With Ginger Extract in Acute Respiratory Distress Syndrome

This study has been completed.
Sponsor:
Information provided by:
Shahid Beheshti University
ClinicalTrials.gov Identifier:
NCT00958685
First received: August 3, 2009
Last updated: August 12, 2009
Last verified: August 2009
  Purpose

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).


Condition Intervention Phase
Acute Respiratory Distress Syndrome
Dietary Supplement: ginger
Dietary Supplement: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Enteral Feeding With Ginger Extract in Acute Respiratory Distress Syndrome

Resource links provided by NLM:


Further study details as provided by Shahid Beheshti University:

Primary Outcome Measures:
  • changes in oxygenation, respiratory mechanics and serum inflammatory factors [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]
  • oxygenation [ Time Frame: 21 days ] [ Designated as safety issue: Yes ]

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. [ Time Frame: after intervention ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: January 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ginger
Study group received 1200 mg of ginger extract and control group 2 gram of coconut oil as placebo
Dietary Supplement: ginger
Study group received 1200 mg of ginger extract and control group 2 gram of coconut oil as placebo
Other Name: Zingiber officinale
Experimental: placebo
Study group received 1200 mg of ginger extract and control group 2 gram of coconut oil as placebo
Dietary Supplement: placebo
Study group received 1200 mg of ginger extract and control group 2 gram of coconut oil as placebo
Other Name: Zingiber officinale

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00958685

Locations
Iran, Islamic Republic of
Faculty of Nutrition Sciences and Food Technology
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Shahid Beheshti University
Investigators
Principal Investigator: zahra vahdat shariatpanahi, MD, Ph.D Faculty of Nutrition Sciences and Food Technology
  More Information

No publications provided

Responsible Party: Zahra Vahdat Shariatpanahi, Faculty of Nutrition Sciences and Food Technology
ClinicalTrials.gov Identifier: NCT00958685     History of Changes
Other Study ID Numbers: INFI-112
Study First Received: August 3, 2009
Last Updated: August 12, 2009
Health Authority: Iran: Ministry of Health

Keywords provided by Shahid Beheshti University:
ginger extract
ARDS
enteral feeding
mechanical ventilation
ICU

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Syndrome
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014