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

NCT00958685 | Completed Phase 2 DMC

• 1 other identifier: INFI-112
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Respiratory Distress Syndrome

Keywords

ginger extract; ARDS; enteral feeding; mechanical ventilation; ICU

Outcome Measures

Primary Outcomes (2)

• changes in oxygenation, respiratory mechanics and serum inflammatory factors

  21 days

• oxygenation

  21 days

Secondary Outcomes (1)

• 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.

  after intervention

Study Arms (2)

ginger

EXPERIMENTAL

Study group received 1200 mg of ginger extract and control group 2 gram of coconut oil as placebo

Dietary Supplement: ginger

placebo

EXPERIMENTAL

Study group received 1200 mg of ginger extract and control group 2 gram of coconut oil as placebo

Dietary Supplement: placebo

Interventions

ginger DIETARY_SUPPLEMENT

Study group received 1200 mg of ginger extract and control group 2 gram of coconut oil as placebo

Also known as: Zingiber officinale

ginger

placebo DIETARY_SUPPLEMENT

Study group received 1200 mg of ginger extract and control group 2 gram of coconut oil as placebo

Also known as: Zingiber officinale

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shahid Beheshti University: lead

Study Sites (1)

Faculty of Nutrition Sciences and Food Technology

Tehran, Iran

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

ginger extract

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• zahra vahdat shariatpanahi, MD, Ph.D

  Faculty of Nutrition Sciences and Food Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 3, 2009
• First Posted: August 13, 2009
• Study Start: January 1, 2007
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: August 13, 2009

Record last verified: 2009-08

Locations

IR (1)