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

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

Effect of Enteral Feeding With Ginger Extract in Acute Respiratory Distress Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00958685
• Other study ID #: INFI-112
• Status: Completed
• Phase: Phase 2
• First received: August 3, 2009
• Last updated: August 12, 2009
• Start date: January 2007
• Est. completion date: January 2009

Study information

• Verified date: August 2009
• Source: Shahid Beheshti University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Faculty of Nutrition Sciences and Food Technology	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Shahid Beheshti University

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in oxygenation, respiratory mechanics and serum inflammatory factors		21 days	Yes
Primary	oxygenation		21 days	Yes
Secondary	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	Yes