Trials / Completed
CompletedNCT00958685
Safety Study of Feeding With Ginger Extract in Acute Respiratory Distress Syndrome
Effect of Enteral Feeding With Ginger Extract in Acute Respiratory Distress Syndrome
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 32 (actual)
- Sponsor
- Shahid Beheshti University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | ginger | 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 |
Timeline
- Start date
- 2007-01-01
- Primary completion
- 2009-01-01
- Completion
- 2009-01-01
- First posted
- 2009-08-13
- Last updated
- 2009-08-13
Locations
1 site across 1 country: Iran
Source: ClinicalTrials.gov record NCT00958685. Inclusion in this directory is not an endorsement.