A Phase 2 interventional study of ginger and placebo in Acute Respiratory Distress Syndrome, sponsored by Shahid Beheshti University. Completed at 1 site in Iran. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-08-13.
Sponsored by Shahid Beheshti University · Phase 2, Interventional, and Treatment
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).
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.
1,619 studies on the registry are indexed under Respiratory Distress Syndrome; 319 are open to participants now.
This study's enrollment of 32 is below the median of 60 across 973 interventional studies indexed under Respiratory Distress Syndrome.
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Exclusion Criteria:
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
Dietary Supplement: placebo
Study group received 1200 mg of ginger extract and control group 2 gram of coconut oil as placebo
Also known as: Zingiber officinale
Study group received 1200 mg of ginger extract and control group 2 gram of coconut oil as placebo
Also known as: Zingiber officinale
changes in oxygenation, respiratory mechanics and serum inflammatory factors
Time frame: 21 days
oxygenation
Time frame: 21 days
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
This study is completed, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ginger extract
Respiratory Distress Syndrome →
Shahid Beheshti University