Effect of Enteral Feeding With Ginger Extract in Acute Respiratory Distress Syndrome
ginger
+ placebo
Lung Diseases+1
+ Respiration Disorders
+ Respiratory Distress Syndrome
Treatment Study
Summary
Study start date: January 1, 2007
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.32 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Faculty of Nutrition Sciences and Food Technology
Tehran, IranOpen Faculty of Nutrition Sciences and Food Technology in Google Maps