Acute Respiratory Distress SyndromePhase 2NCT00958685
Safety Study of Feeding With Ginger Extract in Acute Respiratory Distress Syndrome
A Phase 2 study testing ginger in people with Acute Respiratory Distress Syndrome, run by Shahid Beheshti University at 1 site in Iran.
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Respiratory Distress Syndrome
- What is being tested?
- ginger
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteIran
- Study dates
- Jan 2007to Jan 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Enteral Feeding With Ginger Extract in Acute Respiratory Distress Syndrome
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).
Read the 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
- Acute Respiratory Distress Syndrome
- Being tested
- ginger, placebo
- Keywords
- ginger extract, ARDS, enteral feeding, mechanical ventilation, ICU
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gingerDietary supplement
Also called Zingiber officinale
Study group received 1200 mg of ginger extract and control group 2 gram of coconut oil as placebo
placeboDietary supplement
Also called Zingiber officinale
Study group received 1200 mg of ginger extract and control group 2 gram of coconut oil as placebo
| Study group | Role | What they receive |
|---|---|---|
| ginger | Experimental | Study group received 1200 mg of ginger extract and control group 2 gram of coconut oil as placebo Receives: Dietary Supplement: ginger |
| placebo | Experimental | Study group received 1200 mg of ginger extract and control group 2 gram of coconut oil as placebo Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in oxygenation, respiratory mechanics and serum inflammatory factors
Measured: 21 days
oxygenation
Measured: 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.
Measured: after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study startJan 2007
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University
- Sponsor type
- University, hospital or other
- Investigators
- zahra vahdat shariatpanahi, MD, Ph.D, Principal investigator, Faculty of Nutrition Sciences and Food Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00958685
- Sponsor's protocol ID
- INFI-112
- Status last verified
- Aug 2009
- First submitted
- 3 Aug 2009
- Last updated
- 13 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Enteral Feeding With Ginger Extract in Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT00958685
- Acronym / sponsor ID
- INFI-112
- Conditions
- Acute Respiratory Distress Syndrome
- Keywords
- ginger extract, ARDS, enteral feeding, mechanical ventilation, ICU
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Shahid Beheshti UniversityUniversity, hospital or other
- Study start
- Jan 2007
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 13 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ginger | Experimental | Dietary Supplement: gingerStudy group received 1200 mg of ginger extract and control group 2 gram of coconut oil as placebo |
| placebo | Experimental | Dietary Supplement: placeboStudy group received 1200 mg of ginger extract and control group 2 gram of coconut oil as placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gingerAlso: Zingiber officinaleStudy group received 1200 mg of ginger extract and control group 2 gram of coconut oil as placebo | Dietary supplement | ginger |
| placeboAlso: Zingiber officinaleStudy group received 1200 mg of ginger extract and control group 2 gram of coconut oil as placebo | Dietary supplement | placebo |
Primary outcome
changes in oxygenation, respiratory mechanics and serum inflammatory factors
Time frame: 21 days
oxygenation
Time frame: 21 days
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
zahra vahdat shariatpanahi, MD, Ph.D principal investigator
Faculty of Nutrition Sciences and Food Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ginger in people with Acute Respiratory Distress Syndrome, run by Shahid Beheshti University at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in oxygenation, respiratory mechanics and serum inflammatory factors (time frame: 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2009.