Effect of Ginger on Nausea and Vomiting During Acute Gastroenteritis in Children
NCT ID: NCT02701491
Last Updated: 2019-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
150 participants
INTERVENTIONAL
2016-02-29
2016-09-30
Brief Summary
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To limit vomiting and facilitate oral rehydration have been proposed several pharmacological strategies. Unfortunately, these therapies are unsuccessful (domperidone), expensive and side effects (ondansetron and metoclopramide) and therefore contraindicated in patients of pediatric age.
The administration of some medicinal herbs is able to induce an effective anti-emetic power. Among the various types of plants studied, the rhizome of Zingiber officinale, commonly known as ginger is used as an antiemetic in various traditional systems of medicine for over 2000 years. There are several scientific evidence on the beneficial properties of ginger, including antioxidant, antimicrobial, anti-inflammatory and anti-allergic . It was also demonstrated that ginger is effective in resolving the post-operative nausea and vomiting and in pregnant. A recent meta-analysis has confirmed that ginger is effective in non-pharmacological treatment of nausea and vomiting in the early periods of pregnancy.
To date there are several formulations of the ginger on the market in Italy, and their use is fairly widespread in children for the treatment of vomiting by acute gastroenteritis in the absence of clinical evidence of efficacy.
The purpose of the proposed study is to demonstrate the effectiveness of treatment with ginger in reducing episodes of vomiting associated with acute gastroenteritis in children.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ginger
Ginger
Ginger
ginger
Placebo
Placebo-no intervention
Placebo
Placebo
Interventions
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Ginger
ginger
Placebo
Placebo
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of acute gastroenteritis (duration less than 24 hours they had at least one episode of vomiting (no bile, no blood) in the previous four hours, with mild-state of dehydration moderate).
Exclusion Criteria
* concomitant presence of chronic diseases,
* malnutrition (z score for lower 3 standard deviations weight / height),
* severe dehydration,
* malformations of the gastrointestinal tract,
* malignancy,
* neurological diseases,
* metabolic diseases,
* eosinophilic esophagitis or other gastrointestinal diseases,
* history of functional dyspepsia or cyclic vomiting,
* history of abdominal surgery,
* history of food allergy ginger,
* renal failure and/or hypoalbuminemia
1 Year
10 Years
ALL
No
Sponsors
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Federico II University
OTHER
Responsible Party
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Roberto Berni Canani
MD, PhD
Locations
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University of Naples Federico II
Naples, , Italy
Countries
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References
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Nocerino R, Cecere G, Micillo M, De Marco G, Ferri P, Russo M, Bedogni G, Berni Canani R. Efficacy of ginger as antiemetic in children with acute gastroenteritis: a randomised controlled trial. Aliment Pharmacol Ther. 2021 Jul;54(1):24-31. doi: 10.1111/apt.16404. Epub 2021 May 21.
Other Identifiers
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273/15
Identifier Type: -
Identifier Source: org_study_id