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Effect of Ginger on Nausea and Vomiting During Acute Gastroenteritis in Children

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ClinicalTrials.gov Identifier: NCT02701491
Recruitment Status : Unknown
Verified March 2016 by Roberto Berni Canani, Federico II University.
Recruitment status was:  Recruiting
First Posted : March 8, 2016
Last Update Posted : March 8, 2016
Sponsor:
Information provided by (Responsible Party):
Roberto Berni Canani, Federico II University

Brief Summary:

The acute gastroenteritis is a very common problem in children. The frequency and duration of this condition involves a high discomfort for the child and his family, and significant costs, in connection with the purchase of therapeutic aids, medical visits, days of work lost by parents, requiring hospitalization. Vomiting is a typical symptom of the majority of the cases of acute gastroenteritis and is very often the cause of failure of oral rehydration use and hospitalization.

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.


Condition or disease Intervention/treatment Phase
Nausea Vomiting Dietary Supplement: Ginger Other: Placebo Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Ginger on Nausea and Vomiting Related to Acute Gastroenteritis in Pediatric Age
Study Start Date : February 2016
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Ginger
Ginger
Dietary Supplement: Ginger
ginger
Placebo Comparator: Placebo
Placebo-no intervention
Other: Placebo
Placebo



Primary Outcome Measures :
  1. Change in rate of subjects with persistence of symptoms [ Time Frame: Change from baseline at 24 hours ]
    Rate of patients who present at least one more episode of vomiting following the beginning of the treatment assignment ( ginger or placebo) during the oral rehydration .

  2. Change in rate of subjects with persistence of symptoms [ Time Frame: Change from baseline at 48 hours ]
    Rate of patients who present at least one more episode of vomiting following the beginning of the treatment assignment ( ginger or placebo) during the oral rehydration .


Secondary Outcome Measures :
  1. Number of episodes of vomiting [ Time Frame: Change from baseline at 24 hours ]


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Ages Eligible for Study:   1 Year to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children, both sexes, aged 1-10 years,
  • 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:

  • Children under 12 months of age and older than 10 years,
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02701491


Locations
Italy
University of Naples Federico II Recruiting
Naples, Italy, 80131
Contact: Roberto Berni Canani, MD, PhD    +390817462680      
Sponsors and Collaborators
Federico II University

Responsible Party: Roberto Berni Canani, MD, PhD, Federico II University
ClinicalTrials.gov Identifier: NCT02701491     History of Changes
Other Study ID Numbers: 273/15
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: March 8, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Nausea
Vomiting
Gastroenteritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases