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

Primary Purpose

Nausea, Vomiting

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Ginger
Placebo
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nausea

Eligibility Criteria

1 Year - 10 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Naples Federico II

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ginger

Placebo

Arm Description

Ginger

Placebo-no intervention

Outcomes

Primary Outcome Measures

Change in rate of subjects with persistence of symptoms
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

Number of episodes of vomiting
Change in rate of subjects with persistence of symptoms
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 .

Full Information

First Posted
February 29, 2016
Last Updated
December 17, 2019
Sponsor
Federico II University
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1. Study Identification

Unique Protocol Identification Number
NCT02701491
Brief Title
Effect of Ginger on Nausea and Vomiting During Acute Gastroenteritis in Children
Official Title
Effect of Ginger on Nausea and Vomiting Related to Acute Gastroenteritis in Pediatric Age
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
February 2016 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ginger
Arm Type
Experimental
Arm Description
Ginger
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo-no intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
Ginger
Intervention Description
ginger
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change in rate of subjects with persistence of symptoms
Description
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 .
Time Frame
Change from baseline at 24 hours
Secondary Outcome Measure Information:
Title
Number of episodes of vomiting
Time Frame
Change from baseline at 24 hours
Title
Change in rate of subjects with persistence of symptoms
Description
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 .
Time Frame
Change from baseline at 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Naples Federico II
City
Naples
ZIP/Postal Code
80131
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34018223
Citation
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.
Results Reference
derived

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

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