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

NCT02701491 | Completed Phase 2

• 1 other identifier: 273/15
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Nausea; Vomiting

Outcome Measures

Primary Outcomes (1)

• 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 .

  Change from baseline at 24 hours

Secondary Outcomes (2)

• Number of episodes of vomiting

  Change from baseline at 24 hours

• Change in rate of subjects with persistence of symptoms

  Change from baseline at 48 hours

Study Arms (2)

Ginger

EXPERIMENTAL

Ginger

Dietary Supplement: Ginger

Placebo

PLACEBO COMPARATOR

Placebo-no intervention

Other: Placebo

Interventions

Ginger DIETARY_SUPPLEMENT

ginger

Ginger

Placebo OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 1 Year - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

University of Naples Federico II

Naples, 80131, Italy

Location

Related Publications (1)

• 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.

  PMID: 34018223 DERIVED

MeSH Terms

Conditions

Nausea; Vomiting

Interventions

ginger extract

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 29, 2016
• First Posted: March 8, 2016
• Study Start: February 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: December 19, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)