Effect of Ginger on Nausea and Vomiting During Acute Gastroenteritis in Children
|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
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|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|
Dietary Supplement: Ginger
Placebo Comparator: Placebo
- 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 .
- 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 .
- Number of episodes of vomiting [ Time Frame: Change from baseline at 24 hours ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02701491
|University of Naples Federico II||Recruiting|
|Naples, Italy, 80131|
|Contact: Roberto Berni Canani, MD, PhD +390817462680|