Abstract
BackgroundAcute pediatric diarrhea is one of the most common causes of morbidity and mortality worldwide and seriously affects the health of children. Previous studies have shown that pediatric Tuina, a traditional Chinese medicine therapy, has potential therapeutic benefits for acute pediatric diarrhea. However, the evidence for its effectiveness is insufficient due to the lack of high-quality clinical studies. Our aim is to evaluate the efficacy of Chinese pediatric Tuina for children aged 0–6 years with acute diarrhea.Methods/designThis study is a randomized, double-blind, sham-controlled trial. We will include 122 children with acute diarrhea from Dongguan Kanghua Hospital in Guangdong province, China. The patients will be allocated into either the pediatric Tuina group or the sham Tuina group in a 1:1 ratio. The treatment will last for 3 days followed by an 11-day follow-up period. Both groups will receive usual care. In addition, the experimental group will receive 15–25 min of Chinese pediatric Tuina, while the control group will receive 15–25 min of sham pediatric Tuina. Both groups will receive treatments once per day, for 3 consecutive days. Primary outcome measures are diarrhea days from baseline and diarrhea times on the third day. Secondary outcome measures are the global change rating and period of days when the stool character changes to normal. Safety assessments will be monitored during each visit.DiscussionThis clinical trial is designed to evaluate the efficacy of pediatric Tuina for children with acute diarrhea. We expect results to provide solid evidence and support for pediatric Tuina as an appropriate treatment for children with acute diarrhea.Trial registrationClinicalTrials.gov, NCT03005821. Registered on 29 December 2016.
Highlights
Acute pediatric diarrhea is one of the most common causes of morbidity and mortality worldwide and seriously affects the health of children
This clinical trial is designed to evaluate the efficacy of pediatric Tuina for children with acute diarrhea
The aim of this study is to evaluate the efficacy of pediatric Tuina as an add-on therapy compared with sham Tuina in addition to usual care for children aged 0–6 years with acute diarrhea
Summary
Acute pediatric diarrhea is one of the most common causes of morbidity and mortality worldwide and seriously affects the health of children. Acute pediatric diarrhea is a common and potentially serious condition with global significance It is a major cause of morbidity and mortality for children, especially in low- and middle-income countries [1, 2]. The recommended treatments for diarrhea include continued feeding or increased breastfeeding, lowosmolarity oral rehydration solution (ORS) or intravenous infusion, probiotics, zinc supplementation and antimicrobial usage for bloody diarrhea [6,7,8,9] These therapeutic methods play important roles in the treatment of diarrhea; some interventions, such as zinc supplementation and ORS, are not accepted by children or their parents which can lead to low compliance and impacting their effect [10,11,12].
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