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Chinese pediatric Tuina on children with acute diarrhea: study protocol for a randomized sham-controlled trial
Taoying Lu1,2, Huiyan Zhang3, Lingjia Yin1
1Program for Outcome Assessment in TCM, 2nd Affiliated Hospital of Guangzhou University of Chinese Medicine, Guangzhou, China.
Insights
This study investigates Chinese pediatric Tuina for acute diarrhea in children. Results will determine if this traditional therapy offers effective treatment for pediatric diarrhea.
Area of Science:
- Integrative Medicine
- Pediatric Gastroenterology
- Traditional Chinese Medicine
Background:
- Acute pediatric diarrhea is a major global health concern, causing significant morbidity and mortality in children.
- Pediatric Tuina, a traditional Chinese medicine therapy, shows promise for treating acute pediatric diarrhea.
- High-quality clinical evidence supporting the efficacy of pediatric Tuina for acute diarrhea is currently limited.
Purpose of the Study:
- To evaluate the efficacy of Chinese pediatric Tuina as a treatment for acute diarrhea in children aged 0-6 years.
- To provide robust clinical evidence for the therapeutic benefits of pediatric Tuina in managing pediatric diarrhea.
Main Methods:
- A randomized, double-blind, sham-controlled trial involving 122 children with acute diarrhea.
- Participants were allocated 1:1 to receive either pediatric Tuina or sham Tuina, alongside usual care, for 3 consecutive days.
- Primary outcomes included reduction in diarrhea days and diarrhea frequency on day three; secondary outcomes assessed overall improvement and normalization of stool character.
Main Results:
- The study is designed to measure the impact of pediatric Tuina on key diarrhea indicators.
- Safety assessments were conducted throughout the trial to monitor any adverse events.
- The trial aims to provide quantitative data on the effectiveness of pediatric Tuina compared to a sham intervention.
Conclusions:
- This clinical trial is expected to yield significant findings on the efficacy of pediatric Tuina for acute pediatric diarrhea.
- The results are anticipated to support the integration of pediatric Tuina into standard treatment protocols for childhood diarrhea.
- This research seeks to establish pediatric Tuina as a viable and evidence-based therapeutic option for acute diarrhea in children.
Background:
Acute 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/Design:
This 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.
Discussion:
This 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 Registration:
ClinicalTrials.gov, NCT03005821. Registered on 29 December 2016.

