Chinese pediatric Tuina on children with acute diarrhea: study protocol for a randomized sham-controlled trial

• Published in: Current controlled trials in cardiovascular medicine Vol. 20; no. 1; p. 689
• Main Authors: Lu, Taoying, Zhang, Huiyan, Yin, Lingjia, Cai, Jianxiong, Li, Meiling, Dai, Lin, Zhu, Conghao, Zhang, Yongping, Xiang, Feng, Wang, Li, Li, Lu, Wang, Lixin, Wu, Darong
• Format: Journal Article
• Language: English
• Published: England BioMed Central Ltd 09.12.2019; BioMed Central; BMC
• Subjects: Acute diarrhea; Acute Disease; Age; Asian medicine; Child; Child health; Child, Preschool; Childhood diarrhea; Children; Children & youth; China; Chinese medicine; Clinical trials; Diarrhea; Diarrhea - drug therapy; Double-Blind Method; Health aspects; Humans; Infant; Infant, Newborn; Medical research; Medicin och hälsovetenskap; Medicine, Chinese Traditional - adverse effects; Morbidity; Mortality; Outcome Assessment, Health Care; Pediatric Tuina; Pediatrics; Randomized controlled trial; Randomized Controlled Trials as Topic; Retirement benefits; Sample Size; Study Protocol; Therapy; Traditional Chinese medicine; Tropical diseases; China; Pediatric Tuina; Randomized controlled trial; Acute diarrhea
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-019-3818-1

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. 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. 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. ClinicalTrials.gov, NCT03005821. Registered on 29 December 2016.