Chinese Pediatric Massage on Children With Acute Diarrhea: a Randomized Sham Massage Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Diarrhea days
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of Chinese pediatric massage as an add-on therapy while comparing with sham massage both on the basis of usual care for 0-6 years old children with acute diarrhea.
详细描述
Chinese pediatric massage has been practised as an option for the treatment of pediatric diarrhea for hundreds of years (since Ming Dynasty). The history of Chinese pediatric massage for health promotion is much longer, it can be traced back to more than one thousand years ago (652 AD). Many of the acupoints adopted in Chinese pediatric massage are unique if it is compared with those for adult massage. The manipulation is found to be easily accepted by children, as the strength of massage is gentle and soft. No severe adverse reaction in regards of Chinese pediatric massage was reported, the mild adverse reaction such as skin abrasion can be completely avoided with correct operating instructions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject's symptoms meet the diagnosis criteria of acute diarrhea.
- •The occurrence of diarrhea is no more than 72 hours.
- •Stool frequency is equal or more than 5 times a day.
- •Subject has not been involved in any other clinical trials at the same period of time.
- •Subject's guardian may coordinate during the clinical trial.
- •Subject's guardian have signed the informed consent.
排除标准
- •A history of experiencing Chinese pediatric massage on hands
- •Subject has cholera or malaria
- •Subject with the following conditions on the manipulating part: phlebitis，open wound，fracture，tissue damage
- •Subject has the follow complications: severe dehydration，metabolic acidosis，disorders of consciousness, seizures or twitching, shock, azotemia
结局指标
主要结局
Diarrhea days
时间窗: Within 14 days, the period of days from baseline to the first day that the diarrhea time reduces to equal to or less than 2 times per day.
The diarrhea times
时间窗: On the 3rd day.
The baseline and the 1st day of intervention are on the same day.
次要结局
- Global change rating(On the 7th day and 14th day from baseline (the baseline and the 1st day of intervention are on the same day).)
- Period of days when the stool character turns to normal(Within 14 days, the period of days from baseline to the first day that the stool character turns to normal.)
- Incidence of Treatment-Emergent Adverse Events(Within 14 days)
研究者
Darong Wu
MD, PhD, Director,Program for Outcome Assessment in TCM, Professor, Chief Physician
Guangzhou University of Traditional Chinese Medicine