Diarrhea
Conditions
Keywords
pediatric massage, Tuina therapy, acute diarrhea
Brief summary
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.
Detailed description
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.
Interventions
OTHERChinese pediatric massage therapy + usual care
OTHERSham massage therapy + usual care
Sponsors
Dongguan Kanghua Hospital
Guangzhou University of Traditional Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 6 Years
Healthy volunteers
No
Inclusion criteria
1. Subject's symptoms meet the diagnosis criteria of acute diarrhea. 2. The occurrence of diarrhea is no more than 72 hours. 3. Stool frequency is equal or more than 5 times a day. 4. Subject has not been involved in any other clinical trials at the same period of time. 5. Subject's guardian may coordinate during the clinical trial. 6. Subject's guardian have signed the informed consent.
Exclusion criteria
1. A history of experiencing Chinese pediatric massage on hands 2. Subject has cholera or malaria 3. Subject with the following conditions on the manipulating part: phlebitis，open wound，fracture，tissue damage 4. Subject has the follow complications: severe dehydration，metabolic acidosis，disorders of consciousness, seizures or twitching, shock, azotemia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diarrhea days | 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 | On the 3rd day. | The baseline and the 1st day of intervention are on the same day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). | much better，slightly better，unchanged，slightly worse，much worse |
| 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 | monitor adverse events |
Countries
China
Outcome results
None listed