Clinical trial NCT03005821: Chinese Pediatric Massage on Children With Acute Diarrhea: a Randomized Sham Massage Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diarrhea
Keywords: pediatric massage
Tuina therapy
acute diarrhea
Lead sponsor: Guangzhou University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Dongguan Kanghua Hospital
First posted: 2016-12-29
Enrollment: 84
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Diarrhea days
timeFrame: 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.
measure: The diarrhea times
timeFrame: On the 3rd day.
Secondary outcomes:
measure: Global change rating
timeFrame: On the 7th day and 14th day from baseline (the baseline and the 1st day of intervention are on the same day).
measure: Period of days when the stool character turns to normal
timeFrame: Within 14 days, the period of days from baseline to the first day that the stool character turns to normal.
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: Within 14 days
Other outcomes:
Locations:
city: Dongguan
country: China
facility: Dongguan Kanghua Hospital
state: Guangdong
Study officials:
References:
citation: Lu T, Yin L, Chen R, Zhang H, Cai J, Li M, Dai L, Zhu C, Zhang Y, Xiang F, Wang L, Li L, Wang L, Wu D. Chinese pediatric Tuina on children with acute diarrhea: a randomized sham-controlled trial. Health Qual Life Outcomes. 2021 Jan 6;19(1):4. doi: 10.1186/s12955-020-01636-1.
citation: Lu T, Zhang H, Yin L, Cai J, Li M, Dai L, Zhu C, Zhang Y, Xiang F, Wang L, Li L, Wang L, Wu D. Chinese pediatric Tuina on children with acute diarrhea: study protocol for a randomized sham-controlled trial. Trials. 2019 Dec 9;20(1):689. doi: 10.1186/s13063-019-3818-1.