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| Name | Class |
|---|---|
| Dongguan Kanghua Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pediatric massage | Experimental | Patients will receive Montmorillonite Powder and racecadotril granules as usual care according to different age or weight. Intravenous infusion, Oral Rehydration Salts (ORS), Zn,and antibiotics will be used if the pediatrician in charge considers necessary. Patients will receive Chinese pediatric massage once per day and for three days continuously. A cloak which can cover the child's hands and upper body will be required to put on, all the manipulations will be done under the cloak. Six acupoints will be adopted,i.e. Neibagua, Dachang,Xiaochang, Banmen, Fu, Tuishang Qijiegu. Each visit, children who are under 2 years old will receive manipulations on Neibagua for 500 times, 300 times for the other 5 acupoints each; if they are from 2-3 years old, the manipulations on Neibagua will be 700 times and 500 times for the other 5 acupoints respectively; while the manipulations on Neibagua will be 1000 times, and 800 times for the other 5 acupoints if the children are from 4-6 years old. |
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| sham massage | Sham Comparator | Patients will receive the same usual care as the experimental group. For the sham massage, the therapist will use one hand to hold the childrens' hand or just put one hand on childrens' body and the other hand will do the manipulations on the therapist's own hand instead childrens' hand or childrens' body. Patients will be required to put on the same kind of cloak as that for the the experimental group, all the manipulations will be done under the cloak. The manipulation times for each acupoints will be the same as those for experimental group in accordance with different age. The sham massage will be given once per day for 3 days continuously. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chinese pediatric massage therapy + usual care | Other |
| ||
| Sham massage therapy + usual care |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | The baseline and the 1st day of intervention are on the same day. | On the 3rd day. |
| Measure | Description | Time Frame |
|---|---|---|
| Global change rating | much better,slightly better,unchanged,slightly worse,much worse | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongguan Kanghua Hospital | Dongguan | Guangdong | 523080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33407547 | Derived | 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. | |
| 31815655 | Derived | 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. |
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| ID | Term |
|---|---|
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Other |
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| 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 | monitor adverse events | Within 14 days |