Chinese Pediatric Massage on Children With Acute Diarrhea: a Randomized Sham Massage Controlled Trial

NCT03005821 | Completed

• 1 other identifier: 2013B032500014
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhea

Keywords

pediatric massage; Tuina therapy; acute diarrhea

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (3)

• 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

Study Arms (2)

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.

Other: Chinese pediatric massage therapy + usual care

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.

Other: Sham massage therapy + usual care

Interventions

Chinese pediatric massage therapy + usual care OTHER

pediatric massage

Sham massage therapy + usual care OTHER

sham massage

Eligibility Criteria

• Age: Up to 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangzhou University of Traditional Chinese Medicine: lead
• Dongguan Kanghua Hospital: collaborator

Study Sites (1)

Dongguan Kanghua Hospital

Dongguan, Guangdong, 523080, China

Location

Related Publications (2)

• 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.

  PMID: 33407547 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.

  PMID: 31815655 DERIVED

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Director,Program for Outcome Assessment in TCM, Professor, Chief Physician

Study Record Dates

• First Submitted: December 25, 2016
• First Posted: December 29, 2016
• Study Start: January 1, 2017
• Primary Completion: October 25, 2019
• Study Completion: October 25, 2019
• Last Updated: October 29, 2019

Record last verified: 2019-10

Locations

CN (1)