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

Diarrhea Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03005821
• Other study ID #: 2013B032500014
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: October 25, 2019

Study information

• Verified date: October 2019
• Source: Guangzhou University of Traditional Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: October 25, 2019
• Est. primary completion date: October 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Diarrhea

Intervention

Other:
• Chinese pediatric massage therapy + usual care

• Sham massage therapy + usual care

Locations

Country	Name	City	State
China	Dongguan Kanghua Hospital	Dongguan	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Guangzhou University of Traditional Chinese Medicine	Dongguan Kanghua Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	The diarrhea times	The baseline and the 1st day of intervention are on the same day.	On the 3rd day.
Secondary	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).
Secondary	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.
Secondary	Incidence of Treatment-Emergent Adverse Events	monitor adverse events	Within 14 days