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

Not Applicable

Completed

• Conditions: Diarrhea

• Registration Number: NCT03005821
• Lead Sponsor: Guangzhou University of Traditional Chinese Medicine

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.

Study Timeline

• Study First Submitted: 2016-12-25
• Study First Submitted QC: 2016-12-25
• Study First Posted: 2016-12-29
• Study Start: 2017-01
• Status Verified: 2019-10
• Primary Completion: 2019-10-25
• Study Completion: 2019-10-25
• Last Update Submitted: 2019-10-25
• Last Update Posted: 2019-10-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dongguan Kanghua Hospital; 🇨🇳 Dongguan, Guangdong, China