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OpenTrials
Completed

NCT Number: NCT03005821

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

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.

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Key information

Conditions

Diarrhea Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

Up to 6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dongguan Kanghua Hospital

Dongguan, Guangdong, 523080, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Chinese pediatric massage therapy + usual care

Other

Sham massage therapy + usual care

Other

Primary outcomes

  1. Diarrhea days

    Time frame: 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.

  2. The diarrhea times

    Time frame: On the 3rd day.

    The baseline and the 1st day of intervention are on the same day.

Secondary outcomes

  1. Global change rating

    Time frame: 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

  2. Period of days when the stool character turns to normal

    Time frame: Within 14 days, the period of days from baseline to the first day that the stool character turns to normal.

  3. Incidence of Treatment-Emergent Adverse Events

    Time frame: Within 14 days

    monitor adverse events

Sponsors and collaborators

Lead sponsor

Guangzhou University of Traditional Chinese Medicine

Other

Collaborators

  • Dongguan Kanghua Hospital

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Dec 29, 2016
Registry last updated
Oct 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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