Randomized controlled clinical trial of the efficacy and safety of Pediatric massage in the treatments of children's functional dyspepsia

• Register: ChiCTR
• Last refreshed on: 19 June 2017
• Main ID: ChiCTR-INR-17011685
• Date of registration: 2017-06-17
• Prospective Registration: Yes
• Primary sponsor: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
• Public title: Randomized controlled clinical trial of the efficacy and safety of Pediatric massage in the treatments of children's functional dyspepsia
• Scientific title: Randomized controlled clinical trial of the efficacy and safety of Pediatric massage in the treatments of children's functional dyspepsia
• Date of first enrolment: 2017-07-01
• Target sample size: Treatment Group:58;Control Group:58;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=19704
• Study type: Interventional study
• Study design: Randomized parallel controlled trial
• Phase: New Treatment Measure Clinical Study

Countries of recruitment

China

Contacts

• Name: Qin Fan
• Affiliation: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

• Name: Na Zhao
• Affiliation: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Key inclusion & exclusion criteria

Inclusion criteria: 1. Children aged 3~6 years old, male and female;
2. Continuous or recurrent anorexia, early satiety and postprandial abdominal discomfort such as full bilge, or epigastric pain (navel);
3. After defecate cannot alleviate, or seizures has nothing to do with defecation frequency or excrement characters change (that is, except for irritable bowel syndrome);
4. No inflammatory, anatomy, metabolic or evidence of tumor diseases can explain the patient's symptoms;
5. At least 2 months prior to diagnosis, symptoms occur at least once a week;
6. The patient's legal guardian sign the informed consent, agreed to participate in research.
Exclusion criteria: 1. Illnesses caused by anorexia, such as acute or chronic gastroenteritis, peptic ulcers, gastrointestinal surgery history, respiratory tract infection, acute or chronic hepatitis, anorexia and anorexia caused by certain drugs;
2. Children with moderate and severe malnutrition;
3. With cardiovascular, brain, lung, and children with severe primary diseases such as hematopoietic system;
4. Children with mental illness, dementia, discourse is not clear;
5. Allergic constitution , for a variety of drugs have allergy history;
6. Four weeks have participated in other clinical trials or with other drugs in clinical trials;
7. Application site have severe skin lesions or skin diseases;
8. According to the investigator, have lower possibility into the group or complicate the group or other lesions, such as the living environment is not stable, easy to cause such as traffic inconvenience lost to follow-up.

Age minimum: 3
Age maximum: 6
Gender: Both

Health Condition(s) or Problem(s) studied

Functional Dyspepsia

Intervention(s)

Treatment Group:Pediatric massage;Control Group:Domperidone;

Primary Outcome(s)

NDI;

Secondary Outcome(s)

EGG;height;weight;

Source(s) of Monetary Support

self-raised