Infantile functional dyspepsia syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: For a qualified child subject, the answer to all inclusion criteria must be "yes": (1) Children with functional dyspepsia syndrome in infants; (2) Children aged 1-36 months; (3) Children who have not used other drugs for dyspepsia in recent 1 week; (4) The informed consent process complies with the regulations, and the parents or guardians sign the informed consent form.
Exclusion criteria
Exclusion criteria: For a qualified child subject, the answer to all exclusion criteria must be "no": (1) There are digestive tract organic diseases such as peptic ulcer, gastrointestinal tumor, inflammatory bowel disease, pancreatitis and intestinal tuberculosis; (2) Suffering from serious heart, brain, liver, kidney, hematopoietic system, connective tissue diseases, endocrine diseases, and mental diseases; (3) Children with severe malnutrition; (4) Children who are using or need to use antacids, antacids and drugs to promote gastrointestinal motility; (5) Allergic to the test drug and its components; (6) Participate in other clinical studies within 12 weeks before screening; (7) The researcher believes that it is not suitable to participate in this experiment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comprehensive effective rate of dyspepsia symptoms; | — |
Secondary
| Measure | Time frame |
|---|---|
| Comprehensive effective rate of dyspepsia symptoms;Single symptom score of dyspepsia;Disappearance rate of single symptom of dyspepsia;weight;Head circumference;length;Recurrence rate of symptoms after body length withdrawal; | — |
Countries
China
Contacts
Guangzhou Women and children's Medical Center