children’s functional constipation with dyspepsia.
Conditions
Interventions
A:Xiao‘er Biantong Granules, 1 to 3 years: take1/2 bag (5g), 3 times a day, 4 to 6 years: take 1 bag (5g), 2 times a day, =7years: take 1 bag (5g), 3 times a day
Sponsors
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
1 Years to 14 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed with functional constipation; 2. Meeting the criteria of TCM syndrome of dyspepsia; 3. Aged 1 to 14 years; 4. Fully informed, voluntary consent, and signed the ICF by legal guardians.
Exclusion criteria
Exclusion criteria: 1. intestinal stenosis caused by Rectum, colon organic disease (such as cancer, inflammation, anal fissure, Crohn's disease, intestinal obstruction, adhesions, colon polyps, intestinal tuberculosis, etc.); 2. Caused by a Hirschsprungs discase, sigmoid long disease and neurological disorders, mental disorders, endocrine metabolic disorders; 3. Constipation caused by the systemic organic lesions; 4. outlet obstruction or mixed constipation; 5. Allergic children or allergic to the components of this preparation; 6. Combined with cardiovascular disease, cerebrovascular disease, hepatic disease, renal disease, hematopoietic system disorders or other severe diseases; 7. Positive fecal occult blood; 8. Have used other medication in treating this disease in the past 2 weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Defecation interval time;Stool consistency score on Bristol stool scale;difficulty defecation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Relief of constipation defined by modified ROME criteria;Sum score of TCM syndrome;recurrence rate during follow-up; | — |
Countries
China
Contacts
Public ContactSiyuan Hu
Outcome results
None listed