Constipation in children (Syndrome of internal heat accumulation)
Conditions
Interventions
experimental group:Experimental group: The medication and specification are Zhishutongbian Granules: 5g per bag (each 1g is equivalent to 1.33g of herbal slice)
Control group:Control group: medication with a specification of 10% drug concentration in the test drug: 5g per bag (each 1g is equivalent to 0.133g of herbal slice)
Sponsors
Jiangsu Provincial Hospital of Chinese Medicine ( the Affiliated Hospital of Nanjing University of Chinese Medicine)
Eligibility
Sex/Gender
All
Age
4 Years to 14 Years
Inclusion criteria
Inclusion criteria: (1) It meets the diagnostic criteria for functional constipation in Western medicine; (2) It conforms to the diagnostic criteria for constipation caused by internal heat in traditional Chinese medicine; (3) Age: 4 to 14 years old (inclusive), gender not limited; (4) The child patient's SBM is less than 3 times a week and lasts for at least 2 weeks. (5) The most recent stool consistency of the child patient conforms to Bristol stool classification types 1 to 3. (6) For children aged 4 to 7 (inclusive), the informed consent form shall be signed by their legal guardians. For children aged 8 to 14 (inclusive), the informed consent form shall be signed separately by both the child and the legal guardian.
Exclusion criteria
Exclusion criteria: 1. Constipated children with potential organic causes, such as celiac disease, intestinal obstruction, congenital megacolon, cystic fibrosis, or gastrointestinal malformations; 2. Constipated children with constipation-predominant irritable bowel syndrome or functional dyspepsia; 3. Constipated children with significant developmental delay associated with muscular, skeletal, or neurological diseases that impact gastrointestinal function; 4. Constipated children with constipation secondary to endocrine disorders (e.g., hypothyroidism), metabolic, neurological, organ, autoimmune diseases, abdominal surgery, or medications; 5. Constipated children with alarm symptoms (indicating potential underlying diseases, such as family history of congenital megacolon, ribbon-like stools, blood in stools without anal fissures, developmental stagnation, bile vomiting, severe abdominal distension, thyroid abnormalities, abnormal anal position, absence of anal or cremasteric reflexes, decreased lower limb muscle strength/tone/reflexes, shallow sacral dimples, tufts of hair on the spine, deviated gluteal cleft, anal scars, etc.); 6. Children with severe constipation, as judged by the investigator, such as severe impaction leading to overflow incontinence, requiring manual assistance for defecation, bowel movements lasting over 20 minutes, and accompanied by behavioral changes (e.g., becoming sensitive or unhappy); 7. Children with severe chronic diseases requiring special care, such as urolithiasis, ureteropelvic junction stenosis, sickle cell disease, or cerebral palsy; 8. Children with severe psychiatric disorders (e.g., autism spectrum disorder, bipolar disorder, schizophrenia, severe depression) who are unable to cooperate with treatment or whose response to treatment is affected; 9. Children treated with sacral nerve stimulation (SNS) or sequential colonic irrigation via cecostomy or appendicostomy (ACE); 10. Children who have used drugs with significant effects on efficacy evaluation within 1 week prior to screening, including but not limited to Chinese or Western medications with laxative effects, or drugs affecting constipation (e.g., opioids like codeine, calcium supplements, iron supplements, clonidine, anticholinergics like atropine, non-potassium-sparing diuretics, and Chinese medicines with similar effects), or those who have undergone acupuncture or massage therapy; 11. Children with severe systemic diseases (e.g., cardiovascular, cerebrovascular, pulmonary, hepatic, renal, or hematopoietic disorders) or severe malnutrition; 12. Children with alanine aminotransferase (ALT) > 1.5 times the upper limit of normal, aspartate aminotransferase (AST) > 1.5 times the upper limit of normal, or creatinine (Cr) > upper limit of normal; 13. Children with known allergies to any components of the investigational drug; 14. Children who have participated in other clinical trials within the past month; 15. Other situations deemed unsuitable for enrollment by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SBM response rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| SBM frequency after 2 weeks of treatment;Interval between bowel movements;Effective time of defecation;Constipation symptom score after 2 weeks of treatment;Therapeutic effect of traditional Chinese medicine syndrome after 2 weeks of treatment;After 2 weeks of treatment, the efficacy of single symptoms in traditional Chinese medicine syndrome;The disappearance rate of individual symptoms of traditional Chinese medicine syndrome after 2 weeks of treatment;The frequency of use of remedial medication; | — |
Countries
China
Contacts
Public ContactBin Yuan
Jiangsu Provincial Hospital of Chinese Medicine ( the Affiliated Hospital of Nanjing University of Chinese Medicine)
Outcome results
None listed