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Research on the Clinical Standardized Application of the Xiaodao-Huaji Method in Traditional Chinese Medicine (TCM) for Children with Functional Constipation and Promotion Plan

A Research and Application Promotion Plan for the Standardized Clinical Study of the Traditional Chinese Medicine (TCM) Xiaduohuaji Method in Treating Pediatric Functional Constipation.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000412
Enrollment
Unknown
Registered
2026-02-25
Start date
2025-12-01
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Functional constipation

Interventions

Xiaodao Hua ji Granules Treatment Group:Oral Xiaduohua Granules
Lactulose Oral Solution Group:Lactulose Oral Solution

Sponsors

Shanghai Jiao Tong University School of Medicine Affiliated Shanghai Children's Medical Center Guizhou Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1)Diagnosis conforms to the latest revised Rome IV criteria published in 2016: defecation frequency less than 2 times per week; at least 1 episode of fecal incontinence per week; presence of significant fecal retention or postures related to fecal retention; history of defecation pain or difficulty; presence of large fecal masses in the rectum; feces large enough to obstruct the toilet. For children aged 4 years or older, under the condition of not meeting the diagnostic criteria for irritable bowel syndrome, the following symptoms should include at least 2 items, occurring at least once a week, and persisting for at least 1 month. 2)Children aged 3 to 12 years.

Exclusion criteria

Exclusion criteria: Individuals who cannot be ruled out as having constipation caused by other systemic diseases; Individuals who cannot be ruled out as having constipation caused by organic lesions in the digestive tract; Individuals with primary diseases of the stomach, heart, liver, kidneys, hematopoietic system, or mental disorders; Individuals who did not take medication as prescribed or have incomplete records.

Design outcomes

Primary

MeasureTime frame
Symptom Scoring;

Countries

China

Contacts

Public ContactLi Jijun

Shanghai Jiao Tong University School of Medicine Affiliated Shanghai Children's Medical Center Guizhou Hospital

lijijun523@163.com13681876829

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Mar 14, 2026