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A Study on the Role of Modified Sijunzi Decoction in the Clinical Treatment of Pediatric Food Accumulation (spleen-deficiency with Food Accumulation Syndrome)

The effects of modified Sijunzi Decoction on the clinical symptoms and adverse reactions of children with food accumulation (spleen deficiency with food accumulation syndrome)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000335
Enrollment
Unknown
Registered
2026-02-09
Start date
2024-02-10
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

Pediatric Food Accumulation

Interventions

Control Group:pepsin tablets + domperidone tablets
Observation Group:pepsin tablets + domperidone tablets + modified Sijunzi decoction

Sponsors

Heping Hospital Affiliated to Changzhi Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 7 Years

Inclusion criteria

Inclusion criteria: (1)Western Medical Diagnosis: Meets the diagnostic criteria for Functional Dyspepsia according to the Rome IV criteria. (2)Traditional Chinese Medicine (TCM) Diagnosis: Meets the diagnostic criteria for Pediatric Food Accumulation as outlined in the Guidelines for TCM Diagnosis and Treatment of Pediatric Food Accumulation, specifically the syndrome type of spleen-deficiency with food accumulation syndrome. Primary Symptoms: Poor appetite, abdominal fullness and distension after eating, abdominal fullness relieved by pressure, vomiting of sour and fermented material. Secondary Symptoms: Sallow complexion, emaciated physique, fatigue and weak limbs, restless sleep. Tongue and Pulse: Pale lips and tongue, white greasy tongue coating, thready and slippery pulse, pale superficial venule of the index finger. (3)Age between 3 and 7 years old. (4)Disease course = 1 week. (5)No use of prokinetic agents or digestive enzyme preparations within the past week. (6)Good compliance from both the child and their guardian, with the ability to complete treatment and follow-up according to medical advice.

Exclusion criteria

Exclusion criteria: (1) Individuals with organic digestive system diseases such as acute gastroenteritis, intestinal obstruction, or intussusception; (2) Individuals with diseases affecting growth and development such as rickets, anemia, or thyroid dysfunction; (3) Individuals allergic to any of the drug components studied; (4) Individuals with intellectual disability or who are unable to cooperate with symptom assessment.

Design outcomes

Primary

MeasureTime frame
Overall efficacy;

Secondary

MeasureTime frame
Serum gastrointestinal hormone levels;Trace element levels;Body mass index and food intake;Traditional Chinese medicine syndrome score;Incidence of adverse reactions;

Countries

China

Contacts

Public ContactGong Xiu

Heping Hospital Affiliated to Changzhi Medical College

GX1823459@163.com18234591677

Outcome results

None listed

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