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Clinical study on the combination of Bupi Xiaoji oral liquid and basic treatment for pediatric mesenteric lymphadenitis

Clinical study on the combination of Bupi Xiaoji oral liquid and basic treatment for pediatric mesenteric lymphadenitis

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072910
Enrollment
Unknown
Registered
2023-06-28
Start date
2023-06-30
Completion date
Unknown
Last updated
2023-07-02

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

Conditions

Pediatric mesenteric lymphadenitis

Interventions

Test group:Oral Bupi Xiaoji Oral Liquid Combined with Basic Treatment
control group: Basic treatment

Sponsors

The First Affiliated Hospital of Air Force Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 14 Years

Inclusion criteria

Inclusion criteria: Meets the diagnostic criteria of Western medicine for pediatric mesenteric lymphadenitis; Meets the diagnostic criteria of traditional Chinese medicine for pediatric abdominal pain; Meets the traditional Chinese medicine syndrome differentiation standards for milk food retention syndrome; Age range from 3 to 14 years (inclusive), regardless of gender; Abdominal pain score = 6; Children or family members can understand and cooperate in abdominal pain scoring; The child and their family agree and sign an informed consent form.

Exclusion criteria

Exclusion criteria: Patients with surgical indications; Patients with abdominal diseases caused by surgical acute abdomen, appendicitis, lymphoma, intestinal worms, and other gastrointestinal diseases; Patients with severe liver and kidney dysfunction: alanine transaminase (ALT) or aspartate transaminase (AST)>2.0 × Upper limit of normal value (ULN), and/or other known liver diseases such as acute and chronic hepatitis, cirrhosis, etc; Serum creatinine>2.0 × ULN, and/or known severe renal insufficiency. Severe primary diseases with concomitant heart, lung, brain, and hematopoietic systems; Individuals with allergic constitution or known allergies to this drug or its components; Having intellectual or mental disabilities; Those who have participated in other clinical trials within three months or are currently participating in other clinical trials; Other situations that the researcher deems unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
The proportion of patients with a 50% decrease in abdominal pain score after 30 minutes of randomization;Time of disappearance of abdominal pain;Efficacy of abdominal pain score;

Secondary

MeasureTime frame
Traditional Chinese Medicine Syndrome Curative Effect;Single symptom efficacy;

Countries

The People's Republic of China

Contacts

Public ContactMa Jing

The First Affiliated Hospital of Air Force Military Medical University

jingma@fmmu.edu.cn+86 130 9690 9166

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026