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Clinical evaluation of spleen aminopeptide in improving liver function damage and immune function in children with cytomegalovirus hepatitis

Clinical evaluation of spleen aminopeptide in improving liver function damage and immune function in children with cytomegalovirus hepatitis

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800018299
Enrollment
Unknown
Registered
2018-09-10
Start date
2019-01-01
Completion date
Unknown
Last updated
2018-09-17

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

Conditions

Cytomegalovirus hepatitis

Interventions

Basic treatment group:Altomoland
Spleen aminopeptide treatment group:Spleen aminopeptide
Basic treatment + spleen aminopeptide treatment group:Altomoland + spleen aminopeptide
Healthy control (not randomization):no

Sponsors

Department of Gastroenterology, Affiliated Children's Hospital, Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) It is planned to be included in the children with CMV hepatitis admitted to the Department of Gastroenterology, Children's Hospital of Nanjing Medical University from January 2019 to December 2020. They were randomly divided into basic treatment group, spleen amino peptide treatment group, basic treatment + spleen amino peptide. Treatment group, 30 people in each group; (2) The above-mentioned groups of children with atomolan + compound glycyrrhizin basic treatment or combined with spleen aminopeptide treatment; (3) basic treatment: combination of atomolan and glycyrrhizin, treatment course for 1 month; spleen amino peptide oral lyophilized powder dissolved in 10ml cold water after oral administration, >1 year old children 2mg / time, 1 time / d, Oral before going to bed at night; = 1 year old children 2mg / time, 1 time / every other day, oral before going to bed at night, 2 weeks after going home, the total course of treatment in January; (4) The first and 30th days of treatment were evaluated; (5) Aged 6-14 years old; (6) There was no significant difference in age and gender between the children in the experimental group and the healthy group. CMV hepatitis inclusion criteria: according to the Chinese Medical Association Pediatrics Branch infection CHEN infection CMV infection diagnosis program (Chinese Journal of Pediatrics, 1999, 37: 441), and other hepatitis caused by other common hepatitis virus infection in infancy, that is, the following conditions: (1) Peripheral blood or urine CMV-DNA and CMV-IgM positive, Toxoplasma antibody, rubella virus antibody, herpes virus antibody, EB virus, hepatitis A, hepatitis B, hepatitis C, hepatitis D and pent Hepatitis B antibody test was negative; (2) Peripheral blood ALT and bound bilirubin (DB) were higher than normal.

Exclusion criteria

Exclusion criteria: 1) have contraindications to the use of spleen aminoglycans; 2) exclude primary immunodeficiency diseases, congenital heart disease, rickets, malnutrition and other diseases, as well as children who have been treated with other immunopotentiators.

Design outcomes

Primary

MeasureTime frame
Alanine aminotransferase;Bilirubin;serum IL-17, IL-23;Peripheral blood lymphocytes IL-17R, ROR?t, IL-10, IL-1ß and TNF-a mRNA;IL-17R, ROR?t mRNA expression and supernatant IL-17 levels in Th17 cells;

Countries

China

Contacts

Public ContactYang Hui

Department of Gastroenterology, Affiliated Children 's Hospital, Nanjing Medical University

xinghui7325@sina.com+86 18951769765

Outcome results

None listed

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