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A randomized controlled double-blind multicenter clinical study on the prevention and treatment of neonatal jaundice with traditional Chinese medicine Tuihuang San medicated bath using placebo-controlled evaluation

A randomized controlled double-blind multicenter clinical study on the prevention and treatment of neonatal jaundice with traditional Chinese medicine Tuihuang San medicated bath using placebo-controlled evaluation

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000364
Enrollment
Unknown
Registered
2025-02-19
Start date
2025-01-20
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

neonatal jaundice

Interventions

Control group:5% Traditional Chinese Medicine Tuihuang Powder Medicinal Bath
Treatment group:Traditional Chinese Medicine Tuihuang Powder Medicinal Bath

Sponsors

First affiliated hospital of guizhou traditional chinese medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 1 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria (1) Meets the above diagnostic criteria; (2) The age of the patient is = 7 days; (3) Children aged 37 weeks = GA<42 weeks; (4) Birth weight = 2500g and = 4000g; (5) Apgar score = 8 points; (6) TCB is between the 75th and 95th percentiles of the Bhutani curve; (7) The family members of the patient were informed and agreed to participate in this study.

Exclusion criteria

Exclusion criteria: Exclusion criteria (1) Exclude those who do not meet the above diagnostic criteria; (2) Exclude children who meet the criteria for blood exchange; (3) Exclude children with skin injuries; (4) Exclude children with extravascular hemolysis; (5) Exclude children with infection indicators; (6) Exclude congenital or genetic diseases (such as congenital hypothyroidism and congenital UDPGT deficiency) Children with congenital bile duct obstruction etc; (7) Exclude children with obstructive jaundice.

Design outcomes

Primary

MeasureTime frame
The ratio of transcutaneous bilirubin TCB changes below the 95th percentile of the Bhutani curve;

Secondary

MeasureTime frame
Skin and facial yellowing changes;25/10000 25/10000 First defecation time daily defecation frequency time of fetal stool turning yellow and urine color;Time of onset and resolution of jaundice;Changes in TCB values before after and during treatment;

Countries

China

Contacts

Public Contactyang yang

First affiliated hospital of guizhou traditional chinese medicine

523483997@qq.com15329002022

Outcome results

None listed

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