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The evaluation of the therapeutic effects of topical gel containing barley flour on hyperbilirubinemia in neonates under phototherapy

The evaluation of the therapeutic effects of topical gel containing barley flour on hyperbilirubinemia in neonates under phototherapy: A pilot randomized clinical trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200128046288N7
Enrollment
20
Registered
2026-05-05
Start date
2026-04-21
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Neonatal jaundice, Neonatal hyperbilirubinemia. Neonatal jaundice, unspecified

Interventions

Intervention 1: Intervention group: Infants will be divided into 2 groups using block randomization. In the first group, infants will be given barley flour gel and will undergo phototherapy. In this g

Sponsors

Ahvaz University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Days to 11 Days

Inclusion criteria

Inclusion criteria: Babies aged 37-42 weeks gestation Birth weight 2.5-4 kg Total bilirubin level 14-20 mg/dl Their jaundice began after the second day of life. They are hospitalized.

Exclusion criteria

Exclusion criteria: Patients with conjugated hyperbilirubinemia Phototherapy or blood exchange for the previous child Blood type incompatibility between mother and baby Any apparent abnormality on physical examination Hematocrit level above 65% or hemoglobin level above 20 Abnormal blood tests indicating pathological jaundice or an underlying condition

Design outcomes

Primary

MeasureTime frame
Determining the effect of topical oat flour gel on the bilirubin level in newborns' blood before and after intervention. Timepoint: Total bilirubin and direct bilirubin levels will be measured at the beginning of the study and 12, 24, 36, and 48 hours after admission. Method of measurement: A venous blood sample will be collected from the neonate’s peripheral vein.Total and direct bilirubin levels will be measured using an automated biochemical analyzer (e.g., BT-3000 or equivalent) in the hospital laboratory.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFereshteh Golfakhr Abadi

Ahvaz University of Medical Sciences

golfakhrabadi-f@ajums.ac.ir+98 61 3373 8378

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026