The effect of oil massage therapy along with phototherapy on jaundice in newborns

Add-on efficacy of oil massage (Abhyanga) along with standard neonatal care in neonatal hyperbilirubinemia: An open-label Randomized Controlled Clinical Study - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/03/064576

Enrollment

Registered

2024-03-21

Start date

Unknown

Completion date

Unknown

Last updated

2024-04-01

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

Conditions

Health Condition 1: P58- Neonatal jaundice due to other excessive hemolysis Health Condition 2: P59- Neonatal jaundice from other and unspecified causes

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy Neonates immediately after birth irrespective of sex and ethnicity 2. Gestational age greater than 28 weeks and birth weight greater than 1500 g 3. An APGAR Score of more than 7 in the first minute. 4. Neonates who do not require oxygen support or positive ventilation or parenteral nutrition. 5. Neonates fulfilling KA87 that is neonatal hyperbilirubinemia clinical features as per ICD 11.

Exclusion criteria

Exclusion criteria: 1. Extremely preterm neonates that is less than 1.5 kg 2. Extremely Low Birth Weight that is less than 28 weeks 3. Rhesus and ABO incompatibility and G6PD deficiency. 4. Birth injuries 5. Congenital anomalies 6. Signs of infection or intraventricular or subgaleal hemorrhage 7. Signs of gastrointestinal obstruction or biliary atresia 8. Neonates who are on/require oxygen support/positive ventilation/parenteral nutrition or other intravenous infusions. 9. Neonates expressing hypersensitivity to oil test dose 10. Neonates whose both parents are minors. 11. Mothers receiving drugs narcotic agents/ barbiturates/aspirin/chloral hydrate/reserpine/ phenytoin sodium pre or post parturition.

Design outcomes

Primary

Measure	Time frame
Lowering of total serum bilirubin levels below phototherapy thresholds for the day of life and gestational age following oil massage with Arukaladi tailaTimepoint: Baseline Day two Day four Day six Day eight	—

Secondary

Measure	Time frame
Reduction in adverse reactions to phototherapyTimepoint: After phototherapy and at discharge;Reduction in Malondialdehyde and increase in insulin-like growth factor 1 and Glutathione reduced/oxidized ratio (GSH/GSSG ratio) in neonates following oil massage and SNCTimepoint: at birth, after day two, and at discharge;Reduction in salivary cortisol level following oil massage with Bala tailaTimepoint: at birth, after first massage, after day two, and at discharge;Thermoregulation in neonates following oil massage and SNCTimepoint: at birth, after first massage, and daily till discharge	—

Measure

Time frame

Reduction in adverse reactions to phototherapyTimepoint: After phototherapy and at discharge;Reduction in Malondialdehyde and increase in insulin-like growth factor 1 and Glutathione reduced/oxidized ratio (GSH/GSSG ratio) in neonates following oil massage and SNCTimepoint: at birth, after day two, and at discharge;Reduction in salivary cortisol level following oil massage with Bala tailaTimepoint: at birth, after first massage, after day two, and at discharge;Thermoregulation in neonates following oil massage and SNCTimepoint: at birth, after first massage, and daily till discharge

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Countries

India

Contacts

Public ContactDr Mahapatra Arun Kumar

All India Institute of Ayurveda

srajagopala@gmail.com7600902564

Outcome results