Efficacy of Bhringaraja Arka as an Add–On to Standard Care in the Management of Neonatal Jaundice – A Study Protocol for an Open Labelled Randomized Controlled Clinical Trial

Background: Neonatal jaundice (NNJ) is common biochemical hyperbilirubinemia, affecting 85% of term and 95% of preterm infants in India. Mild cases are self-limiting, but severe NNJ (Serum Bilirubin > 15 mg/dL) remains a global concern, especially in low- and middle-income countries. Severe hyperbilirubinemia can cause long-term neurocognitive sequelae such as cerebral palsy, auditory neuropathy, deafness, and increased mortality. Current treatments include phototherapy, exchange transfusion, and phenobarbitone, although each has limitations. Phototherapy may lead to loose stools, dehydration, rashes, and retinal damage, whilst phenobarbitone can cause somnolence and dependence. <i>Bhringaraja</i> (Eclipta prostrata L.), traditionally used in Ayurveda for liver disorders and hyperbilirubinemia, has been investigated as a complementary therapy. It acts as a <i>Rakta Shodhaka</i> (blood purifier) and <i>Pittahar</i> (<i>Pitta</i>-balancer). Phytochemicals like wedelolactone and ecliptine provide hepatoprotective effects including, supporting hepatocyte function, metabolism, and bilirubin clearance. Despite its long traditional use in NNJ, scientific evaluation of efficacy is lacking.Methods: Eligible NNJ patients will be randomized into two groups (≥ 20 each). Group A will receive <i>Bhringaraja Arka</i> (5 drops 3×daily) plus standard care, while Group B will receive standard care alone (clinical observation and phototherapy if required). Treatment will continue for 7 days or until Serum Bilirubin reaches remission levels.Conclusion: This study protocol aims to produce a study which will generate evidence on the potential of <i>Bhringaraja Arka</i> to determine whether it accelerates recovery and prevent NNJ progression.