A SINGLE CENTER RANDOMIZED SINGLE BLIND COMPARATIVE CLINICAL TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF LACTOHIL PLUS (BANANA FLAVOUR) IN THE SUBJECTS SUFFERING WITH INADEQUACY OF LACTATION

Title: A single center randomized single blind comparative clinical trial to evaluate the safety and efficacy of Lactohil Plus (Banana Flavour) in the subjects suffering with inadequacy of lactation (Stanyakshaya). Introduction: Breast milk is vital for a baby’s growth, and inadequate lactation (Stanyakshaya) can result in nutrient deficiencies, affecting the baby's development. Proper postnatal care (Sutika paricharya) is essential in preventing these issues. This study aims to evaluate the efficacy and safety of Lactohil Plus (Banana Flavor) in managing lactation inadequacy by monitoring both subjective and objective parameters, alongside any potential adverse events. Materials and Methods: A single-blind randomized control trial was conducted on 60 lactating mothers with term deliveries whose newborns (?2000g) had not regained birth weight by 15 days and were receiving ?250 ml/day of top feed after four weeks. Mothers with chronic illnesses or breast complications, and infants with low birth weight or congenital issues, were excluded. Liver and renal function tests were performed before and after treatment to ensure safety. Results and Discussion: Lactohil Plus significantly improved lactation outcomes over Shatavari churna administered alone, as evidenced by increased baby weight gain (P = 0.0177), reduced supplementary feed (P = 0.0014), and higher post-breastfeeding satisfaction (P = 0.0012). Mothers reported enhanced breast fullness and milk production (P < 0.0015). No significant changes were observed in liver, kidney, or blood sugar profiles, confirming the safety of the treatments.