Clinical evaluation of Ayush-SS granules in exclusively breastfeeding mothers with insufficient lactation: A randomized, double-blind, placebo-controlled trial

Abstract Background Breast milk is essential for infant growth and development, with exclusive breastfeeding (EBF) recommended for the first six months. Many mothers experience insufficient milk production, leading to early supplementation or cessation of breastfeeding. Ayurvedic formulations, such as Ayush-SS granules, have been proposed to enhance lactation. This study evaluated Ayush-SS granules as a galactagogue, with EBF at six months as the primary outcome. Secondary outcomes included infant weight gain over 90 days and maternal perceptions of lactation sufficiency. Methods A double-blind, randomized, placebo-controlled trial was conducted between 1 February 2021 and 31 January 2023 at Vardhman Mahavir Medical College and Safdarjung Hospital, Delhi, India. A total of 210 lactating mothers (aged 20–40 years) with full-term singleton infants (≥ 37 weeks, ≥ 2.5 kg) experiencing insufficient lactation were enrolled. Infants who had not regained birth weight by day 14 or gained < 20 g/day after day 15 were included. Participants were randomized (1:1) to receive 6 g of Ayush-SS granules or placebo twice daily for 12 weeks. All participants received standardized breastfeeding counseling. Safety monitoring was conducted, and an intention-to-treat analysis was performed. Results At six months, 74 of 106 (69.8%) infants in the Ayush-SS group were exclusively breastfed, compared to 47 of 105 (44.8%) in the placebo group (p < 0.001). After 90 days, 81 of 106 infants (76.5%) in the Ayush-SS group gained ≥ 20 g/day compared to 44 of 105 (41.8%) in the placebo group (p < 0.001). Maternal perceptions of insufficient lactation were significantly lower in the Ayush-SS group (15.3% vs. 58.2%). No severe adverse events related to the intervention were observed. Conclusion Ayush-SS granules significantly improved EBF rates at six months, maternal perceptions of lactation sufficiency, and infant weight gain. These findings suggest their potential as a galactagogue for mothers with insufficient milk production. Further research is needed to explore long-term effects and maternal dietary influences. Clinical trial registration CTRI/2019/08/020579 [Registered on: 06/08/2019].