The efficacy of diet supplemented with Lepidium sativum (Chandrashoor) on expressed breast milk volume in hypogalactic mothers - An open-label noncross-over randomized trial.

Background: Hypogalactia is the common condition, especially in preterm deliveries. Some herbs in Indian medicines such as Lepidium sativum L. (L. sativum) have galactogogeus effects. The galactogogeus effect of L. sativum (Chandrashoora) has not been quantified in randomized control trials in humans till date. We intend to study the galactogogeus effects of L. sativum in hypogalactic mothers through an open-label noncross-over trial.

Materials and methods: The target population were women who had delivered infants <32 weeks gestation with no lower limit to gestational age and their babies admitted in neonatal intensive care unit for prematurity. Participants who were taking specific drugs as a result of their primary illnesses, such as chemotherapy, sedatives, or antiseziure medications, were excluded. The randomization was achieved with computer-generated random number table. The experimental group (n = 23) received 2.5 g of L. sativum (Chandrashoora) seeds each day, soaked in luke warm water for half an hour in the morning, along with instructions about how to take the seeds. The control group did not receive any medication (n = 23). According to the institutional procedure, participants were trained to express breast milk six times using a breast pump. The amount of milk extracted was measured every day for 28 days. The difference in milk production between the two groups at 28 days was the primary endpoint. The secondary endpoint was to asses if any of the trial medicines had any adverse drug effects.

Results: A total of 46 participants completed the study till 28 days. In both groups, demographic factors were comparable. The study group surpassed the control group in terms of breast milk volume slowly and reached statistical significance (P = 0.00002) after 28 days of therapy. No adverse drug effects were reported by the participants.

Conclusion: There was statistically significant improvement in breast milk production at 28 days in hypogalactic mothers in the experimental group. L. sativum can be used as cheap alternatives to costly medicines to improve lactation with minimal costs and no adverse drug reactions.