Investigating the Effectiveness of Fenugreek on the Quantity of Breast Milk and the Level of Prolactin in Mothers of Preterm Newborns: A Randomized Controlled Clinical Trial

Rouhi et al., 2025 | Curr Drug Res Rev | Rct

Citation

Rouhi Mahsa, Hossieni Mohammad Bagher, ... Mirghafourvand Mojgan. Investigating the Effectiveness of Fenugreek on the Quantity of Breast Milk and the Level of Prolactin in Mothers of Preterm Newborns: A Randomized Controlled Clinical Trial. Curr Drug Res Rev. 2025;17(3):471-480. doi:10.2174/0125899775313919240822102906

Abstract

INTRODUCTION: Breast milk is the preferred source of nutrition for premature infants. Galactagogues are used in initiation, induction, and maintenance of lactation. This study examined the effectiveness of fenugreek on prolactin levels and milk volume (primary outcomes), neonatal weight gain, breastfeeding satisfaction, and side effects (secondary outcomes). METHODS: This triple-blind randomized controlled trial was conducted on 68 mothers with preterm newborns less than 32 weeks in Al-Zahra and Taleghani hospitals in Tabriz-Iran. Participants were randomly allocated into fenugreek and placebo groups. About 500 mg of fenugreek and placebo capsules were administered to the participants three times a day, from the fifth day after delivery to the 14th day. Breast milk volume was measured on the fourth day after delivery (one day before the intervention), the seventh day, and the fifteenth day after the intervention. Prolactin levels were measured in the morning before and after the intervention. RESULTS: On the seventh day of the intervention, milk volume was significantly higher in the fenugreek group than in the placebo group (p =0.017). Nevertheless, no statistically significant difference was observed between groups in milk volume (p =0.073) and prolactin level (p =0.324) on day 15. Moreover, no statistically significant difference was observed between groups regarding newborn weight after intervention (p =0.172) or satisfaction with breastfeeding (p =0.484). None of the participants reported any side effects. CONCLUSIONS: Fenugreek increases milk volume but has no significant effect on prolactin levels. Further trials with larger sample sizes should be performed to obtain conclusive results. CLINICAL TRIAL REGISTRATION NUMBER: IRCT20120718010324N62.

Key Findings

On the seventh day of the intervention, milk volume was significantly higher in the fenugreek group than in the placebo group (p =0.017). Nevertheless, no statistically significant difference was observed between groups in milk volume (p =0.073) and prolactin level (p =0.324) on day 15. Moreover, no statistically significant difference was observed between groups regarding newborn weight after intervention (p =0.172) or satisfaction with breastfeeding (p =0.484). None of the participants reporte

Outcomes Measured

  • Requires manual extraction

Population

Field Value
Population See abstract
Sample Size See abstract
Age Range See abstract
Condition See abstract

MeSH Terms

  • Humans
  • Female
  • Trigonella
  • Milk, Human
  • Prolactin
  • Infant, Newborn
  • Adult
  • Infant, Premature
  • Breast Feeding
  • Plant Extracts
  • Galactogogues
  • Lactation
  • Young Adult

Evidence Classification

  • Level: Rct
  • Publication Types: Journal Article, Randomized Controlled Trial
  • Vertical: fenugreek

Provenance


Source extracted via PubMed E-utilities API on 2026-04-10