A randomized double-blind placebo-controlled trial of a standardized extract of Matricariae recutita, Foeniculum vulgare and Melissa officinalis (ColiMil) in the treatment of breastfed colicky infants

Phytother Res. 2005 Apr;19(4):335-40. doi: 10.1002/ptr.1668.


Objective: The aim of this randomized, double-blind, placebo-controlled trial was to investigate the effectiveness and side effects of a phytotherapeutic agent with Matricariae recutita, Foeniculum vulgare and Melissa officinalis in the treatment of infantile colic.

Methods: 93 breastfed colicky infants were enrolled, the diagnosis was made according to Wessel's criteria. After a 3 day observation period, the infants were randomly divided into two groups, one treated with phytotherapeutic agent (PA) and the other with placebo twice a day for 1 week. Crying time and side effects were recorded.

Results: 88 infants completed the trial: 41 in the PA group and 47 in the control. The daily average crying time for the PA was 201.2 min/day (SD 18.3) at the baseline and 76.9 min/day (SD 23.5) at the end of the study; for the placebo it was 198.7 min/day (SD 16.9) and 169.9 min/day (SD 23.1) (p < 0.005). Crying time reduction was observed in 85.4% subjects for the PA and in 48.9% subjects for the placebo (p < 0.005). No side effects were reported.

Conclusion: The present study shows that colic in breastfed infant improves within 1 week of treatment with an extract based on Matricariae recutita, Foeniculum vulgare and Melissa officinalis.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Breast Feeding
  • Colic / drug therapy*
  • Colic / pathology
  • Double-Blind Method
  • Drug Administration Schedule
  • Female
  • Foeniculum
  • Humans
  • Infant
  • Infant, Newborn
  • Male
  • Melissa
  • Pain Measurement
  • Parasympatholytics / administration & dosage
  • Parasympatholytics / therapeutic use*
  • Phytotherapy*
  • Plant Extracts / administration & dosage
  • Plant Extracts / therapeutic use*
  • Plants, Medicinal*
  • Prospective Studies
  • Severity of Illness Index
  • Treatment Outcome


  • Parasympatholytics
  • Plant Extracts