Fumaria parviflora Lam. Aqueous Extract Versus Simethicone in the Treatment of Infantile Colic: A Prospective Randomized Clinical Trial
Vahid Ramezani1, Mahmood Noori Shadkam2, Mobina Ghiasirad3, Sayedeh Ebrahimi3, Ali Mohammad Ranjbar3,4★★ Corresponding author
- 1Department of Pharmaceutics, Faculty of Pharmacy, Traditional Pharmacy and Pharmaceutical Sciences Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, IRAN.
- 2Department of Pediatrics and Mother and Newborn Health Research Center, Shahid Sadoughi University of Medical Sciences, Yazd, IRAN.
- 3Department of Pharmacognosy, Faculty of Pharmacy, Shahid Sadoughi University of Medical Sciences, Yazd, IRAN.
- 4Department of Pharmacognosy, Traditional Pharmacy and Pharmaceutical Sciences Research Center, Faculty of Pharmacy, Shahid Sadoughi University of Medical Sciences, Yazd, IRAN.
CORRESPONDENCE
Ali Mohammad Ranjbar
1Department of Pharmacognosy, Faculty of Pharmacy, Shahid Sadoughi University of Medical Sciences, Yazd, IRAN. 2Department of Pharmacognosy, Traditional Pharmacy and Pharmaceutical Sciences Research Center, Faculty of Pharmacy, Shahid Sadoughi University of Medical Sciences, Yazd, IRAN.
Received: 13-08-2024; Revised: 22-01-2025; Accepted: 07-05-2025.
Volume 17, Issue 3 · pp. 867–872 · PUBLISHED Jul-Sep 2025 · DOI: 10.5530/pres.20251909
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ABSTRACT
Background infantile colic observes 10 to 40% of infants during first few months of life. Objectives The purpose of the present study was to evaluate the effectiveness of Fumaria parviflora Lam. (will fumitory) aqueous extract on infantile colic. Materials and Methods A total of 52 breastfed infants suffering from infantile colic were randomly assigned to two groups. Will fumitory group and simethicone group received will fumitory extract and simethicone for 10 days, respectively. During the period of study, changing in infants’ colic symptoms including duration of crying, stooling frequency and consistency as well as probable side effects were inquired every day from the parents. Results The reduction in daily crying duration (<50%) was significantly in will fumitory group (25 vs. 6; p<0.001) as well as cure rate of 100% in this group. There were no significant differences in weight gain, stooling frequency, incidence of constipation, diarrhea and regurgitation between two groups (p>0.05). No adverse effects related to will fumitory and simethicone group were observed. Conclusion Will fumitory make a considerable improvement in colic related crying in comparison with simethicone. It was also well tolerable by infants suggesting as a new therapeutic approach in infantile colic.
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Ramezani, V., Shadkam, M. N., Ghiasirad, M., Ebrahimi, S., & Ranjbar, A. M. (2025). Fumaria parviflora Lam. Aqueous Extract Versus Simethicone in the Treatment of Infantile Colic: A Prospective Randomized Clinical Trial. Pharmacognosy Research, 17(3), 867–872. https://doi.org/10.5530/pres.20251909
