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IRCT20140817018828N5 IRCT 2018-06-18 Yazd University of Medical Sciences Effect of will fumitory on infantile colic Study of the effect of Fumaria parviflora Lam. aqueous extract versus simethicone on infantile colic 2017-04-21 anticipated 52 Complete https://irct.ir/trial/31279 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Restricted randomization based on random allocation rule where among 52 patients included, 26 were assigned to receive extract by lot and the remaining were assigned to simethicone group.Randomization was concealed in sequentially numbered, sealed, opaque envelopes, Blinding description: Patients; Statiscian; The author responsible for gathering data. 2-3 Infantile colic. Intervention 1: Intervention group: fumitory extract group. Intervention 2: Intervention group: simethicone group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is information not available
public Alimohamad Ranjbar Jamal abadi
Professor Hesabi Blvd, Yazd, Iran
Yazd Iran (Islamic Republic of) 8917693571 +98 35 3820 3409 amranjbar@razi.tums.ac.ir Yazd University of Medical Sciences scientific Mahmood Noori Shadkam
Yazd, Ba Honar square
Yazd Iran (Islamic Republic of) 8917693571 +98 35 1724 4551 mahmood7072005@yahoo.com Yazd University of Medical Sciences Iran (Islamic Republic of) 3 to 16 weeks age Cry-fuss behavior that lasted ≥3 hours a day for ≥3 days in the 1 week before enrollment 21 days 120 days Both Evidence of gastrointestinal disorders or chronic illness Receiving other drugs for colic treatment K20-K31 Diseases of oesophagus, stomach and duodenum Treatment - Drugs Treatment - Drugs Intervention group: fumitory extract group Intervention group: simethicone group Infant crying duration. Timepoint: before enrollment-day 10 from baseline. Method of measurement: daily diary to assess crying duration. Number of respondends. Timepoint: day 10 from baseline. Method of measurement: Number of infants who experienced≥50% reduction in average crying duration. Yazd university of medical sciences Approved 2016-10-16 Ethics committee of Yazd University of Medical Sciences Ba Honar square Yazd Yazd Iran (Islamic Republic of)