Peppermint versus dimethicone in the treatment of infantile colic: a randomized clinical trial
A randomized controlled crossover study comparing the clinical response of Peppermint against Dimethicone in infants with colic
Hebron Farmaceutica
25 participants
Aug 23, 2010
Interventional
Conditions
Summary
Randomized clinical trial to determine the efficacy of Peppermint in infantile colic. It will be a crossover study with one week of intervention of each treatment (Peppermint vs dimethicone). It will be studies 30 healthy infants.
Eligibility
Inclusion Criteria1
- It will be studied infants with colic (crying for more than 3 hours on at least three ocasions a week), but otherwise healthy.
Exclusion Criteria2
- Low birth weight and prematurity;
- Gastrointestinal, neurological or allergic diseases
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Interventions
The intervention will be the administration of Peppermint for the treatment of infantile colic. The drug will be administered orally during the episode of colic, up to four times daily. The dosage will be 20 mg/Kg administered in the form of drops. Peppermint and dimethicone will be administered for one week each in a randomised order with wash-out period of 24 hours. The duration of the follow-up of the intervention/control will be two weeks.
Locations(1)
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ACTRN12610000577011