Not Yet RecruitingPhase 3ACTRN12610000577011

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


Sponsor

Hebron Farmaceutica

Enrollment

25 participants

Start Date

Aug 23, 2010

Study Type

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

Sex: Both males and femalesMin Age: 15 DayssMax Age: 75 Dayss

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 wi

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)

Pernambuco, Brazil

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