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

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000577011

Enrollment

Registered

2010-07-19

Start date

2010-08-23

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

15 Days to 75 Days

Healthy volunteers

Inclusion criteria

It will be studied infants with colic (crying for more than 3 hours on at least three ocasions a week), but otherwise healthy.

Exclusion criteria

Low birth weight and prematurity; Gastrointestinal, neurological or allergic diseases

Outcome results