Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000577011
Ethics application status
Approved
Date submitted
13/07/2010
Date registered
19/07/2010
Date last updated
19/07/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Peppermint versus dimethicone in the treatment of infantile colic: a randomized clinical trial
Scientific title
A randomized controlled crossover study comparing the clinical response of Peppermint against Dimethicone in infants with colic
Secondary ID [1] 252207 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infantile colic 257737 0
Condition category
Condition code
Oral and Gastrointestinal 257911 257911 0 0
Inflammatory bowel disease
Reproductive Health and Childbirth 257921 257921 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 256801 0
Treatment: Drugs
Intervention code [2] 256816 0
Treatment: Other
Comparator / control treatment
The control group will be given Dimethicone, a drug commonly used to control infantile colic. The drug also will be administered orally during the episode of colic, up to four times daily for a period of one week. The dosage will be 20 mg/Kg administered in the form of drops. The duration of the follow-up of the intervention/control will be two weeks.
The washout period before participants are crossed over to receive the other treatment studied in this trial will be 24 hours.
Control group
Active

Outcomes
Primary outcome [1] 258772 0
Crying time. It will be assessed by a stopwatch previously provides to parents.
Timepoint [1] 258772 0
Minutes per day at baseline and 1 week after intervention
Secondary outcome [1] 264832 0
Number of daily episodes of colic noted by parents.
Timepoint [1] 264832 0
At baseline and 1 week after intervention

Eligibility
Key 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.
Minimum age
15 Days
Maximum age
75 Days
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Low birth weight and prematurity;
Gastrointestinal, neurological or allergic diseases

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
25
Accrual to date
Final
Recruitment outside Australia
Country [1] 2760 0
Brazil
State/province [1] 2760 0
Pernambuco

Funding & Sponsors
Funding source category [1] 257281 0
Commercial sector/Industry
Name [1] 257281 0
Hebron Farmaceutica
Country [1] 257281 0
Brazil
Primary sponsor type
Commercial sector/Industry
Name
Hebron Farmaceutica
Address
Av Lins Petit 320/11 Edf. Boa Vista
CEP: 50070-230
Recife - PE
Country
Brazil
Secondary sponsor category [1] 256526 0
Hospital
Name [1] 256526 0
Instituto de Medicina Integral Prof Fernando Figueira (IMIP)
Address [1] 256526 0
Rua dos Coelhos, 300
Boa Vista
CEP: 50070-550
Recife - PE
Country [1] 256526 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259306 0
Instituto de Medicina Integral Prof Fernando Figueira (IMIP)
Ethics committee address [1] 259306 0
Rua dos Coelhos, 300 - Boa Vista
CEP: 50070-550
Recife - PE
Ethics committee country [1] 259306 0
Brazil
Date submitted for ethics approval [1] 259306 0
10/11/2008
Approval date [1] 259306 0
08/07/2009
Ethics approval number [1] 259306 0
1/09/1451

Summary
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.
Trial website
www.imip.org.br
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31389 0
Address 31389 0
Country 31389 0
Phone 31389 0
Fax 31389 0
Email 31389 0
Contact person for public queries
Name 14636 0
Marcio Gueiros
Address 14636 0
Av Lins Petit 320/11 - Boa Vista
CEP: 50070-230
Recife - PE
Country 14636 0
Brazil
Phone 14636 0
+558133669294
Fax 14636 0
Email 14636 0
[email protected]
Contact person for scientific queries
Name 5564 0
Joao Guilherme Bezerra Alves
Address 5564 0
Rua dos Coelhos, 300 - Boa Vista
CEP: 50070-550
Recife - PE
Country 5564 0
Brazil
Phone 5564 0
+558199746351
Fax 5564 0
Email 5564 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
New Record*Study results articleYeshttps://doi.org/10.1155/2012/981352 Evid Based Complement Alternat Med . 2012:201... [More Details]

Documents added automatically
No additional documents have been identified.