Infantile colic. Other and unspecified abdominal pain
Conditions
Interventions
Intervention 1: The first group (interventional group) was given Pedilact with dose 5 drops per day orally for 4 weeks. Intervention 2: The second group (control group) received placebo with dose 5 dr
Treatment - Drugs
The first group (interventional group) was given Pedilact with dose 5 drops per day orally for 4 weeks.
The second group (control group) received placebo with dose 5 drops per day orally for 4 weeks.
Sponsors
Vice chancellor for research, Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
21 Days to 4 Months
Inclusion criteria
Inclusion criteria: The main inclusion criteria include: the infants with crying at least 3 hours a day; for at least 3 days a week; The main exclusion criteria include: the children with organic gastrointestinal disorders; consumption of any antibiotic, probiotics and formula containing probiotics and other madications for colic before entering the study;
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Duration of crying. Timepoint: on days 7, 21 and 30 after initiation of treatment. Method of measurement: Questionnaire.;Crying day in week. Timepoint: on days 7, 21 and 30 after initiation of treatment. Method of measurement: Questionnaire.;Number of crying and irritability attacks per day. Timepoint: on days 7, 21 and 30 after initiation of treatment. Method of measurement: Questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| Vomiting. Timepoint: On days 7, 21 and 30 after initiation of treatment. Method of measurement: Questionnaire.;Constipation. Timepoint: On days 7, 21 and 30 after initiation of treatment. Method of measurement: Questionnaire.;Skin reactions. Timepoint: On days 7, 21 and 30 after initiation of treatment. Method of measurement: Questionnaire. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactKambiz Eftekhari
Tehran University of Medical Sciences
Outcome results
None listed