Health Condition 1: K00-K95- Diseases of the digestive system
Conditions
Interventions
Intervention1: Tummy soft drops: 5 drops orally twice daily for 28 days
Control Intervention1: Placebo: 5 drops orally twice daily for 28 days
Sponsors
Tablets India
Eligibility
Inclusion criteria
Inclusion criteria: 1) Infants (age one month to 6 months) fulfilling the Rome-IV diagnostic criteria for infantile colic with no evidence of acute/ chronic illness. 2) Rome-IV diagnostic for clinical research purposes, diagnosis of infantile colic also includes both of the following: Caregiver reports infant has cried or fussed for three or more hours per day during three or more days in 7 days in a telephone or face-to-face screening interview. Total 24-h crying plus fussing in the selected group of infants is confirmed to be three h or more when measured by at least one prospectively kept 24-h behaviour diary. 3) Parents who report their infant crying excessively must be screened on an outpatient basis.
Exclusion criteria
Exclusion criteria: 1) Infants born before completing 34 weeks of gestation or birth weight 2) Infants with known gastrointestinal disorders, previous abdominal surgery, known galactosemia or diabetes mellitus will be excluded from the study. 3) Infants with severe dehydration. 4) Presence of systemic infections. 5) Infants with known immunocompromising morbidities. 6) Infants with severe acute malnutrition. 7) Infants with chronic or severe respiratory, cardiovascular, central nervous system, endocrine and other gastrointestinal disorders on clinical examination. 8) Infants with cystic fibrosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PRIMARY OUTCOME: After a 28-day study, the principal results would be a complete remission of complaints & a decrease in more than 50% of daily crying periods.Timepoint: 28 days | — |
Secondary
| Measure | Time frame |
|---|---|
| SECONDARY OUTCOME: Parental satisfaction on a Likert scale & occurrence of AEs (e.g.Milk regurgitation, vomiting, diarrhoea, constipation). AEs such as illness signs or symptoms that occur or worsen during the study through parental interviews after examining their daily records maintained in the dairy.Timepoint: 28 days | — |
Countries
India
Contacts
Public ContactDr S Siva Sankar
Chettinad hospital and research institute
Outcome results
None listed