Skip to content

Simethicone-Fennel oil (anti-foaming agent) vs Indian Hammock (also known as thooli) intervention in the prevention of functional gastrointestinal disorders in early infants: an open-labelled, randomized controlled trial

Simethicone-Fennel oil vs Indian Hammock intervention in the prevention of functional gastrointestinal disorders in early infants: an open-labelled, randomized controlled trial - NIL

Status
Active, not recruiting
Phases
Phase 1Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/057220
Enrollment
240
Registered
2023-09-01
Start date
Unknown
Completion date
Unknown
Last updated
2023-09-18

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

Conditions

Health Condition 1: K00-K95- Diseases of the digestive system

Interventions

Intervention1: Simethicone-Fennel Oil: Simethicone is an anti-foaming substance that helps to decrease abdominal bloating, uneasiness, and cramps created by abundant gas. Its main mechanism of action

Sponsors

Noorul Aina
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The term neonates with gestational age between 37 and 42 weeks of life and weighing between 2500 and 4000 grams at birth were included

Exclusion criteria

Exclusion criteria: Infants who were aged less than 37 weeks (pre-term), more than 42 weeks (post-term), with existing gastrointestinal disorders, comorbidities, and history of Neonatal Intensive care unit (NICU) admission, and parents who did not consent were excluded from the present study.

Design outcomes

Primary

MeasureTime frame
the expected outcome is the reduction of the incidence of FGID episodes in the intervention group compared to the control groupTimepoint: 6 weeks, 10 weeks, 14 weeks and 5 months

Secondary

MeasureTime frame
the secondary outcome is the reduction of the number of FGID episodes all the 3 groupsTimepoint: 5 months

Countries

India

Contacts

Public ContactNoorul Aina

Chettinad hospital and Research Institute

paedsalex@gmail.com9551607900

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026