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A study to assess the safety and efficacy of TumsUP® oral drops in the treatment of baby colic.

An open label, multicentric, prospective study to evaluate the safety and efficacy of fixed dose combination of Simethicone 40 mg, Dill Oil 0.005 mL, Fennel Oil 0.0007 mL oral drops in the treatment of infantile colic.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/04/024552
Enrollment
200
Registered
2020-04-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: R108- Other abdominal pain

Interventions

Intervention1: Fixed Dose Combination of Simethicone 40 mg, Dill Oil 0.005 mL, Fennel Oil 0.0007 mL oral drops.: Infants (Below 6 months): 5-10 drops 4 times daily, 15 minutes before feed. Infants (6-

Sponsors

Zuventus Healthcare Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children from 2 weeks to 2 years of age. 2. Healthy children with a diagnosis of infantile colic symptoms observed > 3 hours per day, occurring on > 3 days in a week. 3. Parents of the children willing to give informed consent.

Exclusion criteria

Exclusion criteria: 1. Children with currently diagnosed illness or gastrointestinal disorders. 2. Children having fever. 3. Children suffering from any infection. 4. Children having history of hyperbilirubinemia. 5. Children having congenital anomalies or illness.

Design outcomes

Secondary

MeasureTime frame
1. Reduction in crying time from baseline to the end of the treatment period. 2. Reduction in severity of infantile colic symptoms. 3. Number of children with complete remission. Timepoint: 1. Day 0, Day 7 2. Day 0, Day 7 3. Day 0, Day 7—

Primary

MeasureTime frame
1. Number of children reporting incidences of adverse events. 2. Investigator and parentâ??s assessment of response to therapy at end of the study. Timepoint: 1. Day 7 2. Day 7—

Countries

India

Contacts

Public ContactDr Bhupesh Dewan

Zuventus Healthcare Limited

Bhupesh.Dewan@zuventus.com022-30610000

Outcome results

None listed

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