A study to assess the safety and efficacy of TumsUP® oral drops in the treatment of baby colic.
Phase 4
Completed
- Conditions
- Health Condition 1: R108- Other abdominal pain
- Registration Number
- CTRI/2020/04/024552
- Lead Sponsor
- Zuventus Healthcare Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Number of children reporting incidences of adverse events. <br/ ><br>2. Investigator and parentâ??s assessment of response to therapy at end of the study. <br/ ><br>Timepoint: 1. Day 7 <br/ ><br>2. Day 7
- Secondary Outcome Measures
Name Time Method 1. Reduction in crying time from baseline to the end of the treatment period. <br/ ><br>2. Reduction in severity of infantile colic symptoms. <br/ ><br>3. Number of children with complete remission. <br/ ><br>Timepoint: 1. Day 0, Day 7 <br/ ><br>2. Day 0, Day 7 <br/ ><br>3. Day 0, Day 7