Health Condition 1: K590- Constipation
Conditions
Interventions
Intervention1: HCLX031706: Herbal syrup for treating constipation for children aged 3 to 12 years
Intervention2: HCLX031706: herbal laxative syrup to drink orally to relieve constipation for children
Sponsors
The Himalaya Drug Company
Eligibility
Inclusion criteria
Inclusion criteria: 1. Paediatric subjects aged between >=3 years to 2. Pediatric subjects clinically diagnosed with Functional Constipation as per ROME III criteria. 3. Parents/caregivers willing to consent for the participation of their child. 4. Child >= 7 years willing to assent for its participation in the study.
Exclusion criteria
Exclusion criteria: 1. Pediatric subjects with any clinically significant systemic illness requiring long term medication. 2. A known history or present condition of allergic response to products its components or to any of the ingredients in the test product 3. Pediatric Subjects treated with any laxatives, 2 weeks prior to screening and are experiencing the laxative effect. 4. Pediatric Subjects on any drugs which can induce constipation especially opioid induced constipation (OIC) will be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase in the total number of stools per day at day 7 as compared to baseline. Improvement in the stool consistency at day 7 as compared to baseline Timepoint: 7 Days Study. To Check the overall improvement from day 1 to Day 7. | — |
Secondary
| Measure | Time frame |
|---|---|
| Global assessment of efficacy based on the evaluation of severity of functional constipation as compared to the baseline using the 4-point rating scale as below; Improvement in the associated symptoms like irritability, loss of appetite and abdominal bloating at the end of the study or the early satiety(which disappear following the passage of a large stool Timepoint: 7 days | — |
Countries
India
Contacts
Public ContactDr Palaniamma
The Himalaya Drug Company
Outcome results
None listed