Health Condition 1: null- Functional constipation
Conditions
Interventions
Intervention1: Straw containing Sennoside with Probiotic: Straw Containing Sennoside and EBC probiotic for Treatment of Functional constipation
Sponsors
Inzpera Healthsciences Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children between the age group 5-12 years of age. (Both inclusive) 2. Children suffering from functional constipation diagnosed with Rome III criteria. 3. Parents or legal guardians willing to sign written informed consent form for the child. 4. Children and parents / Guardians who agree to comply with study requirement and schedule.
Exclusion criteria
Exclusion criteria: 1) Children having constipation secondary to any of other disorder like hypothyroidism, hirschprungâ??s disease and structural anomalies of anal canal. 2) Children suffering from any type of infection having fever. 3) Children not fulfilling Rome III criteria for functional constipation. 4) Inability to keep return appointments. 5) Children having sensitivity reaction to components of study medication (Sennoside with probiotic). 6) Children with Type I diabetes.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in ROME III criteria scoreTimepoint: day 1 day 3 day 6 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Bristol stool gradingTimepoint: day 1 day 3 day6;Global assessment of efficacy and tolerabilityTimepoint: day 6 | — |
Countries
India
Contacts
Public ContactDr Nilesh Hol
AnaZeal Analyticals and Research Pvt.Ltd.
Outcome results
None listed