Health Condition 1: R194- Change in bowel habit
Conditions
Interventions
Intervention1: Lactulose: Osmotic laxative
Liquid medicine: 3.1â??3.7 g in 5 mL of medicine
Children: 0.7 to 2 g/kg/day (1 to 3 mL/kg/day) orally in divided doses daily
generally recommended not to exceed the adult maximum of 40 g/day (60 mL/day)
for 3 month
Control Intervention1: Shudhhi vati: Ayurvedic drug
use in children age 5-10 year @ 200 mg tab , 1 tab /day
Sponsors
National Institute Of Medical Sciences Research Jaipur
Patanjali yogpeeth
Eligibility
Inclusion criteria
Inclusion criteria: 1-Healthy children of either gender between 2-14 years of age . 2-Subject in a good clinical condition as judged by the investigator based on 3-3-3-medical history and physical examination Written informed consent obtained from the subjectâ??s parents or legally acceptable representative
Exclusion criteria
Exclusion criteria: 1-Age less than 2 years and more than 14 years. 2-Children with associated conditions like hypothyroidism, celiac disease, Malnutrition, HIV, Malignancies and Acute or Chronic illnesses will be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average change in passing Frequency & consistency of stool Change in routine activity school going Timepoint: Visit 1: Day 0 â?? Baseline visit Visit 2: Day 7 â?? First follow-up visit Visit 3: One month â?? Second follow-up visit Visit 4: Two month â?? Third follow-up visit Visit 5: Three monthâ?? Fourth follow-up visit Visit 6: Six Month â?? Fifth follow-up visit | — |
Secondary
| Measure | Time frame |
|---|---|
| Passing Blood / Pain/ Distension during trial Find any abnormal investigation parameter during trial Timepoint: 12 Months | — |
Countries
India
Contacts
Public ContactDr Meenaxi Sharma
National Institute Of Medical Sciences & Research Jaipur
Outcome results
None listed