survey to examine the acceptability of the product Vitazyme Drops in young child to manage severe pain in the abdomen caused by wind or obstruction in the intestine characterized by high pitch crying, restlessness
- Conditions
- Health Condition 1: K598- Other specified functional intestinal disorders
- Registration Number
- CTRI/2019/04/018561
- Lead Sponsor
- East India Pharmaceutical Works Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
i.Infants & young children of both sexes aged between 1 month and 2 years.
ii.Suffering from symptoms suggestive of indigestion, flatulence, chronic constipation, persistent loose stools or poor appetite in general (as perceived by the parent) with or without colicky abdominal pain.
iii.Parent or legally acceptable representative willing to provide written informed consent.
i.Preterm infants (born before 37 completed weeks of gestation).
ii.Low-birth weight infants (weighing less than 2500 gms at birth).
iii.Concomitant serious medical problems including failure to thrive.
iv.Known lactose intolerance or intolerance to infant feeding formulae (baby food).
v.Suffering from diarrhoea or loose stools which could be of infectious origin.
vi.Suffering from any other symptoms suggestive of an ongoing infection.
vii.Child receiving non-permitted concomitant medication.
viii.Any other condition which in the opinion of the investigator is not conducive towards inclusion of the subject in the study.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method i.Improved digestion & flatulence â?? as judged by the absence of excessive regurgitation, hiccups, belching / eructation, abdominal distension, excessive flatulence, nausea, vomiting. <br/ ><br>ii.Increase in colic-free periods â?? as judged by a reduction in mean daily crying time, particularly during the night.Timepoint: 3 visits in a complete study
- Secondary Outcome Measures
Name Time Method safetyTimepoint: In case of Adverse Event unscheduled visit at any time in the study duration