A study to evaluate the taste and acceptability of Zinc tablets in children with diarrhoea
- Conditions
- Health Condition 1: null- Acute childhood diarrhoea
- Registration Number
- CTRI/2009/091/000592
- Lead Sponsor
- Panacea Biotec Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 320
Children aged less than or equal 3 months to less than 59 months who present in the hospital with more than three unformed stools in 24 hours and diarrheal duration of <7 days will be eligible after written informed consent from their parent/legally acceptable representative (LAR)
-Children with intractable vomiting, pre-renal or renal failure, respiratory distress, altered sensorium or any such co-morbid condition that precludes the use of oral rehydration solution (ORS) will be excluded from the trial
-Child enrolled earlier in this or any other clinical trial in last one month
-Children with severe malnutrition (kwashiorkar and marasmus)
-Children with clinically significant co-morbid condition that in the opinion of the investigator could affect the safety of the subject and efficacy outcome of the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method -To evaluate the acceptability which will be evaluated by the parent/LAR report of his/her child's behavior when given the medication.Timepoint: At the end of study;-To evaluate the adherence: this will be evaluated in relation to the dose given, frequency of daily administration, duration of treatment and preparation.Timepoint: At the end of study
- Secondary Outcome Measures
Name Time Method oneTimepoint: None