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A study to evaluate the taste and acceptability of Zinc tablets in children with diarrhoea

AN OPEN LABEL STUDY TO EVALUATE THE ACCEPTABILITY OF AND ADHERENCE TO ZINC THERAPY IN THE TREATMENT OF ACUTE CHILDHOOD DIARRHEA

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2009/091/000592
Enrollment
320
Registered
2009-08-07
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Acute childhood diarrhoea

Interventions

Intervention1: Zinc Dispersible Tablets: 10 mg and 20 mg tablet. Duration 10 days Control Intervention1: None: None

Sponsors

Panacea Biotec Limited
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: -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.

Design outcomes

Primary

MeasureTime frame
-To evaluate the acceptability which will be evaluated by the parent/LAR report of his/her child&#039;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

MeasureTime frame
NoneTimepoint: None

Countries

India

Contacts

Public ContactDr Arani Chatterjee
aranichatterjee@panaceabiotec.com011-41679000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026