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Nitazoxanide for the treatment of in acute rotavirus diarrhea

A Hospital-based Study of Rotaviral Diarrhea and the effect of Nitazoxanide in reducing the severity

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2017/02/007865
Enrollment
50
Registered
2017-02-14
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- Children with acute onset diarrhea of 48 hrs duration, some (mild and moderate) to severe dehydration, and aged between 12 months to 5 years

Interventions

Intervention1: Nitazoxanide: Syrup nitazoxanide administered twice daily (100mg in 12-47 months
200mg in â?¥4 yrs) for 3 days Control Intervention1: Placebo: Similar product (colour and tase being similar) to the active drug being adminstered twice daily for 3 days

Sponsors

Department of Pediatrics HiTech Medical College Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Children with acute onset diarrhea of <48 hrs duration, some (mild and moderate) to severe dehydration, and aged between 12 months to 5 years were eligible for inclusion

Exclusion criteria

Exclusion criteria: Children with dysentery, severe malnutrition (weight for height <3SD of WHO growth-chart), co-existing systemic illnesses and chronic diseases

Design outcomes

Primary

MeasureTime frame
1. Duration (in hrs) of acute diarrheaTimepoint: Time of discharge

Secondary

MeasureTime frame
1. Duration (in hrs) of hospitalizationTimepoint: Time of discharge;2. Duration (in hrs) of vomitingTimepoint: Time of discharge discharge;3. Duration (in hrs) of feverTimepoint: Time of discharge;4. Proportion of children requiring parenteral rehydrationTimepoint: Time of discharge;5. Any adverse effectsTimepoint: Time of discharge

Countries

India

Contacts

Public ContactSamarendra Mahapatro

Hi-Tech Medical College & Hospital

samarendramahapatro@yahoo.com9438884180

Outcome results

None listed

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