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A observational Data collection study on monitoring the drug safety in paediatric population.

A Non-Interventional Data collection study on pharmacovigilance to improve the drug safety in paediatric population. - NIL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2023/08/056666
Enrollment
150
Registered
2023-08-21
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Health Condition 1: Z762- Encounter for health supervision and care of other healthy infant and child

Interventions

Intervention1: NIL: NIL

Sponsors

Mr D Naga Satish Babu
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Healthy male and female subjects of age below 13 years Subject Parents Should Willing to sign written informed consent and comply with study protocol Subject Parents Should Willing to give their child past & current medical history Subject Parents Should accept to answer the questionnaires as per protocol

Exclusion criteria

Exclusion criteria: Subjects who are having past history of chronic diseases Subjects who are currently using any medication for chronic Diseases

Design outcomes

Primary

MeasureTime frame
As the study was observational and single visit data collection main outcome of the study is to find out the ways of avoiding adverse events using knowledge based questionnaires collected from children parents and Naranjo Adverse Event probability scale which used to record the Probability of Adverse Events Timepoint: As the study was observational and single visit data collection there was no Time points designed and only single visit data recording based on past and current medical histories

Secondary

MeasureTime frame
The Secondary End Point is to improve the pharmacovigilance to minimize Adverse Events by identifying its route cause of AE in paediatric population.Timepoint: The Secondary End Point is to improve the pharmacovigilance to minimize Adverse Events by identifying its route cause of AE in paediatric population.

Countries

India

Contacts

Public ContactD Naga Satish Babu

Sun Rise University

drctresearch@gmail.com7893062708

Outcome results

None listed

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