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Clinical , Economic and Humanistic Outcomes of Suspected Adverse Drug Reactions among In-Patients in a Tertiary Care Hospital

Monitoring Suspected Adverse Drug Reactions among In-Patients in a Tertiary Care Hospital: An Outcomes Research Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2019/04/018776
Enrollment
500
Registered
2019-04-24
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: R00-R99- Symptoms, signs and abnormal clinical and laboratory findings, not elsewhere classified

Interventions

None listed

Sponsors

Shatavisa Mukherjee
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Those encountering one or more adverse drug reaction during their hospital stay 2. Those being admitted with adverse drug reaction

Exclusion criteria

Exclusion criteria: 1. Those not providing informed consent for participation in the study

Design outcomes

Primary

MeasureTime frame
1. Clinical Outcomes: Suspected medications, treatment given, clinical outcome 2. Economic Outcomes: Direct healthcare cost - Facility expenses, Treatment expenses Direct Non Healthcare cost â?? Travel cost of patient and caregiver(s) Non-direct Healthcare Cost â?? Lost Wages 3. Humanistic Outcomes - Health Related Quality of Life assessed in patients encountering ADRs. Impact of ADRs on caregiver assessed. Timepoint: For the entire length of stay. Follow up for 4 weeks post discharge over telephone or visit to facility

Secondary

MeasureTime frame
1. Association of economic and humanistic burden with clinical proforma of ADRsTimepoint: For the entire length of stay. Follow up for 4 weeks post discharge over telephone or visit to facility

Countries

India

Contacts

Public ContactShatavisa Mukherjee

School of Tropical Medicine Kolkata

shatavisa100@gmail.com

Outcome results

None listed

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