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To check for the effect of hydroxyurea on inflammation among adults with sickle cell disease

Evaluation of effect of hydroxyurea on inflammatory markers and oxidative stress markers among adults with sickle cell disease: A prospective observational study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/04/083830
Enrollment
30
Registered
2025-04-01
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Health Condition 1: D648- Other specified anemias

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

All India Institute of Medical Sciences Nagpur
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Newly diagnosed sickle cell disease patients using HPLC & who are not on hydroxyurea for past 1month

Exclusion criteria

Exclusion criteria: 1 Alcoholic with 2 or more positive CAGE questionnaire 2 Pregnant females 3 Any significant complications (ACS, Sequestration crisis, CKD etc.) 4 Smokers with more than 20 pack years 5 Presence of infectious diseases (Pneumonia, Meningitis, bacterial sepsis etc.)

Design outcomes

Primary

MeasureTime frame
1 Evaluation in change of inflammatory biomarkers with treatment using hydroxyurea at baseline and 6months. 2 Evaluation in change of oxidative stress markers with treatment using hydroxyurea at baseline and 6months. Timepoint: 1 Evaluation in change of inflammatory biomarkers with treatment using hydroxyurea at baseline and 6months. 2 Evaluation in change of oxidative stress markers with treatment using hydroxyurea at baseline and 6months.

Secondary

MeasureTime frame
1 Association of clinical parameters (Number of VOC, Number of blood transfusions, Number of hospital admissions) with biomarkers (inflammatory & biomarkers) at 6 months of hydroxyurea therapy 2 Evaluation in change in haematological parameters (HbF, HbS, CBC for leucocyte count) with treatment using hydroxyurea at baseline & at 6months 3 Evaluation of compliance to hydroxyurea treatment in the 6 months duration 4 Evaluation of ADR with hydroxyurea therapy in the 6 months duration 5 Assessment of change in quality of life using SF-36 questionnaire at baseline & at 6 months Timepoint: 6months

Countries

India

Contacts

Public ContactBattina Anusha

AIIMS Nagpur

dr.ssborkar@aiimsnagpur.edu.in9769153876

Outcome results

None listed

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