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A Prospective Observational Study on Clinical Management Practices in Sickle Cell Disease

A Prospective Observational Study on the Documentation of the clinical management practices in the Management of Sickle Cell Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2025/11/098143
Enrollment
30
Registered
2025-11-27
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Health Condition 1: D578- Other sickle-cell disorders

Interventions

Intervention1: Nil: Nil

Sponsors

Central Council for Research in Ayurvedic Sciences, Ministry of Ayush, Govt. of India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Confirmed diagnosis of SCD Patients experiencing recurrent pain crises Willingness to comply with the study protocol and followup schedule Written informed consent obtained

Exclusion criteria

Exclusion criteria: Patients with severe SCD complications requiring immediate intensive care History of blood transfusion in the last 3 months Pregnant or lactating women Patients on other alternative medical therapies for SCD Known hypersensitivity to study medication components

Design outcomes

Primary

MeasureTime frame
Reduction in frequency and severity of pain crises over 6 months (Based on Visual analogue score (VAS), Brief Pain Inventory (BPI), days with home analgesic use) Timepoint: Reduction in frequency and severity of pain crises over 6 months (Based on Visual analogue score (VAS), Brief Pain Inventory (BPI), days with home analgesic use) (Time baseline, 30th dy, 60th day, 90 th day, 120th day, 150th day, 180th day)

Secondary

MeasureTime frame
Change in hemoglobin levels, reticulocyte count, and other hematological markers Reduction in hospitalizations and need for blood transfusions Patient-reported quality of life improvements Change in associated symptoms (fatigue, jaundice, infections, etc.) Safety parameters including liver and renal function testsTimepoint: Change in hemoglobin levels, reticulocyte count, and other hematological markers Reduction in hospitalizations and need for blood transfusions Patient-reported quality of life improvements Change in associated symptoms (fatigue, jaundice, infections, etc.) Safety parameters including liver and renal function tests (0,30,90,180th day)

Countries

India

Contacts

Public ContactProf Dr Pradip Kumar Panda

Sri Sri College of Ayurvedic Science and Research Hospital, Sri Sri University, Cuttack

profpkpanda@gmail.com9777868699

Outcome results

None listed

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