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Can Atorvastatin Help Recovery After Serious Head Injury? A Clinical Trial at AIIMS Patna

Evaluating the Neuroprotective Effects of Atorvastatin in Moderate to Severe Traumatic Brain Injury- A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/11/097655
Enrollment
122
Registered
2025-11-18
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: V892- Person injured in unspecified motor-vehicle accident, traffic

Interventions

Intervention1: Adding drug to compare if there is any change in the outcome of traumatic brain injury patients: Tab Atorvastatin 20mg P/O OD for 10 days Control Intervention1: Standard of Care: All pa

Sponsors

AIIMS PATNA
Lead Sponsor
SHAMAN SINGH
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1. Isolated TBI 2. GCS-3-12

Exclusion criteria

Exclusion criteria: 1. Polytrauma with life threatening Extracranial injuries. 2. Pre existing statin therapy or contraindications to statins (e.g., hepatic dysfunction, myopathy). 3 Severe hepatic or renal impairment. 4 Pregnancy or lactation. 5 Patients with penetrating head injuries or prior neurosurgical interventions. 6 Patients or guardians unwilling to participate. 7 Patients requiring surgical intervention.

Design outcomes

Primary

MeasureTime frame
1. To compare the rate of reduction in contusion volume in TBI patients with statin therapy vs placebo 2. To assess and compare the rates of improvement in GOS-E and DRS in patients with statins vs placebo 3. To evaluate and compare the duration of in-hospital stay in patients receiving statins vs placebo Timepoint: 1. At 1,3,7 and 10 days 2. At 4 weeks and 9 weeks

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactShaman Singh

AIIMS PATNA

dranil4@gmail.com9835699103

Outcome results

None listed

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