drugset / Trial / NCT03845322

Curcumin/Turmeric as a Treatment for Patients With Subdural Hematomas Recurrence

NCT03845322

Phase 0 Withdrawn University of New Mexico
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Our long-term objective is to evaluate the efficacy of curcumin (CC) in preventing a recurrence of chronic subdural hematoma (cSDH) following surgical evacuation. Recurrence is defined as an increase in total hematoma volume on the operated side compared to a post-operative day one CT scan with persistent or recurrent neurological symptoms. The investigators propose this pilot study to assess feasibility and obtain preliminary benefit assessment of the proposed therapeutic approach. Objective 1: To determine if the use of CC treatment reduces the total hematoma cavity volume over a 6-month interval, compared to a post-subdural drain removal CT scan. This evaluation is expected to offer sufficient evidence for a larger definitive trial. Objective 2: Study the effect of CC on interleukin-8 (IL-8)-induced disruption of endothelial permeability in vitro using human vascular endothelial cells. Central hypothesis: CC treatment prevents the re-accumulation of cSDH, which may occur by inhibition of IL-8 and allowing resolution of the total hematoma cavity volume over six months.

Timeline

Start
2018-12-18
Primary completion
2020-02-26
Completion
2020-02-26

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Curcumin Small molecule 270 mg Oral
Background Piperine Other / unclassified 3 mg Oral

Indications

No indication recorded.