Vascular Endothelial Protection Effects of Dextromethorphan
To test the hypothesis that DM could have anti-inflammatory effect and thus achieve vascular protection effect on heavy smokers.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Anti-Inflammation & Vascular Endothelial Protection Effects of Dextromethorphan on Heavy Smoker|
- Endothelial function [ Time Frame: 1, 2, 3 and 6 month ] [ Designated as safety issue: No ]
- Surrogate end-points of the study: hs-CRP, sPLA2, matrix metalloproteinase-3, interleukin-6, tumor necrosis factor-alfa receptor II, GSH-Px, and urinary excretion of 8-PGF2alfa [ Time Frame: 1, 2, 3 and 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||March 2005|
|Study Completion Date:||December 2005|
|Primary Completion Date:||December 2005 (Final data collection date for primary outcome measure)|
120 mg/day, single once daily dose taken after breakfast by oral route
Other Name: medicon for DM
Dextromethorphan (DM), an ingredient widely used in antitussive remedies, had been reported to reduce the inflammation-mediated degeneration of neurons. We recently found that DM can prevent vascular remodeling and neuron injury in animal models of carotid ligation and cerebral ischemia injuries, respectively. It was believed that its action was through the anti-oxidant and NADPH pathway to protect brain cells. However, the mechanism and actual effect on human vascular protection remained unclear.
To test the hypothesis that DM could have anti-inflammatory effect and thus achieve vascular protection effect on heavy smokers, this prospective study will be conducted to treat subjects with heavy smoking history with DM or not and evaluate the anti-inflammatory and the improvement of endothelial function.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00605605
|National Cheng Kung University Hospital|
|Tainan, Taiwan, 704|
|Principal Investigator:||Ping-Yen Liu, MD, PhD||Assiatant Professor of National Cheng Kung University Medical Center|