Vascular Endothelial Protection Effects of Dextromethorphan

Sponsor

National Cheng-Kung University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT00605605

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

4.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To test the hypothesis that DM could have anti-inflammatory effect and thus achieve vascular protection effect on heavy smokers.

Condition or Disease	Intervention/Treatment	Phase
Atherosclerosis Smoking Inflammation	Drug: Dextromethorphan	Phase 4

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Anti-Inflammation & Vascular Endothelial Protection Effects of Dextromethorphan on Heavy Smoker

Study Start Date :

Mar 1, 2005

Actual Primary Completion Date :

Dec 1, 2005

Actual Study Completion Date :

Dec 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: Dextromethorphan 120 mg/day, single once daily dose taken after breakfast by oral route Other Names: medicon for DM

Arm

Intervention/Treatment

Experimental: 1

Drug: Dextromethorphan

120 mg/day, single once daily dose taken after breakfast by oral route

Other Names:

medicon for DM

Outcome Measures

Primary Outcome Measures

Endothelial function [1, 2, 3 and 6 month]

Secondary Outcome Measures

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 [1, 2, 3 and 6 months]