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Vascular Endothelial Protection Effects of Dextromethorphan

NCT ID: NCT00605605

Last Updated: 2008-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2005-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Atherosclerosis Smoking Inflammation

Keywords

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endothelial function atherosclerosis smoking inflammation antioxidant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Dextromethorphan

Intervention Type DRUG

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

Interventions

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Dextromethorphan

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

Intervention Type DRUG

Other Intervention Names

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medicon for DM

Eligibility Criteria

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Inclusion Criteria

* healthy male volunteers who are currently smoking

Exclusion Criteria

* personal history of hypertension or diabetes mellitus
* family history with
* documented premature cardiovascular events
* cardiovascular-associated sudden death
* total cholesterol \> 240 mg/dL
* triglyceride \> 200 mg/dL
* low-density lipoprotein \> 160 mg/dL.
Minimum Eligible Age

30 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Cheng-Kung University Hospital

OTHER

Sponsor Role lead

Responsible Party

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National Cheng-Kung University Medical Center

Principal Investigators

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Ping-Yen Liu, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assiatant Professor of National Cheng Kung University Medical Center

Locations

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National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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91-B-FA09-2-4 grant number

Identifier Type: -

Identifier Source: secondary_id

HR-93-28

Identifier Type: -

Identifier Source: org_study_id