Skip to main content
OpenTrials
Completed

NCT Number: NCT00605605

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Behavior Cardiovascular Diseases Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Smoking Vascular Diseases

Age range

30 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 4

Primary location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dextromethorphan

Drug

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

Other names: medicon for DM

Primary outcomes

  1. Endothelial function

    Time frame: 1, 2, 3 and 6 month

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Jan 31, 2008
Registry last updated
Jan 31, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.