Clinical Trials Directory

Trials / Completed

CompletedNCT00002149

Acupuncture and Herbal Treatment of Chronic HIV Sinusitis

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
40 (planned)
Sponsor
Immune Enhancement Project · Academic / Other
Sex
All
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

Summary

To compare Traditional Chinese Medicine versus standard antibiotic therapy consisting of pseudoephedrine ( Sudafed ) plus amoxicillin / clavulanate potassium combination ( Augmentin ) in reducing symptoms and recurrence of acute HIV-related sinusitis. Chronic sinusitis in HIV-infected individuals is a recurrent and persistent infection with potentially serious complications: it can exacerbate pulmonary disease, cause recurrences of life-threatening sepsis, and progress to central nervous system involvement. Symptoms of sinusitis in HIV patients are often refractory to aggressive Western medical management, and antibiotic intolerance can occur. Traditional Chinese Medicine consisting of acupuncture and herbal treatment may provide a low-risk, low-cost alternative to conventional antibiotic therapy.

Detailed description

Chronic sinusitis in HIV-infected individuals is a recurrent and persistent infection with potentially serious complications: it can exacerbate pulmonary disease, cause recurrences of life-threatening sepsis, and progress to central nervous system involvement. Symptoms of sinusitis in HIV patients are often refractory to aggressive Western medical management, and antibiotic intolerance can occur. Traditional Chinese Medicine consisting of acupuncture and herbal treatment may provide a low-risk, low-cost alternative to conventional antibiotic therapy. Patients are randomized to receive either Traditional Chinese Medicine (acupuncture and herbal treatment) or conventional antibiotic therapy (Sudafed and Augmentin). Treatment continues for 8 weeks, followed by a 4 week washout, with final follow-up at week 12. Patients must undergo endoscopic nasal exam and CT scan of paranasal sinus prior to study entry and at week 12.

Conditions

Interventions

TypeNameDescription
DRUGClavulanate potassium
DRUGPseudoephedrine hydrochloride
DRUGAmoxicillin trihydrate

Timeline

First posted
2001-08-31
Last updated
2005-06-24

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00002149. Inclusion in this directory is not an endorsement.