Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00002149
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
Acupuncture and Herbal Treatment of Chronic HIV Sinusitis
Sponsor:
Immune Enhancement Project
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
Acupuncture and Herbal Treatment of Chronic HIV Sinusitis
Status:
COMPLETED
Status Verified Date:
1997-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: