Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00029250
Status:
WITHDRAWN
Last Update Posted:
2013-03-22
First Post:
2002-01-09
Brief Title:
Garlic in Hyperlipidemia Caused by HAART
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Phase II Randomized Double-blind Placebo-controlled Dose-escalation Study on the Effects of Garlic on Hyperlipidemia Induced by HAART in HIV-positive Individuals
Status:
WITHDRAWN
Status Verified Date:
2013-03
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:
The purpose of this study is to test the effectiveness and tolerability of garlic pills in lowering cholesterol and triglycerides in hyperlipidemic HIV-infected individuals who are being treated with highly active antiretroviral therapy HAART
Detailed Description:
Clinical evaluation of garlic in HIV disease is warranted for several reasons First garlic is used as a botanical medicine and as an alternative therapy by many HIV-infected individuals Baseline data from the Bastyrs Alternative Medicine Care Outcomes in AIDS AMCOA study 1 indicate that garlic is the most frequently used botanical medicine among HIV-infected men and women 529 who utilize complementary and alternative medicine CAM In the same cohort 50 of the subjects who use antiretroviral therapy are also taking garlic supplements Second there is a growing body of studies that indicate that garlic exhibits lipid and glucose lowering as well as hepato-protective activities Third several of the pharmacological activities of garlic and their reported clinical benefits in other conditions especially in hyperlipidemia may be relevant in the management of highly active antiretroviral therapy HAART in HIV-infected subjects
Study Medication We will utilize GarlicinTM an allicin-standardized dried garlic supplement in two escalating doses in HIV-infected subjects who are receiving HAART
Study Medication We will utilize GarlicinTM an allicin-standardized dried garlic supplement in two escalating doses in HIV-infected subjects who are receiving HAART
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None