Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00246363
Status:
COMPLETED
Last Update Posted:
2011-09-15
First Post:
2005-10-27
Brief Title:
A Clinical Research Study Designed To Determine If Treatment of Hepatitis C With Milk Thistle is More Effective Than No Treatment In Patients Infected With Both HIV And Hepatitis C
Sponsor:
Henry Sacks
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
A Pilot Randomized Placebo-Controlled Trial Designed to Determine the Tolerability and Efficacy of Silymarin Milk Thistle vs Placebo for the Treatment of Chronic Hepatitis C in HIV Infected Patients
Status:
COMPLETED
Status Verified Date:
2011-09
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:
There is some information available that indicates that Milk Thistle is an effective treatment for liver disease This study will compare Milk Thistle with a placebo a medicine that looks just like Milk Thistle but does not contain any Milk Thistle to see if people with both Hepatitis C and HIV infections show improvement or cure of Hepatitis C The study will last one year
Detailed Description:
Patients with many different diseases are requesting information from health care providers physicians and nurses about alternative therapies The paucity of evidence based information requires that rigidly structured clinical trials comparing dietary supplements herbal products and other alternative modalities with either placebo or standard of care be conducted in a timely fashion There is a body of evidence that Silymarin is both well tolerated and efficacious for the treatment of Hepatitis C In patients co-infected with HIV HCV treatment choices are sometimes limited by intolerable toxicities of standard therapies for the treatment of HCV when combined with antiretroviral therapy for treatment of HIV This study will seek to determine if Silymarin an herbal product that is widely used will be well tolerated and effective in slowing progression of liver damage in patients co-infected with HIV HCV
The Informed Consent Document contains all the required elements of informed consent as required by 21CFR50 The consent clearly states that this is research participation is voluntary and that treatment with Silymarin may not be effective Every effort has been made to outline whatever is known about any side effects There are very few All study participants are followed closely are given their test results which are also shared with primary care providers The investigators have convened a Data and Safety Monitoring Board and the Mount Sinai IRB has approved and will monitor the study
The Informed Consent Document contains all the required elements of informed consent as required by 21CFR50 The consent clearly states that this is research participation is voluntary and that treatment with Silymarin may not be effective Every effort has been made to outline whatever is known about any side effects There are very few All study participants are followed closely are given their test results which are also shared with primary care providers The investigators have convened a Data and Safety Monitoring Board and the Mount Sinai IRB has approved and will monitor the study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R21NR008860 | NIH | None | httpsreporternihgovquickSearchR21NR008860 |