Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00405769
Status:
COMPLETED
Last Update Posted:
2007-10-31
First Post:
2006-11-29
Brief Title:
Lipid Lowering in Patients With Statin Intolerance
Sponsor:
Chestnut Hill Health System
Organization:
Chestnut Hill Health System
Study Overview
Official Title:
Alternative Lipid Lowering in Patients With Statin Intolerance Use of Red Yeast Rice and Therapeutic Lifestyle Changes in a Randomized Placebo-Controlled Trial
Status:
COMPLETED
Status Verified Date:
2007-10
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:
This study will attempt to further validate a clinical treatment plan to lower LDL values using non-prescription supplements combined with a lifestyle change and education program which could represent an alternative approach to improve compliance in group of people who are unable to take traditional medication to lower cholesterol
Detailed Description:
Up to 70 participants will be randomized into 2 groups Each shall have similar total and LDL cholesterol values obtained prior to the study Study Group 1 will participate in the Change of Heart Program an intensive program to make therapeutic lifestyle changes and take a placebo pill Study Group 2 will also participate in Change of Heart Group 2 will be provided an over the counter supplement consisting of red rice yeast 24-36 gms day
Blood work consisting of a lipid panel cardiac CRP CPK liver function panel and TSH will be obtained prior to study and at 12 and 26 wks Questionnaires will be administered regarding quality of life indexes and ancillary symptom relief ie degree of arthritis discomfort generalized weakness before 12 and 26 weeks After the Change of Heart program ends 12 weeks participants will continue on study medication for a total of 6 months A final questionnaire and final blood work will be obtained at 6 months and at that point medications can be discontinued
Blood work consisting of a lipid panel cardiac CRP CPK liver function panel and TSH will be obtained prior to study and at 12 and 26 wks Questionnaires will be administered regarding quality of life indexes and ancillary symptom relief ie degree of arthritis discomfort generalized weakness before 12 and 26 weeks After the Change of Heart program ends 12 weeks participants will continue on study medication for a total of 6 months A final questionnaire and final blood work will be obtained at 6 months and at that point medications can be discontinued
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