A Phase 4 interventional study of Nutraceutical combination (NC) and No nutraceutical combination (noNC) in Hypercholesterolemia, Inflammation and Atherosclerosis, sponsored by University Of Perugia. Completed. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-03-23.
Sponsored by University Of Perugia · Phase 4, Interventional, and Treatment
The effects of a nutraceutical combination (NC) containing low-dose monacolin K and berberine on lipid profile, proprotein convertase subtilisin/kexin type 9 (PCSK9), subclinical inflammation and arterial stiffness were investigated in human immunodeficiency virus (HIV)-infected patients receiving stable antiretroviral therapy (ART).
This is a crossover interventional study of 26 HIV-infected patients on stable ART with low density lipoprotein cholesterol (LDL-C) >100 mg/dL, not receiving any lipid-lowering treatment. After a 3-week lipid stabilization period with a standardized diet regimen, the effect of a 3-month oral NC containing red yeast rice-derived monacolin K 3 mg, berberine 500 mg, policosanol 10 mg, astaxanthin 0.5 mg, folic acid 0.2 mg and coenzyme Q10 2 mg vs no active treatment (noNC) was tested on plasma total cholesterol (TC), LDL-C, high density lipoprotein cholesterol (HDL-C), triglyceride, lipoprotein(a), PCSK9, high-sensitivity C-reactive protein (hsCRP) levels and aortic pulse wave velocity (aPWV).
1,175 studies on the registry are indexed under Hypercholesterolemia; 93 are open to participants now.
This study's enrollment of 26 is below the median of 110 across 975 interventional studies indexed under Hypercholesterolemia.
Browse Hypercholesterolemia studies →University Of Perugia is the lead sponsor of 55 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients on standardized diet regimen taking a NC (red yeast rice-derived monacolin K 3 mg, berberine 500 mg, policosanol 10 mg, astaxanthin 0.5 mg, folic acid 0.2 mg and coenzyme Q10 2 mg) one pill/day for 3 months
Dietary Supplement: Nutraceutical combination (NC)
Patients on standardized diet regimen without taking any NC
Behavioral: No nutraceutical combination (noNC)
An oral NC (red yeast rice-derived monacolin K 3 mg, berberine 500 mg, policosanol 10 mg, astaxanthin 0.5 mg, folic acid 0.2 mg and coenzyme Q10 2 mg) one pill/day was administered for 3 months along with prosecution of standardized diet regimen
Also known as: Armolipid Plus, Meda Pharma - Mylan
Prosecution of standardized diet regimen for 3 months
Change from baseline in LDL-C levels at 3 months
plasma LDL-C levels
Time frame: 3 months after treatment randomization
Change from baseline in PCSK9 levels at 3 months
plasma PCSK9 levels
Time frame: 3 months after treatment randomization
Change from baseline in subclinical inflammation at 3 months
plasma hs-CRP levels
Time frame: 3 months after treatment randomization
Change from baseline in arterial stiffness at 3 months
aPWV
Time frame: 3 months after treatment randomization
Change from baseline in creatine phosphokinase (CPK) levels at 3 months
plasma CPK levels
Time frame: 3 months after treatment randomization
Change from baseline in aspartate transaminase (AST) levels at 3 months
plasma AST levels
Time frame: 3 months after treatment randomization
Change from baseline in alanine transaminase (ALT) levels at 3 months
plasma ALT levels
Time frame: 3 months after treatment randomization
Change from baseline in CD4+ cell count at 3 months
CD4+ cell count
Time frame: 3 months after treatment randomization
Change from baseline in HIV-1 RNA levels at 3 months
HIV-1 RNA levels
Time frame: 3 months after treatment randomization
No study locations are listed for this record.
Ran from Jan 2017 to primary completion in Nov 2017, 10 months.
Of 40 phase 4 interventional studies under Hypercholesterolemia, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 26. This study's 10 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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University Of Perugia