| Trial ID: | L6304 |
| Source ID: | NCT03676309
|
| Associated Drug: |
Nutriceutical Oral Capsule,
|
| Title: |
Efficacy and Safety of Nutraceuticals in Patients With Diabetes Mellitus Type II and Dyslipidemia.
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2|Nutritional and Metabolic Diseases|Vascular System Injury|Therapy-Related Morphologic Change
|
| Interventions: |
DRUG: Nutriceutical Oral Capsule,|DRUG: Placebo Oral Tablet
|
| Outcome Measures: |
Primary: colesterol, change cholesterol,, "day 0" , "month 1", "month 3" | Secondary: Endothelial function, change shear rate, "day 0" , "month 3"|Endothelial function, change shear rate after ischemia, "day 0" , "month 3"
|
| Sponsor/Collaborators: |
Sponsor: Villa dei Gerani | Collaborators: University Magna Graecia
|
| Gender: |
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
90
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2017-09-01
|
| Completion Date: |
2018-03-26
|
| Results First Posted: |
|
| Last Update Posted: |
2018-09-18
|
| Locations: |
Capomolla Antonio, Monterosso Calabro, VV, 89819, Italy
|
| URL: |
https://clinicaltrials.gov/show/NCT03676309
|
