Status:
COMPLETED
Comparison of the Effects of Standardized Chokeberry Extracts With Various Formulations on the Levels of Selected Markers Associated With Cardiovascular Disease
Lead Sponsor:
AronPharma Sp. z o. o.
Conditions:
Hypertension
Hypercholesterolemia
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
The aim of the study is to compare in a clinical condition the effect of standardized chokeberry extract in different formulations and a complex preparation containing chokeberry extract and other act...
Detailed Description
Randomized, double-blind, parallel study conducted under medical supervision on a group of 40 patients with known hypertension and/or hypercholesterolemia. Patients receive one of the investigational ...
Eligibility Criteria
Inclusion
- Women and men, 18-55 years old
- Patients with known: hypertension or hypercholesterolemia,
- Patients on hypotensive or hypolipemic therapy for at least 6 months prior to study enrollment
- Signed informed consent
Exclusion
- Intake of supplements containing plant extracts, polyphenols or anthocyanins,
- Intake of supplements with antioxidant properties,
- Participation in another clinical trial,
- Women who are pregnant, planning to become pregnant during the study, or breastfeeding,
- Oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis, leukemia, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplant,
- Patients receiving glucocorticosteroids, anti-allergic drugs, non-steroidal anti-inflammatory drugs in exacerbations of chronic disease.
- Patients with signs of inflammation such as increased body temperature, redness, swelling, pain.
- Patients who have not given written consent to participate in the study.
Key Trial Info
Start Date :
February 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 28 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05988099
Start Date
February 20 2023
End Date
July 28 2023
Last Update
August 23 2023
Active Locations (1)
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1
Centum Zdrowia Eter-Med sp. z o.o.
Gdansk, Poland, 80-822