DRKS00031955
Recruiting
未知
Effects of a combination of olive leaf extract and potassium on blood pressure in subjects with mild to moderate hypertension - a doubleblind, randomized, placebocontrolled study - BTS1929/22
APOMEDICA Pharmazeutische Produkte GmbH0 sites70 target enrollmentStarted: June 12, 2023Last updated:
Overview
- Phase
- 未知
- Status
- Recruiting
- Enrollment
- 70
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized controlled study
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (—)
- Sex
- All
Inclusion Criteria
- •Subject is able and willing to sign the Informed Consent Form prior to screening evaluations
- •Sex: female and male (minimum 25% of each gender)
- •Mild to moderate elevated blood pressure (systolic: 130\-159 mmHg, during on site blood pressure measurement)
- •BMI: 18\.5 – 35 kg/m²
- •Except elevated blood pressure, the subject is in good physical and mental health as established by medical history, physical examination, ECG, results of biochemistry, hematology
- •Visit 1: Confirmed mild to moderate elevated blood pressure (systolic: 130\-159 mmHg, during on site blood pressure measurement)
Exclusion Criteria
- •Main exclusion criteria:
- •Relevant history or presence of any severe medical disorder, potentially interfering with this study (e.g. malabsorption, chronic gastro\-intestinal diseases (e.g. Morbus Crohn, Colitis Ulcerosa), heavy depression, significant cardiovascular disease or co\-morbidities (e.g. myocardial infarction, stroke, congestive heart failure), diabetes, acute malignant disease within last 3 years except basal cell carcinoma of the skin, etc.)
- •Under medication which could affect blood pressure (including anti\-hypertensive drugs) or stopped less than 3 months before randomization (e.g. Beta 2 agonists like salbutamol, Adrenergic agonists and antagonists, Angiotensin Converting Enzyme (ACE) inhibitors, Angiotensin receptor blockers, Calcium channel blockers, Beta\-blockers, Thiazide diuretics, Direct renin inhibitors, Direct\-acting vasodilators, etc)
- •Intake of lipid lowering medication (e.g. statins, plant stanols, plant sterols etc.)
- •Under dietary supplement which could have a direct influence on blood pressure in the month before screening (e.g. high dose L\-arginine, high dose niacin, high dose omega\-3 fatty acids, olive extracts, olive polyphenols, hydroxytyrosol, garlic extract / allicin, hawthorn etc.)
- •Smoker \>15 cigarettes / day
Investigators
Similar Trials
Completed
Not Applicable
The effect of olive leaf extract administration on cardiovascular healthRisicofactoren voor cardiovasculaire ziekten(borderline) hypercholesterolemiahigh cholesteroloverweightobesityNL-OMON44077niversiteit Maastricht80
Terminated
Phase 4
Effect of an Olive Leaf Extract compared to a placebo on Cold and Flu Symptoms in an AdultPopulation – A double blind, randomised controlled trialCommon ColdInfluenza virus infectionAlternative and Complementary Medicine - Herbal remediesInfection - Other infectious diseasesACTRN12619001722189Pharmactive135
Recruiting
Phase 1
Study of effect of olive leaves on diabetic neuropathyIRCT20100513003922N4Kermanshah University of Medical Sciences66
Completed
Phase 2
Olive (Olea europaea) leaf extract on blood pressureEssential hypertension.Hypertensive diseasesIRCT2017043033730N1Vice Chancellor for research of Qazvin University of Medical Sciences60
Recruiting
Phase 2
The effect of olive extract on arthrosis of the kneeosteoarthrit.Osteoarthritis of kneeIRCT20170514033961N7Khoram-Abad University of Medical Sciences120