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| Name | Class |
|---|---|
| Pharmactive Biotech Products S.L.U | INDUSTRY |
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The goal of this clinical trial is to evaluate the dose response effect on cardiovascular disease risk factors of a Black Garlic Extract in subjects with Grade I Hypertension. The main questions it aims to answer are:
Participants will be randomly assign to a low dose (250 mg/day), high dose (600 mg/day) or placebo of a standardized Garlic Extract (ABG+/GarlACE) during 12 weeks
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose | Experimental | 250 mg/day of Garlic Extract |
|
| High Dose | Experimental | 600 mg/day of Garlic Extract |
|
| Placebo | Placebo Comparator | Placebo tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low dose | Dietary Supplement | 2 tablets per day during the morning for 12 weeks. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | Upper arm blood pressure (Systolic and Diastolic) | Pre-treatment and 12 weeks post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Lipid Profile | Blood lipid profile including total cholesterol, LDL-cholesterol, HDL-cholesterol and triacylglycerides | Pre-treatment and 12 weeks post-treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Lleida | Recruiting | Lleida | 25198 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37686723 | Result | Serrano JCE, Castro-Boque E, Garcia-Carrasco A, Moran-Valero MI, Gonzalez-Hedstrom D, Bermudez-Lopez M, Valdivielso JM, Espinel AE, Portero-Otin M. Antihypertensive Effects of an Optimized Aged Garlic Extract in Subjects with Grade I Hypertension and Antihypertensive Drug Therapy: A Randomized, Triple-Blind Controlled Trial. Nutrients. 2023 Aug 23;15(17):3691. doi: 10.3390/nu15173691. |
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No individual participant data will be available to other researchers. Group data could be asked by demand
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D003276 | Contraceptives, Oral |
| ID | Term |
|---|---|
| D003271 | Contraceptive Agents, Female |
| D003270 | Contraceptive Agents |
| D012102 | Reproductive Control Agents |
| D045505 | Physiological Effects of Drugs |
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| High dose |
| Dietary Supplement |
2 tablets per day during the morning for 12 weeks. |
|
| Placebo | Dietary Supplement | 2 tablets per day during the morning for 12 weeks. |
|
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045506 | Therapeutic Uses |