Cardiovascular Effects of Salvia Miltiorrhiza Extract (Danshen)
Ključne riječi
Sažetak
Datumi
| Posljednja provjera: | 12/31/2011 |
| Prvo podneseno: | 03/22/2012 |
| Predviđena prijava predata: | 03/25/2012 |
| Prvo objavljeno: | 03/26/2012 |
| Zadnje ažuriranje poslato: | 05/22/2012 |
| Posljednje ažuriranje objavljeno: | 05/23/2012 |
| Stvarni datum početka studija: | 03/31/2012 |
| Procijenjeni datum primarnog završetka: | 11/30/2012 |
| Predviđeni datum završetka studije: | 02/28/2013 |
Stanje ili bolest
Intervencija / liječenje
Dietary Supplement: Salvia miltiorrhiza extract (Danshen)
Dietary Supplement: placebo
Faza
Grupe ruku
| Arm | Intervencija / liječenje |
|---|---|
| Experimental: Salvia miltiorrhiza extract (Danshen) p.o. Salvia miltiorrhiza extract, 1.5 g twice daily for four consecutive weeks | Dietary Supplement: Salvia miltiorrhiza extract (Danshen) 3 capsules of 500 mg Salvia miltiorrhiza extract, twice daily for four consecutive weeks |
| Placebo Comparator: placebo p.o. placebo, twice daily | Dietary Supplement: placebo 3 placebo capsules, twice daily for four consecutive weeks |
Kriteriji prihvatljivosti
| Uzrast podoban za studiranje | 40 Years To 40 Years |
| Polovi podobni za studiranje | All |
| Prihvaća zdrave volontere | Da |
| Kriterijumi | Inclusion Criteria: - Age: 40-70 - Women: - postmenopausal, or - use of contraceptive pill - Hyperlipidemia: - elevated level of triglycerides: > 1.7 mmol/L, or - elevated level of LDL-cholesterol: > 3.5 mmol/L - Hypertension: - systolic pressure > 140 mm Hg, or - diastolic pressure > 90 mm Hg - Signed informed consent Exclusion Criteria: - Alcohol or drug abuse - History of cardiovascular disease (myocard infarct, angina pectoris, CVA) - Diabetes mellitus, when treated with insulin - Pregnancy - Hyperlipidemia which needs conventional treatment - elevated level of triglycerides: > 8 mmol/L - elevated level of LDL-cholesterol: > 5 mmol/L - Hypertension which needs conventional treatment: - systolic pressure > 180 mm Hg - diastolic pressure > 110 mm Hg - Clinically significant liver disease (3 times the upper normal limit of ALAT,ASAT) - Clinically significant anemia (male Hb < 6,9 mmol/L, female < 6,25 mmol/L) - Renal disease defined as MDRD < 60 ml/min/1.73m2 - Participation to any drug-investigation during the previous 90 days - Use of any herbal product during the previous 30 days - Concomitant (chronic) use of: Medicinal products: - ACE-inhibitors, including a.o. captopril, enalapril, ramipril - AT1-antagonists, including a.o. losartan, valsartan, irbesartan - Statins, including a.o. simvastatin, rosuvastatin - Anticoagulant drugs, including a.o. aspirin - Calciumantagonists (including a.o. amlodipine, nifedipine, verapamil) - Use of more than 1 antihypertensive drug - High-dose antihypertensive medication (above defined daily dose) - Drugs which are exclusively metabolised by CYP3A4 (Flockhart DA; P450 drug interaction table, including a.o. erythromycin, midazolam, cyclosporine, HIV antivirals) Food products: - (Antioxidant) vitamin supplements - Other herbs, including a.o. St John's wort - Grapefruit juice |
Ishod
Primarne mjere ishoda
1. Hyperlipidemia [after 4 weeks of treatment with Danshen]
Sekundarne mjere ishoda
1. Hypertension [after 4 weeks of treatment with Danshen]
2. Endothelial function [after 4 weeks of treatment with Danshen]
3. Plasma markers of oxidative stress [after 4 weeks of treatment with Danshen]
4. Vascular inflammation and inflammatory activation of adipose tissue [after 4 weeks of treatment with danshen]
5. Hemostasis and hemorheological parameters [after 4 weeks of treatment with Danshen]
6. Insulin sensitivity [after 4 weeks of treatment with Danshen]
