Cardiovascular-Protective Effects of Herbal Medicine Danshen-Gegen
A Novel Randomized Double-Blind Placebo-Control Clinical Trial in High-Risk Hypertensive Subjects
Atherosclerosis (in particular stroke and heart attack) is the most important health issue in modernized society and high blood pressure is an important predisposing factor. Hypertensive subjects with other chronic disease such as diabetes mellitus or impaired renal function are particularly vulnerable to these atherosclerotic complications in spite of standard antihypertensive therapies.
Danshen and Gegen are commonly used in Chinese materia medica as treatment for cardiac symptoms and atherosclerosis-related disorders.
The objective of this study is to test Danshen and Gegen as an cardiovascular-protective adjunctive regimen to prevent high-risk hypertensive cohort from primary atherosclerosis.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Danshen and Gegen (D&G) are two traditional herbal medicines used for cardiac symptoms in ancient Chinese medicinal literature. Recent studies suggest their therapeutic effects in blood pressure and lipid-lowering, anti-oxidation, microcirculation-promoting, foam cells-modulation and have beneficial effects on atherogenic process in coronary patients.
To evaluate the potential of D&G in primary atherosclerosis prevention in high risk hypertension. Patients with high risk hypertension associated with left ventricular hypertrophy, diabetes mellitus and renal insufficiency were randomized to receive D&G herbal capsules (2gm/day), or (1gm/day) or identical placebo capsules in double-blind and parallel fashion for 12 months on top of their anti-hypertensive treatments. Flow-mediated dilation (endothelium-dependent dilation, FMD) and nitroglycerin-induced dilation (endothelium-independent dilation, NTG) of brachial artery, and carotid intima-media thickness (surrogate atherosclerosis marker, IMT) were measured by high resolution B-mode ultrasound.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 2
Contatti e Sedi
Luoghi di studio
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Hong Kong, Hong Kong
- Prince of Wales Hospital
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Hong Kong, Hong Kong
- Alice Ho Miu Ling Nethersole Hospital
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Hong Kong, Hong Kong
- Yan Chai Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- High-risk hypertension: Asymptomatic hypertensive (pretreatment BP>160/95mmHg) subjects, currently blood pressure under control (BP<140/90mmHg),
- Aged 35-70 years
- With either (i)left ventricular hypertrophy on ECG or echocardiographic criteria, (ii) diabetes mellitus, or (iii) mild renal impairment (plasma creatinine 120-250µmol/l)
Exclusion Criteria:
- Known intolerance to D&G due to adverse effect, patients with bleeding, disorders or on long-term anticoagulation.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Comparatore placebo: Placebo
Image-matched placebo of active treatment
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Image-matched placebo, made with starch.
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Comparatore attivo: D&G 1g
Randomly allocated into three groups, D&G capsule 1g/day
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Danshen consists of the dried root and rhizome of the perennial herb Salvia miltiorrhiza Bge.
Gegen is the dried roots of Pueraria lobata (willd.).
The combination in the ratio of 7:3 of the raw herbs.
Capsule form, Orally taken 1g per Day
Altri nomi:
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Comparatore attivo: D&G 2g
Randomly allocated into three groups, D&G capsule 2g/day
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Danshen consists of the dried root and rhizome of the perennial herb Salvia miltiorrhiza Bge.
Gegen is the dried roots of Pueraria lobata (willd.).
The combination in the ratio of 7:3 of the raw herbs.
Capsule form, Orally taken 2g per Day
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
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Ultrasound study for measuring carotid intima-media thickening (IMT)
Lasso di tempo: 1 year
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1 year
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
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Blood tests: lipids, creatinine, glucose, fibrinogen, hs-CRP and haemoglobin A1-C Physical examination: Blood pressure, weight, height, body mass index, hip waist ratio
Lasso di tempo: 1 year
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1 year
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Thomas YK Chan, Prof., Department of Medicine & Therapeutics, Prince of Wales Hospital
Pubblicazioni e link utili
Pubblicazioni generali
- Bots ML, Hoes AW, Koudstaal PJ, Hofman A, Grobbee DE. Common carotid intima-media thickness and risk of stroke and myocardial infarction: the Rotterdam Study. Circulation. 1997 Sep 2;96(5):1432-7. doi: 10.1161/01.cir.96.5.1432.
- O'Leary DH, Polak JF, Kronmal RA, Manolio TA, Burke GL, Wolfson SK Jr. Carotid-artery intima and media thickness as a risk factor for myocardial infarction and stroke in older adults. Cardiovascular Health Study Collaborative Research Group. N Engl J Med. 1999 Jan 7;340(1):14-22. doi: 10.1056/NEJM199901073400103.
- Woo KS, Chook P, Raitakari OT, McQuillan B, Feng JZ, Celermajer DS. Westernization of Chinese adults and increased subclinical atherosclerosis. Arterioscler Thromb Vasc Biol. 1999 Oct;19(10):2487-93. doi: 10.1161/01.atv.19.10.2487.
- Sieveking DP, Woo KS, Fung KP, Lundman P, Nakhla S, Celermajer DS. Chinese herbs Danshen and Gegen modulate key early atherogenic events in vitro. Int J Cardiol. 2005 Oct 20;105(1):40-5. doi: 10.1016/j.ijcard.2004.10.052.
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Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CRE2005123T
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