Preventive Effects of Ginseng Against Atherosclerosis
Palabras clave
Abstracto
fechas
| Verificado por última vez: | 06/30/2016 |
| Primero enviado: | 05/25/2016 |
| Inscripción estimada enviada: | 06/06/2016 |
| Publicado por primera vez: | 06/12/2016 |
| Última actualización enviada: | 07/05/2016 |
| Última actualización publicada: | 07/06/2016 |
| Fecha de inicio real del estudio: | 05/31/2016 |
| Fecha estimada de finalización primaria: | 04/30/2017 |
Condición o enfermedad
Intervención / tratamiento
Dietary Supplement: Ginseng
Dietary Supplement: Placebo
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Active Comparator: Ginseng 2grams twice per day (0.5gram/capsule, 2capsules twice a day) for 12months | Dietary Supplement: Ginseng 2grams twice per day (0.5gram/capsule, 2capsuels twice a day) for 12months |
| Placebo Comparator: Placebo Placebo has the same appearance (same size and color) of the real drug. 2grams twice per day (0.5gram/capsule, 2capsules twice a day) for 12months | Dietary Supplement: Placebo 2grams twice per day (0.5gram/capsule, 2capsuels twice a day) for 12months |
Criterio de elegibilidad
| Edades elegibles para estudiar | 20 Years A 20 Years |
| Sexos elegibles para estudiar | All |
| Acepta voluntarios saludables | si |
| Criterios | Inclusion Criteria: 1. Severe stenosis or occlusion of the internal carotid artery, middle cerebral artery and vertebrobasilar system 2. No adverse reaction to ginseng 3. Aged between 20 to 80 years Exclusion Criteria: 1. Genetic cerebrovascular diseases 2. Adverse reaction to contrast medium 3. Pregnant woman 4. History of previous cerebral angioplasty and stenting, carotid endarterectomy, and bypass surgery 5. History of cardioembolic stroke or possibility of cardioembolic stroke 6. Possibility of cancer stroke 7. Renal failure (GFR< 30 ml/min) or liver disease |
Salir
Medidas de resultado primarias
1. Presence of ischemic stroke or TIA (transient ischemic attacks) assessed by symptom history during one year follow-up and measured by number of patients in each group [one year]
2. Presence of other cerebro-cardiovascular morbidity or mortality assessed by aggravation of patient status (Modified Rankin Scale) at out-patient clinic during one year follow-up and measured by number of patients. [one year]
Medidas de resultado secundarias
1. Changes in blood flow volume (ml/sec) in quantitative MRA measured by percentage change from the baseline study [one year]
2. Changes in velocity (cm/sec) in quantitative MRA measured by percentage change from the baseline study [one year]
3. New FLAIR MR lesion assessed on one year follow-up MRI and measured by number of patients. [one year]
