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| Name | Class |
|---|---|
| Korea Ginseng Corporation | INDUSTRY |
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This study is a 12-month, double-blind, randomized, placebo-controlled trial. The purpose of this study is to determine whether ginseng is effective in the prevention of atherosclerosis and subsequent ischemic stroke. High-risk patients with severe atherosclerosis in the major intracranial arteries and extracranial carotid artery were enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ginseng | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ginseng | Dietary Supplement | Korean Red Ginseng extract tablet (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Composite of Cerebral Ischemic Stroke and Transient Ischemic Attack | The 1-year composite of cerebral ischemic stroke and transient ischemic attack downstream to an atherosclerotic lesion | Twelve months after randomization. |
| Modified Rankin Scale | Presence of other cerebro-cardiovascular morbidity or mortality assessed by aggravation of patient status (modified Rankin Scale). The modified Rankin Scale is ranging from 0 to 5. The higher scale indicates the worse outcome. | Twelve months after randomization. |
| Measure | Description | Time Frame |
|---|---|---|
| The Changes in Volumetric Blood Flow (ml/Sec) in Intracranial Vessels. | The changes in volumetric blood flow (ml/sec) in intracranial vessels assessed by quantitative magnetic resonance angiography with noninvasive optimal vessel analysis. | At randomization and twelve months after randomization. |
| The Changes of White Matter Hyperintensities. |
| Measure | Description | Time Frame |
|---|---|---|
| Drug Compliance | We calculated average drug compliance based on the number of remained drugs at each follow-up. | At twelve months after randomization. |
"Inclusion Criteria"
Patients were included if they
"Exclusion Criteria"
Patients were excluded if they
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| Name | Affiliation | Role |
|---|---|---|
| Dae Chul Suh | Asan Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | 05505 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29854792 | Background | Zheng M, Xin Y, Li Y, Xu F, Xi X, Guo H, Cui X, Cao H, Zhang X, Han C. Ginsenosides: A Potential Neuroprotective Agent. Biomed Res Int. 2018 May 8;2018:8174345. doi: 10.1155/2018/8174345. eCollection 2018. | |
| 24462216 | Background | Zhou Y, Li HQ, Lu L, Fu DL, Liu AJ, Li JH, Zheng GQ. Ginsenoside Rg1 provides neuroprotection against blood brain barrier disruption and neurological injury in a rat model of cerebral ischemia/reperfusion through downregulation of aquaporin 4 expression. Phytomedicine. 2014 Jun 15;21(7):998-1003. doi: 10.1016/j.phymed.2013.12.005. Epub 2014 Jan 22. |
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Patients in a single center, from June 2016 to June 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ginseng | Korean Red Ginseng extract tablet (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months. |
| FG001 | Placebo | Placebo (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ginseng | Korean Red Ginseng extract tablet (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months. |
| BG001 | Placebo | Placebo (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Composite of Cerebral Ischemic Stroke and Transient Ischemic Attack | The 1-year composite of cerebral ischemic stroke and transient ischemic attack downstream to an atherosclerotic lesion | Full analysis set | Posted | Count of Participants | Participants | Twelve months after randomization. |
|
1, 3, 6 and 12 months after randomization.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ginseng | Korean Red Ginseng extract tablet (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | Non-systematic Assessment |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dae Chul Suh | Asan Medical Center | +82-2-3010-4366 | dcsuh@amc.seoul.kr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 2, 2018 | Oct 18, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D050197 | Atherosclerosis |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C000713447 | Asian ginseng |
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| Placebo | Dietary Supplement | Placebo (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months. |
|
The changes of white matter hyperintensities, assessed by the Fazekas scale using brain magnetic resonance imaging. The Fazekas scale is a 4 point white matter disease severity scale with values ranging from 0 to 3. It quantifies the amount of white matter T2 hyperintense lesions each in periventricular white matter and deep white matter. Higher scales mean a worse white matter status. In the region of the periventricular white matter, 0 means absence of the lesion; 1, caps or pencil-thin lining lesion; 2, smooth halo lesion; 3, irregular high intense signal extending into the deep shite matter. In the region of the deep white matter, 0 means absence of the lesion; 1, punctate foci lesions; 2, beginning confluence; 3, large confluent hyperintense areas. |
| At randomization and twelve months after randomization. |
| Number of Participants With Changes of Parenchymal Ischemic Lesions | The changes of ischemic parenchymal lesions, assessed by brain magnetic resonance images acquired at randomization and twelve months after randomization. We counted the number of participants who had new ischemic parenchymal lesions at twelve months after randomization. | At randomization and twelve months after randomization. |
| 26384017 | Background | Bao C, Wang Y, Min H, Zhang M, Du X, Han R, Liu X. Combination of ginsenoside Rg1 and bone marrow mesenchymal stem cell transplantation in the treatment of cerebral ischemia reperfusion injury in rats. Cell Physiol Biochem. 2015;37(3):901-10. doi: 10.1159/000430217. Epub 2015 Sep 18. |
| 23811400 | Background | Aleshin S, Strokin M, Sergeeva M, Reiser G. Peroxisome proliferator-activated receptor (PPAR)beta/delta, a possible nexus of PPARalpha- and PPARgamma-dependent molecular pathways in neurodegenerative diseases: Review and novel hypotheses. Neurochem Int. 2013 Oct;63(4):322-30. doi: 10.1016/j.neuint.2013.06.012. Epub 2013 Jun 25. |
| 26886418 | Background | Kernan WN, Viscoli CM, Furie KL, Young LH, Inzucchi SE, Gorman M, Guarino PD, Lovejoy AM, Peduzzi PN, Conwit R, Brass LM, Schwartz GG, Adams HP Jr, Berger L, Carolei A, Clark W, Coull B, Ford GA, Kleindorfer D, O'Leary JR, Parsons MW, Ringleb P, Sen S, Spence JD, Tanne D, Wang D, Winder TR; IRIS Trial Investigators. Pioglitazone after Ischemic Stroke or Transient Ischemic Attack. N Engl J Med. 2016 Apr 7;374(14):1321-31. doi: 10.1056/NEJMoa1506930. Epub 2016 Feb 17. |
| 26045754 | Background | Yang Y, Li X, Zhang L, Liu L, Jing G, Cai H. Ginsenoside Rg1 suppressed inflammation and neuron apoptosis by activating PPARgamma/HO-1 in hippocampus in rat model of cerebral ischemia-reperfusion injury. Int J Clin Exp Pathol. 2015 Mar 1;8(3):2484-94. eCollection 2015. |
| 25832422 | Background | Liu XY, Zhou XY, Hou JC, Zhu H, Wang Z, Liu JX, Zheng YQ. Ginsenoside Rd promotes neurogenesis in rat brain after transient focal cerebral ischemia via activation of PI3K/Akt pathway. Acta Pharmacol Sin. 2015 Apr;36(4):421-8. doi: 10.1038/aps.2014.156. Epub 2015 Mar 16. |
| 18464084 | Background | Chen LM, Zhou XM, Cao YL, Hu WX. Neuroprotection of ginsenoside Re in cerebral ischemia-reperfusion injury in rats. J Asian Nat Prod Res. 2008 May-Jun;10(5-6):439-45. doi: 10.1080/10286020801892292. |
| 22925661 | Background | He B, Chen P, Yang J, Yun Y, Zhang X, Yang R, Shen Z. Neuroprotective effect of 20(R)-ginsenoside Rg(3) against transient focal cerebral ischemia in rats. Neurosci Lett. 2012 Sep 27;526(2):106-11. doi: 10.1016/j.neulet.2012.08.022. Epub 2012 Aug 19. |
| 28592775 | Background | Hong KS. Blood Pressure Management for Stroke Prevention and in Acute Stroke. J Stroke. 2017 May;19(2):152-165. doi: 10.5853/jos.2017.00164. Epub 2017 May 31. |
| Death |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Hypertension | Count of Participants | Participants |
|
| Diabetes mellitus | Count of Participants | Participants |
|
| Hyperlipidemia | Count of Participants | Participants |
|
| Previous stroke history | Count of Participants | Participants |
|
| Atrial fibrillation | Count of Participants | Participants |
|
| Myocardial infarction | Count of Participants | Participants |
|
| Angina pectoris | Count of Participants | Participants |
|
| Alcohol drinking | Count of Participants | Participants |
|
| Smoking | Count of Participants | Participants |
|
| Antiplatelet medication | Count of Participants | Participants |
|
| Antihypertensive medication | Count of Participants | Participants |
|
| Antidiabetic medication | Count of Participants | Participants |
|
| Antihyperlipidemic medication | Count of Participants | Participants |
|
| Baseline modified Rankin Scale (mRS) | The modified Rankin scale (mRS) is a 6 point disability scale with possible scales ranging from 0 to 5. If the patient has no stroke symptoms, the value of the mRS is 0; able to carry out all pre-stroke activities, 1; unable to carry out all pre-stroke activities but is able to look after self without daily help, 2; requires some external help but is able to walk without the assistance of another individual, 3; unable to walk or attend to bodily functions without the assistance of another individual, 4; bedridden, incontinent, requires continuous care, 5. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Primary | Modified Rankin Scale | Presence of other cerebro-cardiovascular morbidity or mortality assessed by aggravation of patient status (modified Rankin Scale). The modified Rankin Scale is ranging from 0 to 5. The higher scale indicates the worse outcome. | Full analysis set | Posted | Count of Participants | Participants | Twelve months after randomization. |
|
|
|
|
| Secondary | The Changes in Volumetric Blood Flow (ml/Sec) in Intracranial Vessels. | The changes in volumetric blood flow (ml/sec) in intracranial vessels assessed by quantitative magnetic resonance angiography with noninvasive optimal vessel analysis. | Posted | Count of Participants | Participants | At randomization and twelve months after randomization. |
|
|
|
|
| Secondary | The Changes of White Matter Hyperintensities. | The changes of white matter hyperintensities, assessed by the Fazekas scale using brain magnetic resonance imaging. The Fazekas scale is a 4 point white matter disease severity scale with values ranging from 0 to 3. It quantifies the amount of white matter T2 hyperintense lesions each in periventricular white matter and deep white matter. Higher scales mean a worse white matter status. In the region of the periventricular white matter, 0 means absence of the lesion; 1, caps or pencil-thin lining lesion; 2, smooth halo lesion; 3, irregular high intense signal extending into the deep shite matter. In the region of the deep white matter, 0 means absence of the lesion; 1, punctate foci lesions; 2, beginning confluence; 3, large confluent hyperintense areas. | Posted | Count of Participants | Participants | At randomization and twelve months after randomization. |
|
|
|
|
| Secondary | Number of Participants With Changes of Parenchymal Ischemic Lesions | The changes of ischemic parenchymal lesions, assessed by brain magnetic resonance images acquired at randomization and twelve months after randomization. We counted the number of participants who had new ischemic parenchymal lesions at twelve months after randomization. | Posted | Count of Participants | Participants | At randomization and twelve months after randomization. |
|
|
|
|
| Other Pre-specified | Drug Compliance | We calculated average drug compliance based on the number of remained drugs at each follow-up. | Posted | Mean | Standard Deviation | percentage of drug compliance | At twelve months after randomization. |
|
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 1 |
| 29 |
| EG001 | Placebo | Placebo (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months. | 1 | 29 | 1 | 29 | 2 | 29 |
| Bruise | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
| Subjective hair loss | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
|
Not provided
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| Other antiplatelet |
|
| None |
|
| mRS 2 |
|
| mRS 3 |
|
| mRS 4 |
|
| mRS 5 |
|
| mRS 2 |
|
| mRS 3 |
|
| mRS 4 |
|
| mRS 5 |
|
| Aggravated |
|
| The flow change in collateral vessel |
|
| Chi-squared |
| 0.17 |
| Other |
Equality test |
| Fazekas scale 2 |
|
| Fazekas scale 3 |
|
| Deep white matter |
|
| Fisher Exact |
| 0.95 |
| Other |
Equality test |