Preventive Effects of Ginseng Against Atherosclerosis

NCT02796664 | Completed Results DMC

• 1 other identifier: KGC2016-26
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ischemic Stroke; Atherosclerosis

Keywords

Ginseng; Stroke; Quantitative magnetic resonance flow analysis

Outcome Measures

Primary Outcomes (2)

• 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.

Secondary Outcomes (3)

• The Changes in Volumetric Blood Flow (ml/Sec) in Intracranial Vessels.

  At randomization and twelve months after randomization.

• The Changes of White Matter Hyperintensities.

  At randomization and twelve months after randomization.

• Number of Participants With Changes of Parenchymal Ischemic Lesions

  At randomization and twelve months after randomization.

Other Outcomes (1)

• Drug Compliance

  At twelve months after randomization.

Study Arms (2)

Ginseng

EXPERIMENTAL

Dietary Supplement: Ginseng

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Ginseng DIETARY_SUPPLEMENT

Korean Red Ginseng extract tablet (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.

Ginseng

Placebo DIETARY_SUPPLEMENT

Placebo (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.

Placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients were included if they
• were aged 20 to 80 years;
• had occlusion or severe stenosis (≥ 70%) of extracranial carotid artery and major intracranial arteries (intracranial carotid artery, middle cerebral artery, anterior cerebral artery, intracranial vertebral, basilar, or posterior cerebral artery) as documented by cerebral catheter angiography;
• had any risk factor for stroke, such as hypertension, diabetes mellitus, hypercholesterolemia, smoking, alcohol drinking, or previous stroke history;
• had no adverse reactions to administration of ginseng; and
• agreed to participate in the trial.

You may not qualify if:

• Patients were excluded if they
• did not agree to participate in the trial;
• had any genetic cerebrovascular diseases;
• had adverse reactions to contrast medium;
• were pregnant or planning to be pregnant;
• had a history of cardioembolic stroke;
• had an emboligenic cardiac disease such as atrial fibrillation, valve disease, congestive heart failure, or recent myocardial infarction;
• had a risk of stroke of other determined etiology according to the TOAST classification;
• had undergone any neurointervention procedure or surgery, such as intra-arterial thrombolysis, angioplasty procedures, carotid endarterectomy, or bypass surgery;
• had chronic kidney disease (GFR \< 30 ml/min); or
• had severe hepatic dysfunction.

Sponsors & Collaborators

• Dae Chul Suh: lead
• Korea Ginseng Corporation: collaborator

Study Sites (1)

Asan Medical Center

Seoul, 05505, South Korea

Location

Related Publications (10)

• 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.

  PMID: 29854792 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.

  PMID: 24462216 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.

  PMID: 26384017 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.

  PMID: 23811400 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.

  PMID: 26886418 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.

  PMID: 26045754 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.

  PMID: 25832422 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.

  PMID: 18464084 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.

  PMID: 22925661 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.

  PMID: 28592775 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke; Atherosclerosis; Stroke

Interventions

Asian ginseng

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Limitations and Caveats

1. The difficulty in determining the size of the study population due to the lack of previous studies. 2. The relatively short follow-up period considering chronic atherosclerotic disease. 3. The absence of surrogate biochemical markers to confirm ginsenosides' effects.

Results Point of Contact

• Title: Dr. Dae Chul Suh
• Organization: Asan Medical Center

dcsuh@amc.seoul.kr

+82-2-3010-4366

Study Officials

• Dae Chul Suh

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 26, 2016
• First Posted: June 13, 2016
• Study Start: June 23, 2016
• Primary Completion: July 4, 2018
• Study Completion: July 4, 2018
• Last Updated: August 24, 2021
• Results First Posted: August 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)