Trial Outcomes & Findings for Preventive Effects of Ginseng Against Atherosclerosis (NCT NCT02796664)
NCT ID: NCT02796664
Last Updated: 2021-08-24
Results Overview
The 1-year composite of cerebral ischemic stroke and transient ischemic attack downstream to an atherosclerotic lesion
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
58 participants
Primary outcome timeframe
Twelve months after randomization.
Results posted on
2021-08-24
Participant Flow
Patients in a single center, from June 2016 to June 2017.
Participant milestones
| Measure |
Ginseng
Korean Red Ginseng extract tablet (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
|
Placebo
Placebo (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
29
|
|
Overall Study
COMPLETED
|
28
|
24
|
|
Overall Study
NOT COMPLETED
|
1
|
5
|
Reasons for withdrawal
| Measure |
Ginseng
Korean Red Ginseng extract tablet (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
|
Placebo
Placebo (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
3
|
|
Overall Study
Noncompliance
|
1
|
1
|
|
Overall Study
Death
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Ginseng
n=28 Participants
Korean Red Ginseng extract tablet (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
|
Placebo
n=24 Participants
Placebo (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Previous stroke history
|
13 Participants
n=28 Participants
|
9 Participants
n=24 Participants
|
22 Participants
n=52 Participants
|
|
Atrial fibrillation
|
0 Participants
n=28 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=52 Participants
|
|
Myocardial infarction
|
0 Participants
n=28 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=52 Participants
|
|
Age, Continuous
|
63.4 years
STANDARD_DEVIATION 12.5 • n=28 Participants
|
58.8 years
STANDARD_DEVIATION 13.6 • n=24 Participants
|
60.3 years
STANDARD_DEVIATION 13.0 • n=52 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=28 Participants
|
8 Participants
n=24 Participants
|
21 Participants
n=52 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=28 Participants
|
16 Participants
n=24 Participants
|
31 Participants
n=52 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
South Korea
|
28 Participants
n=28 Participants
|
24 Participants
n=24 Participants
|
52 Participants
n=52 Participants
|
|
Hypertension
|
20 Participants
n=28 Participants
|
14 Participants
n=24 Participants
|
34 Participants
n=52 Participants
|
|
Diabetes mellitus
|
10 Participants
n=28 Participants
|
4 Participants
n=24 Participants
|
14 Participants
n=52 Participants
|
|
Hyperlipidemia
|
23 Participants
n=28 Participants
|
15 Participants
n=24 Participants
|
38 Participants
n=52 Participants
|
|
Angina pectoris
|
5 Participants
n=28 Participants
|
2 Participants
n=24 Participants
|
7 Participants
n=52 Participants
|
|
Alcohol drinking
|
6 Participants
n=28 Participants
|
9 Participants
n=24 Participants
|
15 Participants
n=52 Participants
|
|
Smoking
|
5 Participants
n=28 Participants
|
13 Participants
n=24 Participants
|
18 Participants
n=52 Participants
|
|
Antiplatelet medication
Mono antiplatelet
|
8 Participants
n=28 Participants
|
9 Participants
n=24 Participants
|
17 Participants
n=52 Participants
|
|
Antiplatelet medication
Dual antiplatelet
|
17 Participants
n=28 Participants
|
14 Participants
n=24 Participants
|
31 Participants
n=52 Participants
|
|
Antiplatelet medication
Other antiplatelet
|
2 Participants
n=28 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=52 Participants
|
|
Antiplatelet medication
None
|
1 Participants
n=28 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=52 Participants
|
|
Antihypertensive medication
|
21 Participants
n=28 Participants
|
13 Participants
n=24 Participants
|
34 Participants
n=52 Participants
|
|
Antidiabetic medication
|
9 Participants
n=28 Participants
|
3 Participants
n=24 Participants
|
12 Participants
n=52 Participants
|
|
Antihyperlipidemic medication
|
25 Participants
n=28 Participants
|
21 Participants
n=24 Participants
|
46 Participants
n=52 Participants
|
|
Baseline modified Rankin Scale (mRS)
mRS 0
|
21 Participants
n=28 Participants
|
22 Participants
n=24 Participants
|
43 Participants
n=52 Participants
|
|
Baseline modified Rankin Scale (mRS)
mRS 1
|
5 Participants
n=28 Participants
|
1 Participants
n=24 Participants
|
6 Participants
n=52 Participants
|
|
Baseline modified Rankin Scale (mRS)
mRS 2
|
0 Participants
n=28 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=52 Participants
|
|
Baseline modified Rankin Scale (mRS)
mRS 3
|
2 Participants
n=28 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=52 Participants
|
|
Baseline modified Rankin Scale (mRS)
mRS 4
|
0 Participants
n=28 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=52 Participants
|
|
Baseline modified Rankin Scale (mRS)
mRS 5
|
0 Participants
n=28 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=52 Participants
|
PRIMARY outcome
Timeframe: Twelve months after randomization.Population: Full analysis set
The 1-year composite of cerebral ischemic stroke and transient ischemic attack downstream to an atherosclerotic lesion
Outcome measures
| Measure |
Ginseng
n=28 Participants
Korean Red Ginseng extract tablet (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
|
Placebo
n=24 Participants
Placebo (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
|
|---|---|---|
|
The Composite of Cerebral Ischemic Stroke and Transient Ischemic Attack
Ischemic stroke
|
0 Participants
|
0 Participants
|
|
The Composite of Cerebral Ischemic Stroke and Transient Ischemic Attack
Transient ischemic attack
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Twelve months after randomization.Population: Full analysis set
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.
Outcome measures
| Measure |
Ginseng
n=28 Participants
Korean Red Ginseng extract tablet (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
|
Placebo
n=24 Participants
Placebo (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
|
|---|---|---|
|
Modified Rankin Scale
mRS 0
|
21 Participants
|
22 Participants
|
|
Modified Rankin Scale
mRS 1
|
5 Participants
|
1 Participants
|
|
Modified Rankin Scale
mRS 2
|
0 Participants
|
0 Participants
|
|
Modified Rankin Scale
mRS 3
|
2 Participants
|
1 Participants
|
|
Modified Rankin Scale
mRS 4
|
0 Participants
|
0 Participants
|
|
Modified Rankin Scale
mRS 5
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At randomization and twelve months after randomization.The changes in volumetric blood flow (ml/sec) in intracranial vessels assessed by quantitative magnetic resonance angiography with noninvasive optimal vessel analysis.
Outcome measures
| Measure |
Ginseng
n=28 Participants
Korean Red Ginseng extract tablet (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
|
Placebo
n=24 Participants
Placebo (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
|
|---|---|---|
|
The Changes in Volumetric Blood Flow (ml/Sec) in Intracranial Vessels.
The flow change in steno-occlusive lesion · Improved
|
4 Participants
|
5 Participants
|
|
The Changes in Volumetric Blood Flow (ml/Sec) in Intracranial Vessels.
The flow change in steno-occlusive lesion · No change
|
17 Participants
|
18 Participants
|
|
The Changes in Volumetric Blood Flow (ml/Sec) in Intracranial Vessels.
The flow change in steno-occlusive lesion · Aggravated
|
7 Participants
|
1 Participants
|
|
The Changes in Volumetric Blood Flow (ml/Sec) in Intracranial Vessels.
The flow change in collateral vessel · Improved
|
7 Participants
|
7 Participants
|
|
The Changes in Volumetric Blood Flow (ml/Sec) in Intracranial Vessels.
The flow change in collateral vessel · No change
|
17 Participants
|
9 Participants
|
|
The Changes in Volumetric Blood Flow (ml/Sec) in Intracranial Vessels.
The flow change in collateral vessel · Aggravated
|
4 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: At randomization and twelve months after randomization.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.
Outcome measures
| Measure |
Ginseng
n=28 Participants
Korean Red Ginseng extract tablet (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
|
Placebo
n=24 Participants
Placebo (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
|
|---|---|---|
|
The Changes of White Matter Hyperintensities.
Periventricular white matter · Fazekas scale 0
|
2 Participants
|
1 Participants
|
|
The Changes of White Matter Hyperintensities.
Periventricular white matter · Fazekas scale 1
|
9 Participants
|
11 Participants
|
|
The Changes of White Matter Hyperintensities.
Periventricular white matter · Fazekas scale 2
|
15 Participants
|
10 Participants
|
|
The Changes of White Matter Hyperintensities.
Periventricular white matter · Fazekas scale 3
|
2 Participants
|
2 Participants
|
|
The Changes of White Matter Hyperintensities.
Deep white matter · Fazekas scale 0
|
9 Participants
|
6 Participants
|
|
The Changes of White Matter Hyperintensities.
Deep white matter · Fazekas scale 1
|
15 Participants
|
15 Participants
|
|
The Changes of White Matter Hyperintensities.
Deep white matter · Fazekas scale 2
|
3 Participants
|
2 Participants
|
|
The Changes of White Matter Hyperintensities.
Deep white matter · Fazekas scale 3
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At randomization and twelve months after randomization.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.
Outcome measures
| Measure |
Ginseng
n=28 Participants
Korean Red Ginseng extract tablet (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
|
Placebo
n=24 Participants
Placebo (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
|
|---|---|---|
|
Number of Participants With Changes of Parenchymal Ischemic Lesions
Ischemic lesion (+)
|
22 Participants
|
15 Participants
|
|
Number of Participants With Changes of Parenchymal Ischemic Lesions
Ischemic lesion (-)
|
6 Participants
|
9 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At twelve months after randomization.We calculated average drug compliance based on the number of remained drugs at each follow-up.
Outcome measures
| Measure |
Ginseng
n=28 Participants
Korean Red Ginseng extract tablet (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
|
Placebo
n=24 Participants
Placebo (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
|
|---|---|---|
|
Drug Compliance
|
97.4 percentage of drug compliance
Standard Deviation 4.7
|
97.8 percentage of drug compliance
Standard Deviation 4.3
|
Adverse Events
Ginseng
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Ginseng
n=29 participants at risk
Korean Red Ginseng extract tablet (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
|
Placebo
n=29 participants at risk
Placebo (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
|
|---|---|---|
|
General disorders
Death
|
0.00%
0/29 • 1, 3, 6 and 12 months after randomization.
|
3.4%
1/29 • Number of events 1 • 1, 3, 6 and 12 months after randomization.
|
Other adverse events
| Measure |
Ginseng
n=29 participants at risk
Korean Red Ginseng extract tablet (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
|
Placebo
n=29 participants at risk
Placebo (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/29 • 1, 3, 6 and 12 months after randomization.
|
3.4%
1/29 • Number of events 1 • 1, 3, 6 and 12 months after randomization.
|
|
Skin and subcutaneous tissue disorders
Bruise
|
0.00%
0/29 • 1, 3, 6 and 12 months after randomization.
|
3.4%
1/29 • Number of events 1 • 1, 3, 6 and 12 months after randomization.
|
|
Skin and subcutaneous tissue disorders
Subjective hair loss
|
3.4%
1/29 • Number of events 1 • 1, 3, 6 and 12 months after randomization.
|
0.00%
0/29 • 1, 3, 6 and 12 months after randomization.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place