Trial Outcomes & Findings for The Effect of Farlong® NotoGinseng™ (Ginseng Plus®) on Cholesterol and Blood Pressure (NCT NCT04069715)
NCT ID: NCT04069715
Last Updated: 2021-05-17
Results Overview
The difference in serum LDL-C (mmol/L) from baseline to week 12 between Farlong NotoGinseng™ (Farlong Ginseng Plus® Panax Notoginseng extract) and placebo after 12 weeks of supplementation.
COMPLETED
PHASE2
95 participants
12 weeks
2021-05-17
Participant Flow
Participant milestones
| Measure |
Farlong NotoGinseng™
Farlong NotoGinseng™ (Treatment Group)
|
Placebo
Placebo Group
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
48
|
|
Overall Study
COMPLETED
|
42
|
43
|
|
Overall Study
NOT COMPLETED
|
5
|
5
|
Reasons for withdrawal
| Measure |
Farlong NotoGinseng™
Farlong NotoGinseng™ (Treatment Group)
|
Placebo
Placebo Group
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
Baseline Characteristics
The Effect of Farlong® NotoGinseng™ (Ginseng Plus®) on Cholesterol and Blood Pressure
Baseline characteristics by cohort
| Measure |
Farlong NotoGinseng™
n=47 Participants
Farlong NotoGinseng™ (Treatment Group)
|
Placebo
n=48 Participants
Placebo Group
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.83 years
STANDARD_DEVIATION 12.65 • n=5 Participants
|
49.96 years
STANDARD_DEVIATION 11.85 • n=7 Participants
|
50.39 years
STANDARD_DEVIATION 12.19 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Central American
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Eastern European White
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
South American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
South Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Western European White
|
36 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
47 participants
n=5 Participants
|
48 participants
n=7 Participants
|
95 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: ITT Population. The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
The difference in serum LDL-C (mmol/L) from baseline to week 12 between Farlong NotoGinseng™ (Farlong Ginseng Plus® Panax Notoginseng extract) and placebo after 12 weeks of supplementation.
Outcome measures
| Measure |
Farlong NotoGinseng™
n=41 Participants
Farlong NotoGinseng™ (Treatment Group)
|
Placebo
n=43 Participants
Placebo Group
|
|---|---|---|
|
The Difference in Serum LDL-C From Baseline to Week 12 Between Farlong NotoGinseng™ (Farlong Ginseng Plus® Panax Notoginseng Extract) and Placebo After 12 Weeks of Supplementation.
|
-0.07 percentage of change
Standard Deviation 0.47
|
-0.12 percentage of change
Standard Deviation 0.54
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: ITT Population. The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
1\. The difference in serum LDL-C (mmol/L) from baseline to week 8 between Farlong Notoginseng and placebo
Outcome measures
| Measure |
Farlong NotoGinseng™
n=42 Participants
Farlong NotoGinseng™ (Treatment Group)
|
Placebo
n=44 Participants
Placebo Group
|
|---|---|---|
|
1. The Difference in Serum LDL-C From Baseline to Week 8 Between Farlong Notoginseng and Placebo
|
-0.11 percentage of change
Standard Deviation 0.55
|
0.01 percentage of change
Standard Deviation 0.42
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: ITT Population. The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
2\. The difference in blood pressure (mmHg) from baseline to week 8 between Farlong Notoginseng and placebo
Outcome measures
| Measure |
Farlong NotoGinseng™
n=43 Participants
Farlong NotoGinseng™ (Treatment Group)
|
Placebo
n=44 Participants
Placebo Group
|
|---|---|---|
|
2. The Difference in Blood Pressure From Baseline to Week 8 Between Farlong Notoginseng and Placebo
Systolic Blood Pressure
|
-0.22 percentage of change
Standard Deviation 7.95
|
-0.46 percentage of change
Standard Deviation 9.99
|
|
2. The Difference in Blood Pressure From Baseline to Week 8 Between Farlong Notoginseng and Placebo
Diastolic Blood Pressure
|
-0.51 percentage of change
Standard Deviation 5.95
|
-0.39 percentage of change
Standard Deviation 7.65
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: ITT Population. The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
3\. The difference in blood pressure (mmHg) from baseline to week 12 between Farlong Notoginseng and placebo
Outcome measures
| Measure |
Farlong NotoGinseng™
n=42 Participants
Farlong NotoGinseng™ (Treatment Group)
|
Placebo
n=44 Participants
Placebo Group
|
|---|---|---|
|
3. The Difference in Blood Pressure From Baseline to Week 12 Between Farlong Notoginseng and Placebo
Systolic Blood Pressure
|
-1.47 percentage of change
Standard Deviation 8.10
|
1.23 percentage of change
Standard Deviation 9.57
|
|
3. The Difference in Blood Pressure From Baseline to Week 12 Between Farlong Notoginseng and Placebo
Diastolic Blood Pressure
|
-0.18 percentage of change
Standard Deviation 5.17
|
1.08 percentage of change
Standard Deviation 6.89
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: ITT Population. The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
4\. The difference in triglycerides (mmol/L) from baseline to week 8 between Farlong Notoginseng and placebo
Outcome measures
| Measure |
Farlong NotoGinseng™
n=43 Participants
Farlong NotoGinseng™ (Treatment Group)
|
Placebo
n=45 Participants
Placebo Group
|
|---|---|---|
|
4. The Difference in Triglycerides From Baseline to Week 8 Between Farlong Notoginseng and Placebo
|
0.05 percentage of change
Standard Deviation 0.63
|
-0.11 percentage of change
Standard Deviation 0.53
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: ITT Population. The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
5\. The difference in triglycerides (mmol/L) from baseline to week 12 between Farlong Notoginseng and placebo
Outcome measures
| Measure |
Farlong NotoGinseng™
n=42 Participants
Farlong NotoGinseng™ (Treatment Group)
|
Placebo
n=44 Participants
Placebo Group
|
|---|---|---|
|
5. The Difference in Triglycerides From Baseline to Week 12 Between Farlong Notoginseng and Placebo
|
-0.03 percentage of change
Standard Deviation 0.58
|
-0.05 percentage of change
Standard Deviation 0.6
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: ITT Population. The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
6\. The difference in HDL-C (mmol/L) from baseline to week 8 between Farlong Notoginseng and placebo
Outcome measures
| Measure |
Farlong NotoGinseng™
n=43 Participants
Farlong NotoGinseng™ (Treatment Group)
|
Placebo
n=45 Participants
Placebo Group
|
|---|---|---|
|
6. The Difference in HDL-C From Baseline to Week 8 Between Farlong Notoginseng and Placebo
|
0.02 percentage of change
Standard Deviation 0.24
|
-0.02 percentage of change
Standard Deviation 0.17
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: ITT Population. The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
7\. The difference in HDL-C (mmol/L) from baseline to week 12 between Farlong Notoginseng and placebo
Outcome measures
| Measure |
Farlong NotoGinseng™
n=42 Participants
Farlong NotoGinseng™ (Treatment Group)
|
Placebo
n=44 Participants
Placebo Group
|
|---|---|---|
|
7. The Difference in HDL-C From Baseline to Week 12 Between Farlong Notoginseng and Placebo
|
0.03 percentage of change
Standard Error 0.19
|
-0.02 percentage of change
Standard Error 0.15
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: ITT Population. The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
8\. The difference in total cholesterol from baseline to week 8 between Farlong Notoginseng and placebo
Outcome measures
| Measure |
Farlong NotoGinseng™
n=43 Participants
Farlong NotoGinseng™ (Treatment Group)
|
Placebo
n=45 Participants
Placebo Group
|
|---|---|---|
|
8. The Difference in Total Cholesterol From Baseline to Week 8 Between Farlong Notoginseng and Placebo
|
-0.06 percentage of change
Standard Deviation 0.73
|
-0.03 percentage of change
Standard Deviation 0.57
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: ITT Population. The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
9\. The difference in total cholesterol from baseline to week 12 between Farlong Notoginseng and placebo
Outcome measures
| Measure |
Farlong NotoGinseng™
n=42 Participants
Farlong NotoGinseng™ (Treatment Group)
|
Placebo
n=44 Participants
Placebo Group
|
|---|---|---|
|
9. The Difference in Total Cholesterol From Baseline to Week 12 Between Farlong Notoginseng and Placebo
|
-0.01 percentage of change
Standard Deviation 0.64
|
-0.13 percentage of change
Standard Deviation 0.60
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: ITT Population. The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
10\. The difference in endothelial vasodilation (LnRHI), as measured by the EndoPAT, from baseline to week 8 between Farlong Notoginseng and placebo. The reactive hyperemia index (RHI) is a measure of endothelial function and LnRHI is a similar index after natural log transformation (Normal: LnRHI \> 0.51 Abnormal: LnRHI ≤ 0.51). An increase in LnRHI is indicative of improvement in endothelial function.
Outcome measures
| Measure |
Farlong NotoGinseng™
n=41 Participants
Farlong NotoGinseng™ (Treatment Group)
|
Placebo
n=39 Participants
Placebo Group
|
|---|---|---|
|
10. The Difference in Endothelial Vasodilation, as Measured by the EndoPAT, From Baseline to Week 8 Between Farlong Notoginseng and Placebo
|
0.00 percentage of change
Standard Deviation 0.35
|
0.00 percentage of change
Standard Deviation 0.28
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: ITT Population. The analysis population takes into account participants that were withdrawn by the qualified investigator and those who were withdrawn at their own request.
11\. The difference in endothelial vasodilation (LnRHI), as measured by the EndoPAT, from baseline to week 12 between Farlong Notoginseng and placebo. The reactive hyperemia index (RHI) is a measure of endothelial function and LnRHI is a similar index after natural log transformation (Normal: LnRHI \> 0.51 Abnormal: LnRHI ≤ 0.51). An increase in LnRHI is indicative of improvement in endothelial function.
Outcome measures
| Measure |
Farlong NotoGinseng™
n=38 Participants
Farlong NotoGinseng™ (Treatment Group)
|
Placebo
n=37 Participants
Placebo Group
|
|---|---|---|
|
11. The Difference in Endothelial Vasodilation, as Measured by the EndoPAT, From Baseline to Week 12 Between Farlong Notoginseng and Placebo
|
-0.04 percentage of change
Standard Deviation 0.40
|
-0.06 percentage of change
Standard Deviation 0.30
|
Adverse Events
Farlong NotoGinseng™
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Farlong NotoGinseng™
n=47 participants at risk
Farlong NotoGinseng™ (Treatment Group)
|
Placebo
n=48 participants at risk
Placebo Group
|
|---|---|---|
|
Cardiac disorders
Dizziness
|
0.00%
0/47 • 12 weeks
|
2.1%
1/48 • 12 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
8.5%
4/47 • 12 weeks
|
4.2%
2/48 • 12 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
2.1%
1/47 • 12 weeks
|
4.2%
2/48 • 12 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.1%
1/47 • 12 weeks
|
0.00%
0/48 • 12 weeks
|
|
Gastrointestinal disorders
Constipation
|
4.3%
2/47 • 12 weeks
|
0.00%
0/48 • 12 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
2.1%
1/47 • 12 weeks
|
0.00%
0/48 • 12 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
2.1%
1/47 • 12 weeks
|
0.00%
0/48 • 12 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/47 • 12 weeks
|
2.1%
1/48 • 12 weeks
|
|
Gastrointestinal disorders
Flatulence
|
4.3%
2/47 • 12 weeks
|
0.00%
0/48 • 12 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.1%
1/47 • 12 weeks
|
0.00%
0/48 • 12 weeks
|
|
Gastrointestinal disorders
Nausea
|
4.3%
2/47 • 12 weeks
|
2.1%
1/48 • 12 weeks
|
|
Gastrointestinal disorders
Oropharyngeal pain
|
2.1%
1/47 • 12 weeks
|
0.00%
0/48 • 12 weeks
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/47 • 12 weeks
|
2.1%
1/48 • 12 weeks
|
|
Gastrointestinal disorders
Vomiting
|
2.1%
1/47 • 12 weeks
|
0.00%
0/48 • 12 weeks
|
|
General disorders
Fatigue
|
2.1%
1/47 • 12 weeks
|
0.00%
0/48 • 12 weeks
|
|
Gastrointestinal disorders
Influenza like illness
|
2.1%
1/47 • 12 weeks
|
0.00%
0/48 • 12 weeks
|
|
Immune system disorders
Hypersensitivity
|
2.1%
1/47 • 12 weeks
|
2.1%
1/48 • 12 weeks
|
|
Immune system disorders
Psoriasis
|
2.1%
1/47 • 12 weeks
|
0.00%
0/48 • 12 weeks
|
|
Infections and infestations
Herpes zoster
|
2.1%
1/47 • 12 weeks
|
0.00%
0/48 • 12 weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/47 • 12 weeks
|
2.1%
1/48 • 12 weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/47 • 12 weeks
|
2.1%
1/48 • 12 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
2.1%
1/47 • 12 weeks
|
0.00%
0/48 • 12 weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
6.4%
3/47 • 12 weeks
|
0.00%
0/48 • 12 weeks
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/47 • 12 weeks
|
2.1%
1/48 • 12 weeks
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/47 • 12 weeks
|
2.1%
1/48 • 12 weeks
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
2.1%
1/47 • 12 weeks
|
0.00%
0/48 • 12 weeks
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/47 • 12 weeks
|
2.1%
1/48 • 12 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/47 • 12 weeks
|
2.1%
1/48 • 12 weeks
|
|
Nervous system disorders
Dysgeusia
|
2.1%
1/47 • 12 weeks
|
0.00%
0/48 • 12 weeks
|
|
Nervous system disorders
Headache
|
4.3%
2/47 • 12 weeks
|
8.3%
4/48 • 12 weeks
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/47 • 12 weeks
|
2.1%
1/48 • 12 weeks
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/47 • 12 weeks
|
2.1%
1/48 • 12 weeks
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
2.1%
1/47 • 12 weeks
|
0.00%
0/48 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.3%
2/47 • 12 weeks
|
0.00%
0/48 • 12 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/47 • 12 weeks
|
2.1%
1/48 • 12 weeks
|
Additional Information
Malkanthi Evans (Ph.D.), Chief Scientific officer
KGK Science Inc.
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place