Phase 2
Completed N=95
The Effect of Farlong® NotoGinseng™ (Ginseng Plus®) on Cholesterol and Blood Pressure
Source: ClinicalTrials.gov NCT04069715 ↗Enrolled (actual)
95
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcomePrimary: 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; -0.12 percentage of change
Summary
In this randomized, placebo-controlled, double-blind parallel study in human participants with elevated LDL-C and elevated BP described here, the clinical benefits of Farlong NotoGinseng™ (Farlong Ginseng Plus® Panax Notoginseng extract), a product made of highly concentrated pharmaceutical grade notoginseng root extract, and containing high potency bioactive components, notoginsenoside, ginsenoside Rb1 and ginsenoside Rg1, will be investigated for its efficacy on LDL-C and blood pressure.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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; -0.12 | — |
| SECONDARY 1. The Difference in Serum LDL-C From Baseline to Week 8 Between Farlong Notoginseng and Placebo |
-0.11; 0.01 | — |
| SECONDARY 2. The Difference in Blood Pressure From Baseline to Week 8 Between Farlong Notoginseng and Placebo |
-0.22; -0.46; -0.51; -0.39 | — |
| SECONDARY 3. The Difference in Blood Pressure From Baseline to Week 12 Between Farlong Notoginseng and Placebo |
-1.47; 1.23; -0.18; 1.08 | — |
| SECONDARY 4. The Difference in Triglycerides From Baseline to Week 8 Between Farlong Notoginseng and Placebo |
0.05; -0.11 | — |
| SECONDARY 5. The Difference in Triglycerides From Baseline to Week 12 Between Farlong Notoginseng and Placebo |
-0.03; -0.05 | — |
| SECONDARY 6. The Difference in HDL-C From Baseline to Week 8 Between Farlong Notoginseng and Placebo |
0.02; -0.02 | — |
| SECONDARY 7. The Difference in HDL-C From Baseline to Week 12 Between Farlong Notoginseng and Placebo |
0.03; -0.02 | — |
| SECONDARY 8. The Difference in Total Cholesterol From Baseline to Week 8 Between Farlong Notoginseng and Placebo |
-0.06; -0.03 | — |
| SECONDARY 9. The Difference in Total Cholesterol From Baseline to Week 12 Between Farlong Notoginseng and Placebo |
-0.01; -0.13 | — |
| SECONDARY 10. The Difference in Endothelial Vasodilation, as Measured by the EndoPAT, From Baseline to Week 8 Between Farlong Notoginseng and Placebo |
0.00; 0.00 | — |
| SECONDARY 11. The Difference in Endothelial Vasodilation, as Measured by the EndoPAT, From Baseline to Week 12 Between Farlong Notoginseng and Placebo |
-0.04; -0.06 | — |
Eligibility Criteria
Inclusion Criteria
- Male and females age 18-75 years (inclusive)
- BMI 23.0 to 32.5 kg/m2
- Participants with LDL-C ≥2.6 mmol/L and 1 year since last menstruation)
OR
Females of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result. Acceptable methods of birth control include:
- Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (DepoProvera, Lunelle), or hormone implant (Norplant System)
- Double-barrier method (condoms with spermicide or diaphragm with spermicide)
- Intrauterine devices
- Vasectomy of partner (shown successful as per appropriate follow-up)
- Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
- Willing to maintain current physical activity patterns throughout the study
- Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits
- Healthy as determined by laboratory results, medical history, and physical exam
- Has given voluntary, written, informed consent to participate in the study
Exclusion Criteria
- History of allergic reaction or hypersensitivity to any of the study supplement components
- Pregnant, breastfeeding, or planning to become pregnant during the course of the trial.
- Use of cholesterol-lowering or blood pressure lowering prescription drugs within the last 6 months prior to randomization
- LDL-C ≥ 3.37 mmol/L (130 mg/dL), if the 10-year risk of cardiovascular event is ≥ 20% as estimated by the Framingham risk score
- LDL-C > 3.5 mmol/L (135.34 mg/dL) OR if the total cholesterol vs. HDL-C ratio is > 5.0 OR hs-CRP > 2 mg/L in males > 50 years and females > 60 years, and if the 10-year Framingham risk score is 10-19%
- Total cholesterol vs. HDL-C ratio > 6.0, if the 10-year Framingham risk score is 32.5 kg/m2
- Individuals with a history of coronary artery disease, previous myocardial infarction, peripheral vascular disease, atherosclerosis, diabetic men > 45 years old, and diabetic women > 50 years
- Use of medicinal marijuana
- History of chronic use of alcohol (> 2 drinks/day) over the past 6 months
- Currently smoking ≥ 20 cigarettes/day
- Use of systemic antibiotics, corticosteroids, androgens, or phenytoin, and HRT (HRTs are allowed if participant has been on a stable dose for at least 3 months and intends to maintain their dosage regimen).
- Significant or untreated medical disorders including uncontrolled diabetes, recent myocardial ischemia or infarction, unstable angina, peripheral vascular diseases/bruits, uncontrolled thyroid dysfunction, renal failure and serious renal diseases, chronic active hepatitis, acute hepatitis, cirrhosis of liver, AIDS, malignancy, recent cerebrovascular disease and neurological disorders or significant psychiatric illness
- Unstable medical conditions
- History of angina, congestive heart failure, inflammatory bowel disease, pancreatitis, gastrointestinal, renal, pulmonary, hepatic or biliary disease, autoimmune disorders or cancer (evidence of active lesions, chemotherapy or surgery in the past year)
- Anticoagulant/ antiplatelet medications; see section 4.3 for concomitant medications that are exclusionary
- Immunocompromised individuals
- History of hemoglobinopathies such as sickle cell anemia, thalassemia, or sideroblastic anemia
- Individuals who have followed the Therapeutic Lifestyle Changes (TLC) diet within 12 weeks of screening
- Recent surgery or will be undergoing surgery that may have an effect on the study in the opinion of the Qualified Investigator
- Participation in a clinical research trial within 30 days prior to randomization.
- History of eating disorders.
- Clinically significant abnormal laboratory results at screening
- Exercise greater than 24 km (15 miles)/week or 4,00
Data sourced from ClinicalTrials.gov (NCT04069715). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.