The Effect of Farlong® NotoGinseng™ (Ginseng Plus®) on Cholesterol and Blood Pressure
Condition: Hyperlipidemias; Hypertension
MeSH terms: Hypertension; Hyperlipidemias; Hyperlipoproteinemias
Intervention: Farlong NotoGinseng™ (Farlong Ginseng Plus® Panax Notoginseng extract); Placebo
Intervention description: A product made of highly concentrated pharmaceutical grade notoginseng root extract, and containing high potency bioactive components, notoginsenoside, ginsenoside Rb1, Rg1, Rd, Re and Rb2.; Turmeric 0.4%, Rice Flour 76.6%, Magnesium stearate 23%, capsule shell (gelatin) 61 mg
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This was a randomized, placebo-controlled, double-blind, parallel study with a 4-week therapeutic lifestyle change diet (TLC) run-in period and a 12-week supplementation period.
Masking: Double (Participant, Investigator)
Enrollment: 95.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: LDL-C; Blood pressure; triglycerides; HDL-C; total cholesterol; endothelial vasodilation; Hyperlipidemias; Hypertension

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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male and females age 18-75 years (inclusive)

          2. BMI 23.0 to 32.5 kg/m2

          3. Participants with LDL-C ≥2.6 mmol/L and <3.8 mmol/L (≥ 100 mg/dL and < 150 mg/dL)

          4. Participants with pre-hypertension (systolic blood pressure of greater than or equal
             to 100 and less than 140 mmHg)

          5. Participants agree to follow a therapeutic lifestyle changes (TLC) diet

          6. If female, participant is not of child bearing potential, which is defined as females
             who have had a hysterectomy or oophorectomy, bilateral tubal ligation or are
             post-menopausal (natural or surgically with > 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)

          7. Willing to maintain current physical activity patterns throughout the study

          8. Willingness to complete questionnaires, records, and diaries associated with the study
             and to complete all clinic visits

          9. Healthy as determined by laboratory results, medical history, and physical exam

         10. Has given voluntary, written, informed consent to participate in the study

        Exclusion Criteria:

          1. History of allergic reaction or hypersensitivity to any of the study supplement
             components

          2. Pregnant, breastfeeding, or planning to become pregnant during the course of the
             trial.

          3. Use of cholesterol-lowering or blood pressure lowering prescription drugs within the
             last 6 months prior to randomization

          4. 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

          5. 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%

          6. Total cholesterol vs. HDL-C ratio > 6.0, if the 10-year Framingham risk score is < 10%

          7. Use of ginseng-based drinks or products

          8. Health supplements that affect blood pressure and cholesterol levels other than
             vitamins and minerals, such as plant sterols, omega-3, fish oil, soy protein, soluble
             oat fiber, psyllium seed husk, licorice or other blood pressure and cholesterol
             lowering nonprescription supplements within 1 month of enrollment and during the study

          9. Persons on medications listed in section 4.3

         10. BMI > 32.5 kg/m2

         11. 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

         12. Use of medicinal marijuana

         13. History of chronic use of alcohol (> 2 drinks/day) over the past 6 months

         14. Currently smoking ≥ 20 cigarettes/day

         15. 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).

         16. 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

         17. Unstable medical conditions

         18. 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)

         19. Anticoagulant/ antiplatelet medications; see section 4.3 for concomitant medications
             that are exclusionary

         20. Immunocompromised individuals

         21. History of hemoglobinopathies such as sickle cell anemia, thalassemia, or
             sideroblastic anemia

         22. Individuals who have followed the Therapeutic Lifestyle Changes (TLC) diet within 12
             weeks of screening

         23. Recent surgery or will be undergoing surgery that may have an effect on the study in
             the opinion of the Qualified Investigator

         24. Participation in a clinical research trial within 30 days prior to randomization.

         25. History of eating disorders.

         26. Clinically significant abnormal laboratory results at screening

         27. Exercise greater than 24 km (15 miles)/week or 4,000 kcal/week

         28. Cognitively impaired and/or who are unable to give informed consent

         29. Plan to donate blood during the study or within 30 days of completing the study

         30. Any additional underlying medical or psychiatric condition, clinical disorder or
             laboratory finding, which in the opinion of the Qualified Investigator may interfere
             with study objectives