The Effect of Farlong® NotoGinseng™ (Ginseng Plus®) on Cholesterol and Blood Pressure
Condition: Hyperlipidemias; Hypertension
MeSH terms: Hypertension; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      Health statistics include data on health disparities, global impact of cardiovascular
      diseases (CVDs) and risk factors including smoking, physical activity, body weight,
      cholesterol, blood sugar and blood pressure (BP) (1). Based on this, it is estimated that 33%
      of US adults had high blood pressure in 2009-2012 and during the same period, 43% of
      Americans had total cholesterol of 200 mg/dL or higher (2).

      Chronic, elevated BP, defined as systolic BP (SBP) greater than 140 mmHg and diastolic BP
      (DBP) greater than 90 mmHg is clinically known as hypertension (3). Notably, hypertension is
      a strong, consistent, and independent risk factor for CVD and renal disease, including
      stroke, coronary heart disease, and kidney failure (4). Epidemiological evidence indicates
      that there is a log-linear relationship between elevated "bad" cholesterol, or low density
      lipoprotein-cholesterol (LDL-C) concentration, and relative risk of CVD (5). Lifestyle
      factors known to modify BP and cholesterol levels, including a balanced diet and exercise are
      not always met, highlighting the potential for nutritional supplementation.

      The use of nutritional supplements, which might be effective in the reduction of high BP
      (hypertension) and hypercholesterolemia, is rapidly growing. However, most of the products
      available on the market have not been clinically evaluated for their effectiveness. Common
      ingredients found in cholesterol-lowering supplements include plant sterols. Plant sterols
      have been shown to reduce hypercholesterolemia in numerous experimental studies and in
      clinical trials, and are associated with lowering LDL-C by 10-15% (6;7). It has been
      estimated that consumption of at least 1.3 g of plant sterols/day may help to reduce the risk
      of heart disease by lowering blood cholesterol (8). Previous pre-clinical work reported that
      in addition to reduced cholesterol, supplementation with plant sterols can lower BP in
      hypertensive animals, although studies in humans are in early phases of development (9).
      Plant sterol supplementation may also improve vascular function, as one human trial found an
      association with sterol intake and lower levels of carotid wall thickness in older Amish
      participants (10).

      Traditional Chinese Medicine has been used to treat cardiovascular diseases for thousands of
      years and species of the genus Panax plant are widely used in China and all over the world.
      Panax notoginseng (Burk.) F.H. Chen, is one of about 12 species in the Panax genus of the
      Araliaceae. Due to its sensitivity to light, P notoginseng is restricted to narrow geographic
      regions growing at an altitude of 1200-2000 m, primarily in the Wenshan mountains of Yunnan
      province in the People's Republic of China. The plant grows to a height of 30-60 cm and has
      dark green leaves branching from the stem where it typically bears a cluster of berries in
      the middle (11). The root of P notoginseng has a 400-year old history as a tonic and
      hemostatic drug; over 200 compounds have been isolated from this plant, exhibiting a variety
      of pharmacological effects, and appropriately enough the genus name "Panax" is derived from
      the Greek word (Pan = all + axos = medicine) meaning 'cure all' (12). Historically, Chinese
      medicine ascribes Panax ginseng C.A. Meyer to tonifying "qi", while P notoginseng nourishes
      the blood by dissipating blood stasis, inhibiting bleeding, enhancing circulation and
      alleviating pain. While the radix and rhizome of P notoginseng are used for bleeding
      disorders, the flower of this plant has been noted for several properties, including but not
      limited to, treating hypertension, and rejuvenating the liver (11). In the literature,
      extracts from P notoginseng have been referred to as Sanchitongshu, Xueshuantong, Sanqi or
      Tianqi and these ginsenosides from P notoginseng have collectively been referred to as Panax
      Notoginsenoside Saponins.

      The primary bioactive ingredients in notoginseng plants are saponins, of which more than 60
      have been identified (13). Saponins from notoginseng plant exert angiogenic effects by
      activating vascular endothelial growth factor and its receptor in downstream signaling
      pathways (14;15). Further, ginsenoside Rg5, a compound newly synthesized during the steaming
      process of notoginseng was found to promote angiogenesis and improve hypertension in animal
      models without adverse effects in the blood vasculature (16). Rg5 specifically increased
      phosphorylation of insulin-like growth factor-1 receptor (IGF-1R) resulting in stimulation of
      nitric oxide pathways to enhance angiogenesis (16). These studies suggest that notoginseng
      may have beneficial clinical applications in the management of CVD.

      Currently, there is a lack of well-controlled trials evaluating the doses and effects of
      notoginseng (17). In this context, it is imperative to conduct well-controlled clinical
      trials that may unravel the mechanism (s) of action as well as evaluate the clinical
      potential of notoginseng as a natural health product and dietary supplement. 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 BP.
    

Intervention name(s): Farlong NotoGinseng™ (Farlong Ginseng Plus® Panax Notoginseng extract); Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): 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
Other intervention name(s): Farlong Panax NotoGinseng™; Notoginseng total saponins; Panax notoginseng saponins; Ginseng Plus®; Farlong Ginseng Plus®
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)
Primary purpose: Supportive Care
Keywords: LDL-C; Blood pressure; triglycerides; HDL-C; total cholesterol; endothelial vasodilation; Hyperlipidemias; Hypertension