The Effect of Farlong® NotoGinseng™ (Ginseng Plus®) on Cholesterol and Blood Pressure

Hypertension Clinical Trial

Official title: A Randomized, Placebo-controlled, Double-blind, Parallel Study to Determine the Effect of Farlong® NotoGinseng™ (Farlong® Ginseng Plus®) on Cholesterol and Blood Pressure

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Hyperlipidemias
• Hyperlipoproteinemias
• Hypertension

• NCT number: NCT04069715
• Study type: Interventional
• Source: LongStar HealthPro, Inc. DBA Farlong Pharmaceutical
• Status: Completed
• Phase: Phase 2
• Start date: July 20, 2016
• Completion date: June 1, 2019