HyperlipidemiasPhase 2NCT04069715
The Effect of Farlong® NotoGinseng™ (Ginseng Plus®) on Cholesterol and Blood Pressure
A Phase 2 study testing Farlong NotoGinseng™ (Farlong Ginseng Plus® Panax Notoginseng extract) in people with Hyperlipidemias and Hypertension, run by LongStar HealthPro, Inc. DBA Farlong Pharmaceutical.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperlipidemias, Hypertension
- What is being tested?
- Farlong NotoGinseng™ (Farlong Ginseng Plus® Panax Notoginseng extract)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- No sites listed yet
- Study dates
- 20 Jul 2016to 1 Jun 2019
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 <3.8 mmol/L (≥ 100 mg/dL and < 150 mg/dL)
- Participants with pre-hypertension (systolic blood pressure of greater than or equal to 100 and less than 140 mmHg)
- Participants agree to follow a therapeutic lifestyle changes (TLC) diet
- 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)
Show all 17Show fewer
- 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
Who cannot join
- 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 < 10%
Show all 30Show fewer
- Use of ginseng-based drinks or products
- 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
- Persons on medications listed in section 4.3
- BMI > 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 4,000 kcal/week
- Cognitively impaired and/or who are unable to give informed consent
- Plan to donate blood during the study or within 30 days of completing the study
- 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
About this study
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
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.
Read the 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.
- Conditions
- Hyperlipidemias, Hypertension
- Being tested
- Farlong NotoGinseng™ (Farlong Ginseng Plus® Panax Notoginseng extract), Placebo
- Keywords
- LDL-C, Blood pressure, triglycerides, HDL-C, total cholesterol, endothelial vasodilation, Hyperlipidemias, Hypertension
- Medical subject headings
- Hyperlipidemias, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Farlong NotoGinseng™ (Farlong Ginseng Plus® Panax Notoginseng extract)Dietary supplement
Also called Farlong Panax NotoGinseng™, Notoginseng total saponins, Panax notoginseng saponins, Ginseng Plus®
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.
PlaceboOther
Turmeric 0.4%, Rice Flour 76.6%, Magnesium stearate 23%, capsule shell (gelatin) 61 mg
| Study group | Role | What they receive |
|---|---|---|
| Farlong NotoGinseng™ (Farlong Ginseng Plus® Panax Notoginseng) | Experimental | Participants will be instructed to take two capsules once per day in the morning, thirty minutes before a meal. Clinic staff will instruct participants to save all unused and open packages and return them to clinic at each subsequent visit (visit 3, visit 4 and visit 5) for a determination of compliance. If a dose is missed, participants are instructed to take one as soon as they remember that day. Participants will be advised not to exceed two capsules daily. Receives: Dietary Supplement: Farlong NotoGinseng™ (Farlong Ginseng Plus® Panax Notoginseng extract) |
| Placebo | Placebo comparator | Participants will be instructed to take two capsules once per day in the morning, thirty minutes before a meal. Clinic staff will instruct participants to save all unused and open packages and return them to clinic at each subsequent visit (visit 3, visit 4 and visit 5) for a determination of compliance. If a dose is missed, participants are instructed to take one as soon as they remember that day. Participants will be advised not to exceed two capsules daily. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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.
Measured: 12 weeks
Secondary outcomes (11)
1. The Difference in Serum LDL-C From Baseline to Week 8 Between Farlong Notoginseng and Placebo
- The difference in serum LDL-C (mmol/L) from baseline to week 8 between Farlong Notoginseng and placebo
Measured: 8 weeks
2. The Difference in Blood Pressure From Baseline to Week 8 Between Farlong Notoginseng and Placebo
- The difference in blood pressure (mmHg) from baseline to week 8 between Farlong Notoginseng and placebo
Measured: 8 weeks
3. The Difference in Blood Pressure From Baseline to Week 12 Between Farlong Notoginseng and Placebo
- The difference in blood pressure (mmHg) from baseline to week 12 between Farlong Notoginseng and placebo
Measured: 12 weeks
4. The Difference in Triglycerides From Baseline to Week 8 Between Farlong Notoginseng and Placebo
- The difference in triglycerides (mmol/L) from baseline to week 8 between Farlong Notoginseng and placebo
Measured: 8 weeks
5. The Difference in Triglycerides From Baseline to Week 12 Between Farlong Notoginseng and Placebo
- The difference in triglycerides (mmol/L) from baseline to week 12 between Farlong Notoginseng and placebo
Measured: 12 weeks
6. The Difference in HDL-C From Baseline to Week 8 Between Farlong Notoginseng and Placebo
- The difference in HDL-C (mmol/L) from baseline to week 8 between Farlong Notoginseng and placebo
Measured: 8 weeks
7. The Difference in HDL-C From Baseline to Week 12 Between Farlong Notoginseng and Placebo
- The difference in HDL-C (mmol/L) from baseline to week 12 between Farlong Notoginseng and placebo
Measured: 12 weeks
8. The Difference in Total Cholesterol From Baseline to Week 8 Between Farlong Notoginseng and Placebo
- The difference in total cholesterol from baseline to week 8 between Farlong Notoginseng and placebo
Measured: 8 weeks
9. The Difference in Total Cholesterol From Baseline to Week 12 Between Farlong Notoginseng and Placebo
- The difference in total cholesterol from baseline to week 12 between Farlong Notoginseng and placebo
Measured: 12 weeks
10. The Difference in Endothelial Vasodilation, as Measured by the EndoPAT, From Baseline to Week 8 Between Farlong Notoginseng and Placebo
- 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.
Measured: 8 weeks
11. The Difference in Endothelial Vasodilation, as Measured by the EndoPAT, From Baseline to Week 12 Between Farlong Notoginseng and Placebo
- 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start20 Jul 2016
- Primary completion1 Jun 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HyperlipidemiasStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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 blind
- Who is masked
- Participant, Investigator
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- LongStar HealthPro, Inc. DBA Farlong Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Yunnan Panlong Yunhai Pharmaceutical Group Co., Ltd., KGK Science Inc.
- Responsible party
- Sponsor
- Investigators
- David Crowley, MD, Principal investigator, KGK Science Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069715
- Sponsor's protocol ID
- Farlong® NotoGinseng 16GCHY
- Status last verified
- Apr 2021
- First submitted
- 30 Aug 2017
- Last updated
- 17 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04069715
- Acronym / sponsor ID
- Farlong® NotoGinseng 16GCHY
- Conditions
- Hyperlipidemias, Hypertension
- Keywords
- LDL-C, Blood pressure, triglycerides, HDL-C, total cholesterol, endothelial vasodilation, Hyperlipidemias, Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- LongStar HealthPro, Inc. DBA Farlong PharmaceuticalIndustry (pharma, biotech, devices)
- Collaborators
- Yunnan Panlong Yunhai Pharmaceutical Group Co., Ltd., KGK Science Inc.
- Study start
- 20 Jul 2016 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Posted 30 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Farlong NotoGinseng™ (Farlong Ginseng Plus® Panax Notoginseng) | Experimental | Dietary Supplement: Farlong NotoGinseng™ (Farlong Ginseng Plus® Panax Notoginseng extract)Participants will be instructed to take two capsules once per day in the morning, thirty minutes before a meal. Clinic staff will instruct participants to save all unused and open packages and return them to clinic at each subsequent visit (visit 3, visit 4 and visit 5) for a determination of compliance. If a dose is missed, participants are instructed to take one as soon as they remember that day. Participants will be advised not to exceed two capsules daily. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will be instructed to take two capsules once per day in the morning, thirty minutes before a meal. Clinic staff will instruct participants to save all unused and open packages and return them to clinic at each subsequent visit (visit 3, visit 4 and visit 5) for a determination of compliance. If a dose is missed, participants are instructed to take one as soon as they remember that day. Participants will be advised not to exceed two capsules daily. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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 <3.8 mmol/L (≥ 100 mg/dL and < 150 mg/dL)
- Participants with pre-hypertension (systolic blood pressure of greater than or equal to 100 and less than 140 mmHg)
- Participants agree to follow a therapeutic lifestyle changes (TLC) diet
Key exclusion criteria (30 listed)
- 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%
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Farlong NotoGinseng™ (Farlong Ginseng Plus® Panax Notoginseng extract)Also: Farlong Panax NotoGinseng™, Notoginseng total saponins, Panax notoginseng saponins, Ginseng Plus®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. | Dietary supplement | Farlong NotoGinseng™ (Farlong Ginseng Plus® Panax Notoginseng) |
| PlaceboTurmeric 0.4%, Rice Flour 76.6%, Magnesium stearate 23%, capsule shell (gelatin) 61 mg | Other | Placebo |
Primary outcome
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.
Time frame: 12 weeks
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.
11 secondary outcomes
1. The Difference in Serum LDL-C From Baseline to Week 8 Between Farlong Notoginseng and Placebo
Time frame: 8 weeks
2. The Difference in Blood Pressure From Baseline to Week 8 Between Farlong Notoginseng and Placebo
Time frame: 8 weeks
3. The Difference in Blood Pressure From Baseline to Week 12 Between Farlong Notoginseng and Placebo
Time frame: 12 weeks
4. The Difference in Triglycerides From Baseline to Week 8 Between Farlong Notoginseng and Placebo
Time frame: 8 weeks
5. The Difference in Triglycerides From Baseline to Week 12 Between Farlong Notoginseng and Placebo
Time frame: 12 weeks
6. The Difference in HDL-C From Baseline to Week 8 Between Farlong Notoginseng and Placebo
Time frame: 8 weeks
7. The Difference in HDL-C From Baseline to Week 12 Between Farlong Notoginseng and Placebo
Time frame: 12 weeks
8. The Difference in Total Cholesterol From Baseline to Week 8 Between Farlong Notoginseng and Placebo
Time frame: 8 weeks
9. The Difference in Total Cholesterol From Baseline to Week 12 Between Farlong Notoginseng and Placebo
Time frame: 12 weeks
10. The Difference in Endothelial Vasodilation, as Measured by the EndoPAT, From Baseline to Week 8 Between Farlong Notoginseng and Placebo
Time frame: 8 weeks
11. The Difference in Endothelial Vasodilation, as Measured by the EndoPAT, From Baseline to Week 12 Between Farlong Notoginseng and Placebo
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Crowley, MD principal investigator
KGK Science Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Farlong NotoGinseng™ (Farlong Ginseng Plus® Panax Notoginseng extract) in people with Hyperlipidemias and Hypertension, run by LongStar HealthPro, Inc. DBA Farlong Pharmaceutical.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Dec 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2021.