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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04069715
Recruitment Status : Enrolling by invitation
First Posted : August 28, 2019
Last Update Posted : August 28, 2019
Sponsor:
Collaborators:
Yunnan PanLongYunHai Pharmaceuticals, Ltd.
KGK Science Inc.
Information provided by (Responsible Party):
LongStar HealthPro, Inc. DBA Farlong Pharmaceutical

Brief 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®), 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.

Condition or disease Intervention/treatment Phase
Hyperlipidemias Hypertension Dietary Supplement: Farlong NotoGinseng™ (Farlong Ginseng Plus®) Other: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
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
Official Title: A Randomized, Placebo-controlled, Double-blind, Parallel Study to Determine the Effect of Farlong® NotoGinseng™ (Farlong® Ginseng Plu®) on Cholesterol and Blood Pressure
Actual Study Start Date : July 20, 2016
Estimated Primary Completion Date : February 28, 2020
Estimated Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Ginseng

Arm Intervention/treatment
Experimental: Farlong NotoGinseng™ (Farlong Ginseng Plus®)
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.
Dietary Supplement: Farlong NotoGinseng™ (Farlong 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.
Other Names:
  • Farlong Panax NotoGinseng™
  • Notoginseng total saponins
  • Panax notoginseng saponins

Placebo Comparator: Placebo
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.
Other: Placebo
Turmeric 0.4%, Rice Flour 76.6%, Magnesium stearate 23%, capsule shell (gelatin) 61 mg




Primary Outcome Measures :
  1. The difference in serum LDL-C from baseline to week 12 between Farlong NotoGinseng™ (Farlong Ginseng Plus®) and placebo after 12 weeks of supplementation. [ Time Frame: 12 weeks ]
    The difference in serum LDL-C from baseline to week 12 between Farlong NotoGinseng™ (Farlong Ginseng Plus®) and placebo after 12 weeks of supplementation.


Secondary Outcome Measures :
  1. 1. The difference in serum LDL-C from baseline to week 8 between Farlong Notoginseng and placebo [ Time Frame: 8 weeks ]
    1. The difference in serum LDL-C from baseline to week 8 between Farlong Notoginseng and placebo

  2. 2. The difference in blood pressure 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

  3. 3. The difference in blood pressure from baseline to week 12 between Farlong Notoginseng and placebo [ Time Frame: 12 weeks ]
    3. The difference in blood pressure from baseline to week 12 between Farlong Notoginseng and placebo

  4. 4. The difference in triglycerides from baseline to week 8 between Farlong Notoginseng and placebo [ Time Frame: 8 weeks ]
    4. The difference in triglycerides from baseline to week 8 between Farlong Notoginseng and placebo

  5. 5. The difference in triglycerides from baseline to week 12 between Farlong Notoginseng and placebo [ Time Frame: 12 weeks ]
    5. The difference in triglycerides from baseline to week 12 between Farlong Notoginseng and placebo

  6. 6. The difference in HDL-C from baseline to week 8 between Farlong Notoginseng and placebo [ Time Frame: 8 weeks ]
    6. The difference in HDL-C from baseline to week 8 between Farlong Notoginseng and placebo

  7. 7. The difference in HDL-C from baseline to week 12 between Farlong Notoginseng and placebo [ Time Frame: 12 weeks ]
    7. The difference in HDL-C from baseline to week 12 between Farlong Notoginseng and placebo

  8. 8. The difference in total cholesterol from baseline to week 8 between Farlong Notoginseng and placebo [ Time Frame: 8 weeks ]
    8. The difference in total cholesterol from baseline to week 8 between Farlong Notoginseng and placebo

  9. 9. The difference in total cholesterol from baseline to week 12 between Farlong Notoginseng and placebo [ Time Frame: 12 weeks ]
    9. The difference in total cholesterol from baseline to week 12 between Farlong Notoginseng and placebo

  10. 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 ]
    10. The difference in endothelial vasodilation, as measured by the EndoPAT, from baseline to week 8 between Farlong Notoginseng and placebo

  11. 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 ]
    11. The difference in endothelial vasodilation, as measured by the EndoPAT, from baseline to week 12 between Farlong Notoginseng and placebo



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 120 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04069715


Sponsors and Collaborators
LongStar HealthPro, Inc. DBA Farlong Pharmaceutical
Yunnan PanLongYunHai Pharmaceuticals, Ltd.
KGK Science Inc.
Investigators
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Principal Investigator: David Crowley, MD KGK Science Inc.
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Responsible Party: LongStar HealthPro, Inc. DBA Farlong Pharmaceutical
ClinicalTrials.gov Identifier: NCT04069715    
Other Study ID Numbers: NotoGinseng 16GCHY
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by LongStar HealthPro, Inc. DBA Farlong Pharmaceutical:
LDL-C
Blood pressure
triglycerides
HDL-C
total cholesterol
endothelial vasodilation
Hyperlipidemias
Hypertension
Additional relevant MeSH terms:
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Hypertension
Hyperlipidemias
Hyperlipoproteinemias
Vascular Diseases
Cardiovascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases