Status:
COMPLETED
The Effect of Farlong® NotoGinseng™ (Ginseng Plus®) on Cholesterol and Blood Pressure
Lead Sponsor:
LongStar HealthPro, Inc. DBA Farlong Pharmaceutical
Collaborating Sponsors:
Yunnan Panlong Yunhai Pharmaceutical Group Co., Ltd.
KGK Science Inc.
Conditions:
Hyperlipidemias
Hypertension
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 Gin...
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 b...
Eligibility Criteria
Inclusion
- 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)
- 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
Exclusion
- 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%
- 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
Key Trial Info
Start Date :
July 20 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2019
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT04069715
Start Date
July 20 2016
End Date
June 1 2019
Last Update
May 17 2021
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