The Effect of Farlong® NotoGinseng™ (Ginseng Plus®) on Cholesterol and Blood Pressure (NCT04069715) | Clinical Trial Compass
CompletedPhase 2
The Effect of Farlong® NotoGinseng™ (Ginseng Plus®) on Cholesterol and Blood Pressure
95 participantsStarted 2016-07-20
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
âś“. Male and females age 18-75 years (inclusive)
âś“. 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)
âś“. Participants with pre-hypertension (systolic blood pressure of greater than or equal to 100 and less than 140 mmHg)
âś“. Participants agree to follow a therapeutic lifestyle changes (TLC) diet
âś“. 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)
âś“. Willing to maintain current physical activity patterns throughout the study
âś“. Willingness to complete questionnaires, records, and diaries associated with the study and to complete all clinic visits
Exclusion criteria
âś•. History of allergic reaction or hypersensitivity to any of the study supplement components
âś•. Pregnant, breastfeeding, or planning to become pregnant during the course of the trial.
âś•. 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
What they're measuring
1
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.
Timeframe: 12 weeks
Trial details
NCT IDNCT04069715
SponsorLongStar HealthPro, Inc. DBA Farlong Pharmaceutical
âś•. 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%
âś•. Total cholesterol vs. HDL-C ratio \> 6.0, if the 10-year Framingham risk score is \< 10%
âś•. Use of ginseng-based drinks or products
âś•. 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