Safety for 24 Weeks Intake of Korean Red Ginseng in Adults

NCT02428998 | Completed

• 1 other identifier: KGC-S-01
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Korean Red Ginseng appears to adverse events in adults taking 24 weeks Placebo and comparative assessment. And exploratory as Korean Red Ginseng blood sugar control, reduce body fat, URTI prevention, cardiovascular risk, renal function, cholesterol, improve, fatigue, and determine the impact on biological age.

Conditions

Healthy; Diabetes; Hypertension; Hyperlipidemia

Outcome Measures

Primary Outcomes (1)

• All adverse events occurring up to 24 weeks time after taking the Investigational product

  up to 24 weeks time after taking the Investigational product

Secondary Outcomes (6)

• Adverse events that occurred up to 24 weeks to collect all focus point after taking the Investigational product

  up to 24 weeks to collect all focus point after taking the Investigational product

• Cardiovascular adverse events that occurred after taking the Investigational product

  up to 24 weeks time after taking the Investigational product

• Gastrointestinal adverse events that occurred after ingestion of Investigational product

  up to 24 weeks time after taking the Investigational product

• Neuropsychiatric adverse events that occurred after ingestion of Investigational product

  up to 24 weeks time after taking the Investigational product

• Grade 3 adverse events that occurred after ingestion of Investigational product

  up to 24 weeks time after taking the Investigational product

Other Outcomes (8)

• glucose, insulin, HbA1c levels, HOMA-IR index variation

  up to 24 weeks time after taking the Investigational product

• BMI, waist circumference variation

  up to 24 weeks time after taking the Investigational product

• adiponectin, leptin levels of variation

  up to 24 weeks time after taking the Investigational product

Study Arms (2)

Korean Red Ginseng

EXPERIMENTAL

Patients receive oral Korean Red Ginseng twice daily for 24 weeks. Treatment repeats every 4, 12, 24 weeks for 3 courses

Dietary Supplement: Korean Red Ginseng

Placebo

PLACEBO COMPARATOR

Patients receive oral placebo twice daily for 24 weeks. Treatment repeats every 4, 12,24 weeks for 3 courses

Dietary Supplement: Placebo

Interventions

Korean Red Ginseng DIETARY_SUPPLEMENT

Korean Red Ginseng

Placebo DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• agree to participate in this test, voluntarily signed by the parties to a written agreement
• In the case of women of childbearing age and confirmed negative pregnancy test, you agree to contraception during the trial period applying human characters

You may not qualify if:

• Pregnant and lactating mothers
• Patients with a history of hypersensitivity to contain ingredients that caused the test food
• patients with severe renal disease (serum creatinine levels greater than 1.5 times if the upper limit of normal
• Patients with severe hepatic disease, such as cirrhosis (if AST or ALT greater than three times the upper limit of normal)
• autoimmune diseases (multiple sclerosis, lupus, rheumatoid arthritis, etc.) patients with
• patients with uncontrolled diabetes (for HbA1c 8.0% or more)
• Sulphonylureas, diabetic patients being treated with Insulin
• , uncontrolled hypertension (systolic blood pressure of 150mmHg or higher or if diastolic blood pressure greater than 100mmHg)
• uncontrolled hyperlipidemia patients (if LDL-cholesterol is 160mg / dL or higher)
• patients with uncontrolled thyroid dysfunction
• patients with a dementia or psychiatric problems
• treated with systemic steroid screening visit within 1 weeks ago
• before the screening visit 4 weeks continuously for more than two weeks, the mentally ill and insomnia patients receiving antipsychotic medication within
• taking the medicine within 4 weeks before the screening visit
• taking the other investigational drugs or human test food application within four weeks before the screening visit

Sponsors & Collaborators

• Korea Ginseng Corporation: lead

Study Sites (1)

Catholic Universtiy of Korea. Seoul St Mary's Hospital

Seoul, 137-701, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus; Hypertension; Hyperlipidemias

Interventions

Asian ginseng

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders

Study Officials

• Kyungsoo Kim, M.D., Ph.D

  The Catholic University of Korea

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2015
• First Posted: April 29, 2015
• Study Start: September 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: April 1, 2017
• Last Updated: August 11, 2017

Record last verified: 2017-08

Locations

KR (1)