Efficacy of an Extract of Concentrated Korean Red Ginseng for Preventing Upper Respiratory Tract Infections

A Placebo-Controlled Trial of Korean Red Ginseng Extract to Prevent Acute Respiratory Illness in Healthy Subjects

Upper respiratory tract infections are a major source of morbidity throughout the world. Extracts of Korean red ginseng have been found to have the potential to modulate both natural and acquired immune responses. The investigators sought to examine the efficacy of an extract of Korean red ginseng in preventing colds. Therefore, the efficacy and safety of Korean red ginseng will be investigated in healthy subjects during the influenza season.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Dietary supplement: Korean red ginseng; Dietary supplement: Placebo

Detailed Description

The extract of Korean red ginseng has been found efficacious in the prevention of respiratory infections in healthy adults. The investigators will be conducted a randomized, double-blind, placebo-controlled study at the onset of the influenza season. A total of 100 subjects 30-70 years of age with a history of at least 2 colds in the previous year will be recruited from the general population in jeollabuk-do, South Korea. The subjects will be instructed to take 9 capsules per day of either the Korean red ginseng extract or a placebo for a period of 12weeks. The primary outcome measure will be the number of Jackson-verified colds. Secondary outcome measures will be included symptom severity, total number of days of symptoms and duration of all colds. Cold symptoms will be scored by subjects.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeollabuk-do
    • Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
      • Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males and females 30-70 years old
• have contracted at least 2 colds in the past year

Exclusion Criteria:

• if they had been vaccinated against influenza in the previous 6 months.
• Subjects with medical conditions such as multiple sclerosis, tuberculosis, diabetes, cancer, lupus, HIV/AIDS, cardiovascular disease, hypertension, neurologic or psychiatric disease, and renal, pulmonary and hepatic abnormalities
• Subjects taking medications such as immunosuppressive drugs, corticosteroids, warfarin, phenalzine, pentobarbital, haloperidol or cyclosporine
• Abnormal liver or kidney function tests (ALT or AST>2 times the upper limit of normal; elevated creatinine, males>125uM/L, females>110uM/L)
• pregnant or lactating women and heavy smokers.
• being judged by the responsible physician of the local study center as unfit to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Placebo (3.0g/day) for 12 weeks
Experimental: KRG Extract	Dietary supplement: Korean red ginseng; Korean red ginseng(3.0g/day) for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of ILI(Influenza Like Illness)	Subjects received the open-ended questions about frequency of ILI onset during study period. The frequency of ILI onset was checked weekly via telephone.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom Severity of All Colds	Subjects received the open-ended questions about symptom severity of all colds onset during study period. The symptom severity of all colds onset was checked weekly via telephone. Symptom severity of all colds (score 0-27) was measured during study period. The original index consists of 9 Questions(Fever, Rhinorrhea, Nasal congestion, Sore throat, Cough, Sputum, Dyspnea, Headache, Myalgia). Individual question response is assigned a score of between 0 (none) to 3 (severe) and summed to form a total score(summed) ranging from 0 (best) to 27 (worst).	12 weeks
Total Number of Days of Symptoms and Duration of All Colds	Extract of Korean red ginseng intake did not significantly reduced total number of days of symptoms and duration of all colds	up to 12 weeks

Collaborators and Investigators

• Sponsor: Chonbuk National University Hospital
• Investigators: Principal Investigator: Chang-Seop Lee, MD, Chonbuk National University Hospital

Publications and helpful links

General Publications

• Lee CS, Lee JH, Oh M, Choi KM, Jeong MR, Park JD, Kwon DY, Ha KC, Park EO, Lee N, Kim SY, Choi EK, Kim MG, Chae SW. Preventive effect of Korean red ginseng for acute respiratory illness: a randomized and double-blind clinical trial. J Korean Med Sci. 2012 Dec;27(12):1472-8. doi: 10.3346/jkms.2012.27.12.1472. Epub 2012 Dec 7.
• Ha KC, Kim MG, Oh MR, Choi EK, Back HI, Kim SY, Park EO, Kwon DY, Yang HJ, Kim MJ, Kang HJ, Lee JH, Choi KM, Chae SW, Lee CS. A placebo-controlled trial of Korean red ginseng extract for preventing influenza-like illness in healthy adults. BMC Complement Altern Med. 2012 Feb 8;12:10. doi: 10.1186/1472-6882-12-10.

Study record dates

Study Major Dates

• Study Start: November 1, 2010
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: November 16, 2011
• First Submitted That Met QC Criteria: November 22, 2011
• First Posted (Estimate): November 23, 2011

Study Record Updates

• Last Update Posted (Estimate): December 25, 2012
• Last Update Submitted That Met QC Criteria: November 26, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Other Study ID Numbers: IJRG-INFL-KRG