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

NCT ID: NCT01478009

Last Updated: 2012-12-25

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2011-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Healthy Subjects

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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KRG Extract

Group Type EXPERIMENTAL

Korean red ginseng

Intervention Type DIETARY_SUPPLEMENT

Korean red ginseng(3.0g/day) for 12 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo (3.0g/day) for 12 weeks

Interventions

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Korean red ginseng

Korean red ginseng(3.0g/day) for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo (3.0g/day) for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chonbuk National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Soo-Wan Chae

Clinical Trial Center for Functional Foods

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chang-Seop Lee, MD

Role: PRINCIPAL_INVESTIGATOR

Chonbuk National University Hospital

Locations

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Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 23255845 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22314101 (View on PubMed)

Other Identifiers

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IJRG-INFL-KRG

Identifier Type: -

Identifier Source: org_study_id