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

NCT01478009 | Completed Phase 2 Results DMC

• 1 other identifier: IJRG-INFL-KRG
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Subjects

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Symptom Severity of All Colds

  12 weeks

• Total Number of Days of Symptoms and Duration of All Colds

  up to 12 weeks

Study Arms (2)

KRG Extract

EXPERIMENTAL

Dietary Supplement: Korean red ginseng

Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Korean red ginseng DIETARY_SUPPLEMENT

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

KRG Extract

Placebo DIETARY_SUPPLEMENT

Placebo (3.0g/day) for 12 weeks

Placebo

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chonbuk National University Hospital: lead

Study Sites (1)

Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

Jeonju, Jeollabuk-do, 560-822, South Korea

Location

Related Publications (2)

• 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.

  PMID: 23255845 DERIVED

• 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.

  PMID: 22314101 DERIVED

MeSH Terms

Interventions

Asian ginseng

Results Point of Contact

• Title: Dr. Chang-Seop Lee
• Organization: Clinical Trial Center for Functional Foods; Chonbuk National University Hospital

lcsmd@jbnu.ac.kr

82-63-276-8284

Study Officials

• Chang-Seop Lee, MD

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Trial Center for Functional Foods

Study Record Dates

• First Submitted: November 16, 2011
• First Posted: November 23, 2011
• Study Start: November 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: December 25, 2012
• Results First Posted: December 25, 2012

Record last verified: 2012-11

Locations

KR (1)