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

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ClinicalTrials.gov Identifier: NCT01478009
Recruitment Status : Completed
First Posted : November 23, 2011
Results First Posted : December 25, 2012
Last Update Posted : December 25, 2012
Sponsor:
Information provided by (Responsible Party):
Soo-Wan Chae, Chonbuk National University Hospital

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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Dietary Supplement: Korean red ginseng Dietary Supplement: Placebo Phase 2 Phase 3

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  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Placebo-Controlled Trial of Korean Red Ginseng Extract to Prevent Acute Respiratory Illness in Healthy Subjects
Study Start Date : November 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Ginseng
U.S. FDA Resources

Arm Intervention/treatment
Experimental: KRG Extract Dietary Supplement: Korean red ginseng
Korean red ginseng(3.0g/day) for 12 weeks
Placebo Comparator: Placebo Dietary Supplement: Placebo
Placebo (3.0g/day) for 12 weeks



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


Secondary Outcome Measures :
  1. Symptom Severity of All Colds [ Time Frame: 12 weeks ]

    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).


  2. Total Number of Days of Symptoms and Duration of All Colds [ Time Frame: up to 12 weeks ]
    Extract of Korean red ginseng intake did not significantly reduced total number of days of symptoms and duration of all colds



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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01478009


Locations
Korea, Republic of
Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
Jeonju, Jeollabuk-do, Korea, Republic of, 560-822
Sponsors and Collaborators
Chonbuk National University Hospital
Investigators
Principal Investigator: Chang-Seop Lee, MD Chonbuk National University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Soo-Wan Chae, Clinical Trial Center for Functional Foods, Chonbuk National University Hospital
ClinicalTrials.gov Identifier: NCT01478009     History of Changes
Other Study ID Numbers: IJRG-INFL-KRG
First Posted: November 23, 2011    Key Record Dates
Results First Posted: December 25, 2012
Last Update Posted: December 25, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases