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Efficacy and Safety Study of Ginseng Polysaccharide Extract

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ClinicalTrials.gov Identifier: NCT02161198
Recruitment Status : Completed
First Posted : June 11, 2014
Last Update Posted : June 11, 2014
Sponsor:
Collaborator:
Health Biomed Inc.
Information provided by (Responsible Party):
Kyung-Soo Kim, Seoul St. Mary's Hospital

Brief Summary:

Y-75/ginsan is an acidic polysaccharide with a molecular weight of 150,000 Da, isolated from the aqueous Korean Panax ginseng extract. Preclinical laboratory studies have shown its function as an immunomodulatory molecule. The present study performed to evaluate the safety and beneficial effects of Y-75 on immune function in a group of healthy adults.

The focus of this trial was modulation of innate immunity, comprising cytotoxic activity of natural killer cells, phagocytic activity of polymorphonuclear leukocytes and mononuclear phagocytes, and serum levels of monocyte-derived mediators.


Condition or disease Intervention/treatment Phase
Healthy Dietary Supplement: Y-75 Dietary Supplement: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Single-center, Randomized, Placebo-controlled, Double-blind Clinical Trial to Evaluate the Efficacy and Safety After 14-week of Ginseng Polysaccharide Extract
Study Start Date : September 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Ginseng

Arm Intervention/treatment
Experimental: Y-75
volunteers receive 3 packages twice a day up to 14 weeks
Dietary Supplement: Y-75
Y-75 (1 g) and starch (1 g) as a diluting agent and were packed to contain 2 g/package
Other Name: Ginsan

Placebo Comparator: Placebo
volunteers receive 3 packages twice a day up to 14 weeks
Dietary Supplement: Placebo
Caramel syrup (0.03 g) and starch (1.97 g) were packed identically to the active treatment




Primary Outcome Measures :
  1. Mean percentage change in natural killer cell activity from a baseline level [ Time Frame: baseline (prior to the initial dose) , week 8, and week 14 ]

Secondary Outcome Measures :
  1. Changes from baseline in phagocytic activity of macrophages and polymorphonuclear cells [ Time Frame: baseline, week 8, and week 14 ]
  2. Changes from baseline in serum levels of tumor necrosis factor-alpha and interleukin-12 [ Time Frame: baseline, week 8, and week 14 ]
  3. Number of patients with laboratory abnormalities [ Time Frame: baseline, week 8, and week 14 ]
    Laboratory measurements included blood chemistry (BC), complete blood count (CBC), and urinalysis

  4. Number of participants with serious and non-serious adverse events [ Time Frame: Up to 14 weeks ]
    Any change from the baseline status was defined as an adverse event

  5. Number of patients with abnormal findings in physical examination and vital signs [ Time Frame: baseline, week 8, and week 14 ]

    Physical examination includes body weight, ocular inspection, and heart and lung auscultation.

    Vital signs include blood pressure, heart rate, and body temperature




Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Good general health

Exclusion Criteria:

  • human immunodeficiency virus-1 infection
  • malignancy
  • active cardiovascular, renal, pulmonary, hepatic, neurological, psychiatric disease
  • recent (within 4 weeks) acute respiratory tract symptoms
  • immunosuppressive therapy including cytotoxic agents and corticosteroids
  • medication (within 4 weeks) deemed likely to interfere with the evaluation
  • history of allergic or other adverse reactions to ginseng products

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): NCT02161198


Locations
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Korea, Republic of
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, Korea, Republic of, 137-701
Sponsors and Collaborators
Seoul St. Mary's Hospital
Health Biomed Inc.
Investigators
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Principal Investigator: Kyung-Soo Kim, MD, PhD Seoul St. Mary's Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Kyung-Soo Kim, Professor, Seoul St. Mary's Hospital
ClinicalTrials.gov Identifier: NCT02161198    
Other Study ID Numbers: Y-75
First Posted: June 11, 2014    Key Record Dates
Last Update Posted: June 11, 2014
Last Verified: June 2014
Keywords provided by Kyung-Soo Kim, Seoul St. Mary's Hospital:
Panax ginseng CA
ginsan
polysaccharide
immunity
natural killer cell