Efficacy and Safety Study of Ginseng Polysaccharide Extract

NCT ID: NCT02161198

Last Updated: 2014-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Y-75

volunteers receive 3 packages twice a day up to 14 weeks

Group Type EXPERIMENTAL

Y-75

Intervention Type DIETARY_SUPPLEMENT

Y-75 (1 g) and starch (1 g) as a diluting agent and were packed to contain 2 g/package

Placebo

volunteers receive 3 packages twice a day up to 14 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Caramel syrup (0.03 g) and starch (1.97 g) were packed identically to the active treatment

Interventions

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Y-75

Y-75 (1 g) and starch (1 g) as a diluting agent and were packed to contain 2 g/package

Intervention Type DIETARY_SUPPLEMENT

Placebo

Caramel syrup (0.03 g) and starch (1.97 g) were packed identically to the active treatment

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Ginsan

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Health Biomed Inc.

INDUSTRY

Sponsor Role collaborator

Seoul St. Mary's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Kyung-Soo Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kyung-Soo Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul St. Mary's Hospital

Locations

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Seoul St. Mary's Hospital, The Catholic University of Korea

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Cho YJ, Son HJ, Kim KS. A 14-week randomized, placebo-controlled, double-blind clinical trial to evaluate the efficacy and safety of ginseng polysaccharide (Y-75). J Transl Med. 2014 Oct 9;12:283. doi: 10.1186/s12967-014-0283-1.

Reference Type DERIVED
PMID: 25297058 (View on PubMed)

Other Identifiers

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Y-75

Identifier Type: -

Identifier Source: org_study_id

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