HealthyPhase 2NCT02161198
Efficacy and Safety Study of Ginseng Polysaccharide Extract
A Phase 2 study testing Y-75 in people with Healthy, run by Seoul St. Mary's Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Y-75
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2012to Dec 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Good general health
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul St. Mary's Hospital, The Catholic University of Korea
Seoul, 137-701
About this study
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
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.
- Conditions
- Healthy
- Being tested
- Y-75, Placebo
- Keywords
- Panax ginseng CA, ginsan, polysaccharide, immunity, natural killer cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Y-75Dietary supplement
Also called Ginsan
Y-75 (1 g) and starch (1 g) as a diluting agent and were packed to contain 2 g/package
PlaceboDietary supplement
Caramel syrup (0.03 g) and starch (1.97 g) were packed identically to the active treatment
| Study group | Role | What they receive |
|---|---|---|
| Y-75 | Experimental | volunteers receive 3 packages twice a day up to 14 weeks Receives: Dietary Supplement: Y-75 |
| Placebo | Placebo comparator | volunteers receive 3 packages twice a day up to 14 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean percentage change in natural killer cell activity from a baseline level
Measured: baseline (prior to the initial dose) , week 8, and week 14
Secondary outcomes (5)
Changes from baseline in phagocytic activity of macrophages and polymorphonuclear cells
Measured: baseline, week 8, and week 14
Changes from baseline in serum levels of tumor necrosis factor-alpha and interleukin-12
Measured: baseline, week 8, and week 14
Number of patients with laboratory abnormalities
Laboratory measurements included blood chemistry (BC), complete blood count (CBC), and urinalysis
Measured: baseline, week 8, and week 14
Number of participants with serious and non-serious adverse events
Any change from the baseline status was defined as an adverse event
Measured: Up to 14 weeks
Number of patients with abnormal findings in physical examination and vital signs
Physical examination includes body weight, ocular inspection, and heart and lung auscultation.
Vital signs include blood pressure, heart rate, and body temperature
Measured: baseline, week 8, and week 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2014 (estimated)
- Study startSep 2012
- Primary completionApr 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Health Biomed Inc.
- Responsible party
- Principal investigator, Kyung-Soo Kim, Seoul St. Mary's Hospital
- Investigators
- Kyung-Soo Kim, MD, PhD, Principal investigator, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161198
- Sponsor's protocol ID
- Y-75
- Status last verified
- Jun 2014
- First submitted
- 1 Jun 2014
- Last updated
- 11 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25297058
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02161198
- Acronym / sponsor ID
- Y-75
- Conditions
- Healthy
- Keywords
- Panax ginseng CA, ginsan, polysaccharide, immunity, natural killer cell
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Collaborators
- Health Biomed Inc.
- Study start
- Sep 2012
- Primary completion
- Apr 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 11 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Y-75 | Experimental | Dietary Supplement: Y-75volunteers receive 3 packages twice a day up to 14 weeks |
| Placebo | Placebo comparator | Dietary Supplement: Placebovolunteers receive 3 packages twice a day up to 14 weeks |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Good general health
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Y-75Also: GinsanY-75 (1 g) and starch (1 g) as a diluting agent and were packed to contain 2 g/package | Dietary supplement | Y-75 |
| PlaceboCaramel syrup (0.03 g) and starch (1.97 g) were packed identically to the active treatment | Dietary supplement | Placebo |
Primary outcome
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
5 secondary outcomes
Changes from baseline in phagocytic activity of macrophages and polymorphonuclear cells
Time frame: baseline, week 8, and week 14
Changes from baseline in serum levels of tumor necrosis factor-alpha and interleukin-12
Time frame: baseline, week 8, and week 14
Number of patients with laboratory abnormalities
Time frame: baseline, week 8, and week 14
Number of participants with serious and non-serious adverse events
Time frame: Up to 14 weeks
Number of patients with abnormal findings in physical examination and vital signs
Time frame: baseline, week 8, and week 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2014.
- Derived from this study: PubMed 25297058Cho 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyung-Soo Kim, MD, PhD principal investigator
Seoul St. Mary's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Y-75 in people with Healthy, run by Seoul St. Mary's Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02161198, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2014.