HealthyPhase 3NCT02414412
Immunity Improvement Effect of Ulmus Macrocarpa Water Extract in Adults
A Phase 3 study testing Ulmus macrocarpa water extract in people with Healthy, run by Pusan National University Hospital.
Trial summary
This randomized, placebo-controlled, double-blind study evaluates the efficacy and tolerability of Ulmus macrocarpa water extract for immunity improvement in relatively healthy adults. 58 subjects received 500 mg of Ulmus macrocarpa water extract per day or a placebo for 4 weeks. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ulmus macrocarpa water extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to May 2015
- Phase
- Phase 3
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- subject has peripheral white blood cells between 4,000/Ul and 8,000/Ul
Who cannot join
- History of renal disease
- History of diabetes mellitus
- History of immune disease
About this study
This randomized, placebo-controlled, double-blind study evaluates the efficacy and tolerability of Ulmus macrocarpa water extract for immunity improvement in relatively healthy adults. 58 subjects received 500 mg of Ulmus macrocarpa water extract per day or a placebo for 4 weeks.
- Conditions
- Healthy
- Being tested
- Ulmus macrocarpa water extract
- Keywords
- Ulmus macrocarpa water extract, immunity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulmus macrocarpa water extractDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Ulmus | Active comparator | Ulmus macrocarpa water extract 250mg orally 2 times a day for 4 weeks Receives: Dietary Supplement: Ulmus macrocarpa water extract |
| Placebo | Placebo comparator | placebo 250mg orally 2 times a day for 4 weeks Receives: Dietary Supplement: Ulmus macrocarpa water extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum natural killer cell activity
Measured: 1 month
Secondary outcomes (4)
peripheral white blood cell
Measured: 1 month
serum tumor necrosis factor-alpha level
Measured: 1 month
serum interferon-gamma
Measured: 1 month
serum interleukins(1betta, 2,4,8,10, and 12)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionMar 2015
- Study completionMay 2015
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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Bio Port Korea Inc.
- Responsible party
- Principal investigator, Sang Yeoup Lee, Pusan National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02414412
- Sponsor's protocol ID
- 022014031
- Status last verified
- Oct 2015
- First submitted
- 7 Apr 2015
- Last updated
- 3 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cho AR, Lee SY, Cho YH, Kim CM, Kim SG. Effects of 4-Week Intervention with Ulmus macrocarpa Hance Extract on Immune Function Biomarkers in Healthy Adults: A Randomized Controlled Trial. Evid Based Complement Alternat Med. 2018 Feb 25;2018:5690816. doi: 10.1155/2018/5690816. eCollection 2018.
PubMed 29681977
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunity Improvement Effect of Ulmus Macrocarpa Water Extract in Adults
- ClinicalTrials.gov ID
- NCT02414412
- Acronym / sponsor ID
- 022014031
- Conditions
- Healthy
- Keywords
- Ulmus macrocarpa water extract, immunity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Pusan National University HospitalUniversity, hospital or other
- Collaborators
- Bio Port Korea Inc.
- Study start
- Feb 2015
- Primary completion
- Mar 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 10 Apr 2015 (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.
This randomized, placebo-controlled, double-blind study evaluates the efficacy and tolerability of Ulmus macrocarpa water extract for immunity improvement in relatively healthy adults. 58 subjects received 500 mg of Ulmus macrocarpa water extract per day or a placebo for 4 weeks.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ulmus | Active comparator | Dietary Supplement: Ulmus macrocarpa water extractUlmus macrocarpa water extract 250mg orally 2 times a day for 4 weeks |
| Placebo | Placebo comparator | Dietary Supplement: Ulmus macrocarpa water extractplacebo 250mg orally 2 times a day for 4 weeks |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- subject has peripheral white blood cells between 4,000/Ul and 8,000/Ul
Key exclusion criteria (3 listed)
- History of renal disease
- History of diabetes mellitus
- History of immune disease
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 |
|---|---|---|
| Ulmus macrocarpa water extract | Dietary supplement | Placebo, Ulmus |
Primary outcome
serum natural killer cell activity
Time frame: 1 month
4 secondary outcomes
peripheral white blood cell
Time frame: 1 month
serum tumor necrosis factor-alpha level
Time frame: 1 month
serum interferon-gamma
Time frame: 1 month
serum interleukins(1betta, 2,4,8,10, and 12)
Time frame: 1 month
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 3 Nov 2015.
- Derived from this study: PubMed 29681977Cho AR, Lee SY, Cho YH, Kim CM, Kim SG. Effects of 4-Week Intervention with Ulmus macrocarpa Hance Extract on Immune Function Biomarkers in Healthy Adults: A Randomized Controlled Trial. Evid Based Complement Alternat Med. 2018 Feb 25;2018:5690816. doi: 10.1155/2018/5690816. eCollection 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ulmus macrocarpa water extract in people with Healthy, run by Pusan National University Hospital.
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 3 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 3 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
serum natural killer cell activity (time frame: 1 month). 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 NCT02414412, 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 3 Nov 2015.