Immunity Improvement Effect of Ulmus Macrocarpa Water Extract in Adults
October 30, 2015 updated by: Sang Yeoup Lee, Pusan National University Hospital
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
58
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- subject has peripheral white blood cells between 4,000/Ul and 8,000/Ul
Exclusion Criteria:
- History of renal disease
- History of diabetes mellitus
- History of immune disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Ulmus
Ulmus macrocarpa water extract 250mg orally 2 times a day for 4 weeks
|
|
|
Placebo Comparator: Placebo
placebo 250mg orally 2 times a day for 4 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
serum natural killer cell activity
Time Frame: 1 month
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
peripheral white blood cell
Time Frame: 1 month
|
1 month
|
|
serum tumor necrosis factor-alpha level
Time Frame: 1 month
|
1 month
|
|
serum interferon-gamma
Time Frame: 1 month
|
1 month
|
|
serum interleukins(1betta, 2,4,8,10, and 12)
Time Frame: 1 month
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2015
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
April 7, 2015
First Submitted That Met QC Criteria
April 9, 2015
First Posted (Estimate)
April 10, 2015
Study Record Updates
Last Update Posted (Estimate)
November 3, 2015
Last Update Submitted That Met QC Criteria
October 30, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 022014031
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.