NCT02414412CompletedPhase 3
Immunity Improvement Effect of Ulmus Macrocarpa Water Extract in Adults
Conditions
Interventions
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 58
- Primary Endpoint
- serum natural killer cell activity
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 19 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Ulmus
Active Comparator
Ulmus macrocarpa water extract 250mg orally 2 times a day for 4 weeks
Intervention: Ulmus macrocarpa water extract (Dietary Supplement)
Placebo
Placebo Comparator
placebo 250mg orally 2 times a day for 4 weeks
Intervention: Ulmus macrocarpa water extract (Dietary Supplement)
Outcomes
Primary Outcomes
serum natural killer cell activity
Time Frame: 1 month
Secondary Outcomes
- serum interferon-gamma(1 month)
- peripheral white blood cell(1 month)
- serum tumor necrosis factor-alpha level(1 month)
- serum interleukins(1betta, 2,4,8,10, and 12)(1 month)
Investigators
Sang Yeoup Lee
professor
Pusan National University Hospital
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