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
Dietary supplement: Ulmus macrocarpa water extract
Placebo Comparator: Placebo
placebo 250mg orally 2 times a day for 4 weeks
Dietary supplement: Ulmus macrocarpa water extract

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.

Sponsor

Pusan National University Hospital

Collaborators

Bio Port Korea Inc.

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.

General Publications

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.

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