NCT02414412

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for phase_3 healthy

Timeline
Completed

Started Feb 2015

Shorter than P25 for phase_3 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 7, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 10, 2015

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

November 3, 2015

Status Verified

October 1, 2015

Enrollment Period

28 days

First QC Date

April 7, 2015

Last Update Submit

October 30, 2015

Conditions

Healthy

Keywords

Ulmus macrocarpa water extractimmunity

Outcome Measures

Primary Outcomes (1)

  • serum natural killer cell activity

    1 month

Secondary Outcomes (4)

  • peripheral white blood cell

    1 month

  • serum tumor necrosis factor-alpha level

    1 month

  • serum interferon-gamma

    1 month

  • serum interleukins(1betta, 2,4,8,10, and 12)

    1 month

Study Arms (2)

Ulmus

ACTIVE COMPARATOR

Ulmus macrocarpa water extract 250mg orally 2 times a day for 4 weeks

Dietary Supplement: Ulmus macrocarpa water extract

Placebo

PLACEBO COMPARATOR

placebo 250mg orally 2 times a day for 4 weeks

Dietary Supplement: Ulmus macrocarpa water extract

Interventions

Ulmus macrocarpa water extractDIETARY_SUPPLEMENT
PlaceboUlmus

Eligibility Criteria

Age19 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • subject has peripheral white blood cells between 4,000/Ul and 8,000/Ul

You may not qualify if:

  • History of renal disease
  • History of diabetes mellitus
  • History of immune disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 29681977DERIVED

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

April 7, 2015

First Posted

April 10, 2015

Study Start

February 1, 2015

Primary Completion

March 1, 2015

Study Completion

May 1, 2015

Last Updated

November 3, 2015

Record last verified: 2015-10