NCT00598988

Brief Summary

The purpose of this study is to investigate feasibility issues related to conducting an acupuncture study in a population of adolescents and young adults with infectious mononucleosis. Additionally, this study will provide preliminary data regarding treatment parameters (acupuncture and standard care) and outcomes (i.e. fatigue).

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2007

Completed
28 days until next milestone

Study Start

First participant enrolled

January 1, 2008

Completed
22 days until next milestone

First Posted

Study publicly available on registry

January 23, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

July 11, 2022

Status Verified

May 1, 2017

Enrollment Period

11 months

First QC Date

December 4, 2007

Last Update Submit

July 7, 2022

Conditions

Infectious Mononucleosis

Keywords

infectious mononucleosis, mono, acupuncture

Outcome Measures

Primary Outcomes (1)

  • Chalder Fatigue Questionnaire

    12 weeks

Secondary Outcomes (1)

  • MOS SF-36

    12 weeks

Study Arms (2)

Acupuncture

EXPERIMENTAL

Traditional Chinese acupuncture in conjunction with standard medical care

Procedure: traditional Chinese acupuncture

Standard medical care

ACTIVE COMPARATOR

standard medical care

Other: standard medical care

Interventions

traditional Chinese acupuncturePROCEDURE

10 treatments over 6 weeks

Acupuncture
standard medical careOTHER

standard care as provided by primary physician

Standard medical care

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • mono diagnosis confirmed by lab test
  • days or less between start of symptoms and diagnostic test
  • presence of fatigue of at least 4/11 (by Chalder Fatigue Questionnaire)
  • no other illnesses present
  • meets residency requirement

You may not qualify if:

  • insufficient communication in English
  • unable to begin acupuncture within 21 days of diagnostic test
  • acupuncture use currently or in the preceding 3 months
  • currently under the care of a TCM practitioner
  • unwilling to be randomized

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2E1, Canada

Location

MeSH Terms

Conditions

Infectious Mononucleosis

Condition Hierarchy (Ancestors)

Epstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsLeukocyte DisordersHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Sunita Vohra, MD, MSc

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2007

First Posted

January 23, 2008

Study Start

January 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

July 11, 2022

Record last verified: 2017-05

Locations

CA(1)