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Trial record 3 of 32 for:    mononucleosis
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Acupuncture for Infectious Mononucleosis Trial (AIM)

This study has been completed.
Sponsor:
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT00598988
First received: December 4, 2007
Last updated: January 8, 2009
Last verified: January 2009
History of Changes
  Purpose

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).


Condition Intervention Phase
Infectious Mononucleosis
 Procedure: traditional Chinese acupuncture
Other: standard medical care
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Acupuncture for Infectious Mononucleosis Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Chalder Fatigue Questionnaire [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • MOS SF-36 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: January 2008
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Traditional Chinese acupuncture in conjunction with standard medical care
 Procedure: traditional Chinese acupuncture
10 treatments over 6 weeks
Active Comparator: B
standard medical care
 Other: standard medical care
standard care as provided by primary physician

  Eligibility

Ages Eligible for Study:   15 Years to 25 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • mono diagnosis confirmed by lab test
  • 21 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00598988

Locations
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2E1
Sponsors and Collaborators
University of Alberta
Investigators
Principal Investigator: Sunita Vohra, MD, MSc University of Alberta
  More Information

No publications provided

Responsible Party: Sunita Vohra/Dr, University of Alberta
ClinicalTrials.gov Identifier: NCT00598988     History of Changes
Other Study ID Numbers: 6866
Study First Received: December 4, 2007
Last Updated: January 8, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
infectious mononucleosis, mono, acupuncture

Additional relevant MeSH terms:
Infectious Mononucleosis
Communicable Diseases
Infection
Epstein-Barr Virus Infections
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
 Leukocyte Disorders
Hematologic Diseases
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013