Acupuncture for Infectious Mononucleosis Trial - Full Text View

Sponsor:	University of Alberta
Information provided by:	University of Alberta
ClinicalTrials.gov Identifier:	NCT00598988

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 II Phase III

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:

MedlinePlus related topics: Acupuncture Acute Bronchitis Fatigue Infectious Mononucleosis

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:

Communicable Diseases
Infection
Infectious Mononucleosis
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 February 09, 2012