Back to resultsAcupuncture for Infectious Mononucleosis Trial (AIM)
Primary Purpose
Infectious Mononucleosis
Status
Terminated
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
traditional Chinese acupuncture
standard medical care
Sponsored by
About this trial
This is an interventional treatment trial for Infectious Mononucleosis focused on measuring infectious mononucleosis, mono, acupuncture
Eligibility 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
Sites / Locations
- University of Alberta
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Acupuncture
Standard medical care
Arm Description
Traditional Chinese acupuncture in conjunction with standard medical care
standard medical care
Outcomes
Primary Outcome Measures
Chalder Fatigue Questionnaire
Secondary Outcome Measures
MOS SF-36
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00598988
Brief Title
Acupuncture for Infectious Mononucleosis Trial
Acronym
AIM
Official Title
Acupuncture for Infectious Mononucleosis Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Terminated
Why Stopped
Difficulty with recruitment
Study Start Date
January 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
Detailed Description
This study examines the feasibility of treating adolescents and young adults diagnosed with infectious mononucleosis with acupuncture. Additionally, this study will provide preliminary data regarding treatment parameters (acupuncture and standard care) and outcomes (i.e. fatigue).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious Mononucleosis
Keywords
infectious mononucleosis, mono, acupuncture
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture
Arm Type
Experimental
Arm Description
Traditional Chinese acupuncture in conjunction with standard medical care
Arm Title
Standard medical care
Arm Type
Active Comparator
Arm Description
standard medical care
Intervention Type
Procedure
Intervention Name(s)
traditional Chinese acupuncture
Intervention Description
10 treatments over 6 weeks
Intervention Type
Other
Intervention Name(s)
standard medical care
Intervention Description
standard care as provided by primary physician
Primary Outcome Measure Information:
Title
Chalder Fatigue Questionnaire
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
MOS SF-36
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunita Vohra, MD, MSc
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2E1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Acupuncture for Infectious Mononucleosis Trial
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