Infectious MononucleosisPhase 2/3AIMNCT00598988
Acupuncture for Infectious Mononucleosis Trial
A Phase 2/3 study testing traditional Chinese acupuncture and standard medical care in people with Infectious Mononucleosis, run by University of Alberta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Infectious Mononucleosis
- What is being tested?
- traditional Chinese acupuncture and standard medical care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2008to Dec 2008
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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).
- Conditions
- Infectious Mononucleosis
- Being tested
- traditional Chinese acupuncture, standard medical care
- Keywords
- infectious mononucleosis, mono, acupuncture
- Medical subject headings
- Infectious Mononucleosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
traditional Chinese acupunctureProcedure or surgery
10 treatments over 6 weeks
standard medical careOther
standard care as provided by primary physician
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture | Experimental | Traditional Chinese acupuncture in conjunction with standard medical care Receives: Procedure: traditional Chinese acupuncture |
| Standard medical care | Active comparator | standard medical care Receives: Other: standard medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chalder Fatigue Questionnaire
Measured: 12 weeks
Secondary outcomes (1)
MOS SF-36
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: Difficulty with recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious MononucleosisStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sunita Vohra, MD, MSc, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00598988
- Sponsor's protocol ID
- 6866
- Acronym
- AIM
- Status last verified
- May 2017
- First submitted
- 4 Dec 2007
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acupuncture for Infectious Mononucleosis Trial
- ClinicalTrials.gov ID
- NCT00598988
- Acronym / sponsor ID
- AIM / 6866
- Conditions
- Infectious Mononucleosis
- Keywords
- infectious mononucleosis, mono, acupuncture
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty with recruitment
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 23 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture | Experimental | Procedure: traditional Chinese acupunctureTraditional Chinese acupuncture in conjunction with standard medical care |
| Standard medical care | Active comparator | Other: standard medical carestandard medical care |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| traditional Chinese acupuncture10 treatments over 6 weeks | Procedure or surgery | Acupuncture |
| standard medical carestandard care as provided by primary physician | Other | Standard medical care |
Primary outcome
Chalder Fatigue Questionnaire
Time frame: 12 weeks
1 secondary outcome
MOS SF-36
Time frame: 12 weeks
Results and safety
The study was stopped early (reason given: Difficulty with recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sunita Vohra, MD, MSc principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing traditional Chinese acupuncture and standard medical care in people with Infectious Mononucleosis, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Difficulty with recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chalder Fatigue Questionnaire (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2022.