Acupuncture for Infectious Mononucleosis Trial | NCT00598988

Studies
Acupuncture for Infectious Mononucleosis Trial

NCT00598988

Sponsor

University of Alberta

Status

Terminated

Last Update Posted

Jul 11, 2022Actual

Enrollment

3Actual

Phase

Phase 2Phase 3

Conditions

Infectious Mononucleosis

Interventions

traditional Chinese acupuncture
standard medical care

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulty with recruitment

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Dec 4, 2007

First Submission Date that Met QC Criteria

Jan 10, 2008

First Posted Date

Jan 23, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 7, 2022

Last Update Posted Date

Jul 11, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
traditional Chinese acupuncture	Procedure	10 treatments over 6 weeks	Acupuncture

Measure	Description	Time Frame
Chalder Fatigue Questionnaire		12 weeks

Measure	Description	Time Frame
MOS SF-36		12 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

25 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sunita Vohra, MD, MSc	University of Alberta	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alberta		Edmonton	Alberta	T6G 2E1	Canada

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D007244	Infectious Mononucleosis

Ancestor Terms

ID	Term
D020031	Epstein-Barr Virus Infections
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases

Browse Leaves

Not provided

Browse Branches

Not provided