- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01059487
Bringing Acute and Wellness Care to Underserved Populations Using Traditional Chinese Medicine
February 1, 2010 updated by: Chicago College of Oriental Medicine
Bringing Acute and Wellness Care to Underserved Populations Using Traditional Chinese Medicine: A Pragmatic Clinical Trial Using Quality of Life Measures in a Community Health Care Setting
At a time when there is so much focus in the United States on reducing the cost of health care delivery while maximizing the effectiveness of health care performance, Traditional Chinese Medicine (acupuncture, herbal treatment, and accessory techniques) offers decision makers a tantalizing option.
Traditional Chinese Medicine differs from its biomedical counterpart in that it is highly portable, inexpensive to administer, relies on a conversational diagnostic inquiry system to arrive at differential diagnosis for its patients, and has very few reported side effects associated with treatment.
The World Health Organization cites acupuncture has a proven and effective treatment for 28 diseases/disorders including stroke, pain management issues and rheumatoid arthritis; the WHO lists another over 65 diseases for which the therapeutic effect of acupuncture has been shown but for which further proof is needed including alcohol dependence, cancer pain and diabetes mellitus.
With the completion of this pragmatic clinical trial and introduction of the Constant Care method of health care delivery to underserved communities on Chicago's south side, the investigators can both utilize an effective plan of health care delivery, advance the research needed to effectively utilize Traditional Chinese Medicine as a low cost therapeutic option in this country, and successfully treat disenfranchised populations that have been traditionally overlooked and that deserve a better health and wellness care future.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Illinois
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Chicago, Illinois, United States, 60656
- Chicago College of Oriental Medicine, Inc. dba Chicago College of Asian Medicine
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adults age 21 and over
Exclusion Criteria:
- Children
- Pregnant women
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Traditional Chinese Medicine
Assessing efficacy of treating subjects/patients with Traditional Chinese Medicine (TCM) by administering SF-36v2 and PIQ-6 surveys to subjects/patients to create a baseline and then re-assessing quality of life achieved through TCM treatments by administering follow-up SF-12v2 and PIQ-6 surveys every four weeks
|
Traditional Chinese Medicine includes acupuncture, herbal, tuina and other accessory techniques
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
QualityMetric SF36v-2 Quality of Life
Time Frame: Every four weeks
|
Every four weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
QualityMetric PIQ-6
Time Frame: Every four weeks
|
Every four weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Anticipated)
August 1, 2012
Study Completion (Anticipated)
August 1, 2012
Study Registration Dates
First Submitted
January 29, 2010
First Submitted That Met QC Criteria
January 29, 2010
First Posted (Estimate)
February 1, 2010
Study Record Updates
Last Update Posted (Estimate)
February 2, 2010
Last Update Submitted That Met QC Criteria
February 1, 2010
Last Verified
January 1, 2010
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HS-10-003 CEG
- GRANT10504752 (Other Identifier: Agency for Health Care Research and Quality)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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