Acupuncture and Relaxation Response for GI Symptoms and HIV Medication Adherence
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ClinicalTrials.gov Identifier: NCT00545623 |
Recruitment Status
:
Completed
First Posted
: October 17, 2007
Results First Posted
: September 3, 2014
Last Update Posted
: September 3, 2014
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Sponsor:
Boston University
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Bei-Hung Chang, Boston University
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Tracking Information | ||||
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First Submitted Date ICMJE | October 15, 2007 | |||
First Posted Date ICMJE | October 17, 2007 | |||
Results First Submitted Date | July 25, 2014 | |||
Results First Posted Date | September 3, 2014 | |||
Last Update Posted Date | September 3, 2014 | |||
Study Start Date ICMJE | April 2007 | |||
Actual Primary Completion Date | September 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Changes in GI Symptom Per Intervention Session [ Time Frame: 8 weeks ] We used the GI symptom subscale of the Revised HIV Sign and Symptom Checklist (SSC-HIV) to measure the intensity (0-10) of the six targeted GI symptoms: diarrhea, loose stools, gas/bloating, abdominal pain, nausea and vomiting, with 0 indicating no symptom and 10 indicating most sever symptom. Rating changes per intervention session were estimated using a mixed effects regression model controlling for baseline ratings. Data of loose stools are presented here.
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Original Primary Outcome Measures ICMJE |
GI symptoms and HIV medication adherence [ Time Frame: 6 months ] | |||
Change History | Complete list of historical versions of study NCT00545623 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE | Not Provided | |||
Original Secondary Outcome Measures ICMJE |
Quality of Life [ Time Frame: 6 months ] | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Acupuncture and Relaxation Response for GI Symptoms and HIV Medication Adherence | |||
Official Title ICMJE | Acupuncture and Relaxation Response for GI Symptoms and HIV Medication Adherence | |||
Brief Summary | The aims of the study are to investigate individual, combined and added effects of acupuncture and the relaxation response in reducing gastrointestinal symptoms, improving medication adherence and quality of life among people living with HIV/AIDS. The study will also explore the mechanism of these therapeutic effects of acupuncture and the relaxation response. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Factorial Assignment Masking: Triple (Participant, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | HIV Infections | |||
Intervention ICMJE |
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Study Arms |
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Publications * | Chang BH, Sommers E. Acupuncture and the relaxation response for treating gastrointestinal symptoms in HIV patients on highly active antiretroviral therapy. Acupunct Med. 2011 Sep;29(3):180-7. doi: 10.1136/acupmed-2011-010026. Epub 2011 Jun 24. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
130 | |||
Original Estimated Enrollment ICMJE |
80 | |||
Actual Study Completion Date | September 2010 | |||
Actual Primary Completion Date | September 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00545623 | |||
Other Study ID Numbers ICMJE | R21AT003377-01( U.S. NIH Grant/Contract ) R21AT003377-01 ( U.S. NIH Grant/Contract ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Bei-Hung Chang, Boston University | |||
Study Sponsor ICMJE | Boston University | |||
Collaborators ICMJE | National Center for Complementary and Integrative Health (NCCIH) | |||
Investigators ICMJE |
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PRS Account | Boston University | |||
Verification Date | August 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |