Acupuncture and Relaxation Response for GI Symptoms and HIV Medication Adherence
This study has been completed.
Sponsor:
Boston University
Collaborator:
Information provided by (Responsible Party):
Bei-Hung Chang, Boston University
ClinicalTrials.gov Identifier:
NCT00545623
First received: October 15, 2007
Last updated: January 6, 2012
Last verified: January 2012
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Purpose
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.
Condition | Intervention | Phase |
---|---|---|
HIV Infections |
Procedure: Acupuncture Behavioral: Relaxation Response Other: sham acupuncture |
Phase 2 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
Official Title: | Acupuncture and Relaxation Response for GI Symptoms and HIV Medication Adherence |
Resource links provided by NLM:
Further study details as provided by Boston University:
Primary Outcome Measures:
- GI symptoms and HIV medication adherence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Enrollment: | 130 |
Study Start Date: | April 2007 |
Study Completion Date: | September 2010 |
Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Active Comparator: arm 1
acupuncture + relaxation response CD
|
Procedure: Acupuncture
acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks
Behavioral: Relaxation Response
listening to CDs with verbal instructions of techniques to elicit relaxation response
|
Active Comparator: arm 2
sham acupuncture + relaxation response CD
|
Behavioral: Relaxation Response
listening to CDs with verbal instructions of techniques to elicit relaxation response
|
Active Comparator: arm 3
acupuncture+control CD
|
Procedure: Acupuncture
acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks
|
Sham Comparator: arm 4
sham acupuncture+control CD
|
Other: sham acupuncture
sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks
|
Eligibility
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Confirmed HIV-positive status or AIDS diagnosis
- Self report of having at least one of the 6 GI symptoms: diarrhea, loose stools, gas/flatulence or bloating, abdominal pain, nausea, or vomiting that have persisted for at least 8 weeks.
- Being on a stable antiretroviral regimen containing Nucleoside/nucleotide reverse transcriptase inhibitors and/or protease inhibitors- for at least 8 weeks.
Exclusion Criteria:
- Incident diagnosis of any of the following conditions within the past month or during study period: Pneumocystis carinii pneumonia, Kaposi's sarcoma, Mycobacterium avian complex, Cytomegalovirus, Non-Hodgkins lymphoma, Lymphoma or other cancer, Pelvic inflammatory disease, AIDS-related dementia, Bacterial or other infection, Diabetes, Acute moderate or severe neutropenia, Cryptococcus, Progressive multifocal leukoencephalopathy, Idiopathic thrombocytopenic purpura. All of these conditions are major opportunistic infections or medical complications that may require hospitalization and additional pharmaceutical intervention.
- GI diagnoses of irritable bowel syndrome, Crohn's Disease, parasites, any type of gastric ulcer or ulcerative colitis or cancer in any part of the gastrointestinal system. These are conditions not related to HIV diagnosis and could result in digestive problems similar to those we are investigating.
- Onset of acute opportunistic infection.
- Hemophilia or other bleeding disorder since that will make acupuncture treatment unsafe.
- Pregnant women will be excluded since, although none of the acupuncture points or combinations are contraindicated in pregnancy, the presence of morning sickness could serve as a potential confounding factor.
- Current users of acupuncture for treating GI symptoms.
- Current practice of relaxation response.
- Current enrollment in another clinical intervention study.
- Cognitive impairment as measured by Mini Mental Status Examination (MMSE), a reliable and valid screening instrument for the detection of cognitive impairment, using a commonly used cut-off point of 24.
- If use of Chinese herbs has been recently discontinued, a potential participant must have at least 2 weeks without herb use to be eligible for the study. Because use of herbs is occasionally accompanied by digestive disorders,a period of stabilizing is required before acupuncture treatment can be initiated. This washout period has been conservatively estimated by ACP staff herbalists to constitute a sufficient time for effects of herbs to cease.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545623
Locations
United States, Massachusetts | |
Pathways to Wellness | |
Boston, Massachusetts, United States, 02118 |
Sponsors and Collaborators
Boston University
Investigators
Principal Investigator: | Bei-Hung Chang, Sc.D. | Boston University |
More Information
Publications:
Keywords provided by Boston University:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 17, 2012
Publications:
Responsible Party: | Bei-Hung Chang, Associate Professor, Boston University |
ClinicalTrials.gov Identifier: | NCT00545623 History of Changes |
Other Study ID Numbers: | R21 AT003377-01, R21AT003377-01 |
Study First Received: | October 15, 2007 |
Last Updated: | January 6, 2012 |
Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by Boston University:
HIV/AIDS Alternative Medicine Complementary Medicine |
Additional relevant MeSH terms:
HIV Infections Acquired Immunodeficiency Syndrome Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases |
ClinicalTrials.gov processed this record on October 17, 2012