Acupuncture for Nausea in HIV
关键词
抽象
描述
The subjects in the proposed experiment will be 159 men and women with HIV infection who have a history of chronic nausea for three months or greater and show evidence of two or more episodes of nausea and/or report a duration of 2 hours or greater (per day) in prospective baseline symptom diaries. Subjects will be randomized to one of three experimental intervention conditions: Condition 1, subjects receive Standard acupuncture; Condition 2, subjects receive Individualized acupuncture based on Traditional Chinese Medical Diagnosis; Condition 3, (Control Group), subjects receive Sham acupuncture. Subjects in Conditions 1, 2, & 3 will attend 16 scheduled sessions over 24 weeks. All subjects will: be assessed by a diagnostic acupuncturist (blinded to treatment assignments); be administered the same instruments; and submit their symptom diaries for data entry and analysis. After a screening/intake session, randomization and treatment sessions will follow. There will be four weeks of twice weekly treatment sessions, four weekly treatment sessions and three follow-up sessions. All conditions will be identical in duration and be administered by licensed acupuncturists trained in Traditional Chinese Medicine. This study is a prospective, randomized, controlled, blinded (subject and evaluator), parallel groups clinical trial aimed at reducing chronic nausea and improving quality of life in persons with HIV/AIDS.
日期
| 最后验证: | 05/31/2012 |
| 首次提交: | 02/18/2008 |
| 提交的预估入学人数: | 02/18/2008 |
| 首次发布: | 02/26/2008 |
| 上次提交的更新: | 06/20/2012 |
| 最近更新发布: | 06/21/2012 |
| 实际学习开始日期: | 04/30/2005 |
| 预计主要完成日期: | 10/31/2011 |
| 预计完成日期: | 11/30/2011 |
状况或疾病
干预/治疗
Other: I. Standard
Other: 2. Individualized
Other: 3
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: I. Standard Standard - Formula Acup Protocol | Other: I. Standard Standard Acup point protocol for treating nausea |
| Experimental: 2. Individualized Individualized Acup protocol based on TCM diagnosis | Other: 2. Individualized Acup |
| Sham Comparator: 3 (Control Group) Sham acupuncture | Other: 3 Sham Acup - Non-Active |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Men and women HIV positive or CDC AIDS diagnosed - History of chronic nausea for three months or greater - Experience an average of two or more episodes of nausea and/or who experience an average duration of 2 hours or more (of nausea) per day - Verification from Primary provider of subject's: HIV status, knowledge of patient's nausea and their agreement that their patient is clinically suitable for the study. - Individuals able to successfully complete a mini-mental status exam - Individuals who understand and agree to complete daily symptom diaries for the duration of the study. - Individuals taking antiretroviral combinations must have completed an initial 8 weeks of a stable regime (same drug(s), dose & frequency) prior to entry into the study. - Individuals taking anti-emetic medications must be on a stable regime (same drug, dose & frequency) for at least fourteen days prior to entry into the study. - Individuals on all other medications which may have nausea listed as a side effect must be on a stable regime (same drug(s), dose & frequency) for at least fourteen (14) days prior to entry in the study Exclusion Criteria: - Individuals with an acute medical condition, i.e. pneumocystis carinii pneumonia, tuberculosis and or other opportunistic infections or conditions that would require medical attention. - Pregnant women - Individuals receiving acupuncture currently and less than 6 months prior to enrollment. - Individuals currently receiving other types of complementary therapies such as herbs, massage, acupressure wrist bands, reiki etc. - Individuals with plans for travel, lifestyle change, or other activity that would preclude attending all of the planned study sessions and/or recording daily diary information. |
结果
主要结果指标
1. INVR - symptom diary Clinical Global Impression Scales [Baseline, treatment and follow-ups sessions]
次要成果指标
1. QOL scale MOS-SF-36 subscales [Baseline, treatment and follow-up session]
