NCT00545623已完成2 期
Acupuncture and Relaxation Response for GI Symptoms and HIV Medication Adherence
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Changes in GI Symptom Per Intervention Session
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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.
结局指标
主要结局
Changes in GI Symptom Per Intervention Session
时间窗: 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.
次要结局
未报告次要终点
研究者
Bei-Hung Chang
Associate Professor
Boston University
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Acupuncture as Pain Relief and Relaxation During ChildbirthAcupuncture AnalgesiaNatural ChildbirthNCT00261755University of Aarhus607
招募中
不适用
Clinical Evaluation on the Therapeutic Effect of Acupuncture Treatment for Alzheimer's DiseaseAlzheimer DiseaseCognitive ImpairmentNCT03810794Jian Pei,MD180
已完成
不适用
The Effects of Acupressure on Pain, and Gastrointestinal Functions in Women With HysterectomyPain ManagementHysterectomyVomitingNCT06340776Istanbul Medipol University Hospital60
招募中
3 期
The effect of acupuncture on the symptoms of diabetes-related peripheral neuropathy (DPN).Diabetes-related peripheral neuropathy (DPN)..Diabetes mellitus due to underlying condition with diabetic neuropathy, unspecifiedE08.40IRCT20181006041252N13Sabzevar University of Medical Sciences50
已完成
不适用
Stimulation of Gastric Slow Waves With Acupuncture at St36 and Pe6 - a Randomized Single-blind Controlled TrialAcupunctureNCT00636012Charite University, Berlin, Germany65