NCT00598585已完成4 期
Phase 4 Study of the Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood Flow in Patients With Chronic Fatigue Syndrome.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in Fatigue Impact Scale at 6 Weeks
研究概览
简要总结
Use of Viagra to Alter Symptoms in Patients with Chronic Fatigue Syndrome (CFS)
详细描述
Use of Sildenafil (Viagra) to Alter Fatigue, Functional Status and Impaired Cerebral Blood Flow in Patients with Chronic Fatigue Syndrome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 49 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients meeting the CDC definition of CFS.
- •All races, ethnicities, socio-economic status (SES), and gender
- •Age greater than 18 (because of concerns about radioactivity, we and the Cedars-Sinai and Harbor-UCLA IRBs have decided not to enroll subjects below the age of 18).
- •Age less than
- •Because of concern of sildenafil exacerbating coronary artery disease, we will only enroll patients younger than
- •Able to provide informed consent.
- •Willingness to be off all medicines and supplements for 3 weeks prior to the study.
- •Patients with psychiatric disorders (see below) will be included, if they could be off their medications, and if their psychiatric diagnosis clearly occurred after their fatigue symptoms began.
- •Patients with concurrent fibromyalgia will be allowed to participate if the meet diagnostic criteria for CFS.
排除标准
- •Disabilities that would prevent them from participating in the study.
- •Current use of prescription medicines (starting at 3 weeks prior to the study) and supplements (starting at 1 weeks prior to the study) except acetaminophen or aspirin. This includes herbal supplements and vitamins.
- •Existing medical illnesses, such as heart disease, hypertension, cancer, rheumatological diseases, endocrinopathies or hormone replacement therapy, seizure disorders, severe obesity (BMI > 32 kg/m2),
- •Severe psychiatric disorders including bipolar disorder, schizophrenia, dementia and previous or current diagnosis of alcohol or substance abuse within the past year. Patients with depression of such severity as to warrant treatment with anti-depressants will be excluded.
- •Current abuse of illicit drugs or heavy ethanol use.
- •Pregnant women will be excluded because of radioactivity exposure from the SPECT scans.
- •Abnormal EKG
- •Abnormal CBC, blood chemistries, thyroid function tests, and HIV, ANA, RF and ESR tests.
研究组 & 干预措施
sidenafil
Experimental
sidenafil
干预措施: Sildenafil (Viagra) (Drug)
placebo
Placebo Comparator
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Fatigue Impact Scale at 6 Weeks
时间窗: 6 weeks
change in fatigue impact scale there are 42 questions. Each question can be answered from 0 (no problem) to 4 (extreme problem), so a higher score indicates more severe fatigue impact. minimum score=0, maximum score =148 values are calculated at baseline and 6 months and the score at 6 months compared to baseline months is calculated
次要结局
未报告次要终点
研究者
Theodore Friedman
Professor
Charles Drew University of Medicine and Science
研究点 (1)
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