American Ginseng to Improve HIV-Associated Fatigue: A Randomized, Placebo-Controlled, Multiple-Dose Escalation Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Change in Fatigue Severity Score (FSS)
研究概览
简要总结
The purpose of this study is to determine whether American ginseng is effective in the treatment of HIV-associated fatigue.
详细描述
STUDY DESIGN Chronic fatigue is a major problem for HIV-infected patients and contributes to decreased quality of life and physical functioning, higher levels of psychological distress, and antiretroviral non-adherence. The etiology of fatigue in HIV-infected patients is unknown, but changes in systemic inflammation may play a contributing role. The mechanism of action of ginseng in the treatment of fatigue is also not clear, but in its role as a purported "adaptogen," it may decrease fatigue by altering systemic inflammation. Ginseng is one of the most popular botanical products in the US and is marketed to improve fatigue and vitality. Our preliminary data suggested that American ginseng at 1000-2000 mg/day may decrease fatigue in cancer patients. HIV-infected patients frequently use ginseng, in part because they perceive these therapies to be safer than more conventional therapies.
We hypothesized that a standardized American ginseng formulation will improved HIV-related fatigue. To test this hypothesis we propose a 6-week double-blind, placebo-controlled trial, parallel study of four weeks of treatment involving two doses of American ginseng or placebo (1000mg/day or 3000 mg/day) in 120 HIV-infected patients with clinically significant fatigue, as defined by their scores on the Fatigue Severity Scale. Patients will be treated with American ginseng or placebo every morning for a total of two doses of 1000 mg/day or 3000 mg/day. A smaller cohort of 12 out of 120 subjects will be enrolled initially to monitor closely for confirmed virologic failure, If confirmed virologic failure is not observed, enrollment will continue to the proposed 120 subjects. Virologic failure is defined as two consecutive plasma viral loads >200 cells according to the 2012 Department of Health Humans Services Guidelines for the use of antiretroviral agents in HIV-1 infected adults and adolescents
The proposed doses of American ginseng are the same as those used in our previous trials. American ginseng 1000 mg/day showed efficacy in ameliorating fatigue in cancer patients. The highest dose of American ginseng (3000 mg/day) selected for this study was derived from our previous American ginseng trial.
Change on scores of the Fatigue Severity Scale (FSS) between American ginseng and placebo groups at baseline, and treatment weeks 2, 4, and 6 (the last safety visit two weeks after completing the 4-week treatment period with American ginseng or placebo) will be calculated. The primary comparison of interest will involve the primary endpoint of the average change in the FSS scale score from baseline to the end of treatment. Other instruments to supplement the FSS and further assess fatigue will be a modified version of the Brief Fatigue Inventory (BFI), The Epworth Sleepiness Scale (ESS), the Patient Health Questionnaire (PHQ-9), Insomnia Severity Index (ISI), the Medical Outcomes Study HIV Health Survey (MOS-HIV), the Clinical Global Impressions (CGI) of Change Scale, and Patient-Reported Outcomes Measurement Information System (PROMIS) fatigue. To further elucidate the mechanism of HIV-related fatigue, we will evaluate the effects of American ginseng and placebo on markers of systemic inflammation such as IL-6 and soluble receptors of tumor necrosis factor (TNF) α 1 and 2 (sTNFR1 and sTNFR2), at baseline and weeks 2, 4, and 6. cluster of differentiation 4 (CD4) cell counts, plasma HIV RNA levels, and adverse events (AEs) will also be assessed for safety purposes.
DURATION:
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
- Quadruple (Participant, Care Provider, 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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
American ginseng 1000 mg/day
4-week of American ginseng 1000 mg/day every morning
干预措施: American ginseng (Drug)
Placebo for American ginseng 1000 mg/day
4-week of placebo for American ginseng 1000 mg/day every morning
干预措施: Placebo for American ginseng (Dietary Supplement)
American ginseng 3000 mg/day
4-week of American ginseng 3000 mg/day every morning
干预措施: American ginseng (Drug)
Placebo for American ginseng 3000 mg/day
4-week of placebo for American ginseng 3000 mg/day every morning
干预措施: Placebo for American ginseng (Dietary Supplement)
结局指标
主要结局
Change in Fatigue Severity Score (FSS)
时间窗: From baseline to week 4 (28 days of study drugs)
Change in FSS score from baseline to Week 4. The change in fatigue as measured by the FSS (Week 4 minus Baseline) using the Wilcoxon test. The FSS is a scale score ranging from 1 to 63 with higher scores indicative of more fatigue. A negative number indicates a decline in the FSS scale. Participants with FSS data at both times points were assessed.
次要结局
- Change in the Brief Fatigue Inventory(Change in BFI scores from baseline to week 4 (28 days of study drugs))
- Change in Epworth Sleepiness Scale(From baseline to week 4 (28 days of study drugs))
- Change in Medical Outcomes Study HIV Health Survey(From baseline to week 4 (28 days of study drugs))
- Inflammatory Markers(From baseline to week 4 (28 days of study drugs))
- Change in CD4 Cell Count(From baseline to week 5 (28 days of study drugs))
- Change in PROMIS Fatigue(From baseline to week 4 (28 days of study drugs).)
- Number of Participants With Adverse Events in the Ginseng and Placebo Arms(From baseline to week 4 (28 days of study drugs))
- Change in Insomnia Severity Index(From baseline to week 4 (28 days of study drugs))
- Change in Patient Health Questionnaire 9(From baseline to week 4 (28 days of study drugs))
- Changes in Clinical Global Impressions(From baseline to week 4 (28 days of study drugs))
- Change in Plasma HIV RNA(From baseline to week 4 (28 days of study drugs))