NCT00065715已完成3 期
Placebo: Physician or Pill? A Randomized Trial in a Common Cold Model Funded by NIH NCCAM Under RFA "The Placebo Effect in Clinical Practice"
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 719
- 试验地点
- 1
- 主要终点
- Duration and severity of illness, as assessed by the Wisconsin Upper Respiratory Symptom Survey (WURSS-21)
研究概览
简要总结
The design and interpretation of randomized trials is intimately connected to the use of "placebo". The nature and magnitude of placebo effects, however, is very poorly understood. This study will assess and compare placebo effects and physician interaction effects within a community-acquired common cold model. The goal of this study is to assess two kinds of placebo affects and how physician interaction effects;
- The effect of receiving blinded placebo, compared to no treatment; and
- The effect of receiving open-label active Echinacea treatment compared to blinded active treatment.
详细描述
As per Brief Summary
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected or known cold
- •At least one of the following cold symptoms:
- •nasal discharge, nasal congestion, sneezing, or sore throat
- •Enrolled in school, for children 12 to 17 years of age
排除标准
- •Pregnancy;
- •Symptom duration > 36 hrs
- •Concurrent use of antibiotics, antivirals, nasal steroids, decongestants or antihistamines;
- •Anticipated need for symptom-relieving meds during cold
- •Autoimmune/deficiency disease
- •History of allergic rhinitis with current eye itching/sneezing
- •History of asthma w/current cough/SOB
- •Prior study entry
- •Allergy to Echinacea
研究组 & 干预措施
A
No Intervention
No pills
B
Placebo Comparator
Blinded placebo
干预措施: Blinded placebo (Other)
D
Experimental
Echinacea - Unblinded, Open Label
干预措施: Echinacea (Dietary Supplement)
C
Experimental
Echinacea - Blinded
干预措施: Echinacea (Dietary Supplement)
结局指标
主要结局
Duration and severity of illness, as assessed by the Wisconsin Upper Respiratory Symptom Survey (WURSS-21)
时间窗: twice daily during illness
次要结局
- patient satisfaction CARE(after doctor patient interaction)
- SF-8 general health-related quality of life(daily during illness)
- perceived stress PSS-4(daily during illness)
- optimism LOT(two days after enrollment)
- feeling thermometer - EuroQol VAS(daily during illness)
- IL-8 (inflammatory cytokine)from nasal wash(2 days after enrollment)
- neutrophil count from nasal wash(two days after enrollment)
研究者
研究点 (1)
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