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临床试验/CTRI/2020/10/028474
CTRI/2020/10/028474已完成不适用

Quantifying placebo effect on psychomotor and cognitive functions in adult healthy human volunteers

Archana1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2020年2月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
54
试验地点
1
主要终点
To evaluate the effect of single dose placebo, on psychomotor function in healthy human volunteers when compared with no-treatment group

研究概览

简要总结

Placebo has been found to have beneficial effects in manypsychoneurological conditions like pain, depression, Parkinson’s disease andmany others. It can be conceptualized as healing power of mind. The effect hasbeen seen in clinical trial as well as clinical practice settings. Alternativetherapies with elaborate rituals and distinct environmental cues can havepronounced and clinically significant placebo effect. It is imperative to studythe placebo phenomenon from basic science, clinical trial and ethicalperspectives to better understand how placebo operate in clinical settings. Neurobiologically,they have been found to be due to release of endogenous opioids and dopamine.Dopamine has also been studied to be central to mechanism of attention andworking memory in human beings. It has been imperative that intactconsciousness, preserved mental faculties and moderate pathological dysfunctionare needed for demonstration of pathological effect. However, a negativeinteraction has been studied between drug and placebo and in some cases effectof active drug decreases with increasing placebo effect. This indicates thateffects of placebo and active intervention may not be simply additive, and weneed to quantify placebo effect which can be best done when compared tono-treatment. It would be unethical to recruit no-treatment group in diseasedconditions. It has been evidenced earlier that deceptive administration ofplacebo simulated clinical situations in that subjects were led to believe thatthey were receiving an active drug. In contrast, subjects in double-blindconditions were aware that they might receive a placebo. Double-blind anddeceptive administration of the placebo produced different results in studiesof mood, blood pressure and heart rate. However, placebo compared tono-treatment has not been studied. Moreover, response to reward mechanisms of placebo effect may bedifferent in healthy and diseased states. Thus, this study has been planned tostudy and measure the true effects of placebo in healthy human volunteers.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Open Label

入排标准

年龄范围
20.00 Year(s) 至 45.00 Year(s)(—)
性别
All

入选标准

  • •Healthy Participants of either gender with age 20-45 years Education qualification of at least graduation Participants free from any disease requiring treatment Participants willing to give informed consent.

排除标准

  • •Participants taken any medicine in the last 7 days History of clinical anxiety, depressive state or any other psychiatric illness History of visual or auditory impairment Pregnant and lactating women Inability to understand the given instructions Substance abuse disorders including excessive intake of alcohol, tobacco (more than 10 cigarettes / day), coffee, tea or drinks containing caffeine (equivalent to more than 4 cups per day).

结局指标

主要结局

To evaluate the effect of single dose placebo, on psychomotor function in healthy human volunteers when compared with no-treatment group

时间窗: Day 4,5,6

次要结局

  • 1.To evaluate the effect of single dose placebo, on memory of healthy human volunteers when compared with no-treatment group.(Day 4,5,6)
  • 2.To evaluate the effect of single dose placebo, on executive function of healthy human volunteers when compared with no-treatment group(Day 4,5,6)

研究者

发起方
Archana
申办方类型
Other [self]

研究点 (1)

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