NCT03780595Unknown4 期
Efficacy and Safety of the Administration of the Passiflora Extract for Benzodiazepine Withdrawal in Institutionalized Older Adults: Clinical Trial Phase III
Nutricion Medica S.L.8 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2018年9月27日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 108
- 试验地点
- 8
- 主要终点
- To compare the percentage of patients who achieve to reduce the dose of benzodiazepines equal or more than 50% Reduction of the benzodiazepine dose
研究概览
简要总结
The aim of this clinical trials is compare the percentage of patient who achieve a reduction equal to or greater than 50% in the dose of benzodiazepines at 10 weeks of treatment.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 65 years old
- •Stable dose of benzodiazepines during last 3 months ( 4mg loracepam per day or equivalent)
- •Capable of giving consent and to answer the questionnaires according to researcher criteria
排除标准
- •Diagnosis of dementia moderate or severe (Test Minimental ≤ 20).
- •Acute confusional syndrome at the inclusion
- •Panic disorder
- •Obsesive-compulsive disorder
- •Any type of psycosis or bipolar disorder
- •Severe Parkison disease diagnosed
- •Current or past diagnosis of epilepsia
- •Recent stroke (last month)
- •Thyroid disorders not controlled or uncompensated
- •Alteration of deglutition
- •Previous drugs or alcohol abuse
- •Hospitalization (more than 24 hours) during the last month
- •Complex priority treatment (dialisis, chemotherapy...)
- •Life expectation less than 1 year
- •Benzodiazepines therapeutic uses not for anxiety or insomnio
研究组 & 干预措施
Passiflora
Experimental
干预措施: Passiflora incarnata (Drug)
Control
Placebo Comparator
干预措施: Control (Drug)
结局指标
主要结局
To compare the percentage of patients who achieve to reduce the dose of benzodiazepines equal or more than 50% Reduction of the benzodiazepine dose
时间窗: 10 weeks of treatment
次要结局
未报告次要终点
研究者
研究点 (8)
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