Efficacy of high dose Thiamine on cognitive function in patients with alcohol depedence syndrome
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
研究概览
简要总结
This prospective randomized control study investigates the efficacy of high-dose thiamine on cognitive function in patients with Alcohol Dependence Syndrome. Conducted at the Central Institute of Psychiatry, the protocol involves 60 patients (aged 18-50) with mild cognitive impairment, randomized into an experimental group (n=30) and a treatment-as-usual group (n=30)
The experimental group receives 1000mg of thiamine twice daily (IV) for five days, followed by 500mg orally twice daily for 23 days, whereas the control group receives standard lower doses (300mg IV thrice daily, then 100mg oral thrice daily). Key assessment tools include the Montreal Cognitive Assessment (MoCA), Wisconsin Card Sorting Test (WCST), and blood thiamine pyrophosphate (TPP) levels. Evaluations are conducted at baseline, two weeks, and four weeks to statistically analyze the correlation between thiamine levels and cognitive recovery
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients diagnosed with Alcohol Dependence Syndrome as per International Classification of Disease – 10th revision Patients with Severity of Alcohol Dependence Questionnaire (SADQ) greater than 16 Patients with Clinical Institute Withdrawal Assessment for Alcohol (revised version) (CIWA-Ar) less than or equal to 7 Patients will be screened for cognitive deficit with Montreal Cognitive Assessment Test (MoCA), with score between 18 to 25 Patients with Beck Depression Inventory score less than or equal to 9 Patient who is ready to give informed consent.
排除标准
- •Patients with history of significant head injury.
- •Patients having any other co-morbid substance dependence.
- •Patients with clinically diagnosed intellectual disability, autism spectrum disorder.
- •Patients having condition accompanied by impaired cognitive functioning or specific psychiatric conditions Patients with any medical or surgical illness that interferes with the absorption and metabolism of thiamine Patients on any drugs that interferes with the absorption and metabolism of thiamine Patients who have received any form of thiamine within the last 4 weeks.
研究者
Cyril Joy V Merina
Central Institute of Psychiatry, Ranchi, Kanke, Ranchi, Jharkhand