A Prospective, Multi-Center, Randomized, Double-Blind, Parallel, Placebo- Controlled Study to Evaluate Efficacy and Safety of Berberis aristata on Memory and Cognitive Performance in Adult Human Subjects with Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Mean change in memory functions as assessed by Working memory - Monkey Ladder task, Episodic memory - Paired Associates task, Short-term spatial memory - Spatial Span task and Short-term verbal memory - Digit Span task of Cambridge Brain Sciences from Baseline to Visit 5, End of Study Visit (Day 84 + 3 days)
研究概览
简要总结
Berberine is a natural product with a definite structure and a wide range of pharmacological effects. Berberine displays many biological functions and potential therapeutic applications in neurological diseases. Animal research is an essential early step toward evaluating and developing an intervention for clinical trials in humans. The neuroprotective activity of Berberis aristata DC. against 6-hydroxydopamine (6-OHDA) Parkinson’s disease in a rat model was evaluated. The methanol extract of Berberis aristata DC. showed potent neuroprotective activity against 6-OHDA-induced Parkinson’s disease in a rat model. It would be interesting to see if herbal supplementation could help various cognitive parameters in adults with cognitive impairment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adult male/female human participants of ≥ 18 and ≤55 years of age.
- •2.Participants with BMI ≥ 18.5 kg/m2 and ≤ 29.9 kg/m
- •3.Participants with Mini-Mental State Examination (MMSE) score 19 to 26 indicating mild cognitive impairment.
- •4.Participants who agree to maintain their usual dietary habits throughout the trial period.
- •5.Participants who agree to maintain their usual level of activity, i.e., maintain their usual lifestyle throughout the trial period.
排除标准
- •1.Participants Ë‚ 18 or ˃ 55 years of age.
- •2.Participants having hypersensitivity or history of allergy to the study product or any of its ingredients.
- •3.Participants suffering from moderate to severe fatigue or having chronic fatigue syndrome.
- •4.Participants suffering from malignant disease or any concomitant end-state organ disease and/or laboratory abnormalities considered by investigators to be risky or that could interfere with data collection.
- •5.Participants suffering from a metabolic disorder (uncontrolled diabetes, uncontrolled thyroidal condition) and/or from severe chronic disease (cancer, renal failure, HIV, immunodeficiency, hepatic or biliary disorders, arthritis, uncontrolled cardiac disease) or from a disease found to be inconsistent with the conduct of the study by the investigator.
结局指标
主要结局
Mean change in memory functions as assessed by Working memory - Monkey Ladder task, Episodic memory - Paired Associates task, Short-term spatial memory - Spatial Span task and Short-term verbal memory - Digit Span task of Cambridge Brain Sciences from Baseline to Visit 5, End of Study Visit (Day 84 + 3 days)
时间窗: 12 weeks
次要结局
- 1.Mean change in planning as assessed by Spatial Planning task of Cambridge Brain Sciences from Baseline to Visit 5, End of Study Visit (Day 84 plus 3 days)(2.Mean change in reasoning and decision making as assessed by Odd One Out task of Cambridge Brain Sciences from Baseline to Visit 5, End of Study Visit (Day 84 plus 3 days))