Randomized Control Trial of Small-Molecule Natural Flavonoids Intervention for Neurodegenerative Diseases
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 主要终点
- Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
- Explore the effects of natural plant flavonoids on the positive intervention mechanism of neurotransmitter transmission physiological indicators changes (EEG) in the brain of the study subjects;
- Investigate the effects of natural plant flavonoids in positively intervening clinical symptoms of the study subjects.
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
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 25-70 years
- •Patients complaining of sleep disorders, mood disorders (unstable mood, irritability, depression, and anxiety), and cognitive decline (people with memory, decreased reaction time, BPSD symptoms) within one month
- •Montreal Cognitive Assessment Scale (MOCA) score ≤26; if the MOCA score is not satisfied, then Pittsburgh Sleep Quality Index (PSQI) score >10 and Hamilton Anxiety Scale (HAMA) score >14 or Hamilton Depression Scale (HAMD) score ≥8 are required
- •Patients who can understand and communicate in language, and complete aphasia patients are not included;
- •Patients who agree to participate in this clinical observation and sign the informed consent form.
排除标准
- •Patients with severe organ diseases such as heart, kidney, and liver failure, chronic lung diseases such as COPD, and severe diabetes;
- •Patients with severe uncontrolled hypertension;
- •Patients who have taken antipsychotic drugs within the past two weeks;
- •Patients with the core features of Lewy body dementia or significant behavioral variant frontotemporal dementia;
- •Patients with various malignant tumors;
- •Patients with progressive stroke, transient ischemic attack, cerebral hemorrhage after cerebral infarction, and cerebral arteritis;
- •Patients with brain tumors, brain trauma, cerebral parasitic diseases, and other conditions;
- •Pregnant or lactating women;
- •Patients allergic to the known ingredients used in this trial;
- •Patients with active ulcers or bleeding tendencies;
- •Patients with neurodegenerative diseases such as Huntington's disease, amyotrophic lateral sclerosis, and Pick's disease;
- •Other patients who are deemed unsuitable to participate in this trial by the investigators.
结局指标
主要结局
Pittsburgh Sleep Quality Index (PSQI)
时间窗: 4 weeks
The evaluation criteria for this outcome measure are as follows: 0-5 points indicate very good sleep quality; 6-10 points indicate average sleep quality; 11-15 points indicate poor sleep quality; 16-21 points indicate very poor sleep quality.
Hamilton Anxiety Rating Scale (HAMA)
时间窗: 4 weeks
The evaluation criteria for this outcome measure are as follows: 0-6 points indicate no anxiety symptoms; 7-14 points indicate possible anxiety; 15-21 points indicate definite anxiety; 22-29 points indicate significant anxiety; and scores exceeding 29 points suggest severe anxiety.
Electroencephalogram (EEG)-Slow wave frequency
时间窗: 4 weeks
This outcome measure is designed to measure sleep by primarily analyzing slow waves in the resulting graphs. Slow waves are the quality standard of deep sleep, and patients with sleep disorders often fail to produce slow waves or have a shortened slow wave time. If the intervention is effective, the consumption will result in an increase in the duration of slow wave sleep.The frequency of slow waves per minute is obtained by measuring the number of slow waves in two hours divided by 120 minutes.
Hamilton Depression Scale(HAMD)
时间窗: 4 weeks
The evaluation criteria for this outcome measure are as follows:a score of less than 8 is normal, a score of 8-20 may indicate depression, a score of 21-35 may indicate depression, and a score of more than 35 may not indicate severe depression
Montreal Cognitive Assessment (MoCA)
时间窗: 4 weeks
This outcome measure assesses cognitive ability and memory, with evaluation based on a scoring system.The total score ranges from 0 to 30 points, with scores lower than 26 indicating the presence of cognitive impairment. The lower the score, the more severe the disease.
Electroencephalogram (EEG)-Slow wave length
时间窗: 4 weeks
This outcome measure is designed to measure sleep by primarily analyzing slow waves in the resulting graphs. Slow waves are the quality standard of deep sleep, and patients with sleep disorders often fail to produce slow waves or have a shortened slow wave time. If the intervention is effective, the consumption will result in an increase in the duration of slow wave sleep.The length of the slow wave per minute is obtained by measuring the length of the slow wave for two consecutive hours and dividing by the total duration of 120 minutes.
次要结局
未报告次要终点
研究者
Mei Han
Principal Investigator,
Beijing University of Chinese Medicine