Single Arm Clinical Trial of Small Molecule Natural Flavonoid Compounds for Intervention in Neurodegenerative Diseases
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Montreal Cognitive Assessment (MoCA)
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
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 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.
研究组 & 干预措施
SMARTO ONE
干预措施: SMARTO ONE (Drug)
结局指标
主要结局
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.
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.
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 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
次要结局
- Heart rate(baseline, 4 weeks)
- Number of breaths in 1 min(baseline, 4 weeks)
- Abnormality rate of routine blood tests(baseline, 4 weeks)
- Liver function-Total Protein(TP)(baseline, 4 weeks)
- Electrocardiogram(baseline, 4 weeks)
- Blood pressure-Systolic blood pressure(mmHg)(baseline, 4 weeks)
- Numerry of participating with adverse events(baseline, 4 weeks)
- Adverse event occurrence rate(baseline, 4 weeks)
- Body temperature(baseline, 4 weeks)
- Liver function-Alanine aminotransferase#ALT#(baseline, 4 weeks)
- Liver function-Aspartate aminotransferase (AST)(baseline, 4 weeks)
- Blood pressure-Diastolic blood pressure(mmHg)(baseline, 4 weeks)
研究者
Mei Han
Principal Investigator
Beijing University of Chinese Medicine