Randomized Control Trial of Small-Molecule Natural Flavonoids Intervention for Neurodegenerative Diseases
Study Details
Study Description
Brief Summary
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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;
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Investigate the effects of natural plant flavonoids in positively intervening clinical symptoms of the study subjects.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SMARTO ONE
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Dietary Supplement: SMARTO ONE
The SMARTO ONE® small molecule natural flavonoid compound product is provided by Beijing Jiafurui Biological Technology Co., Ltd. The intervention agent formula consists of extracts from Polygonum cuspidatum leaves, Fructus ligustri lucidi, Prunus mume, Semen ziziphi spinosae, celery, resistant maltodextrin, and steviol glycoside. Each package of the test product (3g) contains a total flavonoid content of 150mg.
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| Placebo Comparator: placebo
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Other: placebo
The placebo is provided by Beijing Jiafurui Biological Technology Co., Ltd. The formula consists of maltodextrin, grapefruit powder, and food coloring. The manufacturing facility has adjusted the appearance, color, solubility, and taste of the placebo to match the intervention agent. There is no risk of unblinding.
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Outcome Measures
Primary Outcome Measures
- Electroencephalogram (EEG)-Slow wave length [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.
- Electroencephalogram (EEG)-Slow wave frequency [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.
- Montreal Cognitive Assessment (MoCA) [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.
- Pittsburgh Sleep Quality Index (PSQI) [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) [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.
Other Outcome Measures
- Numerry of participating with adverse events [baseline, 4 weeks]
This is a safety outcome.
- Adverse event occurrence rate [baseline, 4 weeks]
This is a safety outcome.
- Abnormality rate of routine blood tests [baseline, 4 weeks]
This is a safety outcome. Included in the outcome indicators are red blood cell count (WBC), haemoglobin concentration (Hb), white blood cell count (WBC), neutrophil count (Neut), lymphocyte count (Lymph), monocyte count (Mono), eosinophil count (Eos), basophil count (Baso) and platelet count (PLT). The abnormal blood count rate was obtained by dividing the number of people with abnormal blood counts by the total number of people with abnormal blood counts.
- Liver function-Alanine aminotransferase#ALT# [baseline, 4 weeks]
This is a safety outcome.
- Liver function-Aspartate aminotransferase (AST) [baseline, 4 weeks]
This is a safety outcome.
- Liver function-Total Protein(TP) [baseline, 4 weeks]
This is a safety outcome.
- Electrocardiogram [baseline, 4 weeks]
This is a safety outcome.This outcome measure primarily observes ST segment changes to evaluate the presence or improvement of myocardial ischemia.
- Body temperature [baseline, 4 weeks]
This is a safety outcome.
- Heart rate [baseline, 4 weeks]
This is a safety outcome.
- Number of breaths in 1 min [baseline, 4 weeks]
This is a safety outcome.
- Blood pressure-Diastolic blood pressure(mmHg) [baseline, 4 weeks]
This is a safety outcome.
- Blood pressure-Systolic blood pressure(mmHg) [baseline, 4 weeks]
This is a safety outcome.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age: 25-70 years;
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Patients who complain of sleep disorders, emotional disorders (unstable emotions, irritability, depression, anxiety), and decreased cognitive abilities (memory, reaction, and behavioral and psychological symptoms of dementia) within one month, and who have a score of >10 on the Pittsburgh Sleep Quality Index (PSQI);
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Patients who can understand and communicate in language, and complete aphasia patients are not included;
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Patients who agree to participate in this clinical observation and sign the informed consent form.
Exclusion Criteria:
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Patients with severe organ diseases such as heart, kidney, and liver failure, chronic lung diseases such as COPD, and severe diabetes;
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Patients with severe uncontrolled hypertension;
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Patients who have taken antipsychotic drugs within the past two weeks;
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Patients with the core features of Lewy body dementia or significant behavioral variant frontotemporal dementia;
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Patients with various malignant tumors;
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Patients with progressive stroke, transient ischemic attack, cerebral hemorrhage after cerebral infarction, and cerebral arteritis;
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Patients with brain tumors, brain trauma, cerebral parasitic diseases, and other conditions;
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Pregnant or lactating women;
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Patients allergic to the known ingredients used in this trial;
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Patients with active ulcers or bleeding tendencies;
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Patients with neurodegenerative diseases such as Huntington's disease, amyotrophic lateral sclerosis, and Pick's disease;
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Other patients who are deemed unsuitable to participate in this trial by the investigators.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Mei Han
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SMARTO ONE-202305-1