Randomized Control Trial of Small-Molecule Natural Flavonoids Intervention for Neurodegenerative Diseases
NCT ID: NCT05947396
Last Updated: 2023-08-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
10 participants
INTERVENTIONAL
2023-08-15
2024-12-31
Brief Summary
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2. Investigate the effects of natural plant flavonoids in positively intervening clinical symptoms of the study subjects.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SMARTO ONE
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.
placebo
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
2. 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
3. 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
4. Patients who can understand and communicate in language, and complete aphasia patients are not included;
5. Patients who agree to participate in this clinical observation and sign the informed consent form.
Exclusion Criteria
2. Patients with severe uncontrolled hypertension;
3. Patients who have taken antipsychotic drugs within the past two weeks;
4. Patients with the core features of Lewy body dementia or significant behavioral variant frontotemporal dementia;
5. Patients with various malignant tumors;
6. Patients with progressive stroke, transient ischemic attack, cerebral hemorrhage after cerebral infarction, and cerebral arteritis;
7. Patients with brain tumors, brain trauma, cerebral parasitic diseases, and other conditions;
8. Pregnant or lactating women;
9. Patients allergic to the known ingredients used in this trial;
10. Patients with active ulcers or bleeding tendencies;
11. Patients with neurodegenerative diseases such as Huntington's disease, amyotrophic lateral sclerosis, and Pick's disease;
12. Other patients who are deemed unsuitable to participate in this trial by the investigators.
25 Years
70 Years
ALL
No
Sponsors
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Mei Han
OTHER
Responsible Party
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Mei Han
Principal Investigator,
Central Contacts
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Other Identifiers
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SMARTO ONE-202305-1
Identifier Type: -
Identifier Source: org_study_id
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