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Randomized Control Trial of Small-Molecule Natural Flavonoids Intervention for Neurodegenerative Diseases

Primary Purpose

Neurodegenerative Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SMARTO ONE
placebo
Sponsored by
Mei Han
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurodegenerative Diseases

Eligibility Criteria

25 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    SMARTO ONE

    placebo

    Arm Description

    Outcomes

    Primary Outcome Measures

    Electroencephalogram (EEG)-Slow wave length
    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
    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)
    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)
    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)
    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.
    Hamilton Depression Scale(HAMD)
    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

    Secondary Outcome Measures

    Full Information

    First Posted
    June 21, 2023
    Last Updated
    August 8, 2023
    Sponsor
    Mei Han
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05947396
    Brief Title
    Randomized Control Trial of Small-Molecule Natural Flavonoids Intervention for Neurodegenerative Diseases
    Official Title
    Randomized Control Trial of Small-Molecule Natural Flavonoids Intervention for Neurodegenerative Diseases
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 15, 2023 (Anticipated)
    Primary Completion Date
    June 15, 2024 (Anticipated)
    Study Completion Date
    December 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Mei Han

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neurodegenerative Diseases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    SMARTO ONE
    Arm Type
    Experimental
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    SMARTO ONE
    Intervention Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    placebo
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Electroencephalogram (EEG)-Slow wave length
    Description
    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.
    Time Frame
    4 weeks
    Title
    Electroencephalogram (EEG)-Slow wave frequency
    Description
    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.
    Time Frame
    4 weeks
    Title
    Montreal Cognitive Assessment (MoCA)
    Description
    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.
    Time Frame
    4 weeks
    Title
    Pittsburgh Sleep Quality Index (PSQI)
    Description
    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.
    Time Frame
    4 weeks
    Title
    Hamilton Anxiety Rating Scale (HAMA)
    Description
    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.
    Time Frame
    4 weeks
    Title
    Hamilton Depression Scale(HAMD)
    Description
    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
    Time Frame
    4 weeks
    Other Pre-specified Outcome Measures:
    Title
    Numerry of participating with adverse events
    Description
    This is a safety outcome.
    Time Frame
    baseline, 4 weeks
    Title
    Adverse event occurrence rate
    Description
    This is a safety outcome.
    Time Frame
    baseline, 4 weeks
    Title
    Abnormality rate of routine blood tests
    Description
    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.
    Time Frame
    baseline, 4 weeks
    Title
    Liver function-Alanine aminotransferase#ALT#
    Description
    This is a safety outcome.
    Time Frame
    baseline, 4 weeks
    Title
    Liver function-Aspartate aminotransferase (AST)
    Description
    This is a safety outcome.
    Time Frame
    baseline, 4 weeks
    Title
    Liver function-Total Protein(TP)
    Description
    This is a safety outcome.
    Time Frame
    baseline, 4 weeks
    Title
    Electrocardiogram
    Description
    This is a safety outcome.This outcome measure primarily observes ST segment changes to evaluate the presence or improvement of myocardial ischemia.
    Time Frame
    baseline, 4 weeks
    Title
    Body temperature
    Description
    This is a safety outcome.
    Time Frame
    baseline, 4 weeks
    Title
    Heart rate
    Description
    This is a safety outcome.
    Time Frame
    baseline, 4 weeks
    Title
    Number of breaths in 1 min
    Description
    This is a safety outcome.
    Time Frame
    baseline, 4 weeks
    Title
    Blood pressure-Diastolic blood pressure(mmHg)
    Description
    This is a safety outcome.
    Time Frame
    baseline, 4 weeks
    Title
    Blood pressure-Systolic blood pressure(mmHg)
    Description
    This is a safety outcome.
    Time Frame
    baseline, 4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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. Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Li Liu
    Phone
    16619733315
    Email
    lily0496@126.com

    12. IPD Sharing Statement

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    Randomized Control Trial of Small-Molecule Natural Flavonoids Intervention for Neurodegenerative Diseases

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