Neurodegenerative DiseasesNCT05947409
Single Arm Clinical Trial of Small Molecule Natural Flavonoid Compounds for Intervention in Neurodegenerative Diseases
A study testing SMARTO ONE in people with Neurodegenerative Diseases, run by Mei Han.
Trial summary
1. 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; 2. Investigate the effects of natural plant flavonoids in positively intervening clinical symptoms of the study subjects. Read more about this study
- Who is it for?
- Ages 25 to 70 years
- Conditions the study is for
- Neurodegenerative Diseases
- What is being tested?
- SMARTO ONE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
- 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.
- Conditions
- Neurodegenerative Diseases
- Being tested
- SMARTO ONE
- Medical subject headings
- Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMARTO ONEDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| SMARTO ONE | Experimental | Not described Receives: Drug: SMARTO ONE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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.
Measured: 4 weeks
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
Measured: 4 weeks
Secondary outcomes (12)
Numerry of participating with adverse events
This is a safety outcome.
Measured: baseline, 4 weeks
Adverse event occurrence rate
This is a safety outcome.
Measured: baseline, 4 weeks
Abnormality rate of routine blood tests
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.
Measured: baseline, 4 weeks
Liver function-Alanine aminotransferase#ALT#
This is a safety outcome.
Measured: baseline, 4 weeks
Liver function-Aspartate aminotransferase (AST)
This is a safety outcome.
Measured: baseline, 4 weeks
Liver function-Total Protein(TP)
This is a safety outcome.
Measured: baseline, 4 weeks
Electrocardiogram
This is a safety outcome.This outcome measure primarily observes ST segment changes to evaluate the presence or improvement of myocardial ischemia.
Measured: baseline, 4 weeks
Body temperature
This is a safety outcome.
Measured: baseline, 4 weeks
Heart rate
This is a safety outcome.
Measured: baseline, 4 weeks
Number of breaths in 1 min
This is a safety outcome.
Measured: baseline, 4 weeks
Blood pressure-Diastolic blood pressure(mmHg)
This is a safety outcome.
Measured: baseline, 4 weeks
Blood pressure-Systolic blood pressure(mmHg)
This is a safety outcome.
Measured: baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2023
- Study start15 Aug 2023 (estimated)
- Primary completion15 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodegenerative DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mei Han
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mei Han, Beijing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05947409
- Sponsor's protocol ID
- SMARTO ONE-202305-2
- Status last verified
- Aug 2023
- First submitted
- 21 Jun 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Arm Clinical Trial of Small Molecule Natural Flavonoid Compounds for Intervention in Neurodegenerative Diseases
- ClinicalTrials.gov ID
- NCT05947409
- Acronym / sponsor ID
- SMARTO ONE-202305-2
- Conditions
- Neurodegenerative Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mei HanUniversity, hospital or other
- Study start
- 15 Aug 2023 (estimated)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 17 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SMARTO ONE | Experimental | Drug: SMARTO ONE |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SMARTO ONEThe 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. | Drug | SMARTO ONE |
Primary outcome
Montreal Cognitive Assessment (MoCA)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Hamilton Depression Scale(HAMD)
Time frame: 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
12 secondary outcomes
Numerry of participating with adverse events
Time frame: baseline, 4 weeks
Adverse event occurrence rate
Time frame: baseline, 4 weeks
Abnormality rate of routine blood tests
Time frame: baseline, 4 weeks
Liver function-Alanine aminotransferase#ALT#
Time frame: baseline, 4 weeks
Liver function-Aspartate aminotransferase (AST)
Time frame: baseline, 4 weeks
Liver function-Total Protein(TP)
Time frame: baseline, 4 weeks
Electrocardiogram
Time frame: baseline, 4 weeks
Body temperature
Time frame: baseline, 4 weeks
Heart rate
Time frame: baseline, 4 weeks
Number of breaths in 1 min
Time frame: baseline, 4 weeks
Blood pressure-Diastolic blood pressure(mmHg)
Time frame: baseline, 4 weeks
Blood pressure-Systolic blood pressure(mmHg)
Time frame: baseline, 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing SMARTO ONE in people with Neurodegenerative Diseases, run by Mei Han.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Li Liu (16619733315, lily0496@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (MoCA) (time frame: 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023.