Single Arm Clinical Trial of Small Molecule Natural Flavonoid Compounds for Intervention in Neurodegenerative Diseases

NCT ID: NCT05947409

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-15
• Study Completion Date: 2024-12-31

Brief 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.

Conditions

Neurodegenerative Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SMARTO ONE

Group Type: EXPERIMENTAL

SMARTO ONE

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age: 25-70 years

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 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

1. Patients with severe organ diseases such as heart, kidney, and liver failure, chronic lung diseases such as COPD, and severe diabetes;

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mei Han

OTHER

Sponsor Role: lead

Responsible Party

Mei Han

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Li Liu

Role: CONTACT

lily0496@126.com

16619733315

Other Identifiers

SMARTO ONE-202305-2

Identifier Type: -

Identifier Source: org_study_id